NCT06185491Active, not recruitingNot Applicable
Assessment of HGI (Hemoglobin Glycation Index) Variability Over Time in Patients Living With Diabetes Using Continuous Glucose Monitoring
Nantes University Hospital19 sites in 1 country750 target enrollmentStarted: June 24, 2024Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Nantes University Hospital
- Enrollment
- 750
- Locations
- 19
- Primary Endpoint
- Coefficient of variation of individual HGI distribution
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
HGI
Experimental
Data collection from glucose monitoring systems. Dosage of glycated hemoglobin and glycated albumin
Intervention: HGI (Other)
Outcomes
Primary Outcomes
Coefficient of variation of individual HGI distribution
Time Frame: 12 months
calculated from 3 HGI values, measured 6 months apart, HGI = HbA1C measured in laboratory - HbA1C estimated
Secondary Outcomes
- Coefficient of variation of the individual distribution of the albumin glycation index(12 months)
- Glycation gap, determined from comparison between HbA1C measured and HbA1C derived from glycated albumin(12 months)
Investigators
Study Sites (19)
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