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

International audienceIntroduction: 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

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

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.This work was supported by the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No 777460. The JU receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA and T1DExchange, JDRF, International Diabetes Federation (IDF) and The Leona M. and Harry B. Helmsley Charitable Trust (HCT). This paper reflects the author's view and the JU is not responsible for any use that may be made of the information it contains. This study represents independent research supported by the National Institute for Health and Care Research (NIHR) King’s Clinical Research Facility and the NIHR Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and King’s College London. The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care. Work was supported by the NIHR Cambridge Biomedical Research Centre and carried out in the NIHR Cambridge Clinical Research Facility/ Translational Research Facility. The University of Cambridge has received salary support for MLE through the National Health Service in the East of England through the Clinical Academic Reserve

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

Publication status: PublishedFunder: Leona M. and Harry B. Helmsley Charitable Trust; doi: http://dx.doi.org/10.13039/100007028Funder: European Commission; doi: http://dx.doi.org/10.13039/501100000780Funder: Innovative Medicines InitiativeIntroduction: 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

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

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

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

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

The impact of hypoglycaemia on daily functioning among adults with diabetes: a prospective observational study using the Hypo-METRICS Application

Aims/hypothesis: To examine the impact of hypoglycaemia on daily functioning among adults with type 1 diabetes or insulin-treated type 2 diabetes, using the novel Hypo-METRICS application. RESEARCH DESIGN AND METHODS For 70 consecutive days, 594 adults (type 1 diabetes: n=274; type 2diabetes: n=320) completed brief morning and evening Hypo-METRICS ‘check-ins’ about their experiencedhypoglycaemia and daily functioning. Participants wore a blinded glucose sensor for the study duration.Days   and   nights   with   or   without   person-reported   hypoglycaemia   (PRH)   and/or   sensor-detectedhypoglycaemia (SDH) were compared using multilevel regression models.  RESULTS  Participants submitted a mean of 86.3±12.5% morning and 90.8±10.7% evening check-ins.  Forboth types of diabetes, SDH alone had no significant associations to the changes in daily functioning scores.However, daytime and night-time PRH (with or without SDH) were significantly associated with worseningof   energy   levels,   mood,   cognitive   functioning,   negative   affect   and   fear   of   hypoglycaemia   later   thatday/while asleep. In addition, night-time PRH (with or without SDH) was significantly associated withworsening of sleep quality (type 1 and 2 diabetes), and memory (type 2 diabetes). Further, daytime PRH(with or without SDH), was associated with worsening of fear of hyperglycemia while asleep (type 1diabetes), memory (type 1 and 2 diabetes) and social functioning (type 2 diabetes). CONCLUSIONS This prospective, real-world study reveals impact on several domains of daily functioningfollowing PRH, but not following SDH alone.These data suggest that the observed negative impact is mainlydriven   by   subjective   awareness   of   hypoglycaemia   (i.e.,   PRH),   through   either   symptoms   or   sensoralerts/readings and/or the need to take action to prevent or treat them.</p