Diabeloop WP7 : Crossover Evaluation of the Safety and the Efficacy of Artificial Pancreas Diabeloop (WP7)

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

Status: Completed

Conditions: Diabetes Mellitus, Type 1; Closed Loop

Treatments: Device: Continuous Glucose Monitoring; Other: telemdecine; Device: The Diabeloop Software (Model predictive control); Device: External Insulin Pump

Study type: Interventional

Funder types: Other

Identifiers

NCT02987556

2016-A01198-43

Details and patient eligibility

About

The study will be conducted in crossover trial, with two 12-weeks periods separated by a Wash-out period of at least one month. According to randomization ,patients will be provided with either Diabeloop system or the usual system.

Patients will be trained for the use of blood glucose meter, of external Insulin Pump and Diabeloop system.

In both treatment periods, the same blood glucose meter will be used throughout the duration of the study.

In two centers (Centre Hospitalier Sud-Francilien and Grenoble), a pre-study will be performed during four weeks to improve the efficacy of Diabeloop system with data collection, to test the manual settings by health care providers and patients and to check the good-working of the follow-up platform.

Enrollment: 71 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 1 diabetic patient for at least two years
• Patient treated by external insulin pump for at least 6 months
• Patient with HbA1c ≤ 10%; dosage of less than 4 months done in analysis laboratory medical or equivalent.
• Patient requiring a daily dose of insulin ≤ 50 units
• Patient domiciled in an area with Global System for Mobile Communication (GSM)
• Not isolated patient, not living alone, or having a person "resource" living nearby and having a phone and the key of its place of residence
• Patient not envisaging a journey outside France during the "closed-loop" period
• Patient aged over 18 years
• Patient affiliated to Social Security
• Patient who agreed to participate in the study and who signed an informed consent

Exclusion criteria

• Patient with any serious illness that may impair study participation
• Patient having a treatment known to have a significant interference on the glycemia.
• Patient enjoying a measure of legal protection
• Pregnant woman or likely to be

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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71 participants in 2 patient groups

Usual System (open-loop)

Active Comparator group

Description:

In open loop, patients will be provided with an Continuous Glucose Monitoring (CGM) and an external insulin pump programmed with its usual treatment previously prescribed by its physician.

Treatment:

Device: Continuous Glucose Monitoring

Device: External Insulin Pump

DIABELOOP System (closed-loop)

Experimental group

Description:

In the closed-loop, patients will be provided with the Diabeloop system consisting of insulin pump Cellnovo or Kaleido driven by remote control augmented by Diabeloop software and connected to the CGM Prescription of insulin doses proposed by a predictive algorithm.

Treatment:

Other: telemdecine

Device: The Diabeloop Software (Model predictive control)

Device: Continuous Glucose Monitoring

Device: External Insulin Pump