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Assessing the Content Validity, Acceptability, and Feasibility of the Hypo-METRICS App: Survey and Interview Study

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Søholm, Uffe 
Zaremba, Natalie 
Broadley, Melanie 
Lundager Axelsen, Johanne 


Background: The Hypo-METRICS smartphone app was developed to investigate the impact of hypoglycaemia on daily functioning in adults with type 1 diabetes (T1DM) or insulin-treated type 2 diabetes (T2DM). The app uses ecological momentary assessments, thereby minimising recall bias and maximising ecological validity. It was used in the Hypo-METRICS study, a European multi-centre observational study, wherein participants wore a blinded continuous glucose monitoring device and completed the app three times daily for 70 days. The three aims of the study were to explore: 1) the content validity of the app content, 2) the acceptability and feasibility of using the app for the duration of the Hypo-METRICS study, and 3) suggestions for future versions of the app. Methods: Participants who had completed the 70-day Hypo-METRICS study in the United Kingdom were invited to participate in a brief online survey and an online interview (approximately one hour) to explore their experiences with the app during the Hypo-METRICS study. A thematic analysis of the qualitative data was conducted using both deductive and inductive methods. Results: Eighteen adults with diabetes (T1DM: n=10; 50% female, mean±SD age 47±16 years; T2DM: n=8, 25% female, mean±SD age 61±9 years) filled out the survey and were interviewed. In exploring content validity, participants overall described the Hypo-METRICS app as relevant, understandable, and comprehensive. Three themes were derived: 1) hypoglycaemia symptoms and experiences are idiosyncratic, 2) it was easy to select ratings on the app, but day-to-day changes are perceived as minimal and 3) instructions could be improved. Participants offered suggestions for changes or additional questions and functions that could increase engagement and improve content (such as providing more examples with the questions). In exploring acceptability and feasibility, five themes were derived: 1) helping science and people with diabetes; 2) easy to fit in, but more flexibility wanted; 3) hypoglycaemia delaying responses and increasing completion time; 4) design, functionality, and customisability of the app and, 5) limited change in awareness of symptoms and impact. Participants described using the app as a positive experience overall, and as having a possible, although limited, intervention effect, in terms of both hypoglycaemia awareness and personal impact. Conclusions: The Hypo-METRICS app shows promise as a new research tool to assess the impact of hypoglycaemia on an individual’s daily functioning. Despite suggested improvements, participants responses indicate that the app has satisfactory content validity, overall fits in with everyday life, and is suitable for a 10-week research study. Although developed for research purposes, the real-time assessments may have clinical value for monitoring and review of hypoglycaemia symptom awareness and personal impact.



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JMIR Diabetes

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JMIR Publications
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 T1DM Exchange, JDRF, International Diabetes Federation (IDF) 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. GME’s position at King’s College London is funded by a grant from Novo Nordisk.
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