Assessment of HGI (Hemoglobin Glycation Index) Variability Over Time in Patients Living With Diabetes Using Continuous Glucose Monitoring ( GAP OUEST )
GAP OUEST
1 other identifier
interventional
750
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus
Started Jun 2024
Longer than P75 for not_applicable diabetes-mellitus
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 15, 2023
CompletedFirst Posted
Study publicly available on registry
December 29, 2023
CompletedStudy Start
First participant enrolled
June 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2028
November 18, 2025
October 1, 2025
4.2 years
December 15, 2023
November 14, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Coefficient of variation of the individual distribution of the albumin glycation index
12 months
Glycation gap, determined from comparison between HbA1C measured and HbA1C derived from glycated albumin
12 months
Study Arms (1)
HGI
EXPERIMENTALData collection from glucose monitoring systems. Dosage of glycated hemoglobin and glycated albumin
Interventions
Data collection from glucose monitoring systems and dosage of glycated hemoglobin and glycated albumin measured 3 times at 6-month intervals (+/- 3 months)
Eligibility Criteria
You may qualify if:
- 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)
- Regular user of a glucose monitoring system for at least 3 months.
- Known hemoglobinopathy
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
CHU d'Angers
Angers, 49100, France
CHU de Brest
Brest, 29200, France
CHU de Caen
Caen, 14033, France
CH de La Rochelle
La Rochelle, 17019, France
CH du Mans
Le Mans, 72037, France
CHU de Nantes
Nantes, 44093, France
CHU de Poitiers
Poitiers, 86021, France
Hôpital NOVO
Pontoise, 95300, France
CHU de Rennes
Rennes, 35000, France
CHU de Toulouse
Toulouse, 31059, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hélène AUFFRET
Nantes University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2023
First Posted
December 29, 2023
Study Start
June 24, 2024
Primary Completion (Estimated)
September 1, 2028
Study Completion (Estimated)
September 1, 2028
Last Updated
November 18, 2025
Record last verified: 2025-10