Diabetes Mellitus
Conditions
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.
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)
Sponsors
Nantes University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Coefficient of variation of the individual distribution of the albumin glycation index | 12 months | Albumin glycation index = glycated albumin measured in laboratory - glycated albumine estimated |
| Glycation gap, determined from comparison between HbA1C measured and HbA1C derived from glycated albumin | 12 months | — |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORHélène AUFFRET
Nantes University Hospital
Outcome results
None listed