Status:
COMPLETED
The Effect of the Glycemic Variability on Macular Retinal Microcirculation and Cognitive Functions in Patient With Type 1 Diabetes
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Délégation de la Recherche Clinique et de l'innovation (DRCI)
CRC (Centre de Recherche Clinique)
Conditions:
Microvascular Complications
Diabetic Retinopathy
Eligibility:
All Genders
18+ years
Brief Summary
Revadiab is case-control study aimed to demonstrate that retinal capillary density is altered in patients with type 1 diabetes with glycemic variability compared to those with comparable glycemic cont...
Detailed Description
HbA1c doesn't explain all the microvascular complications of diabetes, especially microvascular complications. Glycemic variability is associated with increased oxidative stress, free radicals and end...
Eligibility Criteria
Inclusion
- Patients ≥ 18 years
- Type 1 diabetes (T1D)
- Using Free FreeStyle
- Diabete evolving for 10 years or more
- Case: Patients with glycemic variability, defined by a coefficient of variation (CV) \> 36%, calculated from continuous glucose measurements data by Free Style Libre® (Abbott)
- Controls: Patients without glycemic variability, defined by a coefficient of variation (CV) ≤ 36%, calculated from Free Style Libre® data and matched to patients in the Case group for HbA1c (+/- 0.5%)
Exclusion
- Type 2 diabetic patient
- Corticotherapy
- Comorbidity like cancer
- Antecedent of vitreoretinal pathology
- Antecedent of vitreoretinal surgery
- Important cataract, with an important opacity that prevents a reliable evaluation of capillary density in OCT angio
- Pregnant or lactating woman
Key Trial Info
Start Date :
January 7 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 8 2021
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT03821753
Start Date
January 7 2019
End Date
July 8 2021
Last Update
June 10 2024
Active Locations (1)
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1
Hôpital Lariboisière
Paris, Île-de-France Region, France, 75475