Trials / Completed
CompletedNCT04725591
Diabeloop for Teens
An Open-label, Multicenter, Randomized, Crossover Study, to Assess 4 Weeks Outpatient, the Clinical Efficacy of the Diabeloop Closed-loop Glucose Control Without the Declaration of Meals Compared with the Diabeloop Closed-loop Glucose Control with the Declaration of Meals, in Adolescent Patients with Type 1 Diabetes Poorly Controlled.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 49 (actual)
- Sponsor
- Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète · Academic / Other
- Sex
- All
- Age
- 12 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
An open-label, three-centers, controlled, randomized, and crossover study containing 14 days of baseline period with standard of care (SOC) therapy followed by two-sessions of 4-weeks home study phase with Diabeloop closed-loop (CL) system comparing the declaration of meals and the non-declaration of meals.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2023-01-25
- Primary completion
- 2024-02-14
- Completion
- 2024-05-19
- First posted
- 2021-01-26
- Last updated
- 2024-09-26
Locations
3 sites across 3 countries: Belgium, France, Germany
Source: ClinicalTrials.gov record NCT04725591. Inclusion in this directory is not an endorsement.