Dual hormone fully closed loop in type 1 diabetes: a randomised trial in the Netherlands – study protocol

Dual hormone fully closed loop in type 1 diabetes: a randomised trial in the Netherlands – study protocol

Introduction The management of type 1 diabetes (T1DM) has undergone significant advancements with the availability of novel technologies, notably continuous and flash glucose monitoring (CGM and FGM, respectively) and hybrid closed loop (HCL) therapy. The dual hormone fully closed loop (DHFCL) appro...

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Published in:BMJ open Vol. 13; no. 8; p. e074984
Main Authors: Jancev, Milena, Snoek, Frank J, Frederix, Geert W J, Knottnerus, Heleen, Blauw, Helga, Witkop, Maureen, Moons, Karel G M, van Bon, Arianne C, DeVries, J Hans, Serné, Erik H, van Sloten, Thomas T, de Valk, Harold W
Format: Journal Article
Language:English
Published: London BMJ Publishing Group LTD 23-08-2023
BMJ Publishing Group
Series:Protocol
Subjects:
Body mass index
Clinical outcomes
Cost analysis
Diabetes
Diabetes and Endocrinology
Drug dosages
Glucagon
Glucose monitoring
Hemoglobin
Hyperglycemia
Hypoglycemia
Insulin
Patients
Questionnaires
Sensors
United States > US
Netherlands
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Summary:Introduction The management of type 1 diabetes (T1DM) has undergone significant advancements with the availability of novel technologies, notably continuous and flash glucose monitoring (CGM and FGM, respectively) and hybrid closed loop (HCL) therapy. The dual hormone fully closed loop (DHFCL) approach with insulin and glucagon infusion has shown promising effects in small studies on glycaemic regulation and quality of life in T1DM. Methods and analysis The Dual Hormone Fully Closed Loop for Type 1 Diabetes (DARE) study is a non-commercial 12-month open-label, two-arm randomised parallel-group trial. The primary aim of this study is to determine the long-term effects on glycaemic control, patient-reported outcome measurements and cost-effectiveness of the DHFCL compared with usual care, that is, HCL or treatment with multiple daily insulin injections+FGM/CGM. We will include 240 adult patients with T1DM in 14 hospitals in the Netherlands. Individuals will be randomised 1:1 to the DHFCL or continuation of their current care. Ethics and dissemination Ethical approval has been obtained from the Medical Research Ethics Committee NedMec, Utrecht, the Netherlands. Findings will be disseminated through peer-reviewed publications and presentations at local, national and international conferences. Trial registration number NCT05669547 .
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ISSN:2044-6055
2044-6055
DOI:10.1136/bmjopen-2023-074984