Cargando…

Randomised controlled trial of Advanced Hybrid Closed Loop in an Adult Population with Type 1 Diabetes (ADAPT): study protocol and rationale

INTRODUCTION: For many people with type 1 diabetes who struggle to achieve glycaemic control with multiple daily injections of insulin (MDI) plus self-monitoring of blood glucose, MDI plus intermittently scanned continuous glucose monitoring (IS-CGM) or real-time continuous glucose monitoring (RT-CG...

Descripción completa

Detalles Bibliográficos
Autores principales: de Portu, Simona, Vorrink, Linda, Re, Roseline, Shin, John, Castaneda, Javier, Habteab, Aklilu, Cohen, Ohad
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8811581/
https://www.ncbi.nlm.nih.gov/pubmed/35110310
http://dx.doi.org/10.1136/bmjopen-2021-050635
_version_ 1784644466576982016
author de Portu, Simona
Vorrink, Linda
Re, Roseline
Shin, John
Castaneda, Javier
Habteab, Aklilu
Cohen, Ohad
author_facet de Portu, Simona
Vorrink, Linda
Re, Roseline
Shin, John
Castaneda, Javier
Habteab, Aklilu
Cohen, Ohad
author_sort de Portu, Simona
collection PubMed
description INTRODUCTION: For many people with type 1 diabetes who struggle to achieve glycaemic control with multiple daily injections of insulin (MDI) plus self-monitoring of blood glucose, MDI plus intermittently scanned continuous glucose monitoring (IS-CGM) or real-time continuous glucose monitoring (RT-CGM), or insulin administration using insulin pump therapy represent optimised care in many regions. Through technological advances an advanced hybrid closed loop (AHCL) system has been developed; studies of incremental effects relative to MDI plus IS-CGM are lacking. METHODS AND ANALYSIS: The Advanced Hybrid Closed Loop study in Adult Population with Type 1 Diabetes (ADAPT) study is a multinational, prospective, open-label, confirmatory and exploratory randomised controlled trial to examine outcomes with the MiniMed 670G version 4.0 AHCL system (with an equivalent algorithm and commercialised as the MiniMed 780G system, referred to as AHCL) relative to MDI plus IS-CGM in adults with baseline HbA1c≥8.0%. An exploratory cohort will compare AHCL with MDI plus RT-CGM. The study will be conducted in approximately 124 adults on MDI plus either IS-CGM or RT-CGM for at least 3 months prior to screening. The primary endpoint will be the difference in mean HbA1c change from baseline to 6 months between the AHCL and the MDI plus IS-CGM arms. Secondary endpoints will include proportion of time spent in hypoglycaemic, euglycaemic and hyperglycaemic ranges. ETHICS AND DISSEMINATION: The ADAPT study will be conducted in accordance with the requirements of the Declaration of Helsinki and local laws and regulations, and has been approved by ethics committees. The trial will provide valuable information on the incremental benefits that may be provided by AHCL for patients failing to achieve glycaemic targets on MDI plus IS-CGM or RT-CGM and form a basis for health economic evaluations to support market access. TRIAL REGISTRATION NUMBER: NCT04235504; Pre-results.
format Online
Article
Text
id pubmed-8811581
institution National Center for Biotechnology Information
language English
publishDate 2022
publisher BMJ Publishing Group
record_format MEDLINE/PubMed
spelling pubmed-88115812022-02-09 Randomised controlled trial of Advanced Hybrid Closed Loop in an Adult Population with Type 1 Diabetes (ADAPT): study protocol and rationale de Portu, Simona Vorrink, Linda Re, Roseline Shin, John Castaneda, Javier Habteab, Aklilu Cohen, Ohad BMJ Open Diabetes and Endocrinology INTRODUCTION: For many people with type 1 diabetes who struggle to achieve glycaemic control with multiple daily injections of insulin (MDI) plus self-monitoring of blood glucose, MDI plus intermittently scanned continuous glucose monitoring (IS-CGM) or real-time continuous glucose monitoring (RT-CGM), or insulin administration using insulin pump therapy represent optimised care in many regions. Through technological advances an advanced hybrid closed