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. 2023 Aug 23;13(8):e074984.
doi: 10.1136/bmjopen-2023-074984.

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

Milena Jancev  1 , Frank J Snoek  2 , Geert W J Frederix  3 , Heleen Knottnerus  4 , Helga Blauw  5 , Maureen Witkop  5 , Karel G M Moons  3 , Arianne C van Bon #  6 , J Hans DeVries #  7 , Erik H Serné #  8 , Thomas T van Sloten #  9 , Harold W de Valk #  1 ; DARE study consortium
Collaborators, Affiliations

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

Milena Jancev et al. BMJ Open. .

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.

Keywords: diabetes & endocrinology; general diabetes.

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Conflict of interest statement

Competing interests: HB and MW are employees of Inreda Diabetic B.V., which supplied the bihormonal devices.

Figures

Figure 1
Figure 1
Patients on an HCL (n=170, advanced care) and MDI in combination with FGM or CGM (n=70, usual care) (total n=240) will be included in this trial. In both arms, patients will be randomised 1:1 to receive the intervention or continue their current care (control). CGM, continuous glucose monitoring; DHFCL, dual hormone fully closed loop; FGM, flash glucose monitoring; HCL, hybrid closed loop; MDI, multiple daily insulin injections.
See this image and copyright information in PMC

References

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