Closed Loop, Diabetes Mellitus, Type 1
Conditions
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.
Interventions
DEVICEContinuous Glucose Monitoring
Collection of glucose data
DEVICEExternal Insulin Pump
insulin delivery
OTHERtelemdecine
Remote follow up by care health providers team
DEVICEThe Diabeloop Software (Model predictive control)
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.
Sponsors
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Closed loop vs. Open loop,
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Average blood glucose levels throughout the full period | During 12 weeks for each period of treatment | measurement of glucose by CGM |
| 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 |
| Total supplies of insulin during tests | During 12 weeks for each period | total basal and bolus by 24h |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Countries
France
Outcome results
None listed