Clinical Trial Protocol Journal Article Research Support, Non-U.S. Gov't Epublish 6 citations
PubMed: 37612114 DOI: 10.1136/bmjopen-2023-074984
Dual hormone fully closed loop in type 1 diabetes: a randomised trial in the Netherlands - study protocol.
BMJ Open 13(8):e074984
Authors: Milena Jancev, Frank J Snoek, Geert W J Frederix, Heleen Knottnerus, Helga Blauw, Maureen Witkop, Karel G M Moons, Arianne C van Bon, J Hans DeVries, Erik H Serné, Thomas T van Sloten, Harold W de Valk
Affiliations
- Vascular Medicine and Endocrinology, UMC Utrecht, Utrecht, The Netherlands.
- Medical Psychology, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.
- Epidemiology & Health Economics, Julius Center for Health Sciences and Primary Care, UMC Utrecht, Utrecht University, Utrecht, The Netherlands.
- Dutch Diabetes Association, Amersfoort, The Netherlands.
- Inreda Diabetic, Goor, The Netherlands.
- Department of Internal Medicine, Rijnstate Hospital, Arnhem, The Netherlands.
- Internal Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
- Internal Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.
- Vascular Medicine and Endocrinology, UMC Utrecht, Utrecht, The Netherlands.
Abstract
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.
MeSH
Diabetes Mellitus, Insulin, Hormones, Therapeutics, Diabetes Mellitus, Type 1