loop (AHCL) system has been developed; studies of incremental effects relative to MDI plus IS-CGM are lacking. METHODS AND ANALYSIS: The Advanced Hybrid Closed Loop study in Adult Population with Type 1 Diabetes (ADAPT) study is a multinational, prospective, open-label, confirmatory and exploratory randomised controlled trial to examine outcomes with the MiniMed 670G version 4.0 AHCL system (with an equivalent algorithm and commercialised as the MiniMed 780G system, referred to as AHCL) relative to MDI plus IS-CGM in adults with baseline HbA1c≥8.0%. An exploratory cohort will compare AHCL with MDI plus RT-CGM. The study will be conducted in approximately 124 adults on MDI plus either IS-CGM or RT-CGM for at least 3 months prior to screening. The primary endpoint will be the difference in mean HbA1c change from baseline to 6 months between the AHCL and the MDI plus IS-CGM arms. Secondary endpoints will include proportion of time spent in hypoglycaemic, euglycaemic and hyperglycaemic ranges. ETHICS AND DISSEMINATION: The ADAPT study will be conducted in accordance with the requirements of the Declaration of Helsinki and local laws and regulations, and has been approved by ethics committees. The trial will provide valuable information on the incremental benefits that may be provided by AHCL for patients failing to achieve glycaemic targets on MDI plus IS-CGM or RT-CGM and form a basis for health economic evaluations to support market access. TRIAL REGISTRATION NUMBER: NCT04235504; Pre-results. BMJ Publishing Group 2022-02-02 /pmc/articles/PMC8811581/ /pubmed/35110310 http://dx.doi.org/10.1136/bmjopen-2021-050635 Text en © Author(s) (or their employer(s)) 2022. 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
de Portu, Simona
Vorrink, Linda
Re, Roseline
Shin, John
Castaneda, Javier
Habteab, Aklilu
Cohen, Ohad
Randomised controlled trial of Advanced Hybrid Closed Loop in an Adult Population with Type 1 Diabetes (ADAPT): study protocol and rationale
title Randomised controlled trial of Advanced Hybrid Closed Loop in an Adult Population with Type 1 Diabetes (ADAPT): study protocol and rationale
title_full Randomised controlled trial of Advanced Hybrid Closed Loop in an Adult Population with Type 1 Diabetes (ADAPT): study protocol and rationale
title_fullStr Randomised controlled trial of Advanced Hybrid Closed Loop in an Adult Population with Type 1 Diabetes (ADAPT): study protocol and rationale
title_full_unstemmed Randomised controlled trial of Advanced Hybrid Closed Loop in an Adult Population with Type 1 Diabetes (ADAPT): study protocol and rationale
title_short Randomised controlled trial of Advanced Hybrid Closed Loop in an Adult Population with Type 1 Diabetes (ADAPT): study protocol and rationale
title_sort randomised controlled trial of advanced hybrid closed loop in an adult population with type 1 diabetes (adapt): study protocol and rationale
topic Diabetes and Endocrinology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8811581/
https://www.ncbi.nlm.nih.gov/pubmed/35110310
http://dx.doi.org/10.1136/bmjopen-2021-050635
work_keys_str_mv AT deportusimona randomisedcontrolledtrialofadvancedhybridclosedloopinanadultpopulationwithtype1diabetesadaptstudyprotocolandrationale
AT vorrinklinda randomisedcontrolledtrialofadvancedhybridclosedloopinanadultpopulationwithtype1diabetesadaptstudyprotocolandrationale
AT reroseline randomisedcontrolledtrialofadvancedhybridclosedloopinanadultpopulationwithtype1diabetesadaptstudyprotocolandrationale
AT shinjohn randomisedcontrolledtrialofadvancedhybridclosedloopinanadultpopulationwithtype1diabetesadaptstudyprotocolandrationale
AT castanedajavier randomisedcontrolledtrialofadvancedhybridclosedloopinanadultpopulationwithtype1diabetesadaptstudyprotocolandrationale
AT habteabaklilu randomisedcontrolledtrialofadvancedhybridclosedloopinanadultpopulationwithtype1diabetesadaptstudyprotocolandrationale
AT cohenohad randomisedcontrolledtrialofadvancedhybridclosedloopinanadultpopulationwithtype1diabetesadaptstudyprotocolandrationale