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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) appr...

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Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10450048/
https://www.ncbi.nlm.nih.gov/pubmed/37612114
http://dx.doi.org/10.1136/bmjopen-2023-074984
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author 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
author_facet 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
author_sort Jancev, Milena
collection PubMed
description 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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spelling pubmed-104500482023-08-26 Dual hormone fully closed loop in type 1 diabetes: a randomised trial in the Netherlands – study protocol 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 BMJ Open Diabetes and Endocrinology 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. BMJ Publishing Group 2023-08-23 /pmc/articles/PMC10450048/ /pubmed/37612114 http://dx.doi.org/10.1136/bmjopen-2023-074984 Text en © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Diabetes and Endocrinology
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
Dual hormone fully closed loop in type 1 diabetes: a randomised trial in the Netherlands – study protocol
title Dual hormone fully closed loop in type 1 diabetes: a randomised trial in the Netherlands – study protocol
title_full Dual hormone fully closed loop in type 1 diabetes: a randomised trial in the Netherlands – study protocol
title_fullStr Dual hormone fully closed loop in type 1 diabetes: a randomised trial in the Netherlands – study protocol
title_full_unstemmed Dual hormone fully closed loop in type 1 diabetes: a randomised trial in the Netherlands – study protocol
title_short Dual hormone fully closed loop in type 1 diabetes: a randomised trial in the Netherlands – study protocol
title_sort dual hormone fully closed loop in type 1 diabetes: a randomised trial in the netherlands – study protocol
topic Diabetes and Endocrinology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10450048/
https://www.ncbi.nlm.nih.gov/pubmed/37612114
http://dx.doi.org/10.1136/bmjopen-2023-074984
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