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

Diabetes Mellitus Clinical Trial

— GAP OUEST  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06185491
• Other study ID #: RC22_0502
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: September 2027

Study information

• Verified date: December 2023
• Source: Nantes University Hospital
• Contact: Hélène AUFFRET
• Phone: 2 44 76 85 68
• Email: helene.auffret[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 750
• Est. completion date: September 2027
• Est. primary completion date: September 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
France	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	CHU de Rennes	Rennes
France	CHU de Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coefficient of variation of individual HGI distribution	calculated from 3 HGI values, measured 6 months apart, HGI = HbA1C measured in laboratory - HbA1C estimated	12 months
Secondary	Coefficient of variation of the individual distribution of the albumin glycation index	Albumin glycation index = glycated albumin measured in laboratory - glycated albumine estimated	12 months
Secondary	Glycation gap, determined from comparison between HbA1C measured and HbA1C derived from glycated albumin		12 months