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) 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... Mehr ...

Verfasser: Frank J Snoek
Karel G M Moons
Mirjam M Oosterwerff
Thomas van Bemmel
Catherine B Brouwer
Arianne C van Bon
Harold W de Valk
J Hans deVries
Lioe-Ting Dijkhorst-Oei
Peter R van Dijk
Klaas Hoogenberg
Sarah E Siegelaar
Titia M Vriesendorp
Erik H Serné
Geert W J Frederix
Milena Jancev
Heleen Knottnerus
Helga Blauw
Maureen Witkop
Thomas T van Sloten
Frits A W Kemperman
Lars P Klieverik
Elin Seebus
Dokumenttyp: Artikel
Erscheinungsdatum: 2023
Reihe/Periodikum: BMJ Open, Vol 13, Iss 8 (2023)
Verlag/Hrsg.: BMJ Publishing Group
Schlagwörter: Medicine / R
Sprache: Englisch
Permalink: https://search.fid-benelux.de/Record/base-27193206
Datenquelle: BASE; Originalkatalog
Powered By: BASE
Link(s) : https://doi.org/10.1136/bmjopen-2023-074984

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.