bmj open diabetes research & care author guidelines

An official website of the United States government

The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

• Publications
• Account settings

Preview improvements coming to the PMC website in October 2024. Learn More or Try it out now .

• Advanced Search
• Journal List
• BMJ Open Diabetes Res Care
• v.1(1); 2013

BMJ Open Diabetes Research & Care

Joyce-rachel john.

1 North American Publisher and Journal Business Director, BMJ

Trish Groves

2 Editor-in-Chief, BMJ Open

We are pleased to announce the launch of BMJ Open Diabetes Research & Care — a new online-only, open access research journal published by BMJ in partnership with the American Diabetes Association.

As a pioneer in the open access movement, BMJ understands the need to communicate medical advances to the widest possible audience, and is proud to usher this important new journal into the literature. An estimated 26 million Americans live with type 2 diabetes, many with associated complications such as cardiovascular disease and obesity. The increasing worldwide burden of diabetes has prompted a rapid burgeoning of diabetes research and the launch and approval of new drug classes to manage type 2 diabetes. BMJ's mission is to advance healthcare by sharing knowledge, and we believe that new epidemiology and evaluations of new treatment approaches are best disseminated internationally and rapidly.

BMJ will ensure that BMJ Open Diabetes Research & Care satisfies the open access mandates of governments, institutions and funding bodies, such as the National Institutes of Health and Wellcome Trust. Authors will retain copyright and publish under a Creative Commons license, and the full text of papers will be fully accessible online at BMJ Open Diabetes Research & Care and through PubMed Central.

BMJ Open Diabetes Research & Care will be a high-quality, indexed journal that will only accept original research and rapidly publish articles after peer review. The journal will consider research that covers all aspects of type 1 and type 2 diabetes mellitus, including basic science and clinical research.

We are delighted and honoured to partner with the American Diabetes Association on this journal. The association is a leader in the fight to stop diabetes and in funding research. The strength of our partnership will ensure that the published research is respected, valued and will positively influence healthcare outcomes. BMJ looks forward to working with the diabetes research community to develop a stronger understanding of this disease.

Making an impact on kidney disease in people with type 2 diabetes: the importance of screening for albuminuria

Affiliations.

• 1 Division of Endocrinology, Metabolism and Lipid Research, Washington University School of Medicine, Saint Louis, Missouri, USA [email protected].
• 2 Department of Nephrology, Hannover Medical School, Hannover, Germany.
• 3 Division of Nephrology and Hypertension, Department of Medicine, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, North Carolina, USA.
• 4 Department of Medicine, WG Hefner VA Medical Center, Salisbury, North Carolina, USA.
• 5 Division of Preventive Medicine, Department of Medicine, The University of Alabama at Birmingham, Birmingham, Alabama, USA.
• 6 Department of Nephrology and Laboratory Medicine, Kanazawa University, Kanazawa, Ishikawa, Japan.
• 7 Division of Nephrology and Hypertension, University Hospital of Würzburg, Würzburg, Germany.
• 8 Department of Endocrinology and Metabolism, Peking University People's Hospital, Beijing, China.
• 9 Steno Diabetes Center Copenhagen, Herlev, Denmark.
• 10 Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
• PMID: 35790319
• PMCID: PMC9258490
• DOI: 10.1136/bmjdrc-2022-002806

Albuminuria is useful for early screening and diagnosis of kidney impairment, especially in people with pre-diabetes or type 2 diabetes (T2D), which is the leading cause of chronic kidney disease (CKD) and end-stage kidney disease (ESKD), associated with increased mortality, poor cardiovascular outcomes, and high economic burden. Identifying patients with CKD who are most likely to progress to ESKD permits timely implementation of appropriate interventions. The early stages of CKD are asymptomatic, which means identification of CKD relies on routine assessment of kidney damage and function. Both albuminuria and estimated glomerular filtration rate are measures of kidney function. This review discusses albuminuria as a marker of kidney damage and cardiorenal risk, highlights the importance of early screening and routine testing for albuminuria in people with T2D, and provides new insights on the optimum management of CKD in T2D using albuminuria as a target in a proposed algorithm. Elevated urine albumin can be used to detect CKD in people with T2D and monitor its progression; however, obstacles preventing early detection exist, including lack of awareness of CKD in the general population, poor adherence to clinical guidelines, and country-level variations in screening and treatment incentives. With albuminuria being used as an entry criterion and a surrogate endpoint for kidney failure in clinical trials, and with novel treatment interventions available to prevent CKD progression, there is an urgent need for early screening and diagnosis of kidney function decline in people with T2D or pre-diabetes.

Keywords: diabetes mellitus, type 2; diabetic neuropathies.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Publication types

• Research Support, Non-U.S. Gov't
• Albuminuria / complications
• Albuminuria / diagnosis
• Albuminuria / epidemiology
• Diabetes Mellitus, Type 2* / complications
• Diabetes Mellitus, Type 2* / epidemiology
• Glomerular Filtration Rate
• Kidney Failure, Chronic* / complications
• Prediabetic State* / complications
• Renal Insufficiency, Chronic* / complications
• Renal Insufficiency, Chronic* / diagnosis
• Renal Insufficiency, Chronic* / epidemiology

Grants and funding

• R01 DK132328/DK/NIDDK NIH HHS/United States

Instructions for Authors

Last Update February 1, 2024

• About the Journal
• Data Access and Responsibility

Data Resource Sharing and Availability

• Prepublication and Accessibility of Accepted Articles
• Policies and Procedures

Manuscript Submission Form

Statement of originality and authorship, copyright assignment, reuse and post-prints, duality of interest, author contributions, clinical trials, reporting on human islets.

• Manuscript Submission
• Accepted Manuscripts
• Financial Obligations
• Contact Information
• Manuscript Format

Original Articles

Brief reports, review articles, commentaries, online letters to the editor, perspectives in diabetes.

• Supplemental Material
• Manuscript Style

Terminology and Style

Abbreviations, about the journal.

The editor-in-chief of Diabetes is David A. D’Alessio, MD. Dr. De'Alessio and his editorial team began their term with the January 2022 issue and began reviewing first submissions on July 1, 2021. Learn more about the editorial team at About the Editors .

Diabetes publishes original research about the physiology and pathophysiology of diabetes. Submitted manuscripts can report any aspect of laboratory, animal, or human research. Emphasis is on investigative reports focusing on areas such as the pathogenesis of diabetes and its complications, normal and pathological pancreatic islet function and intermediary metabolism, pharmacological mechanisms of drug and hormone action, and biochemical and molecular aspects of normal and abnormal biological processes. Studies in the areas of diabetes education or the application of accepted therapeutic and diagnostic approaches to patients with diabetes are not published.

Only material that has not been published previously (either in print or electronically) and is not under consideration for publication elsewhere, with the exception of an abstract that is less than 400 words in length, will be considered for publication. Prior presentation of data (e.g., at a scientific meeting or via webcast) does not preclude publication in Diabetes , but should be disclosed in the Acknowledgments of the paper and in the author's comments to the editor upon manuscript submission. All submissions to the journal will be scanned for possible duplicate or prior publication using the CrossCheck/iThenticate plagiarism detection system ( www.ithenticate.com/ ). Any article that eclipses a certain similarity threshold with another article will be closely reviewed by ADA. Authors who submit previously published work to the journal will be banned from submitting future manuscripts to the journal, and their funding body and/or institution will be notified.

All contributions, including solicited Perspectives on Diabetes, are critically reviewed by the editors and, if felt to be appropriate for the journal and potentially competitive, invited referees. Reviewers' comments, when available, are provided to authors. The exception are commentaries, all of which are by invitation only and reviewed only by the invited editor. The decision of the editors is final. Authors are welcome to suggest the names of individuals they consider qualified to serve as reviewers.

All human investigation must be conducted according to the principles expressed in the Declaration of Helsinki. All studies involving animals must state that guidelines for the use and care of laboratory animals of the authors' institution or the National Research Council or any national law were followed.

ADA journals require the reporting of sex for cells, tissues, and experimental animals and humans (i.e., male and female) where appropriate and suitable for the experimental design of the research effort; studies should report whether sex was considered a factor in the statistical analysis of the data.

Data Access and Responsibility

Access.  Very large datasets may be submitted as supplemental material and cited in the text with a URL to the material, hosted on an author-affiliated website or data repository, or may appear with a note that the data is available upon request to the author. Additional details regarding Resource Sharing and Availablity  appear below.

Guarantors.  For all reports (regardless of funding source) containing original data, at least one named author (e.g., the principal investigator) who is independent of any commercial funder or sponsor must indicate that he or she is the " guarantor " of the study (i.e., he or she had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis). A statement identifying the guarantor should be included in the Acknowledgments section at the end of the manuscript. Modified statements or generic statements indicating that all authors had such access are not acceptable.

The statement should appear as follows: C.K. is the guarantor of this work and, as such, had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

For  industry-sponsored studies,  the editors reserve the right to request an analysis of the data (based on the entire raw dataset and evaluation of the study protocol, and prespecified plan for data analysis) by an independent statistician at an academic institution, rather than by statisticians employed by the sponsor or by a commercial contract research organization. In such cases, the independent biostatistician must be a faculty member at a medical school or academic medical center, or an employee of a government research institute, that has oversight over the person conducting the analysis and that is independent of the commercial sponsor. Details of this independent statistical analysis, the name and institutional affiliation of the independent statistician, and whether compensation or funding was received for conducting the analyses should be reported in the Acknowledgments section of the manuscript. The results of this independent statistical analysis should be the results reported in the manuscript.

  The American Diabetes Association supports the efforts of researchers, funders, and agencies to make underlying research data and resources more accessible, more transparent, and easier to share. As part of this effort, as of January 1, 2019, Diabetes  requires authors of original research studies to describe in their papers how readers can access the data and critical resources supporting their reported findings, methods, and conclusions.

Diabetes has adapted and extended to resource sharing the following guidelines from Nature Research’s Policy ( go.nature.com/2bf4vqn ):

All original research papers submitted to and published in Diabetes must provide statements about the availability of data and critical resources supporting the results reported in the article. The data and resource availability statements should be placed at the end of the “Research Design and Methods” section, under the subheading “Data and Resource Availability.”  The section should contain separate statements on 1 ) data sharing and 2 ) resource sharing. Please access the complete policy at diabetesjournals.org/journals/pages/data-resource-sharing-availability  for more specific information and guidance related to these policies.

Prepublication and Accessibility of Accepted Articles

  To make research readily available to subscribers, Diabetes publishes accepted articles online ahead of print weeks before the print/online issue becomes available. These articles have been copyedited, proofread, and typeset but not yet author-approved or finalized and will appear in a future issue of Diabetes in print and online.

Online Ahead of Print articles are citable by unique DOI (digital object identifier). DOIs for Diabetes articles begin with 10.2337, followed by the article number assigned when the manuscript was submitted online via the manuscript submission system. (e.g., 10.2337/db11-1234)

Example: Kohler C, Norton H, Farber K, Briggs E: How to cite a prepublished article in ADA journals. Diabetes 10.2337/db11-1234

As a courtesy to authors, the final print versions of articles funded by the National Institutes of Health (NIH) are deposited in PubMed Central (PMC) at no additional cost. In compliance with NIH’s policy, these articles will appear on PMC 12 months after print publication in Diabetes . All articles, regardless of funding body, are delivered to PubMed for inclusion in the PubMed index. 

Full-text HTML versions of all articles are freely accessible on Diabetes online (diabetes.diabetesjournals.org) 6 months after the print publication date, and PDF content becomes freely accessible 12 months after the print publication date.

POLICIES AND PROCEDURES

ADA's Publications Policy Committee follows the recommendations of the International Committee of Medical Journal Editors (ICMJE), the World Association of Medical Editors (WAME), and the Committee on Publication Ethics (COPE) for guidance on policies and procedures related to publication ethics. The policies for Diabetes have been adopted from those three advisory bodies and, where necessary, modified and tailored to meet the specific content, audiences, and aims of Diabetes . Comprehensive information related to the editorial and ethical policies of Diabetes can be found in Publication Policies and Procedures for ADA Journals .   The Association's Publications Policy Committee or Panel on Ethical Scientific Programs will consider on a case-by-case basis policies that are not addressed in the policies document, which contains information related to the following topics:

• Study Design
• Originality and Prior Publication
• Authorship and Contributions
• Acknowledgments
• Conflict of Interest
• Clinical Trials, Systematic Reviews, and Meta-Analyses
• Digital Image Manipulation
• Responses to Possible Scientific Misconduct
• Peer Review
• Editorial Decisions
• Prepublication of Accepted Articles
• Reuse, Post-Prints, and Public Access
• Media Embargos
• Advertising
• Supplements

Frequently referenced segments of the document appear below.

A manuscript submission form must be completed for each article submitted. The form addresses ADA's policies on 1 ) originality and authorship, 2 ) copyright assignment, and 3 ) potential conflict of interest. The corresponding author should read the three sections, check the appropriate boxes, sign the document where indicated, and upload the completed form to the manuscript submission system upon article submission. ADA will accept ICMJE's Uniform Disclosure Form for Potential Conflicts of Interest .

Submissions will not be considered complete until the manusript submission form has been uploaded/received.

Diabetes subscribes to the requirements stated in the Uniform Requirements for Manuscripts Submitted to Biomedical Journals that authorship implies substantial contributions to conception and design or analysis and interpretation of data and drafting of the article or critical revision for important intellectual content. The editor reserves the right to query authorship contribution.

Any requested changes to authorship (addition or removal of an author) after the initial submission of a manuscript should be made in writing to the  Editorial Office . The new author list must be provided, along with a justification for the change. The author(s) being added or removed should send separate correspondence consenting to the change.

ADA has adopted and modified JAMA’s instructions for authors on the role of artificial intelligence and machine learning in creating content or assisting with writing or manuscript preparation . First, nonhuman artificial intelligence, language models, machine learning, or similar technologies do not qualify for authorship.

Second, if these models or tools are used to create content or assist with writing or manuscript preparation, authors must take responsibility for the integrity of the content generated by these tools.

Third, authors should report the use of artificial intelligence, language models, machine learning, or similar technologies to create content or assist with writing or editing of manuscripts in the Acknowledgments section or the Methods section if this is part of formal research design or methods, as well as in the comments to the editors at the time of submission.

This should include a description of the content that was created or edited and the name of the language model or tool, version and extension numbers, manufacturer, and (where relevant) the query or prompt to create or assist with the development of content. (Note: this does not include basic tools for checking grammar, spelling, references, etc.)

