Diabeloop WP6.2 : Crossover Evaluation of Glycemic Control

Phase 2

Completed

• Conditions: Closed Loop; Diabetes Mellitus, Type 1

• Registration Number: NCT02627911
• Lead Sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-12-07
• Study First Submitted QC: 2015-12-09
• Study First Posted: 2015-12-11
• Primary Completion: 2016-08
• Status Verified: 2016-11
• Study Completion: 2016-11
• Last Update Submitted: 2016-11-18
• Last Update Posted: 2016-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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
Number of technical problems causing interruptions of the closed loop	during 3 days for the closed loop period
Nadir glycemic means after physical activity and time of occurrence.	during 3 days for each period
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
Average blood glucose levels throughout the period and sub- periods: sedentarity, prandial and physical activity.	during 3 days for each period
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
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
Measuring the oral carbohydrates intake	during 3 days for each period
Total supplies of insulin during tests (total unit of insulin)	during 3 days for each period
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
Measurement of time spent in blood glucose <70 mg / dl and blood glucose > 180 mg / dl	during 3 days for each period
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
Average peak postprandial glycemic according meals and delays occurred	during 3 days for each period

Trial Locations

Locations (3)

Hôpital Jean Minjoz; 🇫🇷 Besançon, France

Centre Hospitalier Universitaire; 🇫🇷 Toulouse, France

Centre Hospitalier Sud-Francilien; 🇫🇷 Corbeil-Essonnes, France