Diabeloop WP7 : Crossover Evaluation of the Safety and the Efficacy of Artificial Pancreas Diabeloop (WP7)
NCT ID: NCT02987556
Last Updated: 2019-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
71 participants
INTERVENTIONAL
2017-03-30
2018-08-28
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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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.
Continuous Glucose Monitoring
Collection of glucose data
External Insulin Pump
insulin delivery
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.
Continuous Glucose Monitoring
Collection of glucose data
External Insulin Pump
insulin delivery
telemdecine
Remote follow up by care health providers team
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.
Interventions
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Continuous Glucose Monitoring
Collection of glucose data
External Insulin Pump
insulin delivery
telemdecine
Remote follow up by care health providers team
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
OTHER
Responsible Party
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Locations
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Centre Hospitalier Universitaire Jean Minjoz
Besançon, , France
Centre Hospitalier Universitaire
Caen, , France
Centre Hospitalier Sud-Francilien
Corbeil-Essonnes, , France
Centre Hospitalier Universitaire
Grenoble, , France
Centre Hospitalier Universitaire
Lyon, , France
Centre Hospitalier Universitaire
Marseille, , France
Centre Hospitalier Universitaire
Montpellier, , France
Centre Hospitalier Universitaire
Nancy, , France
Centre Hospitalier Universitaire
Nantes, , France
Centre Hospitalier Universitaire
Reims, , France
Centre Hospitalier Universitaire
Strasbourg, , France
Centre Hospitalier Universitaire
Toulouse, , France
Countries
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References
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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.
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.
Other Identifiers
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2016-A01198-43
Identifier Type: -
Identifier Source: org_study_id
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