The American Diabetes Association (ADA) holds the copyright on all material appearing in Diabetes . All authors must check the appropriate boxes and sign the manuscript submission form, which transfers copyright to the ADA in accordance with the Copyright Revision Act of 1976.

ADA's manuscript submission form addresses permission policies related to reuse and post-prints . Please see below for the statement of provenance and other conditions:

Reuse. Authors are permitted to reuse portions of their ADA-copyrighted work, including tables and figures, in their own work, and to reuse portions or all of their ADA-copyrighted work for educational purposes, without submitting a request to ADA, provided that the proper citation and copyright information is given.

Post-prints. Authors are permitted to submit the final, accepted version of their manuscript to their funding body or institution for inclusion in their funding body or institution's database, archive, or repository, or to post the final, accepted version on their personal website. These manuscripts may be made freely accessible to the public upon acceptance, provided that the following two conditions are observed:

First, post-prints must include the following statement of provenance and, once the final version has been published in the journal, a link to the final published version of the paper on the journal's website:

This is an author-created, uncopyedited electronic version of an article accepted for publication in Diabetes . The American Diabetes Association (ADA), publisher of Diabetes , is not responsible for any errors or omissions in this version of the manuscript or any version derived from it by third parties. The definitive publisher-authenticated version will be available in a future issue of Diabetes in print and online at http://diabetes.diabetesjournals.org.

Second, the version of the manuscript deposited or posted must be identical to the final accepted version, with the exception of the addition of the above statement and any changes necessary to correct errors. Authors may make changes to the posted version to correct mistakes or may issue an erratum at any time. However, the final published version of the manuscript may not be deposited, posted, or later substituted for the post-print.

All authors must read the ADA Policy Statement on Duality of Interest and check the appropriate box on the manuscript submission form, which can be found online and in every issue of Diabetes . Any author who has duality of interest to disclose must attach an additional statement that explains the nature of the duality or conflict of interest. Relevant duality or conflict of interest (or lack thereof) should also be disclosed in the authors' comments to the editor during the submission process.

Authors are required to include a paragraph in the Acknowledgments section listing each author's contribution. Example: "C.K. researched data. L.R. wrote the manuscript and researched data. H.N. reviewed/edited the manuscript. V.S. contributed to discussion and reviewed/edited manuscript. N.B. researched data and contributed to discussion. V.G. wrote the manuscript."

In addition, when authors cite the "editorial assistance" of a colleague, or help provided by a colleague "with preparing the manuscript," authors are required to list the employer/institution with which that colleague is affiliated. Example: "The authors acknowledge the editorial assistance of Mark Smith, Global Informatics, Inc., etc."; "The authors thank Mark Smith, Global Informatics, Inc,. for help with preparing the manuscript."  

All clinical trials submitted to Diabetes  for consideration of publication must be registered. The International Committee of Medical Journal Editors (ICMJE) defines a clinical trial as "any research project that prospectively assigns human subjects to intervention or comparison groups to study the cause-and-effect relationship between a medical intervention and a health outcome. Studies designed for other purposes, such as to study pharmacokinetics or major toxicity (e.g., phase 1 trials), are exempt."

For definitions and further information, please see the section titled Obligation to Register Clinical Trials found in ICMJE's Uniform Requirements for Manuscripts Submitted to Biomedical Journals. Please note, however, that unlike ICMJE, ADA does not require trials to be registered before enrollment begins, although Diabetes does encourage this practice. When submitting your manuscript, please include the unique trial number and the name of the registry (e.g., ClinicalTrials.gov or ISRCTN ) at the end of the abstract and in your cover letter.

Registries must be approved by ICJME. Approved registries include ClinicalTrials.gov , www.ISRCTN.org , www.actr.org.au , www.umin.ac.jp , and www.trialregister.nl .

Diabetes requires authors of papers reporting data obtained from studies on human islets to report critical characteristics of the human islets used for research (download the  Human Islet Checklist ). Such information will facilitate comparisons among studies using isolated human islets and, to the extent possible, standardization of the preparations and methods used by individual laboratories. These objectives are aligned with the current emphasis placed on scientific rigor and reproducibility in research by a number of major funding organizations ( 1 , 2 ). For full details, see the complete Human Islet Policy .

MANUSCRIPT FORMAT

Articles must be in clear and understandable English. Non-native English authors are encouraged to seek the assistance of an English-proficient colleague, or a communications agency such as “American Journal Experts” , to help improve the clarity and readability of a paper before it is submitted to the journal.

Every manuscript must have an accompanying title page . In addition to the full title, the title page should include a short running title (less than 47 characters and spaces); the first name, middle initial, and last name of each author; the affiliation (in English) of each author during the study being reported; the name, current affiliation, telephone number, and email address of the corresponding author; and the word count and number of tables and figures. The text on the title page should be center aligned.

The main text and tables must be saved in Microsoft Word document format, with 12 pt Times New Roman font, and the main text should double spaced.

Please do not use headers, footers, or endnotes in your paper.

Original Articles are expected to present a significant advance in diabetes research and should be arranged in the following order: title page (first page), abstract (see below), introduction (no heading necessary), Research Design and Methods, Results, Discussion, Acknowledgments (including Author Contributions, Guarantor Statement, Conflict of Interest statement, funding, and Prior Presentation information), references, tables (each including a title and legend), and figure legends. Figure files and online supplemental files should be uploaded separately. Note: Methods should not be placed in the supplemental material in order to circumvent word count limits. 

A Graphical abstract  is encouraged but not required. Graphical abstracts are a visual summary of the article. The image should capture the main points in a simple visual format, offering a quick understanding of the research. Graphical abstracts are intended to encourage browsing and offer easy identification of papers relevant to a readers research interests. Graphical abstracts will be published as part of the article online and the article PDF. They are excluded from the printed monthly edition of the journal. Authors submitting a graphical abstract should provide an original image clearly summarizing the focus and findings of the article. A landscape layout is preferred for image orientation. Graphical abstracts are uploaded to the submission website individually, and the file name should be simple and descriptive, e.g., graphical_abstract.tiff. Please use text sparingly and choose common fonts, such as Times, Arial, or Courier. Most image file types are acceptable.

A free graphical abstract template is available for download: Graphical Abstract Template (.ppt) . Several free tools are available online to aide in the creation of graphical abstracts, including Canva , Venngage , Inkscape , and Mind the Graph , among others.

See  Digital Art Guidelines for image specifications. As with all materials submitted to ADA, the copyright is transferred to ADA via the  manuscript submission form .

An abstract is required for all Original Articles. The abstract should be unstructured, concise and precise and should convey the essential findings of the manuscript. The abstract may not exceed 200 words. It should state the rationale, objectives, findings, and conclusions of the manuscript. References, primary data, and statistical significance should not be presented in the abstract, and nonstandard abbreviations must be defined. Authors are encouraged to include a statement that describes the potential translational impact of the study results.

Article Highlights are a list of four bulleted points summarizing the key findings and/or significance of the work described in the paper. Article Highlights should answer the following questions:    a.     Why did we undertake this study?    b.     What is the specific question(s) we wanted to answer?    c.     What did we find?    d.     What are the implications of our findings? Article Highlights are required for Original Articles, Brief Reports, and Reviews and should be placed immediately after the abstract. This section should be 75 to 100 words or fewer and should be written in complete sentences.

The word limit for the main text of Original Articles that will appear in the print version of the journal is 4,000 words. (The total word count excludes the title page, abstract, acknowledgments, references, tables and figures, and table/figure legends.) However, word limit should not prevent authors from providing sufficient methodological and data analysis detail. Authors are encouraged to put additional needed detail into supplemental material. While this will not appear in print, it will be available online and as an addendum to the PDF when downloaded from the site.  It should be labeled “Supplemental Material” or “Supplemental Data”.

The main text should be double spaced .

An Author Contributions paragraph should list each author's contributions as shown on the manuscript submission forms and should be placed in the Acknowledgments.

The Acknowledgments  are located after the main text and before the reference list. Acknowledgments should contain the author contributions paragraph, brief statements of assistance, the guarantor's name (person or persons taking responsibility for the contents of the article), funding/financial support, and reference to prior publication of the study in abstract form, where applicable.

The article should contain no more than 50 references and the reference section should be single spaced with justified margins.

The article should contain no more than a combination of 8 tables and/or figures .

Supporting documents/data may be uploaded for review purposes and will not be published. (When uploading, be sure each file is clearly labeled "supporting document/data.")

Online supplemental material should be uploaded in a separate file for publishing in an online-only supplement. Please do not include supplemental material or supplemental figure legends in the main document.  Very large datasets  may be submitted as supplemental material and cited in the text with a URL to the material, hosted on an author-affiliated website or data repository, or may appear with a note that the data is available upon request to the author. Please see the corresponding sections below for further formatting information on supplemental online-only material, acknowledgments, references, tables, and figures. 

The Brief Report category can be used for any original research pertinent to the journal. The purpose of the category is to permit publication of very important, high-quality mechanistic studies that can be concisely presented. Brief Reports should be arranged in the following order: title page, abstract (see below), introduction (no heading necessary), Research Design and Methods, Results, Discussion, Acknowledgments, references, tables (each including a title and legend), and figure legends.

• A graphical abstract is encouraged but not required for Brief Reports. (Please follow the formatting guidelines listed under Original Articles.)
• An abstract is required for all Brief Reports. (Please follow the formatting guidelines listed under Original Articles.)
• The word limit for the main text of Brief Reports is 2,000 words. (The total word count excludes the title page, abstract, acknowledgments, references, tables and figures, and table/figure legends.) However, word limit should not prevent authors from providing sufficient methodological and data analysis detail. Authors are encouraged to put additional needed detail into supplemental material. While this will not appear in print, it will be available online and as an addendum to the PDF when downloaded from the site.
• The report should contain no more than 25 references and the reference section should be single spaced with justified margins.
• The article should contain no more than a combination of 4 tables and/or figures .
• Supporting documents/data can be uploaded for review purposes and will not be published. (When uploading, be sure each file is clearly labeled "supporting document/data.")
• Online supplemental material  may be uploaded for publishing in an online-only supplement.  Very large datasets  may be submitted as supplemental material and cited in the text with a URL to the material, hosted on an author-affiliated website or data repository, or may appear with a note that the data is available upon request to the author. Please see the corresponding sections below for further formatting information on supplemental online-only material, acknowledgments, references, tables, and figures, and online supplemental material.

Commentaries are brief articles presenting the authors' views on a topic of current interest. Commentaries (and Editorials) are by invitation only.

• Commentaries should be limited to 1,000 words, no more one than table and/or figure, and no more than 20 references. For further information regarding Commentaries, please read Commentaries in Diabetes , instructions for authors .

Manuscript Submission Tip: To bypass the Abstract field when submitting a Commentary, type None in the Abstract field. For more tips on uploading your manuscript, see the Manuscript Submission Tips section.

Online Letters to the Editor are intended to provide an opportunity to comment on articles published within the previous three months in Diabetes . Online Letters to the Editor are not intended as a platform for presenting unpublished data, research, or observations.

While Online Letters are only published online, they are listed in the table of contents of the print version, and will be assigned an "E" page number. Citations for Online Letters should include the letter's unique DOI (digital object identifier) number, which is available in the footnote section of each letter (e.g., 10.2337/db08-XXXX).

• Letters do not have abstracts and should not exceed 500 words and 5 references . The inclusion of tables or figures in letters is discouraged. As with all submissions, letters should be double-spaced with 12 pt. Times New Roman font and justified margins.
• Letters must include a title page with the authors' full names and affiliations and the corresponding author's contact information.
• For comments on or responses to another article or letter, the article or letter on which the letter comments or responds to should be included as reference 1 in the reference list. The editor reserves the right to ask authors of the cited article to respond.

Manuscript Submission Tip: To bypass the "Abstract" field when submitting a Letter to the Editor, type "None" in the "Abstract" field. For more tips on uploading your manuscript, see the Manuscript Submission Tips section .

Perspectives in Diabetes are invited by the Editorial Board or submitted independently. Perspectives may highlight recent exciting research, not primarily that of the author(s), and may provide context for the findings within a field or explain potential interdisciplinary significance. Perspectives commenting on papers in Diabetes should add a dimension to the research and not merely be a summary of the experiments presented in the paper.

The formatting requirements for Perspectives in Diabetes are similar to those for Original Articles.

• An  abstract  is required for Perspectives articles. The abstract should be an unstructured, concise synopsis and may not exceed 200 words. References, primary data, and statistical significance should not be presented in the abstract, and nonstandard abbreviations must be defined.
• The word limit for the main text is 4,000 words and 50 references. (The total word count excludes the title page, abstract, acknowledgments, references, tables and figures, and table/figure legends.) The main text should be double spaced with justified margins.
• Perspectives may include a combination of no more than eight tables and/or figures.

Please see the corresponding sections below for information on acknowledgments, references, tables, and figures.

Supplemental Data (Online Supplemental Material)

If you upload supplemental material intended for publishing online only it should be labeled as an "Online Supplemental Materials" file. If you upload supporting data intended for review purposes only it should be uploaded as "Supporting Data or Supporting Document". Files uploaded as supporting data/supporting document will not be published in print or online if the paper is accepted.

Online-only supplemental material contains only supplemental information that is in addition to the main document (additional writing group members/investigator lists, supplemental tables and/or figures, short videos, etc.). It should not be excessively long. Files should be clearly marked and uploaded individually. Please do not include supplemental figure legends or material in the main document.

Very large datasets  may be submitted as supplemental material and cited in the text with a URL to the material, hosted on an author-affiliated website or data repository, or may appear with a note that the data is available upon request to the author.

Note: If you have online-only supplemental material, you must include justification on the necessity of the online supplement in your cover letter. The main document must contain all relevant material. Sections (i.e., Research Design and Methods, Results, Discussion) and/or portions thereof cannot be moved to an online-only supplemental file to accommodate word limits in the main document. Each section must be complete, without exception.

Please be aware that online-only material is not copyedited. You will want to provide clear, clean final version of any supplemental files.

The reference list should go at the end of the document, after the main text and acknowledgments (if applicable) and before the tables. References should be numbered in the order that they are cited in the text.

Reference numbers in the text should be in normal type and in parentheses [e.g., "In the study by Norton et al. (23)..."]. Please do not use the footnote/endnote functions found in some word processing programs. Reference software is permissible (e.g., EndNotes). Reference lists should be single spaced (no space between citations), and the margins should be justified.

For examples of how to style various citations in the reference list, see "References" in the Manuscript Style section.

