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

Last updated: December 16, 2024
Sponsor: Nantes University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes And Hypertension

Diabetes Prevention

Treatment

HGI

Clinical Study ID

NCT06185491
RC22_0502
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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 monthsat 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 lessthan 70% of interstitial glucose measurements, during the 3 months preceding theinclusion 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 theparticipant's health as a result of participation in the study

Exclusion

Exclusion criteria:

  • Treatment with corticosteroids in the 3 months preceding the visit

  • Unusual acute situation (infection, very unusual physical activity, etc.) deemedsignificant by the investigator

  • Pregnancy started

Study Design

Total Participants: 750
Treatment Group(s): 1
Primary Treatment: HGI
Phase:
Study Start date:
June 24, 2024
Estimated Completion Date:
September 30, 2027

Connect with a study center

  • CHU d'Angers

    Angers, 49100
    France

    Active - Recruiting

  • CHU de Brest

    Brest, 29200
    France

    Active - Recruiting

  • CHU de Caen

    Caen, 14033
    France

    Active - Recruiting

  • CH de La Rochelle

    La Rochelle, 17019
    France

    Site Not Available

  • CH du Mans

    Le Mans, 72037
    France

    Active - Recruiting

  • CHU de Nantes

    Nantes, 44093
    France

    Active - Recruiting

  • CHU de Poitiers

    Poitiers, 86021
    France

    Active - Recruiting

  • Hôpital NOVO

    Pontoise, 95300
    France

    Active - Recruiting

  • CHU de Rennes

    Rennes, 35000
    France

    Active - Recruiting

  • CHU de Toulouse

    Toulouse, 31059
    France

    Active - Recruiting

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