Diabeloop WP7 : Crossover Evaluation of the Safety and the Efficacy of Artificial Pancreas Diabeloop (WP7)
- Conditions
- Closed LoopDiabetes Mellitus, Type 1
- Interventions
- Device: Continuous Glucose MonitoringDevice: External Insulin PumpOther: telemdecineDevice: The Diabeloop Software (Model predictive control)
- Registration Number
- NCT02987556
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 71
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Usual System (open-loop) Continuous Glucose Monitoring 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. DIABELOOP System (closed-loop) Continuous Glucose Monitoring 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. Usual System (open-loop) External Insulin Pump 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. DIABELOOP System (closed-loop) External Insulin Pump 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. DIABELOOP System (closed-loop) telemdecine 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. DIABELOOP System (closed-loop) The Diabeloop Software (Model predictive control) 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.
- Primary Outcome Measures
Name Time Method Percentage of time spent in the tight glycemic control area 70-180 mg/dl continuously measured for 12 weeks For 12 weeks measurement of glucose by CGM
- Secondary Outcome Measures
Name Time Method Total supplies of insulin during tests During 12 weeks for each period total basal and bolus by 24h
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 During 24 hours for 12 weeks measurement of glucose by CGM
Measurement of HbA1c at the onset and at the end of each period of treatment During 12 weeks for each period of treatment Dosage of HbA1c every 3 months
Calculated risks of hypo- and hyperglycemia (LBGI, HBGI) throughout the full period during 12 weeks Throughout the full period during 12 weeks measurement of glucose by CGM
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 During 12 weeks for each period measurement of glucose by CGM
Measuring the oral carbohydrates intake during the last week of each period of treatment During 24 hours for one week before the end of each period of treatment data collected on a booklet
Percentage of time spent in good-working mode during the closed loop period During 12 weeks for the closed loop period measurement of glucose by CGM
Average blood glucose levels throughout the full period During 12 weeks for each period of treatment measurement of glucose by CGM
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) During 12 weeks for each period measurement of glucose by CGM
Number of technical problems causing interruptions of the closed loop During 12 weeks for the closed loop period technical incidents data collected during the study
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 During 12 weeks at the end of each period of treatment DTSQ satisfaction questionnaire, with scale from 6 to 0 where 0 is the worth and 6 the best outcome.
Percentage of time spent in blood glucose <70 mg/dl continuously measured for 12 weeks For 12 weeks measurement of glucose by CGM
Trial Locations
- Locations (3)
Centre Hospitalier Universitaire
🇫🇷Toulouse, France
Centre Hospitalier Universitaire Jean Minjoz
🇫🇷Besancon, France
Centre Hospitalier Sud-Francilien
🇫🇷Corbeil-Essonnes, France