Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2025-12-25 @ 8:57 PM
Study NCT ID:
NCT02987556
Status:
COMPLETED
Last Update Posted:
2019-02-01
First Post:
2016-11-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Diabeloop WP7 : Crossover Evaluation of the Safety and the Efficacy of Artificial Pancreas Diabeloop (WP7)
Sponsor:
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Organization:
Study Overview
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.
Status:
COMPLETED
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WP7
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: