Assessment of HGI (Hemoglobin Glycation Index) Variability Over Time in Patients Living with Diabetes Using Continuous Glucose Monitoring ( GAP OUEST )
NCT ID: NCT06185491
Last Updated: 2024-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
750 participants
INTERVENTIONAL
2024-06-24
2027-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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HGI
Data collection from glucose monitoring systems. Dosage of glycated hemoglobin and glycated albumin
HGI
Data collection from glucose monitoring systems and dosage of glycated hemoglobin and glycated albumin measured 3 times at 6-month intervals (+/- 3 months)
Interventions
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HGI
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
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Inclusion Criteria
* 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 Criteria
* Unusual acute situation (infection, very unusual physical activity, etc.) deemed significant by the investigator
* Pregnancy started
18 Years
ALL
No
Sponsors
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Nantes University Hospital
OTHER
Responsible Party
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Principal Investigators
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Hélène AUFFRET
Role: PRINCIPAL_INVESTIGATOR
Nantes University Hospital
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Claire BRIET
Role: primary
Claire BRIET
Role: backup
Philippe THUILLIER
Role: primary
Philippe THUILLIER
Role: backup
Michael JOUBERT
Role: primary
Michael JOUBERT
Role: backup
Didier GOUET
Role: primary
Didier GOUET
Role: backup
Charly VAILLANT
Role: primary
Charly VAILLANT
Role: backup
Hélène AUFFRET
Role: primary
Hélène AUFFRET
Role: backup
Pierre Jean SAULNIER
Role: primary
Pierre Jean SAULNIER
Role: backup
Catherine CAMPINOS
Role: primary
Catherine CAMPINOS
Role: backup
Agathe GUENEGO
Role: primary
Agathe GUENEGO
Role: backup
Pierre GOURDY
Role: primary
Pierre GOURDY
Role: backup
Other Identifiers
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RC22_0502
Identifier Type: -
Identifier Source: org_study_id