RecruitingNot ApplicableNCT06185491

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

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


Sponsor

Nantes University Hospital

Enrollment

750 participants

Start Date

Jun 24, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria11

  • 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.
  • 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 Criteria3

  • 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

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Interventions

OTHERHGI

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


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

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NCT06185491


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