Associations of clinical, psychological, and sociodemographic characteristics and ecological momentary assessment completion in the 10-week Hypo-METRICS study: Hypoglycaemia MEasurements ThResholds and ImpaCtS
Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
Reporting of hypoglycaemia and its impact in clinical studies is often retrospective and subject to recall bias. We developed the Hypo-METRICS app to measure the daily physical, psychological, and social impact of hypoglycaemia in adults with type 1 and insulin-treated type 2 diabetes in real-time using ecological momentary assessment (EMA). To help assess its utility, we aimed to determine Hypo-METRICS app completion rates and factors associated with completion.
Methods
Adults with diabetes recruited into the Hypo-METRICS study were given validated patient-reported outcome measures (PROMs) at baseline. Over 10 weeks, they wore a blinded continuous glucose monitor (CGM), and were asked to complete three daily EMAs about hypoglycaemia and aspects of daily functioning, and two weekly sleep and productivity PROMs on the bespoke Hypo-METRICS app. We conducted linear regression to determine factors associated with app engagement, assessed by EMA and PROM completion rates and CGM metrics.
Results
In 602 participants (55% men; 54% type 2 diabetes; median(IQR) age 56 (45–66) years; diabetes duration 19 (11–27) years; HbA1c 57 (51–65) mmol/mol), median(IQR) overall app completion rate was 91 (84–96)%, ranging from 90 (81–96)%, 89 (80–94)% and 94(87–97)% for morning, afternoon and evening check-ins, respectively. Older age, routine CGM use, greater time below 3.0 mmol/L, and active sensor time were positively associated with app completion.
Discussion
High app completion across all app domains and participant characteristics indicates the Hypo-METRICS app is an acceptable research tool for collecting detailed data on hypoglycaemia frequency and impact in real-time.
| Originalsprog | Engelsk |
|---|---|
| Tidsskrift | Diabetic Medicine |
| ISSN | 0742-3071 |
| DOI | |
| Status | Accepteret/In press - 2024 |
Bibliografisk note
Funding Information:
We would like to thank all participants in the Hypo\u2010METRICS study. We would like to thank the Hypo\u2010RESOLVE Patient Advisory Committee for their support in the development of the Hypo\u2010METRICS app. Research nurses Charlotte Hansen, Pernille Banck\u2010Petersen, Rikke Carstensen and Stine Kj\u00F8ller are thanked for excellent handling of participants at NOH and SDCC, Denmark. Abbott Diabetes Care provided the continuous glucose monitors used in the study. 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 T1DExchange, JDRF, International Diabetes Federation (IDF) and The Leona M. and Harry B. Helmsley Charitable Trust (HCT). This paper reflects the author's view and the JU is not responsible for any use that may be made of the information it contains. This study represents independent research supported by the National Institute for Health and Care Research (NIHR) King's Clinical Research Facility and the NIHR Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and King's College London. The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care. Work was supported by the NIHR Cambridge Biomedical Research Centre and carried out in the NIHR Cambridge Clinical Research Facility/ Translational Research Facility. The University of Cambridge has received salary support for MLE through the National Health Service in the East of England through the Clinical Academic Reserve.
Publisher Copyright:
© 2024 The Authors. Diabetic Medicine published by John Wiley & Sons Ltd on behalf of Diabetes UK.
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