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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual System (open-loop) | Active Comparator | 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) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Glucose Monitoring | Device | Collection of glucose data |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire Jean Minjoz | Besançon | 25030 | France | |||
| Centre Hospitalier Universitaire |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36172702 | Derived | Benhamou PY, Adenis A, Tourki Y, Pou S, Madrolle S, Franc S, Kariyawasam D, Beltrand J, Klonoff DC, Charpentier G. Efficacy of a Hybrid Closed-Loop Solution in Patients With Excessive Time in Hypoglycaemia: A Post Hoc Analysis of Trials With DBLG1 System. J Diabetes Sci Technol. 2024 Mar;18(2):372-379. doi: 10.1177/19322968221128565. Epub 2022 Sep 29. | |
| 33323237 |
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Closed loop vs. Open loop,
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| External Insulin Pump | Device | insulin delivery |
|
| telemdecine | Other | Remote follow up by care health providers team |
|
| The Diabeloop Software (Model predictive control) | Device | 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. |
|
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 |
| Caen |
| 14033 |
| France |
| Centre Hospitalier Sud-Francilien | Corbeil-Essonnes | 91100 | France |
| Centre Hospitalier Universitaire | Grenoble | 38700 | France |
| Centre Hospitalier Universitaire | Lyon | 69000 | France |
| Centre Hospitalier Universitaire | Marseille | 13000 | France |
| Centre Hospitalier Universitaire | Montpellier | 34295 | France |
| Centre Hospitalier Universitaire | Nancy | 54000 | France |
| Centre Hospitalier Universitaire | Nantes | 44000 | France |
| Centre Hospitalier Universitaire | Reims | 51100 | France |
| Centre Hospitalier Universitaire | Strasbourg | 67000 | France |
| Centre Hospitalier Universitaire | Toulouse | 31400 | France |
| Benhamou PY, Franc S, Reznik Y, Thivolet C, Schaepelynck P, Renard E, Guerci B, Chaillous L, Lukas-Croisier C, Jeandidier N, Hanaire H, Borot S, Doron M, Jallon P, Xhaard I, Melki V, Meyer L, Delemer B, Guillouche M, Schoumacker-Ley L, Farret A, Raccah D, Lablanche S, Joubert M, Penfornis A, Charpentier G; DIABELOOP WP7 Trial Investigators. Closed-loop insulin delivery in adults with type 1 diabetes in real-life conditions: a 12-week multicentre, open-label randomised controlled crossover trial. Lancet Digit Health. 2019 May;1(1):e17-e25. doi: 10.1016/S2589-7500(19)30003-2. Epub 2019 May 2. |
| 32958628 | Derived | Benhamou PY, Madrolle S, Lablanche S, Gallegos A, Tourki Y, Franc S, Doron M, Charpentier G. Comment on Leelarathna et al. Duration of Hybrid Closed-Loop Insulin Therapy to Achieve Representative Glycemic Outcomes in Adults With Type 1 Diabetes. Diabetes Care 2020;43:e38-e39. Diabetes Care. 2020 Oct;43(10):e167. doi: 10.2337/dc20-1291. No abstract available. |
| 29520615 | Derived | Benhamou PY, Huneker E, Franc S, Doron M, Charpentier G; Diabeloop Consortium. Customization of home closed-loop insulin delivery in adult patients with type 1 diabetes, assisted with structured remote monitoring: the pilot WP7 Diabeloop study. Acta Diabetol. 2018 Jun;55(6):549-556. doi: 10.1007/s00592-018-1123-1. Epub 2018 Mar 9. |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000095583 | Continuous Glucose Monitoring |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |
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