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Evaluation of Security and Efficacy of Medtrum Hybrid Closed Loop System in Children, Adolescents and Adults With Type 1 Diabetes
The purpose of this study is to evaluate the safety and effectiveness of the MEDTRUM Hybrid Closed Loop (HCL) System in children, adolescents, and adults with type 1 diabetes (7-75 years old) in a home setting and to test the function of meal announcement in an extend study. The main question it aims to answer is : • Is the Hybrid Closed Loop system superior at increasing the time spent in the target glucose range of 70-180 mg/dL when compared to the Open (manual) Loop system ? Participants will be : * Trained into the use of the Insulin pump MEDTRUM A8 TouchCare® Insulin Management system * Randomized to the Open Loop or Closed Loop group * Respond to self administered questionnaires : the Hypoglycaemia Fear Survey, the Diabetes Quality of Life Questionnaire, and the Diabetes treatment Satisfaction Questionnaire status Researchers will compare the time spent in the target glucose range of 70-180 mg/mL during the last 12 weeks of the study between the patients randomised to the Open Loop group and those randomised to the Closed Loop group.
Age
7 - 75 years
Sex
ALL
Healthy Volunteers
No
CHU Angers
Angers, France
CHU Besançon
Besançon, France
CHU Bordeaux
Bordeaux, France
CHU Caen
Caen, France
Centre Hospitalier Sud-Francilien
Corbeil-Essonnes, France
Centre Hospitalier de Gonesse
Gonesse, France
Centre Hospitalier Saint-Louis
La Rochelle, France
Hôpital Hôtel-Dieu
Le Creusot, France
Hospices Civils de Lyon
Lyon, France
Hôpital Européen
Marseille, France
Start Date
April 15, 2024
Primary Completion Date
November 1, 2025
Completion Date
December 1, 2025
Last Updated
June 18, 2024
160
ESTIMATED participants
Insulin Management System in Manual mode of operation
DEVICE
Insulin Management System in Automatic mode of operation
DEVICE
Lead Sponsor
Medtrum France
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07455994