Clinical trial NCT02987556: Diabeloop WP7 : Crossover Evaluation of the Safety and the Efficacy of Artificial Pancreas Diabeloop (WP7)
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Closed Loop
Diabetes Mellitus, Type 1
Lead sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Sponsor class: OTHER
First posted: 2016-12-09
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Closed loop vs. Open loop,
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of time spent in the tight glycemic control area 70-180 mg/dl continuously measured for 12 weeks
timeFrame: For 12 weeks
Secondary outcomes:
measure: 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
timeFrame: During 24 hours for 12 weeks
measure: Measurement of HbA1c at the onset and at the end of each period of treatment
timeFrame: During 12 weeks for each period of treatment
measure: Average blood glucose levels throughout the full period
timeFrame: During 12 weeks for each period of treatment
measure: Calculated risks of hypo- and hyperglycemia (LBGI, HBGI) throughout the full period during 12 weeks
timeFrame: Throughout the full period during 12 weeks
measure: Total supplies of insulin during tests
timeFrame: During 12 weeks for each period
measure: 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)
timeFrame: During 12 weeks for each period
measure: 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
timeFrame: During 12 weeks for each period
measure: Measuring the oral carbohydrates intake during the last week of each period of treatment
timeFrame: During 24 hours for one week before the end of each period of treatment
measure: Number of technical problems causing interruptions of the closed loop
timeFrame: During 12 weeks for the closed loop period
measure: Percentage of time spent in good-working mode during the closed loop period
timeFrame: During 12 weeks for the closed loop period
measure: 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
timeFrame: During 12 weeks at the end of each period of treatment
measure: Percentage of time spent in blood glucose <70 mg/dl continuously measured for 12 weeks
timeFrame: For 12 weeks
Other outcomes:
Locations:
city: Besancon
country: France
facility: Centre Hospitalier Universitaire Jean Minjoz
city: Caen
country: France
facility: Centre Hospitalier Universitaire
city: Corbeil-Essonnes
country: France
facility: Centre Hospitalier Sud-Francilien
city: Grenoble
country: France
facility: Centre Hospitalier Universitaire
city: Lyon
country: France
facility: Centre Hospitalier Universitaire
city: Marseille
country: France
facility: Centre Hospitalier Universitaire
city: Montpellier
country: France
facility: Centre Hospitalier Universitaire
city: Nancy
country: France
facility: Centre Hospitalier Universitaire
city: Nantes
country: France
facility: Centre Hospitalier Universitaire
city: Reims
country: France
facility: Centre Hospitalier Universitaire
city: Strasbourg
country: France
facility: Centre Hospitalier Universitaire
city: Toulouse
country: France
facility: Centre Hospitalier Universitaire
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.