Diabeloop WP6.2 : Crossover Evaluation of Glycemic Control (WP6-2)

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

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 1; Closed Loop

Treatments: Device: Continuous Glucose Monitoring; Dietary Supplement: Meals; Device: Diabeloop System; Device: Accelerometer and heart rate monitor

Study type: Interventional

Funder types: Other

Identifiers

NCT02627911

2015-A01294-45

Details and patient eligibility

About

The study will be conducted in crossover trial, with two 72-hour hospitalization separated by a period Wash-out of at least one week. Each hospitalization is a period of treatment. According to randomization, patients will be provided with either Diabeloop system or the usual system.

In both treatment periods:

• patients in a situation of sedentarity or physical activity, will be equipped with ActiGraph (measuring motricity) and a ActiHeart ( measuring heart rate)
• meals and physical activities will be similar in both periods
• the same blood glucose meter will be used throughout the duration of the study.
• the capillary blood glucose will be performed : before bolus and 2 hours after a meal, before exercise, in case of hypo or hyper-glycemic episodes and when the patient and / or investigator deem it necessary.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 1 diabetic patient for at least one year, treated by external insulin pump for at least 6 months
• Patient with 7.5 % < HbA1c < 9.5 %
• Patient practicing functional insulin therapy
• In the situation of physical activity , the patient must be able to perform one or more daily physical activities for 3 days in each treatment session
• 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

• Type 2 diabetic patients
• Any serious illness that may impair study participation*
• Patient with insulin resistance defined in insulin requirements > 1.5 U / kg / day
• Patient no longer sensing his hypoglycemia
• 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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36 participants in 2 patient groups

Usual System (open-loop)

Other group

Description:

In open loop, the patient will be provided with its usual pump and a CGM. To estimate rest and physical activity in patients being sedentary situation ( Centers : Caen, Nancy \& Strasbourg) or in situations of physical activity ( Centers : CHSF Marseille and Besancon ) , the usual system will be complemented by an accelerometer " ActiGraph " and a " ActiHeart " heart rate monitor.

Treatment:

Device: Continuous Glucose Monitoring

Device: Accelerometer and heart rate monitor

Dietary Supplement: Meals

DIABELOOP System (closed-loop)

Experimental group

Description:

In the closed loop, the patient's pump will be replaced by the Diabeloop system consisting of insulin pump Cellnovo driven by remote control augmented by Diabeloop software and connected to the CGM.

Treatment:

Device: Continuous Glucose Monitoring

Device: Diabeloop System

Device: Accelerometer and heart rate monitor

Dietary Supplement: Meals