Diabeloop WP7 : Crossover Evaluation of the Safety and the Efficacy of Artificial Pancreas Diabeloop (WP7) (WP7)
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ClinicalTrials.gov Identifier: NCT02987556 |
Recruitment Status :
Completed
First Posted : December 9, 2016
Last Update Posted : February 1, 2019
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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.
Condition or disease | Intervention/treatment | Phase |
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Closed Loop Diabetes Mellitus, Type 1 | Device: Continuous Glucose Monitoring Device: External Insulin Pump Other: telemdecine Device: The Diabeloop Software (Model predictive control) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 71 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Intervention Model Description: | Closed loop vs. Open loop, |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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. |
Actual Study Start Date : | March 30, 2017 |
Actual Primary Completion Date : | August 28, 2018 |
Actual Study Completion Date : | August 28, 2018 |

Arm | Intervention/treatment |
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Active Comparator: Usual System (open-loop)
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.
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Device: Continuous Glucose Monitoring
Collection of glucose data Device: External Insulin Pump insulin delivery |
Experimental: DIABELOOP System (closed-loop)
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.
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Device: Continuous Glucose Monitoring
Collection of glucose data Device: External Insulin Pump insulin delivery Other: telemdecine Remote follow up by care health providers team Device: The 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. |
- Percentage of time spent in the tight glycemic control area 70-180 mg/dl continuously measured for 12 weeks [ Time Frame: For 12 weeks ]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 [ Time Frame: 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 [ Time Frame: During 12 weeks for each period of treatment ]Dosage of HbA1c every 3 months
- Average blood glucose levels throughout the full period [ Time Frame: 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 [ Time Frame: Throughout the full period during 12 weeks ]measurement of glucose by CGM
- Total supplies of insulin during tests [ Time Frame: 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) [ Time Frame: During 12 weeks for each period ]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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: For 12 weeks ]measurement of glucose by CGM

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02987556
France | |
Centre Hospitalier Universitaire Jean Minjoz | |
Besancon, France, 25030 | |
Centre Hospitalier Universitaire | |
Caen, France, 14033 | |
Centre Hospitalier Sud-Francilien | |
Corbeil-Essonnes, France, 91100 | |
Centre Hospitalier Universitaire | |
Grenoble, France, 38700 | |
Centre Hospitalier Universitaire | |
Lyon, France, 69000 | |
Centre Hospitalier Universitaire | |
Marseille, France, 13000 | |
Centre Hospitalier Universitaire | |
Montpellier, France, 34295 | |
Centre Hospitalier Universitaire | |
Nancy, France, 54000 | |
Centre Hospitalier Universitaire | |
Nantes, France, 44000 | |
Centre Hospitalier Universitaire | |
Reims, France, 51100 | |
Centre Hospitalier Universitaire | |
Strasbourg, France, 67000 | |
Centre Hospitalier Universitaire | |
Toulouse, France, 31400 |
Responsible Party: | Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète |
ClinicalTrials.gov Identifier: | NCT02987556 |
Other Study ID Numbers: |
2016-A01198-43 |
First Posted: | December 9, 2016 Key Record Dates |
Last Update Posted: | February 1, 2019 |
Last Verified: | May 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Diabetes Mellitus, Type 1 Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Autoimmune Diseases Immune System Diseases Insulin Hypoglycemic Agents Physiological Effects of Drugs |