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
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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.
| Originalsprog | Engelsk |
|---|---|
| Artikelnummer | e14892 |
| Tidsskrift | Diabetic Medicine |
| Vol/bind | 39 |
| Udgave nummer | 9 |
| Antal sider | 11 |
| ISSN | 0742-3071 |
| DOI | |
| Status | Udgivet - 2022 |
Bibliografisk note
Funding Information:
SAA has served on advisory boards for NovoNordisk and Medtronic and has spoken at an educational symposium sponsored by Sanofi. MLE has served on advisory boards and/or received lecture fees and/or research support from NovoNordisk, Eli Lilly, AstraZeneca, Medtronic, Dexcom, Ypsomed, Abbott Diabetes Care, Roche, NGM Pharma, Zucara, Pila Pharma. UPB has served on advisory boards and has received lecture fees from Sanofi and Novo Nordisk. JKM is a member in the advisory board of Boehringer Ingelheim, Eli Lilly, Medtronic, NovoNordisk AS, Prediktor A/S, Roche Diabetes Care, Sanofi‐Aventis and received speaker honoraria from Abbott Diabetes Care, Astra Zeneca, Dexcom, Eli Lilly, Medtronic, MSD, NovoNordisk AS, Roche Diabetes Care, Sanofi, Servier and Takeda. ER has served as a consultant/advisor for Abbott, Air Liquide SI, Astra‐Zeneca, Boehringer‐Ingelheim, Dexcom, Eli‐Lilly, Hillo, Insulet, Medirio, Novo‐Nordisk, Roche, Sanofi‐Aventis, Tandem, and received research support from Dexcom and Tandem. JS has served on advisory boards for Janssen, Medtronic, Roche Diabetes Care and Sanofi Diabetes; her research group (Australian Centre for Behavioural Research in Diabetes [ACBRD]) has received honoraria for this advisory board participation and has also received unrestricted educational grants and in‐kind support from Abbott Diabetes Care, AstraZeneca, Medtronic, Roche Diabetes Care and Sanofi Diabetes. JS has also received sponsorship to attend educational meetings from Medtronic, Roche Diabetes Care, and Sanofi Diabetes, and consultancy income or speaker fees from Abbott Diabetes Care, AstraZeneca, Medtronic, Novo Nordisk, Roche Diabetes Care and Sanofi Diabetes. PC has received personal fees Abbott Diabetes Care, Insulet, Dexcom, Novo Nordisk, AstraZeneca, Medtronic, Roche Diabetes Care and Sanofi Diabetes. Research funding support from Abbott Diabetes Care, Medtronic and Novo Nordisk.
Funding Information:
Hypo‐RESOLVE has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No 777460. Abbott Diabetes Care provided the continuous glucose monitors used in the study. JS is supported by core funding to the Australian Centre for Behavioural Research in Diabetes provided by the collaboration between Diabetes Victoria and Deakin University.
Funding Information:
Hypo-RESOLVE has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No 777460. Abbott Diabetes Care provided the continuous glucose monitors used in the study. Work was supported by the NIHR Cambridge Biomedical Research Centre. The University of Cambridge has received salary support for MLE from the National Health Service in the East of England through the Clinical Academic Reserve. This study represents independent research supported by the National Institute for Health Reseatch (NIHR)- Wellcome 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 authors and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care.
Funding Information:
Hypo‐RESOLVE has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No 777460. Abbott Diabetes Care provided the continuous glucose monitors used in the study. Work was supported by the NIHR Cambridge Biomedical Research Centre. The University of Cambridge has received salary support for MLE from the National Health Service in the East of England through the Clinical Academic Reserve. This study represents independent research supported by the National Institute for Health Reseatch (NIHR)‐ Wellcome 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 authors and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care.
Publisher Copyright:
© 2022 The Authors. Diabetic Medicine published by John Wiley & Sons Ltd on behalf of Diabetes UK.
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