Tables should be placed at the end of the main document, after the references, with each table starting on a new page. The table number, title, and legend go above or below the table and not within actual table rows.  Tables should be created in Word using the "Insert Table" command; please do not use tabs, hard returns, and/or spaces to create tables, columns, or rows. Tables with internal divisions (Tables 1 A and B ) should be submitted as individual tables, i.e., Tables 1 and 2. Symbols for units should be confined to column headings. Abbreviations should be kept to a minimum and defined in the table legend. Please avoid the use of shading. If a table includes data that require explanation in the legend, apply the following symbol sequence, from top to bottom, left to right: *, †, ‡, §, ||, ¶, #, **, ††, ‡‡, etc.

If tables are taken from other sources, it should be noted in the legend, and the author must be able to provide written permission for reproduction obtained from the original publisher and author.

All figures should be properly numbered and uploaded as separate files. Please place the main figure legends at the end of the main document after the references and tables. 

Data presentation.  In place of bar graphs, for small datasets (n<7-10) show the full data as univariate scatter plots that also show mean and standard deviation, as summary statistics are only meaningful if there are enough data to summarize. For larger data sets, use box and whisker plots or histograms.  While many of these types of graphs can be produced with standard software packages such a GraphPad PRISM, other approaches to creating such plots have been described (see Weissgerberet al. [2015] PLoS Biol 13(4): e1002128. doi:10.1371/journal.pbio.1002128 ). For other graphs not amenable to scatter plots, box plots, or histograms, display standard deviation, rather than SEM, with plungers.

Figures should be created in black and white or color, not shades of gray, which are difficult to reproduce in even tones.

Diabetes uses digital publishing methods throughout the journal production process. If your article is accepted, it will be published both in the printed journal and online. The following sections provide information on how to format your figures to ensure the best possible reproduction of your images.

Size. Figures should be produced at the size they are to appear in the printed journal. Please make sure your figures will fit in one or two columns in width. Multi-paneled figures should be assembled in a layout that leaves the least amount of blank space.

1 column = 21 picas wide, 3.5 in, 8.9 cm 2 columns = 43 picas wide, 7.1 in, 18 cm

Font. At 100% size, fonts should be 8-10 points and used consistently throughout all figures.

Text. Information on the axes should be succinct, using abbreviations where possible, and the label on the y -axis should read vertically, not horizontally. Key information should be placed in any available white space within the figure; if space is not available, the information should be placed in the legend. In general, figures with multiple parts should be marked A, B, C, etc., with a description of each panel included in the legend rather than on the figure.

Reproductions. If materials (e.g., figures and/or tables) are taken from other sources, it should be noted in the legend, and the author must be able to provide written permission for reproduction obtained from the original publisher and author. For more information, refer to Permissions: Help for Authors .

ADA has adopted and modified JAMA’s instructions for authors on the role of artificial intelligence and machine learning in reproducing and re-creating material for publication . In particular, the submission and publication of content created by artificial intelligence, language models, machine learning, or similar technologies is discouraged, unless part of formal research design or methods, and is not permitted without clear description of the content that was created and the name of the model or tool, version and extension numbers, manufacturer, and (where relevant) the query or prompt to create or assist with the development of content. Authors must take responsibility for the integrity of the content generated by these models and tools. 

Figure legends. Figure legends should be clearly numbered. For review and production processes, figure legends should be included beneath the image as well as in a section at the end of the manuscript, clearly labeled as Figure Legends. Please use words to describe symbols used in the figure; e.g., "black circles = group 1; white squares = group 2; black bars = blood glucose; white bars = C-peptide."

Formatting digital figure files for print and online reproduction. To meet ADA's quality standards for publication, it is important to submit digital art that conforms to the appropriate resolution, size, color mode, and file format. Doing so will help to avoid delays in publication and maximize the quality of images, both online and in print. Please refer to ADA's Digital Art Guidelines when preparing your files. If you are unable to provide files that meet the specifications outlined in the Guidelines, you may submit your original source files (files from the program in which they were originally created).

The Diabetes Editorial Office can properly convert digital figure files as a courtesy for authors who are unable to provide files that meet the specifications. To facilitate this process, please indicate the type of software application(s) used to generate the figure in the form of an email to the Editorial Office (address below) and make sure original source files (the initial images created by the original software application) are either uploaded to the submission site or emailed to the Editorial Office ( [email protected] . If figure files are too large to upload or email, please either upload them on a free web server ( http://www.yousendit.com/ ).

It is strongly recommended that authors converting their own digital files also send the original source files (what the figures were created in and saved in that program format) to the Diabetes Editorial Office in the event that the converted files are not acceptable for publication for any reason. Unacceptable files include those of poor quality due to improper conversion and/or incorrect resolution (dpi) and/or the use of too many software applications in the creation of the file.

Digital image manipulation. The American Diabetes Association has adopted the statement developed by the Journal of Cell Biology as its policy on the manipulation of digital images:

“No specific feature within an image may be enhanced, obscured, moved, removed, or introduced. The grouping of images from different parts of the same gel, or from different gels, fields, or exposures must be made explicit by the arrangement of the figure (i.e., using dividing lines) and in the text of the figure legend. Adjustments of brightness, contrast, or color balance are acceptable if they are applied to the whole image and as long as they do not obscure, eliminate, or misrepresent any information present in the original, including backgrounds. Without any background information, it is not possible to see exactly how much of the original gel is actually shown. Non-linear adjustments (e.g., changes to gamma settings) must be disclosed in the figure legend.”

All digital images in manuscripts accepted for publication will be scanned using image forensics software for any indication of improper manipulation. Cases of questionable or inappropriate image alterations will be referred to the Association’s Panel on Ethical Scientific Programs (ESP). The ESP may request the original data from the authors for comparison to the prepared figures. If the authors fail to provide the original data, the acceptance of the manuscript will be revoked. Cases of deliberate misrepresentation of data will result in revocation of acceptance, and will be reported to the corresponding author's home institution and/or funding agency as appropriate.

For examples of what constitutes improper digital manipulation (as well as other forms of scientific misconduct), ADA encourages authors to refer to the 2006 editorial by the Journal of Clinical Investigation titled “Stop Misbehaving!” In addition, authors are encouraged to refer to Adobe’s white paper on using Photoshop CS3 Extended in biomedical imaging. The paper provides useful information on maintaining image integrity, editing nondestructively, and the medical and scientific image workflow.

Artificial intelligence and image development. ADA has adopted and modified JAMA’s instructions for authors on the role of artificial intelligence and machine learning on the development of images presented for publication. In particular, the submission and publication of images created by artificial intelligence, machine learning tools, or similar technologies is discouraged, unless part of formal research design or methods, and is not permitted without clear description of the content that was created and the name of the model or tool, version and extension numbers, manufacturer, and (where relevant) the query or prompt to create or assist with the development of content. Authors must take responsibility for the integrity of the content generated by these models and tools.

Manuscript Submission Tip: Figures are to be uploaded individually as separate files. They should be in their original source format (what they were created in) if you are unable to convert figures properly. For more tips, please see the Manuscript Submission Tips section .

Videos can now be published in the online article, with a still image from the video appearing in the PDF and the print version. Still images are encouraged, but not required, and should represent as best as possible the main subject of the video. Video files should be clearly labeled as "video 1," "video 2," etc., and still images should be named "video 1 still image," etc. Each video must be cited in the text, and a legend must accompany each video. Video legends should include labels that correspond with the in-text citation and should be placed after the figure legends in the manuscript.

Videos can also be submitted as supplementary data and should be labeled "online supplemental video 1," etc. Supplementary videos are not required to have legends. 

Most video formats are acceptable, including .avi, .flv, .mov, .mp4, .swf, .wav, .wma, .wmv, and more. For helpful information about creating videos, please visit the  Video Creation Guide .

Authors are invited to submit images for use on the cover of Diabetes . Black and white or color photographic or photomicrographic images are acceptable. Examples of recent covers can be found on the Diabetes archive page. Cover image submission and selection is completely independent of article submission and the peer review process. Images sent for consideration on the cover are not required to be related to an article submitted to or published in the journal. The author must own copyright to the image and, if chosen, must grant ADA unrestricted free use of the image to be published on the cover of the journal as well as in other ADA publications and marketing materials. If your image is selected, you must be able to provide the file in TIFF or EPS format, with a minimum resolution of 300 dpi and no larger than 2 MB.

Cover image submissions should be sent to [email protected] with a brief caption and complete credit information (e.g., photograph courtesy of...). Please limit inquiries regarding the status of your cover image submission. You will be notified in a timely manner if your image has been selected to appear on a cover of Diabetes .

MANUSCRIPT STYLE

Articles should be written in clear, concise English following the recommendations for scientific writing found in Scientific Style and Format , the Council of Science Editors (CSE) style manual (7th ed., 2006, Reston, VA, Council of Science Editors). All accepted manuscripts will be edited according to the CSE style manual and The Chicago Manual of Style (15th ed., 2003, Chicago, IL, The University of Chicago Press) by ADA professional publications staff. The authors are responsible for all statements made in their articles or editorials, including any editing changes made by staff.

The designations type 1 diabetes and type 2 diabetes should be used when referring to the two major forms of diabetes. Abbreviations for diabetes, such as T2D for type 2 diabetes , should not be used. The term diabetic should not be used as a noun.

Abbreviations should be used only when necessary, e.g., for long chemical names (HEPES), procedures (ELISA), or terms used throughout the article. See the list of abbreviations that need not be defined; all others must be defined at first use. Abbreviate units of measure only when used with numbers. Abbreviations may be used in tables and figures. The American Medical Association style manual contains lists of standard scientific abbreviations.

Clinical laboratory values should be in Système International (SI) form. Kilocalories should be used rather than kilojoules. HbA1c values should be dually reported as “% (mmol/mol).” Please use the NGSP’s HbA1c converter at http://www.ngsp.org/convert1.asp to calculate HbA1c values as both % and mmol/mol.

Authors should provide the name and location (city and state/country) of the source for specified chemicals and other materials only if alternate sources are considered unsatisfactory.

References should be listed according to the following examples and should be numbered in the order that they are cited in the text. All authors must be listed and inclusive page numbers provided. Journal titles should be abbreviated as in the National Library of Medicine's List of Journals Indexed for Medline ; for unlisted journals, complete journal titles should be provided. Material that is in press may be cited, but copies of such material may be requested. Authors are responsible for the accuracy of the references.

When citing the prepublished version of a Diabetes article, please use the DOI (digital object identifier) in place of volume, page range, and year (see below for an example). The DOI of a Diabetes article will begin with 10.2337, followed by an article number (assigned at submission via the online manuscript submission system) (e.g., 10.2337/db08-XXXX).

Example: Kohler C, Norton N, Farber K, Briggs E: How to cite a prepublished article in ADA journals. Diabetes 10.2337/db08-9999

Scientific Sessions abstracts from 2003 to present can be found using the link provided at the bottom of the Diabetes archive page (http://diabetes.diabetesjournals.org/contents-by-date.0.shtml).

MANUSCRIPT SUBMISSION

Diabetes  takes only online manuscript submissions. The submission site can be found at  http://mc.manuscriptcentral.com/diabetes . Please read all instructions carefully. Failure to follow the submission instructions may delay the review process.

• Your manuscript should be submitted under the name of the designated corresponding author's user account (the contact person listed on the title page of the manuscript); the corresponding author is the only author who will receive notification of proof availability. (The system automatically recognizes the user account as the corresponding author, even if another name is designated.)
• Be sure to review the proofs of your submitted files after uploading them.
• To bypass the "Abstract" field when submitting a Letter to the Editor or a Commentary, type "None" in the "Abstract" field, and when submitting a Perspectives, paste the introduction into the "Abstract" field.
• Use simple file names when saving your documents, and do not use special characters such as [brackets], (parentheses), punctuation marks (?, !, .), or symbols (@, #, &, etc.). In addition, avoid spaces in files names, e.g., use "Figure1.tif" rather than "Figure 1.tiff."
• Do not upload .pdf files, Excel files, or zipped files (unless you are uploading original source files of figures). You may, however, upload .pdf copies of the signed manuscript submission form , which can be found in the Editorial Policies section and must be provided for all manuscript submissions.
• The text of your manuscript should be prepared using a word processing program and saved as a .doc, .txt, or a .rtf file.
• When uploading each file, you will be asked to choose a designation from a pull-down menu that describes the content of the file (e.g., "Main Document," "Figure," "Table," etc.). In addition to this designation, please ensure that the name of each file clearly describes the content of the file (e.g., "figure1.tiff," "table2.doc," "coverletter.rtf," etc.).

In addition to following the above listed guidelines for submission:

• When submitting a revised manuscript, all changes should be indicated with red font and underlined. Deletions need not be indicated within the article itself but should be noted in the author responses to reviewers.
• If the "track changes" function of a word processing program is used to show additions and deletions, make sure that all changes are "accepted" before submitting the clean revised version. Once the changes are accepted, deactivate the track changes function before saving and uploading the file.
• Please provide both a marked version showing corrections and a "clean" final version.
• Do not "lock" or "page protect" documents.
• Please adhere to word count, table, and figure limits as previously instructed.

At the revision stage, all authors are required to submit, together with the revised manuscript, a PDF file including all of the original, uncropped, and unedited images representing gels, Western blots, microscopic photos, etc., that are intended to be published as figures in the final version of the article, if accepted. Each gel/blot should be labeled as "Full unedited gel/blot for Figure 1, 2, etc.," and the authors should highlight which lanes of the unedited gel/blot correspond to those shown in the cropped images presented as figures in the manuscript. This file will be temporarily archived in the manuscript submission site if the manuscript is accepted; it will not be available to readers unless specifically requested by the authors to be published online. Please note that the PDF file of unedited images is required in addition to the final individual figure files composed as intended for print/online publication, if accepted. Failure to provide such original photographs will delay, or even preclude, publication of a manuscript in ADA journals.

Failure to follow instructions may result in publication delays if your manuscript is accepted.

ACCEPTED MANUSCRIPTS

Accepted manuscripts will be scheduled for publication as soon as possible.

Correspondence concerning the copyediting and proofreading of accepted manuscripts should be addressed to: Tessa Cooper,  Editorial Content Manager, Scholarly Journal Publishing American Diabetes Association 2451 Crystal Drive, Suite 900 Arlington, VA 22202 Email:  [email protected]

Correspondence concerning the production of accepted articles should be addressed to: Production Coordinator, Scholarly Journal Publishing American Diabetes Association, 2451 Crystal Drive, Suite 900 Arlington, VA 22202 Email:  [email protected]

The designated corresponding author will receive notification of availability of page proofs by email. Corrections should be returned within 24 hours of receipt of the proof. Failure to do so may delay the publication of the article to another issue. 

