Assessment of HGI (Hemoglobin Glycation Index) Variability Over Time in Patients Living With Diabetes Using Continuous Glucose Monitoring ( GAP OUEST )
HGI: Data collection from glucose monitoring systems and dosage of glycated hemoglobin and glycated albumin measured 3 times at 6-month intervals (+/- 3 months)
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Coefficient of variation of individual HGI distribution — 12 months calculated from 3 HGI values, measured 6 months apart, HGI = HbA1C measured in laboratory - HbA1C estimated
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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