Assessment of HGI (Hemoglobin Glycation Index) Variability Over Time in Patients Living With Diabetes Using Continuous Glucose Monitoring ( GAP OUEST )

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.

Official Title
-----------------
Assessment of HGI (Hemoglobin Glycation Index) Variability Over Time in Patients Living With Diabetes Using Continuous Glucose Monitoring

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Other: HGI


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HGI<br>Data collection from glucose monitoring systems. Dosage of glycated hemoglobin and glycated albumin | Other: HGI<br>* Data collection from glucose monitoring systems and dosage of glycated hemoglobin and glycated albumin measured 3 times at 6-month intervals (+/- 3 months)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Glycation gap, determined from comparison between HbA1C measured and HbA1C derived from glycated albumin |  | 12 months |