Psychosocial Aspects


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

"The HypoMETRICS app may be used as a key outcome in clinical trials evaluating new glucose lowering medications or new diabetes technology, but it can perhaps also be used in clinical settings to further optimise diabetes care and outcomes for individuals with diabetes." -

Please click here for the full article.

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