Hypo‐METRICS: Hypoglycaemia—MEasurement, ThResholds and ImpaCtS—A multi‐country clinical study to define the optimal threshold and duration of sensor‐detected hypoglycaemia that impact the experience of hypoglycaemia, quality of life and health economic outcomes: The study protocol

Divilly, Patrick; Zaremba, Natalie; Mahmoudi, Zeinab; Søholm, Uffe; Pollard, Daniel; Broadley, Melanie; Abbink, Evertine J.; Galan, Bastiaan E. de; Pedersen‐Bjergaard, Ulrik; Renard, Éric; Evans, Mark; Speight, Jane; Brennan, Alan; McCrimmon, Rory J.; Müllenborn, M.; Heller, Simon; Seibold, Alexander; Mader, Julia K.; Amiel, Stephanie A.; Pouwer, Frans; Choudhary, Pratik

doi:10.1111/dme.14892

Cited by 11 publications

(5 citation statements)

References 35 publications

(52 reference statements)

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Also, glucometric data among participants using isCGM showed that the percentage of time spent below 3.0 mmol/L in those with NAH was well under 1%. Although studies are ongoing that examine the clinical relevance of sensor‐detected low interstitial glucose values, 31 structural avoidance of blood glucose levels below this threshold has been shown to ameliorate awareness of hypoglycaemia 15–17 . These observations may, thus, suggest that the marked increase in the uptake of sensor technology not only contributed to a decrease in the occurrence of severe hypoglycaemia but also to the true improvement of symptomatic awareness of hypoglycaemia.…”

Section: Discussionmentioning

confidence: 99%

Fall in prevalence of impaired awareness of hypoglycaemia in individuals with type 1 diabetes

et al. 2023

Self Cite

View full text Add to dashboard Cite

show abstract

Section: Discussionmentioning

confidence: 99%

Fall in prevalence of impaired awareness of hypoglycaemia in individuals with type 1 diabetes

et al. 2023

Self Cite

View full text Add to dashboard Cite

show abstract

“…Hypo-METRICS is part of the EU IMI2-funded Hypo-RESOLVE (Hypoglycemia-Redefining SOLutions for better liVEs) project [12,13], across five European countries (Austria, Denmark, France, the Netherlands, and the United Kingdom). The Hypo-METRICS clinical study has received ethical approval at the lead site from the South Central Oxford B Research Ethics Committee (20/SC/0112) and in the other European countries (Ethikkommission der Medizinischen Universita ¨t Graz (Austria), Videnskabsetisk Komite for Region Hovedstaden (Denmark), Comite ´De Protection Des Personnes SUD Mediterranne IV (France), and Commissie Mensgebonden Onderzoek Regio Arnhem-Nijmegen (the Netherlands)).…”

Section: Study Participants and Proceduresmentioning

confidence: 99%

“…To investigate whether broad use of the Hypo-METRICS app in research and practice is indicated, this study investigates the app's acceptability (completion rates) and psychometric characteristics (structural validity, internal consistency reliability, test-retest reliability, convergent and divergent validity). These investigations are essential instrument validation steps, that are required before we can address the Hypo-METRICS study key objectives (outlined in Divilly et al [13]) in future publications.…”

Section: Introductionmentioning

confidence: 99%

Psychometric properties of an innovative smartphone application to investigate the daily impact of hypoglycemia in people with type 1 or type 2 diabetes: The Hypo-METRICS app

Søholm

Broadley²,

Zaremba³

et al. 2023

PLoS ONE

View full text Add to dashboard Cite

Introduction The aim of this study was to determine the acceptability and psychometric properties of the Hypo-METRICS (Hypoglycemia MEasurement, ThResholds and ImpaCtS) application (app): a novel tool designed to assess the direct impact of symptomatic and asymptomatic hypoglycemia on daily functioning in people with insulin-treated diabetes. Materials and methods 100 adults with type 1 diabetes mellitus (T1DM, n = 64) or insulin-treated type 2 diabetes mellitus (T2DM, n = 36) completed three daily ‘check-ins’ (morning, afternoon and evening) via the Hypo-METRICs app across 10 weeks, to respond to 29 unique questions about their subjective daily functioning. Questions addressed sleep quality, energy level, mood, affect, cognitive functioning, fear of hypoglycemia and hyperglycemia, social functioning, and work/productivity. Completion rates, structural validity, internal consistency, and test-retest reliability were explored. App responses were correlated with validated person-reported outcome measures to investigate convergent (rs>±0.3) and divergent (rs<±0.3) validity. Results Participants’ mean±SD age was 54±16 years, diabetes duration was 23±13 years, and most recent HbA1c was 56.6±9.8 mmol/mol. Participants submitted mean±SD 191±16 out of 210 possible ‘check-ins’ (91%). Structural validity was confirmed with multi-level confirmatory factor analysis showing good model fit on the adjusted model (Comparative Fit Index >0.95, Root-Mean-Square Error of Approximation <0.06, Standardized Root-Mean-square Residual<0.08). Scales had satisfactory internal consistency (all ω≥0.5), and high test-retest reliability (rs≥0.7). Convergent and divergent validity were demonstrated for most scales. Conclusion High completion rates and satisfactory psychometric properties demonstrated that the Hypo-METRICS app is acceptable to adults with T1DM and T2DM, and a reliable and valid tool to explore the daily impact of hypoglycemia.

show abstract

“…To help determine optimal parameters for CGM sensor-detected hypoglycemia, the HypoMETRICS study 26 aimed to correlate CGM sensors and patient-detected hypoglycemia. Preliminary data suggest that CGM-reported hypoglycemia occurred about 2 to 3 times more than patient-detected hypoglycemia.…”

Section: Session 7: Technology For Diagnosing Hypoglycemiamentioning

confidence: 99%

Diabetes Technology Meeting 2022

Huang

Yeung

DuBord

et al. 2023

J Diabetes Sci Technol

View full text Add to dashboard Cite

Diabetes Technology Society hosted its annual Diabetes Technology Meeting from November 3 to November 5, 2022. Meeting topics included (1) the measurement of glucose, insulin, and ketones; (2) virtual diabetes care; (3) metrics for managing diabetes and predicting outcomes; (4) integration of continuous glucose monitor data into the electronic health record; (5) regulation of diabetes technology; (6) digital health to nudge behavior; (7) estimating carbohydrates; (8) fully automated insulin delivery systems; (9) hypoglycemia; (10) novel insulins; (11) insulin delivery; (12) on-body sensors; (13) continuous glucose monitoring; (14) diabetic foot ulcers; (15) the environmental impact of diabetes technology; and (16) spinal cord stimulation for painful diabetic neuropathy. A live demonstration of a device that can allow for the recycling of used insulin pens was also presented.

show abstract

Hypo‐METRICS: Hypoglycaemia—MEasurement, ThResholds and ImpaCtS—A multi‐country clinical study to define the optimal threshold and duration of sensor‐detected hypoglycaemia that impact the experience of hypoglycaemia, quality of life and health economic outcomes: The study protocol

Cited by 11 publications

References 35 publications

Fall in prevalence of impaired awareness of hypoglycaemia in individuals with type 1 diabetes

Fall in prevalence of impaired awareness of hypoglycaemia in individuals with type 1 diabetes

Psychometric properties of an innovative smartphone application to investigate the daily impact of hypoglycemia in people with type 1 or type 2 diabetes: The Hypo-METRICS app

Diabetes Technology Meeting 2022

Contact Info

Product

Resources

About