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Associations of clinical, psychological, and sociodemographic characteristics and ecological momentary assessment completion in the 10-week Hypo-METRICS study : Hypoglycaemia MEasurements ThResholds and ImpaCtS

Zaremba, Natalie ; Martine-Edith, Gilberte ; Divilly, Patrick ; Søholm, Uffe ; Broadley, Melanie ; Ali, Namam ; Abbink, Evertine J. ; de Galan, Bastiaan ; Cigler, Monika and Mader, Julia K. , et al. (2024) In Diabetic Medicine
Abstract

Introduction: Reporting of hypoglycaemia and its impact in clinical studies is often retrospective and subject to recall bias. We developed the Hypo-METRICS app to measure the daily physical, psychological, and social impact of hypoglycaemia in adults with type 1 and insulin-treated type 2 diabetes in real-time using ecological momentary assessment (EMA). To help assess its utility, we aimed to determine Hypo-METRICS app completion rates and factors associated with completion. Methods: Adults with diabetes recruited into the Hypo-METRICS study were given validated patient-reported outcome measures (PROMs) at baseline. Over 10 weeks, they wore a blinded continuous glucose monitor (CGM), and were asked to complete three daily EMAs about... (More)

Introduction: Reporting of hypoglycaemia and its impact in clinical studies is often retrospective and subject to recall bias. We developed the Hypo-METRICS app to measure the daily physical, psychological, and social impact of hypoglycaemia in adults with type 1 and insulin-treated type 2 diabetes in real-time using ecological momentary assessment (EMA). To help assess its utility, we aimed to determine Hypo-METRICS app completion rates and factors associated with completion. Methods: Adults with diabetes recruited into the Hypo-METRICS study were given validated patient-reported outcome measures (PROMs) at baseline. Over 10 weeks, they wore a blinded continuous glucose monitor (CGM), and were asked to complete three daily EMAs about hypoglycaemia and aspects of daily functioning, and two weekly sleep and productivity PROMs on the bespoke Hypo-METRICS app. We conducted linear regression to determine factors associated with app engagement, assessed by EMA and PROM completion rates and CGM metrics. Results: In 602 participants (55% men; 54% type 2 diabetes; median(IQR) age 56 (45–66) years; diabetes duration 19 (11–27) years; HbA1c 57 (51–65) mmol/mol), median(IQR) overall app completion rate was 91 (84–96)%, ranging from 90 (81–96)%, 89 (80–94)% and 94(87–97)% for morning, afternoon and evening check-ins, respectively. Older age, routine CGM use, greater time below 3.0 mmol/L, and active sensor time were positively associated with app completion. Discussion: High app completion across all app domains and participant characteristics indicates the Hypo-METRICS app is an acceptable research tool for collecting detailed data on hypoglycaemia frequency and impact in real-time.

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@article{f4ba94ed-5b76-4683-83c2-8c59e684f76f,
  abstract     = {{<p>Introduction: Reporting of hypoglycaemia and its impact in clinical studies is often retrospective and subject to recall bias. We developed the Hypo-METRICS app to measure the daily physical, psychological, and social impact of hypoglycaemia in adults with type 1 and insulin-treated type 2 diabetes in real-time using ecological momentary assessment (EMA). To help assess its utility, we aimed to determine Hypo-METRICS app completion rates and factors associated with completion. Methods: Adults with diabetes recruited into the Hypo-METRICS study were given validated patient-reported outcome measures (PROMs) at baseline. Over 10 weeks, they wore a blinded continuous glucose monitor (CGM), and were asked to complete three daily EMAs about hypoglycaemia and aspects of daily functioning, and two weekly sleep and productivity PROMs on the bespoke Hypo-METRICS app. We conducted linear regression to determine factors associated with app engagement, assessed by EMA and PROM completion rates and CGM metrics. Results: In 602 participants (55% men; 54% type 2 diabetes; median(IQR) age 56 (45–66) years; diabetes duration 19 (11–27) years; HbA1c 57 (51–65) mmol/mol), median(IQR) overall app completion rate was 91 (84–96)%, ranging from 90 (81–96)%, 89 (80–94)% and 94(87–97)% for morning, afternoon and evening check-ins, respectively. Older age, routine CGM use, greater time below 3.0 mmol/L, and active sensor time were positively associated with app completion. Discussion: High app completion across all app domains and participant characteristics indicates the Hypo-METRICS app is an acceptable research tool for collecting detailed data on hypoglycaemia frequency and impact in real-time.</p>}},
  author       = {{Zaremba, Natalie and Martine-Edith, Gilberte and Divilly, Patrick and Søholm, Uffe and Broadley, Melanie and Ali, Namam and Abbink, Evertine J. and de Galan, Bastiaan and Cigler, Monika and Mader, Julia K. and Brosen, Julie and Pedersen-Bjergaard, Ulrik and Vaag, Allan and Evans, Mark and Renard, Eric and McCrimmon, Rory J. and Heller, Simon and Speight, Jane and Pouwer, Frans and Amiel, Stephanie A. and Choudhary, Pratik}},
  issn         = {{0742-3071}},
  keywords     = {{continuous glucose monitoring; ecological momentary assessment; Hypoglycaemia; Mobile applications; type 1 diabetes; type 2 diabetes}},
  language     = {{eng}},
  publisher    = {{Wiley-Blackwell}},
  series       = {{Diabetic Medicine}},
  title        = {{Associations of clinical, psychological, and sociodemographic characteristics and ecological momentary assessment completion in the 10-week Hypo-METRICS study : Hypoglycaemia MEasurements ThResholds and ImpaCtS}},
  url          = {{http://dx.doi.org/10.1111/dme.15345}},
  doi          = {{10.1111/dme.15345}},
  year         = {{2024}},
}