Uffe Søholm, Melanie Broadley, Natalie Zaremba, Patrick Divilly, Giesje Nefs, Zeinab Mahmoudi, Bastiaan de Galan, Pedersen-Bjergaard, Alan Brennan, Daniel John Pollard, Rory J McCrimmon, Stephanie A. Amiel, Christel Hendrieckx, Jane Speight, Pratik Choudhary, Frans Pouwer, for the HypoRESOLVE Consortium

Investigating the day-to-day impact of hypoglycaemia in adults with type 1 or type 2 diabetes: design and validation protocol of the HypoMETRICS application. BMJ Open. 2022 Feb 1;12(2):e051651

Hypoglycemia is a frequently occurring side-effect of insulin treatment for people with type 1 or type 2 diabetes which can have much impact on people with diabetes (PWDs). Hypoglycemia is regarded as an important barrier for obtaining optimal blood glucose levels: it can be life-threatening, is negatively associated with psychological wellbeing and quality of life, and is associated with future complications and cardiovascular events. Most studies on hypoglycemia so far have relied on PWDs self-reporting hypoglycemic events, often weeks or months afterwards, introducing recall bias and preventing assessment of immediate effects of these events.

 

Ecological momentary assessment (EMA) is a method to collect data of current or very recent events in real-world settings and this method is needed to further understanding on the impact of hypoglycemia on the daily lives of PWDs. To this end the Hypo-METRICS (Hypoglycaemia—MEasurement, ThResholds and ImpaCtS) app was developed, as part of the Hypo-RESOLVE (Hypoglycaemia—Redefining SOLutions for better liVEs) project. This is a 2-year project aimed at providing more scientifically validated knowledge on hypoglycemia by collecting and combining large datasets from clinical studies. This paper, co-authored by Giesje Nefs, outlines the development of the app and planned analyses of data generated using it.

Key aspects:

• In phase 1 a working group with expertise in questionnaire development and validation, medical psychology and endocrinology, together with a patient advisory committee, defined the conceptual framework for the app’s content:
  • Sleep quality and sleep duration.
  • Physical functioning.
  • Negative emotions.
  • Cognitive functioning and concentration.
  • Fear of hypoglycaemia.
  • Avoidance of participation in, or disruption to, usual daily (social) activities.
  • Economic consequences.
• In Phase 2 general principles for design of the app were established:
  • The specific questions (item content).
  • Response options and scales (e.g. check boxes, numerical scale).
  • User-testing of the app by PWD who had not been involved in the development of the app.
• In Phase 3 the study and analysis to validate the app will be designed:
  • 600 PWD aged 18-85 years will be recruited from Austria, Denmark, France, the Netherlands and the UK.
  • They will be asked to complete 3 daily check-ins (morning, afternoon, evening) for 10 weeks.
  • Blinded CGM sensors will be worn during this period.
  • Latent structure, internal consistency, test–retest reliability, construct validity, feasibility and acceptability, and completion rates of the app will be assessed in a subgroup of participants.
  • Feasibility and acceptability will be explored via user-experience interviews (~20 participants).

 

 

Concluding, the authors state

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