FINANCIAL OBLIGATIONS FOR ACCEPTED MANUSCRIPTS

Article-processing charges are assessed for non-invited articles to help defray the costs related to the peer review, editorial production and publication, access and dissemination, and archiving and indexing of articles published in  Diabetes .

For articles submitted on or after February 1, 2024, article processing charges will be assessed at $175 per typeset journal page.

In addition,  Diabetes offers an “Open Choice” option for authors who wish to make their published article immediately accessible to nonsubscribers. By paying an additional article-processing charge of $250 per page, authors may elect to have their articles freely available on the journal's website immediately upon publication online. Upon receipt of payment and on behalf of the author, ADA will also deposit the final version of the published paper into PubMed Central. 

Authors will receive an invoice for publication fees, as well as a reprint order form, when page proofs become available. Unless otherwise indicated, it is assumed that the corresponding author takes responsibility for payment. Questions regarding billing or payment should be directed to  [email protected] .

ADA recognizes that authors, their institutions, or their funding bodies, particularly those from low-income countries, may be unable to meet these financial obligations. In such cases, authors should submit requests for discounts or waivers of article-processing charges via the following form:  Request for Page Fee Waiver .

It should be noted that payment of publication fees or waiver status does not in any way influence the editorial decision-making process or the publication of any paper submitted to ADA journals.  

ADA Professional Publications Personnel and Contacts

ADA professional publications include books, clinical compendia, scholarly journals, professional news, podcasts, and multimedia. Contact Us With Questions .

Peer-Review Office Contact Information

Correspondence concerning manuscript submission/peer review should be addressed to:

Email: [email protected] Phone:  (317) 354-1508  Ext: 1782

Shannon Potts, Director, Scholarly Journals Peer-Review Zora Nazarei, Peer-Review Manager, Diabetes  

Email alerts

• Online ISSN 1939-327X
• Print ISSN 0012-1797
• Diabetes Care
• Clinical Diabetes
• Diabetes Spectrum
• Standards of Medical Care in Diabetes
• Scientific Sessions Abstracts
• BMJ Open Diabetes Research & Care
• ShopDiabetes.org
• ADA Professional Books

Clinical Compendia

• Clinical Compendia Home
• Latest News
• DiabetesPro SmartBrief
• Special Collections
• DiabetesPro®
• Diabetes Food Hub™
• Insulin Affordability
• Know Diabetes By Heart™
• About the ADA
• Journal Policies
• For Reviewers
• Advertising in ADA Journals
• Reprints and Permission for Reuse
• Copyright Notice/Public Access Policy
• ADA Professional Membership
• ADA Member Directory
• Diabetes.org
• X (Twitter)
• Cookie Policy
• Accessibility
• Terms & Conditions
• Get Adobe Acrobat Reader
• © Copyright American Diabetes Association

This Feature Is Available To Subscribers Only

Sign In or Create an Account

• - Google Chrome

Intended for healthcare professionals

• Access provided by Google Indexer
• My email alerts
• BMA member login
• Username * Password * Forgot your log in details? Need to activate BMA Member Log In Log in via OpenAthens Log in via your institution

Search form

• Advanced search
• Search responses
• Search blogs
• Type 2 diabetes:...

Type 2 diabetes: summary of updated NICE guidance

• Related content
• Peer review
• Gregory M Moran , medicines analyst 1 ,
• Chirag Bakhai , general practitioner 2 ,
• Soon H Song , consultant diabetologist 3 ,
• Juliana Chizo Agwu , committee chair and consultant paediatrician in diabetes and endocrinology 4
• on behalf of the Guideline Committee
• 1 National Institute for Health and Care Excellence (NICE), City Tower, Piccadilly Plaza, Manchester M1 4BT, UK
• 2 Bedfordshire, Luton and Milton Keynes Clinical Commissioning Group, Capability House, Bedford MK45 4HR, UK
• 3 Sheffield Teaching Hospitals NHS Foundation Trust, Northern General Hospital, Sheffield S5 7AU, UK
• 4 Sandwell and West Birmingham NHS Trust, Sandwell General Hospital, West Bromwich B71 4HJ, UK
• Correspondence to: G M Moran Gregory.moran{at}nice.org.uk

What you need to know

When assessing or reviewing adults with type 2 diabetes, include an assessment of the person’s cardiovascular status and cardiovascular risk

Assess the lifetime risk of cardiovascular disease in people with type 2 diabetes aged <40 years, instead of 10-year cardiovascular risk

Offer adults with type 2 diabetes who have chronic heart failure or atherosclerotic cardiovascular disease a sodium-glucose transport protein 2 (SGLT2) inhibitor with proven cardiovascular benefit

Consider an SGLT2 inhibitor in adults with type 2 diabetes who have do not have chronic heart failure or atherosclerotic cardiovascular disease but who have an increased cardiovascular risk

If an SGLT2 inhibitor is indicated and no glucose lowering drugs are already being taken, it should be prescribed in combination with metformin as soon as metformin tolerability is confirmed

Check and address modifiable risks for diabetic ketoacidosis before starting treatment with an SGLT2 inhibitor

The National Institute for Health and Care Excellence (NICE) last updated the drug treatment section of the type 2 diabetes guideline in 2015. Since then, further evidence on drug treatment from randomised trials investigating the effects of glucose lowering drugs on cardiovascular outcomes has emerged, prompting a further update. This article summarises the most recent recommendations on drug treatment of type 2 diabetes from the NICE guideline. 1 This rapid update focuses on evidence of cardiovascular outcomes, with a full update of the section now under way. Key changes to current practice include new recommendations for the use of sodium glucose co-transporter 2 (SGLT2) inhibitors in adults with type 2 diabetes who have chronic heart failure or established atherosclerotic cardiovascular disease or who are at high risk of developing cardiovascular disease. New recommendations for adults with type 2 diabetes and chronic kidney disease were added to the guideline in 2021 but are not covered in this article.

Recommendations

NICE recommendations are based on systematic reviews of best available evidence and explicit consideration of cost effectiveness. When minimal evidence is available, recommendations are based on the Guideline Committee’s experience and opinion of what constitutes good practice. Evidence levels for the recommendations are given in italics in square brackets.

Choosing drug treatment

The 2015 guideline recommendation listed several factors to consider when choosing drug treatment, including the effectiveness of drug treatments in terms of metabolic response. The updated recommendation has expanded this point to include cardiovascular and renal protection based on evidence from randomised trials showing that SGLT2 inhibitors have both cardiovascular and renal benefits. The Guideline Committee has also emphasised shared decision making in relation to choosing drug treatments, considering the person’s preferences, needs, and individual clinical circumstances (such as contraindications or concerns about weight).

Assessing cardiovascular risk

Although all people with type 2 diabetes are considered at increased risk of cardiovascular disease, the recently published randomised controlled trials focused on two groups at higher cardiovascular risk: people with established atherosclerotic cardiovascular disease and those at greater risk of developing cardiovascular disease (termed “higher cardiovascular risk” below). The cardiovascular risk score QRISK2 is recommended in current NICE guidance 2 for assessing cardiovascular risk in people with type 2 diabetes and is used widely in practice. However, QRISK2 does not reflect lifetime cardiovascular risk; therefore, additional risk factors should be considered for people aged under 40 years with type 2 diabetes, who may have increased risk for cardiovascular disease and mortality 3 (see box 1 for details).

Assess the person’s cardiovascular status and risk to determine whether they have chronic heart failure or established atherosclerotic cardiovascular disease or are at high risk of developing cardiovascular disease. [ Based on the experience and opinion of the Guideline Committee (GC) ]

Definitions for atherosclerotic cardiovascular disease and high risk of developing cardiovascular disease

Atherosclerotic cardiovascular disease.

Includes coronary heart disease, acute coronary syndrome, previous myocardial infarction, stable angina, previous coronary or other revascularisation, cerebrovascular disease (ischaemic stroke and transient ischaemic attack), and peripheral arterial disease

High risk of developing cardiovascular disease

Defined as adults with type 2 diabetes who have:

QRISK2 cardiovascular risk score >10% in adults aged ≥40 years or

Elevated lifetime risk of cardiovascular disease (defined as the presence of ≥1 cardiovascular risk factor* in someone aged <40 years)

* Cardiovascular disease risk factors: hypertension, dyslipidaemia, smoking, obesity, family history (in a first degree relative) of premature cardiovascular disease

First line drug treatment

In line with the 2015 guideline, the updated guideline recommends metformin as first line drug treatment for all adults with type 2 diabetes. It makes new recommendations to offer an SGLT2 inhibitor with proven cardiovascular benefit (box 2) in addition to metformin to those with chronic heart failure or established atherosclerotic cardiovascular disease, and to consider this treatment for those at high risk of developing cardiovascular disease. The Guideline Committee noted that, although all SGLT2 inhibitors were effective and cost effective, there was greater certainty associated with the cardiovascular benefits of empagliflozin, canagliflozin, and dapagliflozin at the time of publication. The guideline uses the term “SGLT2 inhibitor with proven cardiovascular benefit” to enable prescribers to choose an appropriate SGLT2 inhibitor for each person, while allowing the recommendation to remain current even if additional evidence or new SGLT2 inhibitor become available.

Evidence of cardiovascular benefit for SGLT2 inhibitors

Evidence from randomised trials 4 5 6 7 was included in the NICE analysis for canagliflozin, dapagliflozin, empagliflozin, and ertugliflozin. For the main composite outcome (3-point major cardiovascular events (MACE), which comprised cardiovascular mortality, non-fatal myocardial infarction, and non-fatal stroke), only canagliflozin and empagliflozin showed a statistically significant reduction compared with placebo. In analyses none of the SGLT2 inhibitors could be differentiated from each other for this outcome.

Empagliflozin showed a clinically meaningful reduction compared with placebo and the other SGLT2 inhibitors for cardiovascular mortality, but the remaining SGLT2 inhibitors could not be differentiated from each other or placebo in the network meta-analysis. For non-fatal myocardial infarction and non-fatal stroke, the analyses could not differentiate between empagliflozin, canagliflozin, ertugliflozin, and placebo. The data for dapagliflozin were reported differently and could not be included in the analysis, but dapagliflozin could not be differentiated from placebo for non-fatal myocardial infarction and was not meaningfully different from placebo for stroke.

Empagliflozin, canagliflozin, and dapagliflozin showed a clinically meaningful reduction in the analysis for hospitalisation for heart failure compared with placebo. However, in sensitivity analyses, using a fixed effect model, ertugliflozin also showed a clinically meaningful reduction for this outcome compared with placebo. The SGLT2 inhibitors could not differentiated from each other for this outcome in both analyses. Dapagliflozin showed a clinically meaningful reduction in severe hypoglycaemia compared with placebo, but the remaining SGLT2 inhibitors could not be differentiated from each other and placebo in the network meta-analysis.

The SGLT2 inhibitor should be started as soon as metformin tolerability is confirmed to reduce clinical inertia and optimise cardiovascular benefit. For those at higher cardiovascular risk who cannot take metformin, the recommended first line treatment is monotherapy with an SGLT2 inhibitor. These recommendations are summarised in the infographic, which highlights changes to the guideline alongside those recommendations that remain unchanged. Risk of diabetic ketoacidosis should be considered before prescribing an SGLT2 inhibitor, as outlined in box 3.

Based on the cardiovascular risk assessment for the person with type 2 diabetes:

If they have chronic heart failure or established atherosclerotic cardiovascular disease, offer an SGLT2 inhibitor with proven cardiovascular benefit in addition to metformin

If they are at high risk of developing cardiovascular disease, consider an SGLT2 inhibitor with proven cardiovascular benefit in addition to metformin.

[ Based on moderate to high quality evidence from randomised controlled trials and health economic modelling ]

• Download figure
• Open in new tab
• Download powerpoint

Checking for risk of diabetic ketoacidosis when prescribing SGLT2 inhibitors

Diabetic ketoacidosis (DKA) is a rare but potentially serious or fatal complication of type 2 diabetes. All known risk factors for DKA should be considered before starting SGLT2 inhibitor treatment. Some risk factors for DKA are non-modifiable (such as a person having had a previous episode of DKA)

Any modifiable risk for DKA should addressed before starting treatment with an SGLT2 inhibitor, for example:

Alcohol intake above recommended UK threshold

Use of illegal drugs

Use of other medicines

Concurrent illness, injury, or planned surgery

Very low carbohydrate or ketogenic diet

So, for example, before starting treatment with an SGLT2 inhibitor, adults with type 2 diabetes should be advised to discuss with a healthcare professional if they are on, or plan to start, a very low carbohydrate or ketogenic diet. It may be necessary to delay or suspend treatment until the diet has been changed or completed

The committee considered whether glucagon-like peptide-1 (GLP-1) receptor agonists such as exenatide, dulaglutide, liraglutide, lixisenatide, and semaglutide might also have a role as a first line treatment for adults at higher cardiovascular risk. However, health economic analyses found GLP-1 receptor agonists were not cost-effective options for cardiovascular risk reduction in people at higher cardiovascular risk, including if an SGLT2 inhibitor or metformin is contraindicated.

For those people who have type 2 diabetes but who do not have chronic heart failure or established cardiovascular disease, or who are not assessed as being at high risk of developing cardiovascular disease, then the existing recommendations remain unchanged from the previous guideline.

Reviewing drug treatment

The 2015 guideline recommended reassessing a person’s needs and circumstances at each review and to think about whether to stop any medicines that are not effective. The update has added a separate recommendation to emphasise important aspects of medicines optimisation during a review including considering adverse effects, adherence with treatment, and checking that doses and formulations are appropriate, as well as revisiting diet and lifestyle advice. In addition, the Guideline Committee agreed that it is important to think about stopping medicines that do not have useful clinical impact unless there is likely cardiovascular and renal benefit from continued treatment (this may involve consideration of off label prescribing as glucose-lowering drugs may not have an indication for cardiovascular or renal benefit alone), and whether switching rather than adding drugs could be effective to prevent people taking multiple drugs unnecessarily.

Adding an SGLT2 inhibitor at any stage after first line treatment has been started

The update recommends that people who are at higher cardiovascular risk or whose cardiovascular risk increases over time and who are already taking glucose lowering drugs should have the same access to the cardiovascular benefit of SGLT2 inhibitor as those starting first line treatment. A shared decision about switching treatments or adding an SGLT2 inhibitor should be made at the review.

