CompletedNot Applicable

The Effect of the Glycemic Variability on Macular Retinal Microcirculation and Cognitive Functions in Patient With Type 1 Diabetes

France90 participantsStarted 2019-01-07

Plain-language 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 control without glycemic variability. An OCT angiography will be used to precisely evaluate retinal capillary density. A secondary objective will be to evaluate if glycemic variability is associated with cognitive dysfunction, using a neuro psychologic evaluation.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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

What they're measuring

Macular capillary density in the external deep capillary network

Timeframe: 3 months

Trial details

NCT IDNCT03821753

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-07-08