Diabetes Mellitus Clinical Trial
— GAP OUESTOfficial title:
Assessment of HGI (Hemoglobin Glycation Index) Variability Over Time in Patients Living With Diabetes Using Continuous Glucose Monitoring
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.
Status | Not yet recruiting |
Enrollment | 750 |
Est. completion date | September 2027 |
Est. primary completion date | September 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | CHU d'Angers | Angers | |
France | CHU de Brest | Brest | |
France | CHU de Caen | Caen | |
France | CH de La Rochelle | La Rochelle | |
France | CH du Mans | Le Mans | |
France | CHU de Nantes | Nantes | |
France | CHU de Poitiers | Poitiers | |
France | CHU de Rennes | Rennes | |
France | CHU de Toulouse | Toulouse |
Lead Sponsor | Collaborator |
---|---|
Nantes University Hospital |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Coefficient of variation of individual HGI distribution | calculated from 3 HGI values, measured 6 months apart, HGI = HbA1C measured in laboratory - HbA1C estimated | 12 months | |
Secondary | Coefficient of variation of the individual distribution of the albumin glycation index | Albumin glycation index = glycated albumin measured in laboratory - glycated albumine estimated | 12 months | |
Secondary | Glycation gap, determined from comparison between HbA1C measured and HbA1C derived from glycated albumin | 12 months |
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