Article Text

Protocol
Investigating the day-to-day impact of hypoglycaemia in adults with type 1 or type 2 diabetes: design and validation protocol of the Hypo-METRICS application
  1. Uffe Søholm1,2,
  2. Melanie Broadley2,
  3. Natalie Zaremba1,
  4. Patrick Divilly1,
  5. Giesje Nefs3,4,5,
  6. Zeinab Mahmoudi1,6,
  7. Bastiaan de Galan7,8,9,
  8. Ulrik Pedersen-Bjergaard10,11,
  9. Alan Brennan12,
  10. Daniel John Pollard12,
  11. Rory J McCrimmon13,
  12. Stephanie A. Amiel1,
  13. Christel Hendrieckx14,15,
  14. Jane Speight2,14,15,
  15. Pratik Choudhary1,16,
  16. Frans Pouwer2,15,17
  17. for the Hypo-RESOLVE Consortium
  1. 1 Department of Diabetes, King's College London, School of Life Course Sciences, London, UK
  2. 2 Department of Psychology, University of Southern Denmark, Odense, Denmark
  3. 3 Department of Medical Psychology, Radboud University Medical Centre, Radboud Institute for Health Sciences, Nijmegen, The Netherlands
  4. 4 Department of Medical and Clinical Psychology, Tilburg University, Tilburg, Noord-Brabant, The Netherlands
  5. 5 Diabeter, National treatment and research center for children, adolescents and adults with type 1 diabetes, Rotterdam, Netherlands
  6. 6 Digital Therapeutics, Novo Nordisk A/S, Søborg, Denmark
  7. 7 Department of Internal Medicine, Radboud University Medical Centre, Nijmegen, The Netherlands
  8. 8 Department of Internal Medicine, Maastricht University Medical Centre, Division of Endocrinology and Metabolic Disease, Maastricht, Limburg, The Netherlands
  9. 9 CARIM School for Cardiovascular Diseases, Maastricht University, Maastricht, The Netherlands
  10. 10 Department of Endocrinology & Nephrology, Endocrine Section, Nordsjællands Hospital, Hillerød, Hillerød, Denmark
  11. 11 Faculty of Health Sciences, Copenhagen University, Copenhagen, Denmark
  12. 12 School of Health & Related Research (ScHARR), University of Sheffield, Sheffield, UK
  13. 13 Systems Medicine, School of Medicine, University of Dundee, Dundee, UK
  14. 14 The Australian Centre for Behavioural Research in Diabetes, Diabetes Australia Victoria, Melbourne, Victoria, Australia
  15. 15 School of Psychology, Deakin University, Geelong, Victoria, Australia
  16. 16 Diabetes Research Centre, University of Leicester, UK LE5 4PW, Leicester, UK
  17. 17 Steno Diabetes Center Odense (SDCO), Odense, Denmark
  1. Correspondence to Dr Uffe Søholm; usoeholm{at}health.sdu.dk

Abstract

Introduction Hypoglycaemia is a frequent adverse event and major barrier for achieving optimal blood glucose levels in people with type 1 or type 2 diabetes using insulin. The Hypo-RESOLVE (Hypoglycaemia—Redefining SOLutions for better liVEs) consortium aims to further our understanding of the day-to-day impact of hypoglycaemia. The Hypo-METRICS (Hypoglycaemia—MEasurement, ThResholds and ImpaCtS) application (app) is a novel app for smartphones. This app is developed as part of the Hypo-RESOLVE project, using ecological momentary assessment methods that will minimise recall bias and allow for robust investigation of the day-to-day impact of hypoglycaemia. In this paper, the development and planned psychometric analyses of the app are described.

Methods and analysis The three phases of development of the Hypo-METRICS app are: (1) establish a working group—comprising diabetologists, psychologists and people with diabetes—to define the problem and identify relevant areas of daily functioning; (2) develop app items, with user-testing, and implement into the app platform; and (3) plan a large-scale, multicountry study including interviews with users and psychometric validation. The app includes 7 modules (29 unique items) assessing: self-report of hypoglycaemic episodes (during the day and night, respectively), sleep quality, well-being/cognitive function, social interactions, fear of hypoglycaemia/hyperglycaemia and work/productivity. The app is designed for use within three fixed time intervals per day (morning, afternoon and evening). The first version was released mid-2020 for use (in conjunction with continuous glucose monitoring and activity tracking) in the Hypo-METRICS study; an international observational longitudinal study. As part of this study, semistructured user-experience interviews and psychometric analyses will be conducted.

Ethics and dissemination Use of the novel Hypo-METRICS app in a multicountry clinical study has received ethical approval in each of the five countries involved (Oxford B Research Ethics Committee, CMO Region Arnhem-Nijmegen, Ethikkommission der Medizinischen Universität Graz, Videnskabsetisk Komite for Region Hovedstaden and the Comite Die Protection Des Personnes SUD Mediterranne IV). The results from the study will be published in peer review journals and presented at national and international conferences.

Trial registration number NCT04304963.

  • general diabetes
  • mental health
  • diabetes & endocrinology
  • information technology
  • health economics
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

Statistics from Altmetric.com

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.

Footnotes

  • Twitter @uffehs, @BroadleyMelanie, @nzarembakcl, @janespeight, @drpratikc, @FransPouwer

  • Collaborators Hypo-RESOLVE Consortium.

  • Contributors All authors were involved in the conceptualisation of the app. US, MB, NZ, PD, CH, JS, PC and FP developed the app with expertise input and advice from AB, DJP, BdG, GN, RJM, UP-B and SA. NZ and PC conducted the user testing of app items and response options. US, MB, JS, CH and FP produced the first manuscript draft. US, MB and FP planned the psychometric analyses and semistructured interviews with advice from JS, CH, ZM, NZ and PC. All authors reviewed the manuscript at multiple stages and provided feedback. All authors approved the final draft of the manuscript.

  • Funding This work was supported by the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No 777460. The JU receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA and T1D Exchange, JDRF, International Diabetes Federation and The Leona M. and Harry B. Helmsley Charitable Trust. The industry partners supporting the JU include Abbott Diabetes Care, Eli Lilly, Medtronic, Novo Nordisk and Sanofi-Aventis. JS and CH are supported by core funding to the Australian Centre for Behavioural Research in Diabetes provided by the collaboration between Diabetes Victoria and Deakin University.

  • Competing interests UPB has received grants and personal fees from Novo Nordisk and personal fees from AstraZeneca, Bristol-Meyers Squibb, Sanofi and Zealand Pharma.

  • 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.

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.