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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
71
Collection of glucose data
insulin delivery
Remote follow up by care health providers team
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.
Centre Hospitalier Universitaire Jean Minjoz
Besançon, France
Centre Hospitalier Universitaire
Caen, France
Centre Hospitalier Sud-Francilien
Corbeil-Essonnes, France
Centre Hospitalier Universitaire
Grenoble, France
Centre Hospitalier Universitaire
Lyon, France
Centre Hospitalier Universitaire
Marseille, France
Centre Hospitalier Universitaire
Montpellier, France
Centre Hospitalier Universitaire
Nancy, France
Centre Hospitalier Universitaire
Nantes, France
Centre Hospitalier Universitaire
Reims, France
...and 2 more locations
Percentage of time spent in the tight glycemic control area 70-180 mg/dl continuously measured for 12 weeks
measurement of glucose by CGM
Time frame: For 12 weeks
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
Time frame: 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
Time frame: During 12 weeks for each period of treatment
Average blood glucose levels throughout the full period
measurement of glucose by CGM
Time frame: 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
Time frame: Throughout the full period during 12 weeks
Total supplies of insulin during tests
total basal and bolus by 24h
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: For 12 weeks
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