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

Not Applicable

Recruiting

• Conditions: Diabetes Mellitus
• Interventions: Other: HGI

• Registration Number: NCT06185491
• Lead Sponsor: Nantes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-15
• Study First Submitted QC: 2023-12-15
• Study First Posted: 2023-12-29
• Study Start: 2024-06-24
• Status Verified: 2024-09
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-19
• Primary Completion: 2027-09
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 750

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HGI	HGI	Data collection from glucose monitoring systems. Dosage of glycated hemoglobin and glycated albumin

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (10)

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

Hôpital NOVO; 🇫🇷 Pontoise, France

CHU de Rennes; 🇫🇷 Rennes, France

CHU de Toulouse; 🇫🇷 Toulouse, France