Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06185491

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU d'Angers, Angers, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HGI

Other

Data collection from glucose monitoring systems and dosage of glycated hemoglobin and glycated albumin measured 3 times at 6-month intervals (+/- 3 months)

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Glycation gap, determined from comparison between HbA1C measured and HbA1C derived from glycated albumin

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Acronym: GAP OUEST

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Dec 29, 2023
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.