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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

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posted on 2022-03-14, 12:02 authored by U Søholm, M Broadley, N Zaremba, P Divilly, G Nefs, Z Mahmoudi, B De Galan, U Pedersen-Bjergaard, A Brennan, DJ Pollard, RJ McCrimmon, S A. Amiel, C Hendrieckx, J Speight, P Choudhary, F Pouwer
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.

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.

History

Citation

Søholm U, Broadley M, Zaremba N for the Hypo-RESOLVE Consortium, et alInvestigating the day-to-day impact of hypoglycaemia in adults with type 1 or type 2 diabetes: design and validation protocol of the Hypo-METRICS applicationBMJ Open 2022;12:e051651. doi: 10.1136/bmjopen-2021-051651

Author affiliation

Diabetes Research Centre

Version

  • VoR (Version of Record)

Published in

BMJ Open

Volume

12

Issue

2

Pagination

e051651

Publisher

BMJ Publishing Group

issn

2044-6055

eissn

2044-6055

Acceptance date

2022-01-17

Copyright date

2022

Available date

2022-02-01

Language

eng

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