Treatment options if further interventions are needed

The existing recommendations about what further glucose lowering drugs may be added or switched to as dual or triple therapy remain unchanged from the 2015 guideline (a DPP-4 inhibitor, pioglitazone, or sulfonylurea) and apply to people at all levels of cardiovascular risk. In addition, for people at lower cardiovascular risk an SGLT2 inhibitor could be added at this stage (if they meet the access criteria set out in the existing relevant NICE technology appraisals for the SGLT2 inhibitor). Insulin remains an option in the pathway when people have reached the point of requiring triple therapy.

The 2015 version of the guideline stated that if triple therapy with metformin and two other drugs was not effective, not tolerated, or contraindicated, then a GLP-1 receptor agonist could be considered in combination with metformin and a sulfonylurea, providing body mass index and other clinical criteria were met. However, the committee agreed that this specific combination may not always be clinically appropriate and therefore amended the recommendation to expand the triple therapy treatment combinations possible by allowing switching of one drug for a GLP-1 receptor agonist.

Future updates to the guideline

NICE have taken stakeholder comments into account and concluded that a fuller update of the drug treatment section of the guideline is still warranted. There will be opportunities for stakeholder input during the scoping stage.

Implementation

The 2022 recommendations for adults with type 2 diabetes at higher cardiovascular risk will likely have a large resource impact from increased prescribing of SGLT2 inhibitors. However, the Guideline Committee agreed that, since these drugs are clinically and cost effective for this population, it is correct to recommend them. NICE has undertaken a resource impact assessment taking into account the sizes of the populations covered by the updated recommendations at higher cardiovascular risk to help overcome implementation challenges at a local and national level. NICE has developed two visual summaries of the guidance and a patient decision aid that could be used to help clinicians support discussions with patients and carers about individual treatment targets ( https://www.nice.org.uk/guidance/ng28/resources ).

Guidelines into practice

How will you work with your organisation to ensure that clinical practice is in line with the new recommendations for SGLT2 inhibitors in adults with type 2 diabetes and heart failure, atherosclerotic cardiovascular disease, or higher cardiovascular risk?

When prescribing an SGLT2 inhibitor, what measures do you take to ensure it is prescribed safely and that the person is aware of the risk of diabetic ketoacidosis?

How patients were involved in the creation of this article

Committee members involved in this guideline update included lay members who contributed to the formulation of the recommendations summarised here.

Further information on the guidance

This guidance was developed by NICE’s Guideline Development Team (GDT) in accordance with NICE guideline development methods ( https://www.nice.org.uk/media/default/about/what-we-do/our-programmes/developing-niceguidelines-the-manual.pdf ).

A Guideline Committee (GC) was established by the GDT, which incorporated healthcare and allied healthcare professionals (a consultant paediatrician in diabetes and endocrinology, a general practitioner, four consultant diabetologists, a mental health professional (consultant clinical health psychologist) with a special interest in diabetes, a renal physician, two senior pharmacists, a diabetes nurse consultant, a consultant cardiologist) and two lay members.

The GC was involved in developing and agreeing the protocol for the 2022 update. The GC reviewed the clinical evidence that had been identified and analysed by the GDT using standard systematic review methodology. The clinical evidence was assessed for quality using GRADE methodology ( www.gradeworkinggroup.org/ ) or modified GRADE methodology in the case of the network meta-analyses. The GC also examined the cost effectiveness of interventions, including the use of a de novo economic model that was generated for the 2022 guideline update incorporating the new cardiovascular trial evidence.

The original scope of the update was amended after development began, but the committee members agreed that the initial focus should be on reviewing the evidence from trials looking at cardiovascular outcomes.

The draft of the guideline went through a rigorous reviewing process, in which stakeholder organisations were invited to comment; the GC took all comments into consideration when producing the final version of the guideline.

The evidence reviewed in the 2022 update is available as a separate review document, while the evidence for the sections of the guideline that were not updated is contained in the 2015 full guideline document. The guideline itself contains the recommendations with a new section on the rationale for the 2022 recommendations. The documents are all available at https://www.nice.org.uk/guidance/ng28/evidence .

Acknowledgments

The members of the Guideline Committee were (shown alphabetically): Juliana Chizo Agwu (committee chair), Sarah Ali, Chirag Bakhai, Neel Basudev, Augustin Brooks, Tembi Chinaire (from August 2021), Anne Dornhurst, Dorothy Frizelle, Hugh Gallagher, Natasha Jacques, Sallianne Kavanagh, Sharon McCarthy, Soon H Song, Annette Swinkels, Malgorzata Wamil, Corrine Wykes, Ibrahim Abubakar (until June 2021), Nicola Milne (until June 2021).

The technical members of the Guideline Development Team were Omnia Abdulrazeg (until February 2021), Lucy Beggs (until October 2021), Lindsay Claxton (from November 2021), Gareth Franklin (until April 2021), Marie C Harrisingh, James Jagroo (from January to March 2021), Thomas Jones (until May 2021), Kusal Lokuge (from March 2021), Yolanda V Martinez (from June 2021 to July 2021), Gregory Moran, and Sarah Wood (from April 2021).

Contributors: All authors contributed to the development of the guideline and to the planning, drafting, and revision of this summary, approved the final version, and take responsibility for its accuracy. GMM acts as guarantor. The corresponding authors attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted.

Funding: GMM is an employee of NICE. Other authors received no specific funding to write this summary.

Competing interests: We declared the following interests based on NICE’s policy on conflicts of interests ( https://www.nice.org.uk/Media/Default/About/Who-we-are/Policies-and-procedures/declaration-of-interests-policy.pdf ) The guideline authors’ full declaration of interests can be viewed at https://www.nice.org.uk/guidance/ng28/history

The guideline referred to in this article was produced by the Guideline Development Team at the National Institute for Health and Care Excellence (NICE). The views expressed in this article are those of the authors and not necessarily those of NICE.

• ↵ National Institute for Health and Care Excellence. Type 2 diabetes in adults: management (NICE guideline NG28). 2022. https://www.nice.org.uk/guidance/ng28 .
• ↵ National Institute for Health and Care Excellence. Cardiovascular disease: risk assessment and reduction, including lipid modification (clinical guideline CG181). 2016. https://www.nice.org.uk/guidance/cg181 .
• Rawshani A ,
• Franzén S ,
• Mahaffey KW ,
• Perkovic V ,
• CANVAS Program Collaborative Group
• Wiviott SD ,
• Bonaca MP ,
• DECLARE–TIMI 58 Investigators
• Lachin JM ,
• EMPA-REG OUTCOME Investigators
• Cannon CP ,
• Pratley R ,
• Dagogo-Jack S ,
• VERTIS CV Investigators

Log in using your username and password

• Search More Search for this keyword Advanced search
• Latest content
• For authors
• Browse by collection
• BMJ Journals More You are viewing from: Google Indexer

You are here

• Volume 14, Issue 5
• Feasibility and acceptability of a tailored health coaching intervention to improve type 2 diabetes self-management in Saudi Arabia: a mixed-methods randomised feasibility trial
• Article Text
• Article info
• Citation Tools
• Rapid Responses
• Article metrics

• http://orcid.org/0000-0003-1745-7528 Abdullah N Almulhim 1 , 2 ,
• Atheer Alhowaish 3 ,
• Alaa Madani 3 ,
• Munirah AlQaddan 3 ,
• Abdulaziz S Altuwalah 3 ,
• Elizabeth Goyder 1
• 1 School of Medicine and Population Health , The University of Sheffield , Sheffield , UK
• 2 Public Health Department, College of Health Sciences , Saudi Electronic University , Riyadh , 13316 , Saudi Arabia
• 3 Health Education Administration , King Fahad Medical City , Riyadh , 12231 , Saudi Arabia
• Correspondence to Mr Abdullah N Almulhim; aalmulhim{at}seu.edu.sa

Background Around one-third of the population of Saudi Arabia have been diagnosed with type 2 diabetes, a condition often requiring lifestyle changes. Personalised health coaching, a strategy developed to assist individuals in overcoming challenges to adopt healthy behaviours, has not yet been widely applied in the country.

Aims We aim to explore the feasibility and acceptability of tailored health coaching in Saudi Arabia, in order to help those with type 2 diabetes to more effectively manage their condition.

Methods Using a mixed-methods approach, this research involved a randomised controlled trial with 30 Saudi adults who have type 2 diabetes. They were randomly allocated into either the intervention or control arm for 12 weeks. The Capability, Opportunity, Motivation and Behaviour framework was used to guide the intervention implementation along with the Behaviour Change Techniques Taxonomy V.1. The primary goal was to assess the suitability and duration of the intervention, recruitment, retention and completion rates. The secondary outcome focused on the preliminary efficacy of the health coaching measured by the glycaemic index, blood pressure, body mass index (BMI), waist circumference, weight, patient self-efficacy and diabetes self-management.

Results The results showed high rates of eligibility, recruitment and retention (a screening rate of 90%, a recruiting rate of 79% and a retention rate of 97%). Notable improvements were observed in the health coaching group across five outcomes: haemoglobin A1c, BMI, waist circumference, patient self-efficacy and diabetes self-care. Qualitative findings highlighted the participants’ perceived benefits from the intervention, including enhanced motivation, better understanding of diabetes management and a supportive coaching relationship. Participants expressed high satisfaction with the intervention and advocated for its expansion.

Conclusion The findings demonstrated positive outcomes, supporting the need for a larger randomised controlled trial to evaluate the efficacy of health coaching in improving diabetes self-management among individuals with type 2 diabetes in Saudi Arabia.

• PUBLIC HEALTH
• DIABETES & ENDOCRINOLOGY

Data availability statement

Data are available on reasonable request. Data supporting the findings of this study are available from the corresponding author on reasonable request. Access requests will be reviewed to ensure compliance with ethical and privacy guidelines. Please contact ([email protected]) for inquiries regarding data access.

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See:  https://creativecommons.org/licenses/by/4.0/ .

https://doi.org/10.1136/bmjopen-2023-078631

Statistics from Altmetric.com

Request permissions.

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

STRENGTHS AND LIMITATIONS OF THIS STUDY

First health coaching intervention in Saudi Arabia.

First use of the Capability, Opportunity, Motivation-Behaviour model and Behavioural Change Techniques Taxonomy in a health coaching intervention.

Adherence to Consolidated Standards of Reporting Trials 2010 progression criteria.

Comprehensive impact assessment through mixed methods.

Limited generalisability due to specific settings and demographics.

Introduction

Type 2 diabetes mellitus (T2DM) is a chronic illness that is becoming more common globally and represents a significant public health concern. Lifestyle factors play a crucial role in the development of this disease, with obesity often manifesting as a symptom of other lifestyle factors such as physical inactivity. 1 T2DM can lead to complications such as cardiovascular disease, kidney failure, nerve damage, and ocular and auditory problems, significantly increasing the risk of heart disease and stroke in people with diabetes. 2

Managing diabetes can be a challenging task that encompasses various aspects of life, including social, economic and healthcare domains. 3 To help patients with T2DM effectively manage their condition, prioritising self-management is crucial. 4 T2DM is a prevalent chronic disease in Saudi Arabia (SA), with one of the highest rates in the Middle East and the seventh-highest globally. 5 Unhealthy diets, inactive lifestyles and rapid urbanisation are all contributing factors to this concerning trend. 6

Despite the national efforts to control T2DM in the SA context, the disease continues to pose significant challenges. 7 While awareness campaigns are being employed, there is a notable difficulty among most T2DM patients in adopting healthier diets and lifestyles. 7 To address this issue, it is necessary to implement patient-centred approaches that prioritise the development of self-management skills rather than relying solely on education-based programmes. 8

Health coaching, derived from various disciplines and behaviour change theories, has emerged as a client-centred approach gaining recognition in the field of health promotion. Although it has been widely explored in the literature and has shown promising results, this personalised one-on-one intervention has not yet been implemented within the healthcare systems of SA. Studies have demonstrated that health coaching, centred around patients’ values, may offer additional benefits compared with traditional T2DM education programmes. 9 By focusing on enhancing patients’ self-efficacy and essential skills such as goal-setting and problem-solving, health coaching can prove highly effective and financially viable. 10 Its successful application in diverse contexts has shown it to be a valuable tool in improving diabetes self-management. 11 12

However, the effectiveness of existing health coaching interventions exhibits inconsistency due to variations in methodology, duration and intervention content. 11 Recent systematic reviews of randomised controlled trials (RCTs) employing health coaching have reported mixed results, with some studies suggesting its effectiveness while others claim it to be ineffective. 11 12 There is no agreed on health coaching intervention model, which creates uncertainty regarding the most effective strategies to adopt, particularly in the SA context. The inconsistent findings across studies may be due to the lack of agreement on the active ingredients and content of successful health coaching interventions. 11 Additionally, cultural differences between SA and Western countries highlight the need for tailored interventions to ensure that proposed health coaching models are appropriate and relevant. 13

This feasibility study aims to assess the usability and acceptability of a health coaching intervention for T2DM self-management in SA, with the ultimate goal of reducing haemoglobin A1c (HbA1c) levels and informing a future large-scale RCT.

Materials and methods

This research was reported in accordance with the Consolidated Standards of Reporting Trials (CONSORT) extension guidelines specific to pilot and feasibility RCTs. 14 A comprehensive protocol for this study has already been published. 15

This is a randomised two-arm feasibility trial evaluating a 3-month intervention. The study adopted a mixed-methods approach, enabling the collection of both quantitative and qualitative data. An RCT design to address both evaluate the feasibility of RCT methods for recruitment, delivery and data collection, as well as a valid comparison of health coaching’s effectiveness between the groups. 16 Integral to our approach was the implementation of the Behaviour Change Wheel (BCW) framework, used in adapting the health coaching intervention for the SA context. The BCW informed our intervention design in several key ways: First, by identifying suitable intervention functions from the Capability, Opportunity, Motivation-Behaviour (COM-B) model, we tailored the health coaching to the specific needs and barriers of our target population. Second, we used the Behaviour Change Technique Taxonomy V.1 to code the active ingredients of the intervention, mapping these to the BCW framework for alignment with established behaviour change principles. 17 Furthermore, a behavioural analysis, guided by the Theoretical Domains Framework functions and behavioural change techniques (BCTs), was conducted to address pre-identified barriers (see online supplemental table 1 ). This analysis led to the selection of 36 relevant BCTs, which were mapped to directly target the behavioural barriers in adults with poorly managed T2DM, our intervention’s target population (see online supplemental table 2 ). By integrating the BCW, we were able to define the problem behaviours and target behaviours for intervention, ensuring a comprehensive and theory-driven approach as advised by BCW guidance. 18 Further information on the intervention can be found in a prior publication. 15

Supplemental material

Patient and public involvement.

