NCT02627911CompletedPhase 2
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 .
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète12 sites in 1 country36 target enrollmentStarted: November 1, 2015Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 36
- Locations
- 12
- Primary Endpoint
- Percentage of time spent in the tight glycemic control area 80-140 mg / dl during the night, continuously measured for 3 days with CGM
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Percentage of time spent in the tight glycemic control area 80-140 mg / dl during the night, continuously measured for 3 days with CGM
Time Frame: during the night for 3 days for each period
Secondary Outcomes
- Nadir glycemic means after physical activity and time of occurrence.(during 3 days for each period)
- 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)
- 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)
Investigators
Study Sites (12)
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