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

Abstract

IntroductionHypoglycaemia 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 analysisThe 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 disseminationUse 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 numberNCT04304963.

Hypo‐METRICS: Hypoglycaemia—MEasurement, ThResholds and ImpaCtS—A multi‐country clinical study to define the optimal threshold and duration of sensor‐detected hypoglycaemia that impact the experience of hypoglycaemia, quality of life and health economic outcomes: The study protocol

“…Hypo‐METRICS is a multinational, observational study. It will use blinded CGM, actigraphy, validated questionnaires (Table 1), routine clinical data and daily ecological momentary assessments (EMA) through a bespoke Hypo‐METRICS app 22 over a period of 10 weeks to collect data on sensor glucose levels, sleep, activity and person‐reported outcomes. Recruitment commenced in October 2020 and is due to be completed by April 2022.…”

“…Participants will complete a check‐in on the app three times per day for 10 weeks. The design and development of the Hypo‐METRICS app are detailed in a prior publication 22 . Briefly, the app includes: 'Check‐ins': Participants will complete three short sets of questions ('check‐ins') in the morning, afternoon and evening.…”

“…The design and development of the Hypo-METRICS app are detailed in a prior publication. 22 Briefly, the app includes:…”

“…We will also analyse the rates of SDH and PRH in those using CGM vs those use CBG during the 10 weeks of the study and the impact of different biopsychosocial variables on rates of SDH and PRH. of daily functioning (measured with the Hypo-METRICS app), which have been validated, as described by Søholm et al 22 Using the definition from our primary objective and data collected from the Hypo-METRICS app and the blinded CGM, we will compare daily functioning between days with and without symptomatic and asymptomatic hypoglycaemia. We will also explore whether the impact changes depending on diabetes type, sleep status, hypoglycaemia awareness and after adjustments for related variables.…”

The 12-Item Hypoglycemia Impact Profile (HIP12): psychometric validation of a brief measure of the impact of hypoglycemia on quality of life among adults with type 1 or type 2 diabetes

“…However, as part of Hypo-RESOLVE, a new app-based measure (using ecological momentary assessment methods) has been developed to assess the direct impact of episodes of hypoglycemia on aspects of daily functioning (eg, sleep, emotional wellbeing, work), many of which are relevant to QoL. 37 A potential limitation of the HIP12 is that it was adapted from an existing measure of the impact of diabetes on QoL. 23 However, the content was informed by recent qualitative research on the impact of hypoglycemia in adults with T1D 13 and other relevant literature.…”