WP7
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.
Sponsor study identifier
interventional
71
1 country
12
Study Start
March 30, 2017
Actual (reported)Primary Completion
August 28, 2018
Actual (reported)Study Completion
August 28, 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 28, 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 28, 2016
Actual (reported)December 9, 2016
Actual (reported)March 30, 2017
Actual (reported)August 28, 2018
Actual (reported)August 28, 2018
Actual (reported)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
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 HbA1c at the onset and at the end of each period of treatment
During 12 weeks for each period of treatment
Average blood glucose levels throughout the full period
During 12 weeks for each period of treatment
Calculated risks of hypo- and hyperglycemia (LBGI, HBGI) throughout the full period during 12 weeks
Throughout the full period during 12 weeks
Total supplies of insulin during tests
During 12 weeks for each period
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.
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.
Collection of glucose data
insulin delivery
Centre Hospitalier Universitaire Jean Minjoz
Besançon, 25030, France
Centre Hospitalier Universitaire
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
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.
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.
71 participants (actual enrollment reported by the registry).
First Submitted
November 28, 2016
First Posted
December 9, 2016
Study Start
March 30, 2017
Actual (reported)Comparison of the Use of Energy Substrates and Hormonal Regulation of Blood Sugar During Exercise of Increasing Intensity Between Children With Type 1 Diabetes and Non-diabetic Control Children.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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, 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.
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.
Primary Completion
August 28, 2018
Actual (reported)Study Completion
August 28, 2018
Actual (reported)Last Updated
February 1, 2019
Record last verified: 2018-05
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Source: ClinicalTrials.gov.
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