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

Study Overview
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Brief Summary
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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.

Official Title
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Crossover Evaluation of the Safety and the Efficacy of Artificial Pancreas Diabeloop for Three Months at Home in Comparison With Conventional Treatment by External Insulin Pump in Patients With Type 1 Diabetes.

Conditions
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Closed Loop, Diabetes Mellitus, Type 1

Intervention / Treatment
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* Device: Continuous Glucose Monitoring
* Device: External Insulin Pump
* Other: telemdecine
* Device: The Diabeloop Software (Model predictive control)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Closed loop vs. Open loop,
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual System (open-loop)<br>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. | Device: Continuous Glucose Monitoring<br>* Collection of glucose data<br>Device: External Insulin Pump<br>* insulin delivery<br>|
| Experimental: DIABELOOP System (closed-loop)<br>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. | Device: Continuous Glucose Monitoring<br>* Collection of glucose data<br>Device: External Insulin Pump<br>* insulin delivery<br>Other: telemdecine<br>* Remote follow up by care health providers team<br>Device: The Diabeloop Software (Model predictive control)<br>* Diabeloop is a Closed-loop (CL) system with a Model Predictive Control (MPC) algorithm reinforced by a decisional matrix, uploaded on a dedicated android smartphone linked to Dexcom CGM and a Cellnovo or Kaleido insulin patch-pump. The Diabeloop software calculates the insulin dose according to the patient's needs.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of time spent in the tight glycemic control area 70-180 mg/dl continuously measured for 12 weeks | measurement of glucose by CGM | For 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of time spent in the glycemic range 70-180 mg/dl, 80-140 mg/dl and in blood glucose >180 mg/dL during nights and during 24 hours for 12 weeks | measurement of glucose by CGM | During 24 hours for 12 weeks | 
| Measurement of HbA1c at the onset and at the end of each period of treatment | Dosage of HbA1c every 3 months | During 12 weeks for each period of treatment | 
| Average blood glucose levels throughout the full period | measurement of glucose by CGM | During 12 weeks for each period of treatment | 
| Calculated risks of hypo- and hyperglycemia (LBGI, HBGI) throughout the full period during 12 weeks | measurement of glucose by CGM | Throughout the full period during 12 weeks | 
| Total supplies of insulin during tests | total basal and bolus by 24h | During 12 weeks for each period | 
| Number of hyper-glycemic events defined by American Diabetes Association (ADA) : severe hyperglycemia > 360 mg/dl (20 mmol/l) measured by CGM or significant ketose (acetonemia > 3 mmol/l) | measurement of glucose by CGM | During 12 weeks for each period | 
| Number of hypoglycemic events, defined by any threshold crossing 60 mg/dl ( 3,33 mmol/l); 70 mg/dl (3,9 mmol/l) and < 54 mg/dl (3 mmol/l) measured by the CGM | measurement of glucose by CGM | During 12 weeks for each period | 
| Measuring the oral carbohydrates intake during the last week of each period of treatment | data collected on a booklet | During 24 hours for one week before the end of each period of treatment | 
| Number of technical problems causing interruptions of the closed loop | technical incidents data collected during the study | During 12 weeks for the closed loop period | 
| Percentage of time spent in good-working mode during the closed loop period | measurement of glucose by CGM | During 12 weeks for the closed loop period | 
| For the use and the acceptance, a satisfaction survey will be done on the daily management of diabetes, the modification of daily life with the system dan the fear of hypoglycemia | DTSQ satisfaction questionnaire, with scale from 6 to 0 where 0 is the worth and 6 the best outcome. | During 12 weeks at the end of each period of treatment | 
| Percentage of time spent in blood glucose <70 mg/dl continuously measured for 12 weeks | measurement of glucose by CGM | For 12 weeks |