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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Other: HGI

• Study Type: Interventional
• Enrollment (Actual): 750
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Angers, France, 49100
    • CHU d'Angers
  • Brest, France, 29200
    • CHU de Brest
  • Caen, France, 14033
    • CHU de Caen
  • Le Mans, France, 72037
    • CH du Mans
  • Nantes, France, 44093
    • CHU de Nantes
  • Poitiers, France, 86021
    • CHU De Poitiers
  • Pontoise, France, 95300
    • Hopital NOVO
  • Rennes, France, 35000
    • CHU de Rennes
  • Toulouse, France, 31059
    • CHU de Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: Hélène AUFFRET, Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2024
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: December 15, 2023
• First Submitted That Met QC Criteria: December 15, 2023
• First Posted (Actual): December 29, 2023

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus
• Other Study ID Numbers: RC22_0502

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No