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.
HbA1c doesn't explain all the microvascular complications of diabetes, especially microvascular complications. Glycemic variability is associated with increased oxidative stress, free radicals and endothelial dysfunction; it contributes to the pathogenesis of diabetic complications. The relationship between glycemic variability and microangiopathic complications especially retinal but also neurological, needs to be studied. The principal objective of Revadiab study is to demonstrate a correlation between glycemic variability and macular retinal microcirculation in patient with type 1 diabetes. The secondary objective is to search a correlation between glycemic variability and : * Alteration of cognitive functions. * Severity of peripheral diabetic retinopathy and retinal neuronal damage. * Other micro and macro angiopathic complications. * Oxidative stress and inflammation. Two groups of type 1 diabetic patients will be compared: * Case: Patient with significant glycemic variability. * Control: Patients without glycemic variability. The severity of diabetic retinopathy will be evaluated by the degree of occlusion of small vessels in the central retinal region as measured by OCT angiography. Acts or Product necessary to research : * Non-invasive retinal imaging (OCT and OCT- Angiography, retinophotography) * Neuropsychological tests. * Blood test.
Study Type
OBSERVATIONAL
Enrollment
90
Hôpital Lariboisière
Paris, Île-de-France Region, France
Macular capillary density in the external deep capillary network
Macular capillary density in the external deep capillary network measured by OCT-Angiography (no later than 3 months after inclusion)
Time frame: 3 months
Macular capillary density in the deep capillary and deep capillary network
Macular capillary density in the deep capillary and deep capillary network measured by OCT-angiography (no later than 3 months after inclusion)
Time frame: 3 months
Area of the central avascular zone
Area of the central avascular zone by OCT-Angiography (no later than 3 months after inclusion)
Time frame: 3 months
Macular edema presence
Macular edema presence by OCT (no later than 3 months after inclusion)
Time frame: 3 months
Layer thickness reduction of the ganglion cells
Layer thickness reduction of the ganglion cells measured by OCT (no later than 3 months after inclusion)
Time frame: 3 months
Diabetic retinopathy stage
Diabetic retinopathy stage evaluated with retinographies (no later than 3 months after inclusion)
Time frame: 3 months
Development of pre-retinal neovascular vessels and/or pre-papillary
Development of pre-retinal neovascular vessels and/or pre-papillary (no later than 3 months after inclusion)
Time frame: 3 months
Occurrence of neovascular complications
Occurrence of neovascular complications: vitreous
Time frame: 3 months
Haemorrhage, retina tractional detachment, neovascular glaucoma
Haemorrhage, retina tractional detachment, neovascular glaucoma (no later than 3 months after inclusion)
Time frame: 3 months
Renal function evaluation
Renal function evaluation: microalbuminuria and creatinine determination (no later than 3 months after inclusion)
Time frame: 3 months
Evaluation of peripheral neuropathy
Evaluation of peripheral neuropathy : monofilament test (no later than 3 months after inclusion)
Time frame: 3 months
Ischemic cardiopathy
Measurement method: treatment with angioplasty or coronary artery bypass graft, Assessment of vascular risk by measuring the coronal calcium score, and determination of BNP and troponin. (no later than 3 months after inclusion)
Time frame: 3 months
Number of severe hypoglycemia
Number of severe hypoglycemia since 1 year, threshold for hypoglycemia no later than 3 months after inclusion)
Time frame: 3 months
Markers of inflammation
characterization of circulating inflammatory and endothelial cells and CRP-US assay
Time frame: 3 months
Oxidative stress markers
Oxidative stress markers: Measurements of 8-iso-prostaglandin F2 alpha urinary and 1,5-anhydroglucitol sanguine. (no later than 3 months after inclusion)
Time frame: 3 months
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