160
Participants
Start Date
April 15, 2024
Primary Completion Date
November 30, 2025
Study Completion Date
December 31, 2025
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"
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"
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
Lead Sponsor
Axonal-Biostatem
INDUSTRY
Medtrum France
INDUSTRY