TY - JOUR
T1 - Dual hormone fully closed loop in type 1 diabetes
T2 - a randomised trial in the Netherlands - study protocol
AU - Jancev, Milena
AU - Snoek, Frank J.
AU - Frederix, Geert W. J.
AU - Knottnerus, Heleen
AU - Blauw, Helga
AU - Witkop, Maureen
AU - Moons, Karel G. M.
AU - van Bon, Arianne C.
AU - DeVries, J. Hans
AU - Serné, Erik H.
AU - DARE study consortium
AU - van Sloten, Thomas T.
AU - de Valk, Harold W.
N1 - Funding Information: This study is fully funded by the Promising Care programme from the Dutch National Health Care Institute/ZonMw. Publisher Copyright: © 2023 BMJ Publishing Group. All rights reserved.
PY - 2023/8/23
Y1 - 2023/8/23
N2 - 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.
AB - 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.
KW - diabetes & endocrinology
KW - general diabetes
UR - http://www.scopus.com/inward/record.url?scp=85168606568&partnerID=8YFLogxK
U2 - https://doi.org/10.1136/bmjopen-2023-074984
DO - https://doi.org/10.1136/bmjopen-2023-074984
M3 - Article
C2 - 37612114
SN - 2044-6055
VL - 13
SP - e074984
JO - BMJ Open
JF - BMJ Open
IS - 8
M1 - e074984
ER -