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NCT06363916

Evaluation of Security and Efficacy of Medtrum Hybrid Closed Loop System

Evaluation of Security and Efficacy of Medtrum Hybrid Closed Loop System in Children, Adolescents and Adults With Type 1 Diabetes
Medtrum France·ClinicalTrials.gov·device·Device trialNot yet recruiting
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Study focus
Disease/Condition
Type 1 Diabetes
Drug/Device/Intervention
Insulin Management System in Manual mode of operation
Study type
Observational
Intervention type
device
Sponsor & location
Primary sponsor
Medtrum France
Location
Angers,Besançon,Bordeaux,Caen,Corbeil-Essonnes,Gonesse,La Rochelle,Le Creusot,Lyon,Marseille,Marseille,Montpellier,Nantes,Paris,Paris,Paris,Toulouse, France
Timeline & enrollment
Phase
N/A
Start date
Apr 01, 2024
End date
Dec 01, 2025
Enrollment
160 participants
Primary outcome

Superiority of the algorithm on Time In Range (TIR) between the 2 randomised groups

Summary

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.

ICD-10 classifications
Type 1 diabetes mellitusType 1 diabetes mellitus without complicationsType 1 diabetes mellitus with unspecified complicationsType 1 diabetes mellitus with other specified complicationsType 1 diabetes mellitus with multiple complications
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06363916
Type
Device Trial
About this record

Access comprehensive clinical trial information for NCT06363916 through Pure Global AI's free database. This phase not specified trial is sponsored by Medtrum France and is currently Not yet recruiting. The study focuses on Type 1 Diabetes. Target enrollment is 160 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.