Background: Hypoglycemia and its impact on people with diabetes is typically reported retrospectively and is subject to recall bias. Ecological momentary assessment (EMA) uses repeated sampling to collect real time, granular data about patient experiences, typically over 3-5 days. We developed the Hypo-METRICS app to determine the physical, psychological, and economic impact in people with type 1 (T1D) and type 2 diabetes (T2D) over weeks using EMA. We tested user acceptability of the Hypo-METRICS app.
Methods: We recruited 323 adults (T1D=186, T2D=137, 55% men, mean age 54±16 years, diabetes duration 22±13 years) using insulin with ≥1 episode of hypoglycemia in the last month. Participants were prompted to complete three daily EMA and two weekly questionnaires (the Work Productivity and Activity Impairment Questionnaire and PROMIS Sleep Disturbance scale) for weeks. EMA included 29 items over morning, afternoon and evening time points. EMA questions spanned seven categories including experience of hypoglycemia, sleep, and daily functioning. Participants recorded hypoglycemia episodes using a symptom tracker in real time.
Results: The overall mean completion rate was 89±10% (T1D=87±11%, T2D=91±8%) , with 86,487 completed items. EMAs had a completion rate of 88±11% (T1D=87±11% T2D=90±9%) . Weekly questionnaires had a completion rate of 92±11% (T1D=91±12 T2D=95±8) . A total of 5,585 episodes of participant-reported hypoglycemia (T1D=4,118, T2D=1,467) were recorded in real time with a mean of 1.7±1.4 episodes reported per participant/week (T1D=2.2±1.4 T2D=1.1±1.0) .
Conclusion: The Hypo-METRICS app is an acceptable tool to collect prospective detailed data on the frequency of hypoglycemia episodes and their impact on daily functioning over a prolonged period.
N.Zaremba: None. R.J.Mccrimmon: Advisory Panel; Novo Nordisk, Sanofi, Research Support; Diabetes UK, European Union, MedImmune. E.Renard: Consultant; Abbott, AstraZeneca, Boehringer Ingelheim International GmbH, Dexcom, Inc., Insulet Corporation, LifeScan, Lilly, Novo Nordisk, Roche Diabetes Care, Sanofi, Tandem Diabetes Care, Inc. S.R.Heller: Advisory Panel; Eli Lilly and Company, Medtronic, Mylan N.V., Zealand Pharma A/S, Zucara Therapeutics, Other Relationship; Eli Lilly and Company, Research Support; Dexcom, Inc., Speaker's Bureau; Novo Nordisk A/S. M.Evans: Advisory Panel; Pila Pharma, Zucara Therapeutics, Other Relationship; Abbott Diabetes, Dexcom, Inc., Medtronic, Novo Nordisk, Research Support; AstraZeneca, Sanofi, Speaker's Bureau; Lilly Diabetes. J.K.Mader: Advisory Panel; Abbott Diabetes, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Medtronic, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Roche Diabetes Care, Sanofi-Aventis Deutschland GmbH, Speaker's Bureau; Abbott Diabetes, Eli Lilly and Company, Medtronic, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Roche Diabetes Care, Sanofi-Aventis Deutschland GmbH, Servier Laboratories, Stock/Shareholder; decide Clinical Software GmbH. A.Seibold: Employee; Abbott Diabetes, Stock/Shareholder; Abbott. S.A.Amiel: Advisory Panel; Medtronic, Novo Nordisk, Other Relationship; Sanofi. P.Choudhary: Advisory Panel; Abbott Diabetes, Lilly Diabetes, Medtronic, Research Support; Novo Nordisk, Speaker's Bureau; Dexcom, Inc., Glooko, Inc., Insulet Corporation, Sanofi. Hypo-resolve consortium: n/a. G.Martine-edith: Other Relationship; Novo Nordisk. P.Divilly: None. Z.Mahmoudi: Employee; Novo Nordisk A/S. U.Soeholm: Research Support; Novo Nordisk A/S. M.M.Broadley: None. F.Pouwer: Research Support; Eli Lilly and Company, Novo Nordisk, Sanofi. B.E.De galan: Research Support; Novo Nordisk. U.Pedersen-bjergaard: Advisory Panel; Novo Nordisk A/S, Sanofi.
Innovative Medicines Initiative (777460)