Patients and the public were not involved during the process of this research.

Intervention development

There have been various identified target behaviours that would result in the adoption of a healthy lifestyle and diet as recommended by UK lifestyle guidelines. 19 As of now, there are no evidence-based guidelines in SA for T2DM to adopt a healthy lifestyle and diet. Therefore, we have referred to the UK’s guidelines on lifestyle as they share similarities in their healthcare systems. 19 20 These guidelines have been used to determine the most suitable behaviour targets for the Saudi context. We consulted healthcare professionals in the intervention setting, including a dietician, to establish these targets. Through collaborative discussions, we assessed and prioritised behaviours based on their potential impact, the feasibility of measurement, and achievability. As a result of this process, we have proposed four behaviour targets. 17

The four general behaviour targets of the intervention were as follows 19 21 :

Decrease carbohydrate intake for each meal.

Use unsaturated fats as possible (avoid saturated fats).

Do exercise for 30 min 5 days on a weekly basis.

Monitor waist circumference and maintain it below (80 cm for women and 94 cm for men).

The aim was to gradually reduce carbohydrate intake while ensuring that participants met their nutritional requirements. The specific target amounts were communicated to participants during individualised dietary counselling sessions with health coaches, and participants were provided with guidance and meal plans to help them achieve and maintain the desired carbohydrate intake levels. The health coaching intervention used these targets as the benchmarks to track the progress and changes that the study population would make over 3 months.

We used diverse instruments, including questionnaires, interviews, focus groups and clinical measures, to assess the intervention’s feasibility, acceptability and preliminary impact at two points: baseline and 3 months postintervention. In our mixed-methods study, purposive sampling was crucial to achieve data saturation and gather diverse perspectives. We conducted two distinct focus groups—one with six study participants and another with three health coaches—to assess the intervention’s impact from multiple angles. Additionally, 14 semistructured interviews were carried out with selected participants to delve deeper into individual experiences and perceptions. These qualitative methods were complemented by quantitative evaluations at baseline and 3 months postintervention, using clinical measures such as HbA1c, body mass index (BMI), waist circumference and weight. The quantitative data were analysed using linear regression to determine the mean differences between the intervention and control groups, adjusted for baseline levels.

Participant recruitment

Inclusion criteria were aged over 18, HbA1c level of 7.0% or higher, able to read and understand Arabic, having access to a personal mobile phone, being willing to complete the intervention period, be willing to stay in Riyadh (the capital city of SA) and be able to read, understand and sign the informed consent form.

The recruitment process involved advertising the intervention through multiple channels, including posters, brochures, social media and healthcare provider referrals. Interested and eligible individuals met the research team for a brief study overview and questionnaire completion, providing demographic data and baseline laboratory reports.

Participants were randomly assigned to one of two groups in a 1:1 ratio by an independent individual using a computer-generated random numbers system in Statistical Package for the Social Sciences (SPSS version number: 28.0.0.0), ensuring equal allocation chances. The two groups consisted of the intervention group, which received the health coaching intervention and the control group, which received standard care.

Intervention delivery

The health coaching intervention was completed in 12 weeks. A detailed intervention curriculum was used in delivering the intervention activities towards achieving the four target behaviours (see online supplemental table 3 ).

Three health coaches, AA, AM and MA, who were qualified through the Saudi Ministry of Health, conducted the intervention sessions. They received training in biweekly face-to-face (F2F) meetings over 6 weeks on the intervention curriculum. A workbook was provided as a guide to help them deliver coaching sessions as planned. A detailed explanation has been published elsewhere. 15 It is important to note that participants did not directly receive or review the intervention curriculum. Our approach involved ensuring uniformity in intervention procedures by providing health coaches with the curriculum. Each coach was asked to document the BCTs they use in each session. Different BCTs were reported in each session. Each participant was assigned to one of three coaches at the baseline. Each participant received six sessions in total, which were delivered biweekly via video meetings and telephone coaching over 3 months. Due to the COVID-19 pandemic, the first and last meetings were conducted via video call instead of F2F as planned while the rest were via telephone. Participants were encouraged to contact their coaches via WhatsApp between sessions if they had any related concerns. 84 sessions were undertaken for all participants in the intervention group.

Usual care (control group)

The participants in the control group were provided with the standard care, which involved receiving written materials and brochures on diabetes to increase awareness and promote the advantages of making changes to their health behaviours. Typically, individuals with T2DM have regular appointments with endocrine specialists to monitor their diabetes management. During these visits, the primary objective is to assess if any adjustments are necessary regarding the patient’s medication, such as replacement, dosage increase or maintaining the current prescription.

Data collection

Baseline data collection included demographic information, HbA1c, blood pressure, BMI, weight and waist circumference measurements. Subsequently, we asked participants to complete two electronic questionnaires: the Summary of Diabetes Self-Care Activities (SDSCA) scale and the Self-efficacy Scale for Diabetes. The postintervention data collection replicated the initial session, with repeat measurements of HbA1c, blood pressure, BMI, weight and waist circumference. Participants were also required to fill out the two initial questionnaires again, along with a Satisfaction Questionnaire designed specifically for the intervention group.

Reach and retention

As per the study protocol, 15 this study aimed to recruit a minimum of 9% (n=30) of the required sample size for conducting a complete trial. 22 Each group was expected to have a minimum of 12 participants to ensure meaningful data interpretation for informing a future definitive RCT. 23 A total of 24 participants in each group would be required to detect a meaningful clinical difference in HbA1c. The retention rate was evaluated based on the predefined progression criteria described elsewhere, 15 with successful retention defined as achieving an 83% retention rate at the intervention endpoint.

Fidelity assessment

All coaching sessions audio recorded and transcribed. An Arabic native speaker reviewed the entire transcription for accuracy. To ensure consistency and validity, a 10% sample of the transcription (approximately 50 min) was translated from Arabic to English, backtranslated and then examined by a peer reviewer. The data, including coaching sessions, time spent in each session, semistructured interviews, focus groups and questionnaires, were meticulously stored and managed for quality control. Specifically, all data were entered and stored in Microsoft Excel twice, independently by two research team members. This double-entry process served as a precautionary measure to minimise data entry errors and enhance the accuracy and reliability of the data collected throughout the trial. Adherence to the intervention was defined by the number of participants who completed five out of six coaching sessions, ≥84%.

Feasibility

Evaluation of feasibility included participant eligibility and recruitment, retention, data collection adherence, and adherence to the intervention. We recorded participants’ views about their engagement, capturing their reasons for interest, active participation and lack of interest. We tracked and logged the number and percentage of those who were eligible and interested, those who completed the intervention and those who withdrew to provide insight into the study’s recruitment efficiency and participant retention.

Acceptability

Acceptability of the intervention and its implementation was assessed using qualitative and quantitative data. The aim was to detect any potential challenges within the methodology used to deliver both the trial and the intervention. We conducted postintervention semistructured qualitative interviews and focus groups. The intervention’s acceptability was primarily gauged through a Likert-scale Satisfaction Questionnaire (14 items) applied to the intervention group (n=14). This questionnaire, originally devised by the Dan Abrahams Healthy Living Centre and subsequently employed by DeJesus et al (2018) 24 , incorporates a variety of question styles (open and closed). Using a Likert scale, it offered a response range from 0 (not at all) to 10 (very much) to capture participant feedback. Given that this scale had not been used in Arabic studies before, we translated it into Arabic and pretested it on a smaller subset before implementing it for the full study sample. In addition to quantitative measures, our mixed-methods approach involved semistructured interviews and focus groups to qualitatively assess the acceptability of the health coaching intervention. Thematic analysis was used to identify and interpret patterns within the qualitative data, aiming to understand the perceived benefits, challenges and overall acceptability of the intervention from the participants’ perspective.

Data analysis

We conducted both quantitative and qualitative analyses. For the quantitative part, descriptive analysis was undertaken including screening and recruitment rates, retention rates, adherence to coaching sessions and recruitment duration. We evaluated the use of BCTs and interactions between participants and coaches during these sessions. A Satisfaction Questionnaire captured participants’ experiences while changes in diabetes self-management and patient self-efficacy were assessed at the beginning and end of the study. The data were entered into Excel and subsequently transferred to SPSS and Stata Statistical Software (STATA 17) for advanced analysis, which included a linear regression to estimate the mean differences in outcomes.

For the qualitative aspect of our study, purposive sampling was employed to ensure data saturation in conducting interviews and focus groups. We conducted a total of 14 semistructured interviews and two focus groups, engaging in detailed discussions with participants. The qualitative data were analysed using NVivo software through a reflexive thematic analysis process, adhering to six systematic phases: familiarising ourselves with the data, coding, generating themes, revising themes, defining and finally reporting. 25 Initial coding was conducted by the researcher (ANA), followed by a collaborative review with the research team. During this process, a consensus on the emerging themes was reached through regular team meetings and discussions, ensuring accuracy and comprehensiveness in the identification and categorisation of themes.

In addition, we integrated the qualitative and quantitative data for comprehensive understanding. 26 Using a joint display table (see online supplemental table 4 ), 27 we compared and combined these data types. The display helped us identify areas of agreement (convergence), disagreement (divergence) and enhancement (expansion) between the two data types. 28 In the integrated data, we denoted convergence with ‘=’, complementarity with ‘+’ and inconsistencies with ‘≠’.

Although this feasibility study may not conclusively determine intervention effects, it provides valuable insights for estimating the sample size for a larger trial based on the mean difference and SD of HbA1c.

Participant characteristics

The control group (mean age=53.40, SD=8.47) was slightly older than the intervention group (mean age=52, SD=8.32). The majority were married, with monthly incomes ranging from less than SR5000 (28.6%) to more than SR15 000 (7.1%); 50.0% chose not to declare. About a quarter had completed high school, and an equal proportion had primary education or were literate without formal education. Approximately 31% had lived with T2DM for over 10 years, with 24.1% of the intervention group having T2DM for 1–3 years. The majority (89.7%) were on diabetes medications. Table 1 summarises the demographic characteristics of both groups.

• View inline

Summary of the participants’ demographic characteristics

Feasibility of the intervention

Eligibility and recruitment.

The recruitment process took about 5 weeks, starting on 1 May 2021 to 5 June 2021. Leaflets were used for advertising the intervention and were distributed in different places in the hospital, including in waiting areas and on hospital wall notice boards. In addition, we met physicians in person to introduce the intervention and gave them leaflets with more details to encourage their patients to join in the study.

Of the 42 potential participants initially identified and assessed for eligibility, 38 met the study criteria, resulting in a screening rate of approximately 90%. These 42 individuals were referred by different sources. 22 were referred by their doctors while the others were recruited through various methods. Two were from leaflets, 8 were from suggestions by friends or relatives and 10 were directly engaged at the diabetes clinic. 12 were excluded, of which 4 were ineligible because they did not meet the intervention inclusion criteria for the following reasons: 1 had no access to a personal mobile phone/smartphone, 1 patient was diagnosed with T1DM, 1 had A1c below 7% and 1 was unable to do preassessments and postassessments. Eight were excluded for other reasons; two did not respond and six for different reasons, for example, being too busy. 30 eligible patients were recruited to take part in the intervention. Out of the 38 eligible patients, 30 were successfully recruited and consented to participate in the intervention, yielding a recruitment rate of approximately 79%. All of them completed baseline assessments and questionnaires, and then randomly, 15 patients were allocated to the intervention group while the other 15 participants were assigned to the control group. One person who was part of the intervention group withdrew from the trial prior to the first session and was thus not included in the study (see online supplemental figure 1 , CONSORT diagram for more details).

The intervention started with the first session on 5 June 2021 and ended on 23 September 2021. The average time spent per participant was between ~17.7 and 25.5 in each session. The total range time of all sessions per patient was 109–153 min, with an average of 120.8 (SD=13.7). See online supplemental table 5 for more details about the time duration of each session.

Retention of participants

30 eligible participants consented to participate in the trial and completed the baseline assessment randomly allocated either to the coaching group (n=15) or the control group (n=15). Of those, all 29 who started the intervention and took the first session remained till the endpoint and completed all the intervention activities. Only one participant allocated to the coaching group had withdrawn and discontinued the study before the first session (retention rate=97%). All 29 have completed the intervention endpoint assessments. The main progress criteria and feasibility measurements are summarised in online supplemental table 6 .

Adherence to the coaching sessions

15 out of 30 participants were randomly allocated to the coaching group. Before the first session, one participant withdrew (P12) due to family issues. The rest of the 14 have completed all their coaching sessions (adherence rate 100%), which met the predetermined progression criteria of adhering to ≥84%. Half of the participants took their sessions at the planned time as previously scheduled. However, health coaches have rescheduled different sessions for seven participants for different reasons. The rescheduled sessions varied between 1 and 2 sessions for each one of them. Out of 84 sessions, only 11 sessions have been rescheduled (13%). The reasons for the rescheduling were home/work/appointment conflicts (n=6 sessions), travel (n=1 session), illness (n=3 sessions) and being busy (n=1 session). All participants started their coaching sessions at the same time on 5 June 2021, except four participants who started later on 1 July 2021. A 15-day delay because their coach could not begin at that time due to family issues. In addition, the same four participants had another delay between the fourth and fifth sessions due to the coach’s college exams. This led them to finish their last session on 23 September 2021.

Data collection adherence

Participants recruited for the study were invited to Al-Zulfi General Hospital on 10 June 2021. During this visit, they were given consent forms and information sheets about the intervention, providing them with an opportunity to ask questions and discuss any concerns related to their participation. Furthermore, baseline data, including measures of HbA1c, blood pressure, BMI, weight and waist circumference, were collected during this visit. Due to the restrictions imposed by COVID-19, all required measurements and paperwork were completed in a single visit. Participants were then asked to complete two electronic questionnaires, the SDSCA scale and the Self-efficacy Scale for Diabetes, during the hospital visit on 10 June 2021. The baseline data collection was successfully completed by all 30 participants, yielding a 100% completion rate. The time taken to complete the questionnaires ranged from 7 to 12 min, with no participants reporting difficulties or issues in the completion process.

At the end of the intervention, participants were once again invited to the hospital to gather postintervention data. This second data collection session was much like the first, where we again measured HbA1c, blood pressure, BMI, weight and waist circumference. Participants were also asked to complete the initial two questionnaires, with the addition of a Likert-scale Satisfaction Questionnaire for the intervention group only. This additional questionnaire resulted in a slightly longer completion time, ranging from 9 to 15 min, due to the inclusion of open-ended questions and certain items requiring justifications or explanations for selected responses. Overall, all participants effectively completed the data collection process, demonstrating successful adherence to our study’s data collection procedures.

