Understanding HGI Variability in Diabetes Patients Using Continuous Glucose Monitoring
Assessment of HGI (Hemoglobin Glycation Index) Variability Over Time in Patients Living with Diabetes Using Continuous Glucose Monitoring
This study is testing how the Hemoglobin Glycation Index changes over time in adults with diabetes using continuous glucose monitoring to help improve diabetes management.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 750 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nantes University Hospital Academic / other |
| Locations | 10 sites (Angers and 9 other locations) |
| Trial ID | NCT06185491 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the variability of the Hemoglobin Glycation Index (HGI) over time in individuals diagnosed with diabetes. Participants will utilize continuous glucose monitoring systems to provide real-time data on their glucose levels, which will help in understanding how HGI fluctuates. The study includes adults over 18 years old who have been living with diabetes for at least six months and have been using glucose monitoring systems regularly. The findings could provide insights into diabetes management and treatment adjustments based on HGI variability.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with a diagnosis of diabetes for at least six months and regular users of glucose monitoring systems.
Not a fit: Patients with known hemoglobinopathy, stage 5 renal insufficiency, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diabetes management strategies by providing a better understanding of HGI variability.
How similar studies have performed: While the specific approach of assessing HGI variability using continuous glucose monitoring may be novel, similar studies have shown success in utilizing continuous monitoring to improve diabetes management.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Angers and 9 other locations
- CHU d'Angers — Angers, France (Recruiting)
- CHU de Brest — Brest, France (Recruiting)
- CHU de Caen — Caen, France (Recruiting)
- CH de La Rochelle — La Rochelle, France (Not_yet_recruiting)
- CH du Mans — Le Mans, France (Recruiting)
- CHU de Nantes — Nantes, France (Recruiting)
- CHU de Poitiers — Poitiers, France (Recruiting)
- Hôpital NOVO — Pontoise, France (Recruiting)
- CHU de Rennes — Rennes, France (Recruiting)
- CHU de Toulouse — Toulouse, France (Recruiting)
Study contacts
- Principal investigator: Hélène AUFFRET — Nantes University Hospital
- Study coordinator: Hélène AUFFRET
- Email: helene.auffret@chu-nantes.fr
- Phone: 2 44 76 85 68
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.