NCT02987556: WP7

Diabeloop WP7 : Crossover Evaluation of the Safety and the Efficacy of Artificial Pancreas Diabeloop (WP7)

Completed NA Last updated 1 February 2019

What this trial tests

NA trial testing Continuous Glucose Monitoring in Closed Loop in 71 participants. Completed in 28 August 2018.

Timeline

30 March 2017

Primary endpoint
28 August 2018

28 August 2018

Quick facts

Lead sponsor	Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	71
Start date	30 March 2017
Primary completion	28 August 2018
Estimated completion	28 August 2018
Sites	12 locations across France

Drugs / interventions tested

• Continuous Glucose Monitoring
• External Insulin Pump
• telemdecine
• The Diabeloop Software (Model predictive control)

Conditions studied

• Closed Loop — all drugs for Closed Loop →
• Diabetes Mellitus, Type 1 — all drugs for Diabetes Mellitus, Type 1 →

Sponsor

Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

Who can join

18 and older, any sex, with Closed Loop or Diabetes Mellitus, Type 1. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Closed-loop insulin delivery in adults with type 1 diabetes in real-life conditions: a 12-week multicentre, open-label randomised controlled crossover trial.
   Benhamou PY, Franc S, Reznik Y, Thivolet C, et al · · 2019 · cited 151× · PMID 33323237 · DOI 10.1016/s2589-7500(19)30003-2
2. Glucose control and psychosocial outcomes with use of automated insulin delivery for 12 to 96 weeks in type 1 diabetes: a meta-analysis of randomised controlled trials.
   Godoi A, Reis Marques I, Padrão EMH, Mahesh A, et al · · 2023 · cited 50× · PMID 37759290 · DOI 10.1186/s13098-023-01144-4
3. Better TIR, HbA1c, and less hypoglycemia in closed-loop insulin system in patients with type 1 diabetes: a meta-analysis.
   Jiao X, Shen Y, Chen Y. · · 2022 · cited 45× · PMID 35450868 · DOI 10.1136/bmjdrc-2021-002633
4. Customization of home closed-loop insulin delivery in adult patients with type 1 diabetes, assisted with structured remote monitoring: the pilot WP7 Diabeloop study.
   Benhamou PY, Huneker E, Franc S, Doron M, et al · · 2018 · cited 24× · PMID 29520615 · DOI 10.1007/s00592-018-1123-1
5. Efficacy of a Hybrid Closed-Loop Solution in Patients With Excessive Time in Hypoglycaemia: A Post Hoc Analysis of Trials With DBLG1 System.
   Benhamou PY, Adenis A, Tourki Y, Pou S, et al · · 2024 · cited 22× · PMID 36172702 · DOI 10.1177/19322968221128565
6. No more hypoglycaemia on days with physical activity and unrestricted diet when using a closed-loop system for 12 weeks: A post hoc secondary analysis of the multicentre, randomized controlled Diabeloop WP7 trial.
   Franc S, Benhamou PY, Borot S, Chaillous L, et al · · 2021 · cited 14× · PMID 34009725 · DOI 10.1111/dom.14442
7. 57^th EASD Annual Meeting of the European Association for the Study of Diabetes.
   · 2021 · cited 11× · PMID 34468792 · DOI 10.1007/s00125-021-05519-y
8. Hybrid Closed-Loop Control with Ultrarapid Lispro Compared with Standard Insulin Aspart and Faster Insulin Aspart: An In Silico Study.
   Lachal S, Tourki Y, Franc S, Huneker E, et al · · 2023 · cited 8× · PMID 34658265 · DOI 10.1177/19322968211046021