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

N

Nantes University Hospital (NUH)

Status

Enrolling

Conditions

Diabetes Mellitus

Treatments

Other: HGI

Study type

Interventional

Funder types

Other

Identifiers

NCT06185491
RC22_0502

Details and patient eligibility

About

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.

Enrollment

750 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

750 participants in 1 patient group

HGI
Experimental group
Description:
Data collection from glucose monitoring systems. Dosage of glycated hemoglobin and glycated albumin
Treatment:
Other: HGI

Trial contacts and locations

10

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Central trial contact

Hélène AUFFRET

Data sourced from clinicaltrials.gov

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