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

May 21, 2026 updated by: Nantes University Hospital

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

750

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 12 months
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
Time Frame: 12 months
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
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Investigators

  • Principal Investigator: Hélène AUFFRET, Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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