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Evaluation of Security and Efficacy of Medtrum Hybrid Closed Loop System

NCT06363916 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 160

Last updated 2024-06-18

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Insulin Management System in Manual mode of operation

MEDTRUM A8 TouchCare® Insulin Management system which includes: * Patch pump: Pump base integrated with Hybrid Close Loop (HCL) algorithm not activated * Reservoir Patches * Continuous glucose monitoring (CGM): Glucose Sensor + Transmitter * Personal Diabetes Manager (PDM) and/or EasyPatch® App * EasyFollow® App, EasyView® website System is in conformity with EC marking n° HD 601 357 110001- TUV Rheinland dated February 19th of year 2019 and completed by system DoC 881160 dated June 30th of year 2020. EasyPatch mobile application is in conformity with EC marking n°709972 - BSI - dated March 6th 2020

DEVICE

Insulin Management System in Automatic mode of operation

MEDTRUM A8 TouchCare® Insulin Management system which includes: * Patch pump: Pump base integrated with Hybrid Close Loop (HCL) algorithm activated * Reservoir Patches * Continuous glucose monitoring (CGM): Glucose Sensor + Transmitter * Personal Diabetes Manager (PDM) and/or EasyPatch® App * EasyFollow® App, EasyView® website System is in conformity with EC marking n° HD 601 357 110001- TUV Rheinland dated February 19th of year 2019 and completed by system DoC 881160 dated June 30th of year 2020. EasyPatch mobile application is in conformity with EC marking n°709972 - BSI - dated March 6th 2020

Sponsors & Collaborators

  • Axonal-Biostatem

    collaborator INDUSTRY

  • Medtrum France

    lead INDUSTRY

Principal Investigators

  • Freddy PENFORNIS · Centre Hospitalier Sud-Francilien, Corbeil

Eligibility

Min Age
7 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-15
Primary Completion
2025-11-30
Completion
2025-12-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06363916 on ClinicalTrials.gov