Status:
RECRUITING
Assessment of HGI (Hemoglobin Glycation Index) Variability Over Time in Patients Living With Diabetes Using Continuous Glucose Monitoring ( GAP OUEST )
Lead Sponsor:
Nantes University Hospital
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this clinical trial is to learn about the variability of HGI (Hemoglobin Glycation Index) over time in patients living with diabetes using a continuous glucose monitoring.
Eligibility Criteria
Inclusion
- Major (adult subject over 18), with no upper age limit
- Enrolled in a social security scheme or beneficiary of such a scheme
- Agreement to participate (informed, written consent)
- Established diabetes (regardless the type of diabetes), known for at least 6 months at inclusion
- Regular user of a glucose monitoring system for at least 3 months.
- Non inclusion Criteria:
- Known hemoglobinopathy
- Inadequate use of the flash glucose monitoring system with a capture rate of less than 70% of interstitial glucose measurements, during the 3 months preceding the inclusion visit.
- Stage 5 renal insufficiency (CKD-EPI less than 15 mL/min/1.73 m2)
- Pregnant or breast-feeding
- Major under guardianship, curatorship or safeguard of justice
- Any situation assessed by the investigator as potentially prejudicial to the participant's health as a result of participation in the study
Exclusion
- Treatment with corticosteroids in the 3 months preceding the visit
- Unusual acute situation (infection, very unusual physical activity, etc.) deemed significant by the investigator
- Pregnancy started
Key Trial Info
Start Date :
June 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
750 Patients enrolled
Trial Details
Trial ID
NCT06185491
Start Date
June 24 2024
End Date
September 1 2028
Last Update
November 18 2025
Active Locations (10)
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1
CHU d'Angers
Angers, France, 49100
2
CHU de Brest
Brest, France, 29200
3
CHU de Caen
Caen, France, 14033
4
CH de La Rochelle
La Rochelle, France, 17019