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

Patrick Divilly (Lead / Corresponding author), Natalie Zaremba (Lead / Corresponding author), Zeinab Mahmoudi, Uffe Søholm, Daniel J. Pollard, Melanie Broadley, Evertine J. Abbink, Bastiaan de Galan, Ulrik Pedersen-Bjergaard, Eric Renard, Mark Evans, Jane Speight, Alan Brennan, Rory J. McCrimmon, Matthias Müllenborn, Simon Heller, Alexander Seibold, Julia K. Mader, Stephanie A. Amiel, Frans PouwerPratik Choudhary, Hypo-RESOLVE Consortium

Research output: Contribution to journalArticlepeer-review

9 Citations (Scopus)
102 Downloads (Pure)

Abstract

Introduction: Hypoglycaemia is a significant burden to people living with diabetes and an impediment to achieving optimal glycaemic outcomes. The use of continuous glucose monitoring (CGM) has improved the capacity to assess duration and level of hypoglycaemia. The personal impact of sensor-detected hypoglycaemia (SDH) is unclear. Hypo-METRICS is an observational study designed to define the threshold and duration of sensor glucose that provides the optimal sensitivity and specificity for events that people living with diabetes experience as hypoglycaemia.

Methods: We will recruit 600 participants: 350 with insulin-treated type 2 diabetes, 200 with type 1 diabetes and awareness of hypoglycaemia and 50 with type 1 diabetes and impaired awareness of hypoglycaemia who have recent experience of hypoglycaemia. Participants will wear a blinded CGM device and an actigraphy monitor to differentiate awake and sleep times for 10 weeks. Participants will be asked to complete three short surveys each day using a bespoke mobile phone app, a technique known as ecological momentary assessment. Participants will also record all episodes of self-detected hypoglycaemia on the mobile app. We will use particle Markov chain Monte Carlo optimization to identify the optimal threshold and duration of SDH that have optimum sensitivity and specificity for detecting patient-reported hypoglycaemia. Key secondary objectives include measuring the impact of symptomatic and asymptomatic SDH on daily functioning and health economic outcomes.

Ethics and dissemination: The protocol was approved by local ethical boards in all participating centres. Study results will be shared with participants, in peer-reviewed journal publications and conference presentations.

Original languageEnglish
Article numbere14892
Number of pages11
JournalDiabetic Medicine
Volume39
Issue number9
Early online date28 May 2022
DOIs
Publication statusPublished - Sept 2022

Keywords

  • continuous glucose monitoring,
  • hypoglycaemia
  • patient- reported hypoglycaemia
  • quality of life
  • sensor-detected
  • patient-reported hypoglycaemia
  • continuous glucose monitoring

ASJC Scopus subject areas

  • Endocrinology
  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism

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