Diabeloop WP6.2 : Crossover Evaluation of Glycemic Control

Diabetes Mellitus, Type 1 Clinical Trial

— WP6-2  

Official title:

DIABELOOP WP6.2 : Crossover Evaluation of Glycemic Control Provided for Three Days by the Artificial Pancreas Diabeloop Compared to Conventional Treatment by External Insulin Pump in Patients With Type 1 Diabetes in Sedentary Position, Outstanding Meals and Physical Activity .

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02627911
• Other study ID #: 2015-A01294-45
• Status: Completed
• Phase: Phase 2
• First received: December 7, 2015
• Last updated: November 18, 2016
• Start date: November 2015
• Est. completion date: November 2016

Study information

• Verified date: November 2016
• Source: Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Closed Loop
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Device:
• Diabeloop System
Insulin delivery
• Continuous Glucose Monitoring

• Accelerometer and heart rate monitor
Monitoring and measurement of physical activity

Dietary Supplement:
• Meals
Calibrated meals for all patients and outstanding dinners for patients being in outstanding meals situation (Centers : Grenoble, Toulouse, Montpellier)

Locations

Country	Name	City	State
France	Hôpital Jean Minjoz	Besançon
France	Centre Hospitalier Universitaire	Caen
France	Centre Hospitalier Sud-Francilien	Corbeil-Essonnes
France	Centre Hospitalier Universitaire	Grenoble
France	Centre Hospitalier Universitaire	Marseille
France	Centre Hospitalier Universitaire	Montpellier
France	Centre Hospitalier Universitaire	Nancy
France	Centre Hospitalier Universitaire	Strasbourg
France	Centre Hospitalier Universitaire	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of time spent in the tight glycemic control area 80-140 mg / dl during the night, continuously measured for 3 days with CGM		during the night for 3 days for each period	Yes
Secondary	Percentage of time spent in the area glycemic reference 70-180 mg / dl during the night measured continuously for 3 days with CGM		during the night for 3 days for each period	Yes
Secondary	Percentage of time spent in the glycemic range 70-180 mg / dl at d3 versus d1 during closed-loop period comparing with d3 versus d1 during open-loop period		during 3 days for each period	Yes
Secondary	Measurement of time spent in blood glucose <70 mg / dl and blood glucose > 180 mg / dl		during 3 days for each period	Yes
Secondary	Average blood glucose levels throughout the period and sub- periods: sedentarity, prandial and physical activity.		during 3 days for each period	Yes
Secondary	Calculated risks of hypo- and hyperglycemia ( LBGI , HBGI ) throughout the period and sub- periods: physical inactivity, prandial and physical activity		during 3 days for each period	Yes
Secondary	Measuring the oral carbohydrates intake		during 3 days for each period	No
Secondary	Number of hypoglycemic events , defined by any threshold crossing 70 mg / dL ( 3.9 mml / L) , and < 54 mg / dL ( 3 mmol / l ) measured by the CGM		during 3 days for each period	Yes
Secondary	Total supplies of insulin during tests (total unit of insulin)		during 3 days for each period	Yes
Secondary	Average peak postprandial glycemic according meals and delays occurred		during 3 days for each period	Yes
Secondary	Number of technical problems causing interruptions of the closed loop		during 3 days for the closed loop period	Yes
Secondary	Comparison of postprandial blood glucose sensor 2h , 3h and 4h and AUC in identical conditions of meals, to evaluate the efficacy and safety ( time spent in hypoglycemia, hyperglycemia and euglycemia )		during 3 days for each period	Yes
Secondary	Nadir glycemic means after physical activity and time of occurrence.		during 3 days for each period	Yes
Secondary	Measurement of AUC during physical activity , the two hours, then to lunch time , during dinner and throughout the night		during 3 days for each period	Yes