Progression criteria

The feasibility measurements and predetermined progression criteria yielded positive results. The screening rate was 90%, exceeding the target of 80%, suggesting proceeding to the future definitive RCT. The recruitment rate reached 79%, demonstrating robust engagement with the target population. The retention rate at 3 months was 97%, surpassing the required 83% rate. Baseline data collection adherence and intervention adherence both achieved 100%. Endpoint data collection adherence was 97.6%, with only one participant withdrawing before the first session. Overall, these results support the decision to proceed to the future definitive RCT, indicating the feasibility and acceptability of the health coaching approach for individuals with T2DM in SA.

Sample size

The sample size for this feasibility study was determined in consultation with a statistician and was guided by practical considerations as recommended by the CONSORT guidelines for feasibility trials. 29 Our aim was not to test the intervention for statistical significance but rather to assess the feasibility and variability of outcomes to inform the planning of a definitive RCT. The choice of sample size was also influenced by the need to manage resources efficiently and to ensure a broad enough representation of the target population to capture initial insights into the intervention’s acceptability and implementation.

Furthermore, the statistician advised that for the upcoming main trial, a sample size calculation should be based on a clinically significant mean difference of 0.5% and an SD of 1.4, given the substantial effect size of −0.93 observed in this feasibility study. With these parameters, using a power of 0.8 and an alpha level of 0.05, we estimated that 125 participants per group would be necessary. This sample size would not only allow us to detect a clinically significant difference but also accommodate subgroup analyses to explore variations in effectiveness across different settings or patient groups.

Acceptability of the intervention

Acceptability and suitability of the intervention were assessed through a questionnaire (Likert-scale Satisfaction Questionnaire, 14 items) for the intervention group (n=14). Using a Likert scale of 0 (not at all) to 10, most participants’ responses show that the intervention affected their behaviour ‘quite a bit’ (mean: 8.2 (SD=2.3)). Participants replied, ‘very much’ (mean 9.2 (SD=1.4)) when asked how much participation in the intervention helped them establish a personal vision of wellness. When asked how the intervention boosted their confidence in taking actions toward improved well-being, the overall response was ‘very much’ (mean 9.2 (SD=1.4)). Their motives for making efforts toward enhanced well-being were ‘quite a bit’ (mean 8.3 (SD=1)). The average response to the usage of goal setting was ‘very much’ (mean 9.2. (SD=0.9)). Whereas their mean response to their use of problem-solving abilities was ‘quite a bit’ (mean 8.6 (SD=1.4)). Participants shared that the intervention greatly assisted them in overcoming obstacles and achieving increased levels of wellness, with a high mean score of 9 (SD=1.1) reported. From the 1st–8th question, participants’ responses are presented in online supplemental table 7 .

Participants were asked three ‘yes’ or ‘no’ questions, and they all replied ‘yes’ when asked whether they expected to continue making improvements (n=14, 100%). The majority (n=13, 92.9%) responded with ‘yes’ the intervention met their expectations. All 14 participants who were asked whether they would recommend the intervention to others responded with a positive ‘yes’.

Thematic analysis findings

The thematic analysis of the qualitative interviews and focus groups underscored the intervention’s positive reception, with emergent themes revealing enhanced self-efficacy, increased motivation and the supportive dynamics of the health coaching relationship, which participants found to be a significant aspect of the intervention’s acceptability. We analysed 1691 min of coaching sessions to identify the BCTs used (see online supplemental table 8 ) and transcribed 497 min of focus groups and interviews. A native Arabic speaker confirmed the accuracy of the entire transcription. To further ensure validity, about 10% of the transcription (50 min) underwent a back-translation process checked by a professional native speaker. Throughout the intervention, the first author (ANA), acting as the researcher, maintained field notes. Due to COVID-19 limitations, all interviews and focus groups were conducted online.

Evaluation of participants and health coaches’ experiences

Various qualitative methods were used to assess participant experiences during the intervention, including interviews, focus groups and field notes. After the intervention, two focus groups took place. Participants were given time to understand the questions before engaging in interviews and focus groups, fostering a deeper discussion. The researcher (ANA) conducted all focus groups and interviews, enabling active interaction and understanding of participant perspectives.

Between 15 June2021 and 23 September 2021, 14 semistructured interviews were conducted with seven participants (4 males and 3 females) from the intervention group, both prestudy and post study. Participants predominantly had a high school education or less, and the median age was 59. Three had long-standing diabetes of over 10 years, three had a recent diagnosis of less than 3 years and one was uncertain of the duration. Six of the seven were on diabetes medication.

Two poststudy focus groups were conducted online. One focus group comprised six participants (three males and three females) from the intervention group with a median age of 52.5 years. The majority had a high school education or less, and most were on diabetes medication with a mix of recent and long-term diagnoses. The demographic characteristics of the participants can be seen in table 2 .

Participants’ demographic characteristics

Three female health coaches from King Fahad Medical City in Riyadh formed the second focus group to share their intervention delivery experiences. All had health coaching backgrounds, with two holding master’s degrees in health education. The session lasted 265 min.

We used thematic analysis with inductive and deductive coding to evaluate the trial’s acceptability and feasibility. Open coding initially identified emergent themes, with deductive coding following, grounded in qualitative research guidelines and the Medical Research Council framework. 30

The analysis of translated transcripts produced four key themes, two of which were predetermined. The first theme pertained to trial design, conduct and processes, divided into four subthemes covering different aspects of intervention implementation. The second theme focused on intervention content and delivery, consisting of subthemes on intervention components, perceived consequences, feasibility and acceptability in practice, and reach and dose. The third theme, intervention mechanism, encompassed subthemes around COM-B model application, use of BCTs and intervention curriculum and intervention impact. The fourth theme, future RCT, captured participant and coach suggestions. The thematic map used in the analysis is outlined in online supplemental figure 2 .

Theme 1: intervention design, conduct and processes

This theme primarily focuses on the implementation and design of the intervention, along with the processes involved. Recruitment challenges during the pandemic prompted a shift to remote settings. This transition not only made recruitment a challenging task but also stretched the recruitment period beyond the planned time frame.

Notably, a health coach stated that the recruitment phase was complicated as clinics moved online., ‘ …the recruitment phase, it was complicated only because all clinics become online and we could not see people with type 2 diabetes come to the hospital as usual, so the chance of meeting those people was very rare.’ (Focus Group with Coaches, FGC01, Female).

Misunderstandings about health coaching in SA arose from a lack of understanding and familiarity. This highlighted the need for improved communication with recruiters, as one health coach observed, ‘ …from my communication with recruiters, some of them did not understand, so participants may get a wrong idea’ (Focus Group with Coaches, FGC01, Female).

Limited hospital access due to public health guidelines complicated recruitment further. However, the suggestion to recruit from a secondary hospital made the recruitment process manageable. Participants and health coaches recommended physicians as intermediaries for patient recruitment due to the trust and rapport they have established with patients; as one of them stated, ‘ …I think one of the best and most reliable ways to reach and recruit patients is to start from their direct physicians by suggesting the program for patients and encourage them to join’ (Focus Group with Coaches, FGC02, Female).

Proposing clear communication about programme expectations aimed to reduce dropout rates, with one participant suggesting to ‘ ask participants to sign a contract to commit and if you are hesitating or you have the intention to withdraw to tell us [referred to program provider] at the beginning to give the opportunity to someone who needs it’ (Focus Group with Participants, P03, Female).

Health coaches and participants expressed general satisfaction with the intervention’s design, and they believed that it effectively accommodated the local context of Saudi society. One participant expressed, ‘ I’m very very very satisfied and I think the program is easy to follow and very acceptable as it gradually improves different skills which last with a patient after the program…it is completely different from other programs…’ (Interview with Participants, P13, Male).

Additional workload challenged health coaches, mixing intervention tasks with regular duties. The COVID-19 pandemic further complicated matters by requiring greater flexibility in scheduling coaching sessions, particularly for participants with children engaged in online learning. To alleviate these issues, health coaches proposed securing formal workplace approval to dedicate full time to the intervention. As one health coach noted, ‘ As you know and because of the workload, I was thinking of withdrawing from the intervention… I think it is imperative to work a full-time job as a health coach in the intervention, not as a volunteer, and get formal permission from my work on this…’ (Focus Group with Coaches, FGC01, Female).

Theme 2: intervention content and delivery

This theme encompassed multiple subthemes reflecting on the intervention’s implementation, including its acceptability and adaptability within the Saudi context, potential unintended consequences, the feasibility of the practical application and intervention reach and dosage.

Health coaches suggested modifications for better acceptability and suitability of the intervention in the Saudi context. Emphasising the need for professionalism and structure, they proposed using formal platforms for communication, as one coach stated, ‘ …communication with the participant should be through a formal platform or application… to make the program more formal and organised…’ (Focus Group with Coaches, C02, Female). They also suggested the importance of physical meetings or video calls for a more serious engagement, as expressed by another coach, ‘ I prefer to have a physical meeting where I can sit with the patient face-to-face…’ (Focus Group with Coaches, FGC01, Female).

Coaches highlighted the necessity of prepared private spaces for coaching sessions. to give a professional image to the intervention. As one coach expressed, ‘ …As a coach, there should be a certain prepared private place at work to conduct all of my coaching sessions…’ (Focus Group with Coaches, C02, Female).

Participants preferred visual coaching sessions over phone calls for effective communication. Coaches felt that seeing the participant was vital for effective communication and coaching. A health coach expressed this, saying, ‘ …visual interaction with participants is very very important, you know the importance of reading and understanding the body language for me as a coach…’ (Focus Group with Coaches, C03, Female).

Participants praised the intervention for its straightforwardness and effectiveness in helping them make progress towards their goals. Some suggested a desire for additional sessions to further adopt and maintain new habits. One participant commented, ‘ I think three months was enough’ (Interview with Participants, P03, Female), while another remarked, ‘…it enabled me to stay committed, continue, and achieve my goals’ (Interview with Participants, P09, Male).

Participants appreciated the use of health coaching techniques, such as action plans and SMART goals, which helped set achievable targets and keep them motivated. The flexibility and graduality of the programme were also well received, as one participant mentioned, ‘ …the most thing I liked about the program was the graduality to achieve goals…’ (Interview with Participants, P13, Male).

Coaches confirmed the intervention content’s acceptability and observed its positive impacts. They also suggested the addition of monthly sessions or an extension of the intervention to 6 months for better patient progress monitoring and maintenance. A coach stated, ‘ … I suggest the intervention last longer… I think it would be good if the intervention lasts six months with a session each month …’ (Focus Group with Coaches, FGC01, Female).

Theme 3: intervention mechanism

This theme emphasises the practical application and effects of the COM-B health coaching model. Coaches received specialised training on the curriculum and BCTs, using several tools for efficient delivery. Notably, coaches documented the BCTs employed in each session, enabling tailored strategies to target specific behaviours. Participants appreciated this approach, stating, ‘ The BCTs helped me during each session to address some behaviours…’ (Focus Group with Coaches, FGC01, Female).

The COM-B model played a crucial role in the intervention, targeting four behaviours. Participants noted marked improvements in their knowledge and motivation preintervention and postintervention. Testimonials showed that they were more knowledgeable about their condition, diet and physical activity. One participant said, ‘ I became more knowledgeable…now I know diet types and what carbohydrates mean…’ (Focus Group with Participants, P05, Female).

The intervention also impacted participants’ social and physical environment, leading to a supportive atmosphere for behavioural change. Participants indicated that the changing social environment in SA encouraged the adoption of a healthier lifestyle and influenced their social networks. As one participant put it, ‘ While I was changing some of my old habits, my social network adapted…’ (Interview with Participants, P03, Female).

Health coaching provided a more personalised approach than traditional care, fostering motivation and leading to a change in participants’ views about their condition. This motivation was further fuelled by the noticeable changes in outcomes such as HbA1c levels. Participants recognised the power of lifestyle changes and felt empowered by their improved health results, stating, ‘ …after the intervention, I realised modifying the lifestyle is the actual treatment…’ (Interview with Participants, P13, Male). Consequently, there were requests to extend the intervention, given the observable impacts, including reductions in A1c levels and body weight.

Participants in SA observed notable differences between the novel concept of health coaching and traditional care. The former was seen as superior, with participants expressing dissatisfaction with traditional care’s impersonal nature. Health coaching, in contrast, provided a more personalised approach, allowing patients to voice their concerns. As one participant expressed, ‘ I would choose this program without hesitation; at least I finish each session while I’m comfortable…’ (Interview with Participants, P03, Female).

Traditional care was perceived as a top-down process, with patients passively receiving preprepared information or plans. The health coaching intervention, however, positioned participants as active stakeholders in their own care by encouraging goal-setting and plan creation. A participant noted, ‘ Your program helped me use new skills such as setting plans and having short-term and long-term goals…’ (Interview with Participants, P08, Male).

Frustration and even anger marked participants’ feelings about traditional care, citing time constraints, a lack of empathy and the expense of private consultations. Health coaching was seen as a way to alleviate these issues, with participants suggesting the incorporation of health coaching clinics in hospitals to facilitate meaningful patient discussions and foster better disease self-management. A participant suggested, ‘ I think it is important to recruit a coach in the hospital… 90% of patients with chronic diseases need to sit with someone to have meaningful discussions…’ (Interview with Participants, P08, Male).

Theme 4: improvement opportunities in the future health coaching RCT

As the inaugural health coaching intervention within the Saudi healthcare system, this initiative stands as a landmark reflecting the strategic direction of the Saudi Ministry of Health towards more proactive, patient-centred care. In anticipation of scaling up such interventions, participants and health coaches provided constructive feedback for refinement. Participants expressed a preference for more frequent coaching interactions and the opportunity for extended F2F engagements, suggesting a deeper and more personal connection could enhance the intervention’s impact. ‘ Having more time and direct sessions would greatly benefit the experience’ shared one participant (Interview with Participants, P01, Female).

Health coaches recommended the integration of multidisciplinary expertise, particularly dietitians and physicians, to provide comprehensive care and address the complex needs of diabetes management. ‘ Incorporating a nutritionist and a physician would offer a more rounded approach to patient care,’ proposed a coach (Focus Group with Coaches, C03, Female). This suggestion is indicative of a holistic strategy, recognising the multifactorial nature of diabetes.

