JMIR Publications

ABSTRACT

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 assessment’ methods, 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 complete the app three times daily for 70 days.

Objective:

The present study has two aims: 1) to examine the content validity of the app content, and 2) to explore the acceptability and feasibility of using the app for the duration of the Hypo-METRICS study.

Methods:

Participants who had completed the 70-day Hypo-METRICS study in the United Kingdom were invited to fill out a brief online survey and participate in 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 assessing 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 assessing acceptability and feasibility, five themes were derived: 1) helping science and people with diabetes 2) the app was easy to fit into everyday life; 3) hypoglycaemia delaying responses and increasing completion time; 4) design, functionality, and customisability of the app and 5) intervention effect from using the app. Participants described the app as a positive experience overall, and as having a possible intervention effect, with both increased hypoglycaemia awareness and greater understanding of personal impact from hypoglycaemia.

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 Hypo-METRICS app could have clinical value. Due to its ability to provide real-time assessments, it should be considered for personalized review of the impact of hypoglycaemia in clinical practice. Clinical Trial: The Hypo-METRICS trial is registered with clinicaltrials.gov (NCT04304963) and received ethical approval from the South Central Oxford B Research Ethics Committee.