Status:
COMPLETED
The MiniMed™ 780G Glycemic Control and Quality of Life Study for the Treatment of Pediatric and Adult Subjects With Type 1 Diabetes in France.
Lead Sponsor:
Medtronic Diabetes
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
7+ years
Brief Summary
The purpose of the study is to evaluate the efficacy in glycemic control and the impact on the quality of life of patients using the MiniMed™ 780G System for the treatment of Type 1 diabetes, in real ...
Detailed Description
Local, post-market, non-interventional, prospective, single-arm, multi-center study of patients pediatric and adult. The study is conducted according to the same schedule as the routine follow-up of ...
Eligibility Criteria
Inclusion
- Subject is ≥7 years of age.
- Subject has a clinical diagnosis of type 1 diabetes for more than 1 year as determined via medical records or source documentation by an individual qualified to make a medical diagnosis.
- Subject has a HbA1c value greater than 6.5% and less than 12% at time of enrolment visit.
- Subject is under Continuous Subcutaneous Insulin Infusion (CSII) therapy (with or without Continuous Glucose Monitoring) ≥ 6 months before enrolment.
- Subject requires ≥8 units of insulin per day.
- Subjects and their parent(s)/guardian(s) must be able to speak and be literate in French as verified by the investigator.
- Subjects and their parent(s)/guardian(s) are willing to participate in the study and sign the Data Release Form (DRF).
- Subjects who are ≥18 years of age should be able to provide consent.
Exclusion
- Subject has MiniMed™ 780G System IFU contraindication(s).
- Subject uses Predictive Low-Glucose Management (PLGM) System (i.e. MiniMed™ 640G with SmartGuard) in the last 6 months before the enrolment.
- Subject uses Low Glucose suspend (LGS) feature (i.e. MiniMed™ Paradigm Veo Pump) in the last 6 months before the enrolment.
- Subject under Multiple-Daily Injections (MDI) treatment in the 6 months before the enrolment.
- Subject has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
Key Trial Info
Start Date :
February 15 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 27 2022
Estimated Enrollment :
306 Patients enrolled
Trial Details
Trial ID
NCT04308291
Start Date
February 15 2021
End Date
October 27 2022
Last Update
July 8 2024
Active Locations (32)
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1
CHU Angers
Angers, France
2
CHU Besançon
Besançon, France
3
APHP Avicenne
Bobigny, France
4
CHU Bordeaux (Saint-André)
Bordeaux, France