To bolster participant engagement, the provision of incentives was suggested, alongside enhanced access to healthcare services. Additionally, health coaches proposed the creation of educational content, such as a succinct video delineating the health coaching concept, to facilitate a clearer understanding for future participants. ‘ A visual introduction to health coaching might bridge the initial knowledge gap,’ a coach highlighted (Focus Group with Coaches, C02, Female).

Preliminary effects of the health coaching intervention

Our quantitative analysis, using a linear regression model adjusted for baseline levels, revealed significant health improvements from the health coaching intervention. Specifically, HbA1c levels in the intervention group decreased significantly, with a mean difference of −1.86 (95% CI −2.71 to −1.01, p<0.001) compared with the control group. Secondary outcomes further underscored the intervention’s potential efficacy; BMI decreased by a mean of −1.02 (95% CI −2.01 to −0.041, p=0.042) and waist circumference reduced by −6.89 (95% CI −10.17 to −3.61, p<0.001). While changes in mean arterial pressure (MAP) and weight were observed, they did not reach statistical significance (MAP mean difference: −0.68, 95% CI −7.46 to 6.09, p=0.83; weight mean difference: −2.58, 95% CI −5.25 to 0.082, p=0.057). Detailed outcomes, including improvements in patients’ self-efficacy and diabetes self-management, are delineated in tables 3 and 4 .

Groups means and SDs at study baseline and endpoint

Outcomes mean differences taking into account the baseline value regression

Patients’ self-efficacy questionnaire

The self-efficacy of patients was assessed using an eight-item scale, 31 where scores ranged from 1 (least confident) to 10 (most confident). Higher mean scores indicated greater self-efficacy. Both intervention and control groups displayed an increased average response from baseline to the study endpoint, with higher improvements observed in the intervention group (see online supplemental table 9 ). The groups exhibited a statistically significant difference (p=0.006, 95% CI 0.713 to 3.839) in confidence related to controlling their condition and maintaining exercise. Similarly, a significant difference (p=0.006, 95% CI 0.82 to 4.35) was noted in confidence regarding appropriate food choices when hungry. This suggests the intervention group saw greater improvements in self-efficacy compared with the control group.

Diabetes Self-Care Activity

The Diabetes Self-Care Activity scale, 32 scoring 0 (no adherence) to 7 (complete adherence), measured patients’ adherence to specific activities over the past week. Average scores showed overall improvements in self-care for both the intervention and control groups across all activities, with the intervention group often meeting or exceeding American Diabetes Association recommendations (see online supplemental table 10 ). 33 For instance, adherence to a healthy eating plan in the intervention group increased from an average of 1.64–5.00 days per week. Physical exercise also increased in both groups, with a larger improvement in the intervention group (3.57–5.64 days). Similarly, there was improved management of carbohydrate intake in the intervention group, from 1.71 to 4.00 days per week.

Integration results

The key findings from both quantitative and qualitative data, aligned with research objectives, were assembled in a joint display table (see online supplemental table 4 ). This table was structured to present the study’s critical concepts and the corresponding progression criteria, which provide a comprehensive understanding of the mixed-methods findings. The phrase ‘there is no significance in moving forward’, as used within our progression criteria, draws from the principle of setting clear benchmarks for feasibility studies. These benchmarks are pivotal in assessing whether a study exhibits the potential for upscaling to a full-scale RCT. They embody a balance between the ambition to proceed and the pragmatism to address early issues, as recommended by best practices in trial management. 34 In our context, this phrase indicates that if participant recruitment, retention or adherence falls below the predetermined percentages, the study may not have the robustness required for expansion. Such a stance encourages rigorous scrutiny of recruitment rates and intervention adherence to ensure only well-substantiated research advances.

The integration of quantitative and qualitative data insights offered enhanced comprehension of findings collated and analysed separately. This approach bolstered the credibility and transparency of the overall results through data triangulation, allowing for comparison and validation of findings that a single method would not permit. The integration was critical to comprehensively understand the impacts of our intervention. Qualitative insights not only complemented the quantitative data but also provided deeper explanations for the patterns observed in numerical outcomes. For instance, while quantitative data showed significant improvements in HbA1c levels and BMI, qualitative findings offered nuanced insights into how and why participants made specific behavioural changes. Participants frequently cited the personalised feedback and motivational support from health coaches as pivotal, which helped them to adhere more consistently to their management plans. The integrated results substantiated the pertinence of mixed approaches, essential to the study’s feasibility and acceptability exploration in the Saudi context for a large-scale intervention with patients with T2DM.

The study reported high screening, recruitment and retention rates. These results were corroborated by the integrated analysis, suggesting a promising potential for the study within the Saudi setting. This was further supported by participants’ willingness to engage in the intervention, extend invitations to family members and their adherence to complete the intervention, despite some rescheduled sessions.

Notably, improvements were observed across five out of seven preliminary outcomes, which were validated by qualitative data. Participants and coaches reported positive experiences with the intervention’s usability, design and content. Moreover, qualitative results echoed the high satisfaction levels among participants identified in the quantitative Likert-scale Satisfaction Questionnaire. Despite the challenge posed by session rescheduling flexibility for coaches, it facilitated participant adherence, as supported by quantitative data: all participants completed their sessions with only 11 sessions rescheduled.

The findings from this feasibility study endorse advancing towards a larger RCT for a health coaching intervention among patients with T2DM in SA. Notably, the high rates of eligibility, recruitment and retention reflect the study’s effectiveness in engaging participants, which is pivotal for ensuring the representativeness and reliability of the results.

Achieving a recruitment rate of 79% is particularly significant; it not only indicates the interest and willingness of the target population to participate but also reinforces the potential for this health coaching intervention to be scaled up and applied broadly within the Saudi healthcare setting. This recruitment performance, especially when contrasted with rates from prior studies, such as those by Basak Cinar and Schou and Cho et al , 35–37 highlights the tailored approach’s resonance with the participants even amidst the operational challenges presented by the COVID-19 pandemic.

Retention is another key indicator of a study’s appeal and the practicality of its intervention. The retention rate in this study exceeded that of a similar study (83.6%), 35 as well as the rates reported by Basak Cinar and Schou (87%) 37 and Cho et al (90%). 36 Our retention rate, which remained high throughout the study period, suggests that the intervention was well received and retained its relevance and value to the participants, motivating them to continue through the study’s conclusion. The flexibility allowed in rescheduling coaching sessions contributed to this success, though it did increase the workload for the coaches, an aspect to consider in the planning of future RCTs.

As we reflect on the integrated quantitative and qualitative findings, we see confirmation of the feasibility of conducting a larger RCT, despite restrictions due to COVID-19. The comprehensive data collection, appropriate outcome assessments and participant adherence collectively point to the potential for effective execution and data gathering in a subsequent, more extensive RCT. Enhancing reach and diversity through a variety of recruitment methods, and the use of a concise explanatory video to describe the intervention, are strategies that can further streamline the process and solidify understanding among future participants.

The feasibility study used the COM-B model and the BCTs taxonomy, which proved to be effective in guiding intervention content and addressing participant barriers. The most frequently used BCTs aligned with previous literature. The study adapted to telephone-based sessions due to COVID-19 restrictions, but a mixed approach with F2F interactions was preferred by both participants and coaches. A longer intervention duration of up to 6 months with more F2F sessions was recommended to ensure sustained behaviour changes.

The intervention’s positive outcomes, particularly the reduction in HbA1c levels, align with evidence suggesting that interventions emphasising HbA1c as the primary outcome are more effective. This underscores the importance of selecting outcomes aligned with the intervention’s central goal. This study supports previous findings, 38 indicating that using HbA1c as the primary intervention outcome can enhance effectiveness. Emphasising glycaemic control as the primary outcome significantly impacted participants’ diabetes self-management in this study. Participants actively developed and used key skills to manage their condition, indicating the efficacy of the coaching model. Their satisfaction was notably linked to a meaningful reduction in HbA1c levels after the intervention, emphasising the holistic impact of the health coaching model.

Although feasibility studies are not formally powered to detect conclusive effects on interventions, 39 this study demonstrated the high acceptability and usability of the intervention in the Saudi context. However, concerns were raised by health coaches regarding their volunteer roles and the challenges of finding suitable locations for coaching sessions. These issues need to be addressed in planning for the larger RCT. The ongoing societal changes in SA, along with participants’ satisfaction with the intervention, suggest potential acceptance for a large-scale RCT.

For the upcoming definitive RCT, it is crucial to integrate participant and coach feedback to refine the approach. Recommendations include lengthening the programme to 6 months with increased in-person interactions, involving multidisciplinary experts, regular coach coordination, participant incentives and a brief explanatory video to introduce health coaching.

This study introduces a patient-centred health coaching approach to SA, showcasing its effectiveness in managing T2DM and its potential applicability to other chronic conditions. The use of a detailed curriculum and the COM-B model has proven beneficial, supporting the Saudi Ministry of Health’s move towards behaviour-based strategies and paving the way for broader implementation.

The study’s positive reception and outcomes reinforce the viability of health coaching in T2DM management, offering insights for future research and substantiating its growing acceptance and practicality.

Strengths and limitations of this study

This study applied the BCW framework, proving beneficial for a comprehensive understanding of the issue of T2DM in the context of SA through an in-depth analysis of prior literature. Accurate diagnosis of the identified problem, considering potential barriers and facilitators, plays a pivotal role in the systematic roadmap. This process initiates with recognising the actual issue and concludes with specifying target behaviours necessary to achieve the intended goals. Employing the COM-B model, we conducted a narrative review to pinpoint facilitators and barriers in controlling T2DM. The unique approach involved employing the BCW, COM-B model and BCTs taxonomy, enabling a meticulous analysis of each health coaching session and the coding of each applied BCT. This resulted in a clear and detailed description of the intervention.

The inclusion of progression criteria, as recommended by the CONSORT 2010 statement, aided in decision-making for the larger trial. 40 The study findings, including the effect size and retention rate, will inform the estimation of the sample size for the future main trial. The study also used both the Summary of Diabetes Self-Care Activity questionnaire and the Self-efficacy Scale for Diabetes scale, providing a comprehensive assessment of health coaching’s impact. A mixed-methods approach was employed to gather diverse perspectives, enhance validity and reliability, and produce more comprehensive findings.

However, the study is not without limitations, particularly concerning generalisability due to the specific setting and population. The small sample size may have led to potential type 2 errors, limiting the study’s ability to detect certain effects. While the recruitment of the intervention sample from a public hospital may not be directly applicable to primary care settings, it could impact the broader generalisability of findings to other individuals.

It is essential to note that although statistically significant effects were detected, the study’s acknowledgement of limitations in statistical power reflects an awareness of potential constraints in identifying smaller yet existing effects. These limitations should be considered when interpreting the study’s outcomes.

This mixed-methods feasibility RCT demonstrated the feasibility and acceptability of implementing a health coaching approach for individuals with T2DM in SA. The integration of qualitative and quantitative findings yielded positive outcomes, providing strong support for conducting a larger RCT to further investigate the effectiveness of health coaching in enhancing diabetes self-management among individuals with T2DM in SA. Importantly, this study offers valuable insights for future trials, particularly in terms of incorporating the COM-B model and BCTs taxonomy into the health coaching approach. The positive feedback received for implementing a patient-centred approach indicates that it could help manage other chronic diseases. This aligns with the Saudi Arabian Ministry of Health’s behaviour-focused strategies, providing more evidence to support the expansion of health coaching. As a result, these insights have significant implications for the current management practices of T2DM and beyond. Future research should also explore the social and environmental impacts of Vision 2030, the national vision of SA, on diabetes self-management. By considering contextual factors that may influence the implementation and outcomes of health coaching interventions for diabetes management in SA, further investigations will deepen our understanding and inform strategies to improve diabetes care and other chronic diseases in the country.

Ethics statements

Patient consent for publication.

Not applicable.

Ethics approval

This study involves human participants and ethical approval for this study was granted by both the University of Sheffield and the Institutional Review Board (IRB) committee at King Fahad Medical City (KFMC), with the assigned IRB log number: 21-062E. Participants gave informed consent to participate in the study before taking part.

Acknowledgments

We express our sincere gratitude to the study participants for their valuable time and willingness to participate. We are also grateful to KFMC and Al-Zulfi General Hospital for granting permission to conduct the intervention. Furthermore, we extend our thanks to the University of Sheffield Institutional Open Access Fund for their support towards this research. Finally, we would like to acknowledge that this paper will be published under a Creative Commons Attribution (CC BY) licence.

• Alqurashi KA ,
• Aljabri KS ,
• American Diabetes Association
• Bartlett C ,
• Wright D , et al
• Alqahtani M ,
• Almutairi FE ,
• Albasseet AO , et al
• Organization WH
• Alneami YM ,
• Alabdulbaqi D
• Al Slamah T ,
• Nicholl BI ,
• Alslail FY , et al
• Wolever RQ ,
• Dreusicke M ,
• Fikkan J , et al
• Wong-Rieger D ,
• Richardson B ,
• Skouteris H
• Pirbaglou M ,
• Motamed M , et al
• Alanazi FK ,
• Alotaibi JS ,
• Paliadelis P , et al
• Eldridge SM ,
• Campbell MJ , et al
• Almulhim AN ,
• Hariton E ,
• Locascio JJ
• Ashford S ,
• Sniehotta FF , et al
• van Stralen MM ,
• Twenefour D ,
• Breen C , et al
• Torgerson DJ
• DeJesus RS ,
• Rutten LJF , et al
• McCrudden MT ,
• Marchand G ,
• Creswell JW ,
• Barker M , et al
• Toobert DJ ,
• Hampson SE ,
• Association AD
• Avery KNL ,
• Williamson PR ,
• Gamble C , et al
• Huh B , et al
• Kim H-S , et al
• Basak Cinar A ,
• Hartley H ,
• Norman P , et al
• Whitehead AL ,
• Jacques RM , et al
• Schulz KF ,
• Altman DG ,

Supplementary materials

Supplementary data.

This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.

• Data supplement 1
• Data supplement 2
• Data supplement 3

Contributors ANA was responsible for the study’s conception and design, data acquisition, analysis, and interpretation, as well as the drafting of the manuscript, and acts as the guarantor of the work. ANA accepts full responsibility for the work and the conduct of the study, had access to the data, and controlled the decision to publish. EG contributed to the critical revision of the manuscript based on data analysis. AA, AM, MA, and ASA were responsible for the implementation of the intervention. All authors have thoroughly reviewed and approved the final version of the manuscript for publication.

Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

Competing interests None declared.

Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

Provenance and peer review Not commissioned; externally peer reviewed.

Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

Read the full text or download the PDF: