Assessment of HGI (Hemoglobin Glycation Index) Variability Over Time in Patients Living with Diabetes Using Continuous Glucose Monitoring ( GAP OUEST )

Nantes University Hospital (NUH)

Status

Enrolling

Conditions

Diabetes Mellitus

Treatments

Other: HGI

Study type

Interventional

Funder types

Other

Identifiers

NCT06185491

RC22_0502

Details and patient eligibility

About

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.

Enrollment

750 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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