Evaluation of Security and Efficacy of Medtrum Hybrid Closed Loop System

RecruitingOBSERVATIONAL
Enrollment

160

Participants

Timeline

Start Date

April 15, 2024

Primary Completion Date

November 30, 2025

Study Completion Date

December 31, 2025

Conditions
Type 1 Diabetes
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"

Trial Locations (17)

Unknown

NOT_YET_RECRUITING

CHU Angers, Angers

NOT_YET_RECRUITING

CHU Besançon, Besançon

NOT_YET_RECRUITING

CHU Bordeaux, Bordeaux

NOT_YET_RECRUITING

CHU Caen, Caen

RECRUITING

Centre Hospitalier Sud-Francilien, Corbeil-Essonnes

RECRUITING

Centre Hospitalier de Gonesse, Gonesse

NOT_YET_RECRUITING

Centre Hospitalier Saint-Louis, La Rochelle

RECRUITING

Hôpital Hôtel-Dieu, Le Creusot

NOT_YET_RECRUITING

Hospices Civils de Lyon, Lyon

NOT_YET_RECRUITING

Hôpital Européen, Marseille

NOT_YET_RECRUITING

Hôpital La Timone, Marseille

NOT_YET_RECRUITING

CHU Montpellier, Montpellier

NOT_YET_RECRUITING

CHU Nantes, Nantes

NOT_YET_RECRUITING

Hôpital Lariboisière, Paris

NOT_YET_RECRUITING

Hôpital Necker, Paris

NOT_YET_RECRUITING

Hôpital Robert Debré, Paris

NOT_YET_RECRUITING

Hôpital Rangueil, Toulouse

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Axonal-Biostatem

INDUSTRY

lead

Medtrum France

INDUSTRY

NCT06363916 - Evaluation of Security and Efficacy of Medtrum Hybrid Closed Loop System | Biotech Hunter | Biotech Hunter