Diabeloop for Teens

NACompletedINTERVENTIONAL
Enrollment

49

Participants

Timeline

Start Date

January 25, 2023

Primary Completion Date

February 14, 2024

Study Completion Date

May 19, 2024

Conditions
Closed LoopDiabetes Mellitus, Type 1Adolescents (12 to 17 Years Old)
Interventions
DEVICE

Dexcom G6 Continuous Glucose Monitoring

Collection of glucose data

DEVICE

MEDISAFE WITH External Insulin Pump

Insulin delivery

DEVICE

Diabeloop Software (Model predictive control)

Diabeloop software embeds a regulation algorithm to automatically regulate the patient's glycaemia. It takes as input glycaemia value received every 5 minutes from the CGM and patient inputs related to meals and physical activities and it calculates the amount of insulin to be delivered. It sends this information to the pump that automatically delivers this quantity.

OTHER

Declaration of meals

Patient inputs related to meals

OTHER

No declaration of meals

No patient inputs related to meals

OTHER

Remote monitoring (Telemedicine)

Remote follow up by care health providers team

Trial Locations (3)

Unknown

University Hospitals Leuven, Leuven

Necker Hospital, Paris

Diabetes Center for Children and Adolescents Auf Der Bult, Hanover

All Listed Sponsors
lead

Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

OTHER