RecruitingNot ApplicableNCT06185491
Assessment of HGI (Hemoglobin Glycation Index) Variability Over Time in Patients Living With Diabetes Using Continuous Glucose Monitoring ( GAP OUEST )
Assessment of HGI (Hemoglobin Glycation Index) Variability Over Time in Patients Living With Diabetes Using Continuous Glucose Monitoring
Sponsor
Nantes University Hospital
Enrollment
750 participants
Start Date
Jun 24, 2024
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria11
- 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.
- 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 Criteria3
- 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
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Interventions
OTHERHGI
Data collection from glucose monitoring systems and dosage of glycated hemoglobin and glycated albumin measured 3 times at 6-month intervals (+/- 3 months)
Locations(10)
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NCT06185491
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