Status:
COMPLETED
Clinical Data Collection for the Closed Loop Development for the Type 2 Diabetes Treatment - DT2_1
Lead Sponsor:
Diabeloop
Collaborating Sponsors:
Icadom
AGIR à Dom
Conditions:
Type 2 Diabetes Treated With Insulin
Eligibility:
All Genders
40-75 years
Phase:
NA
Brief Summary
The objective of this study is to collect the evolution of blood glucose levels in type 2 diabetes (T2D) patients under different conditions of their daily life: physical activity, meals, sleep, etc. ...
Detailed Description
T2D is a condition that combines insulin resistance and relative insulin deficiency. The T2D naturally progresses towards an increasingly pronounced insulin deficiency that leads to the need for pancr...
Eligibility Criteria
Inclusion
- Patient with T2D treated with insulin pump for at least 6 months
- Patient with a body mass index (BMI) between 27 and 40 kg/m2
- Patient treated with a total daily dose of insulin between 40 and 300 U/24 h
- Patient with CGM
- Patient with Social security or beneficiary
- Patient able to read and understand the procedure, and able to express consent for the study protocol
Exclusion
- Patient with T1D
- Patient currently participating or having participated in the month prior to inclusion in another interventional clinical research that may impact the study, this impact is left to the investigator's discretion
- Persons referred to in articles L.1121-5 to L.1121-8 of the CSP (corresponds to all the protected persons: pregnant woman (checked by the dosage of β-human chorionic gonadotropin for any woman wishing to participate in the protocol and in childbearing age 60 years), parturient, mother breastfeeding, person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure)
Key Trial Info
Start Date :
September 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT04522882
Start Date
September 9 2020
End Date
December 31 2020
Last Update
June 11 2021
Active Locations (1)
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1
AGIRADOM
Meylan, France, 38140