Microvascular Changes in OCT-angiography in Type 1 Diabetes Mellitus at the Onset of the Disease and After Optimization of Glycemic Control.

Study Overview
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Brief Summary
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The objective of the study is to evaluate the differences in the retinal microcirculation measured by OCT-Angiography in patients with type 1 diabetes between the diagnosis of the disease and after 3 months of insulin treatment.

Official Title
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Study of the Microvascular Changes in the Retina Measured by Optical Coherence Tomography (OCT) - Angiography in Patients With Type 1 Diabetes Mellitus at the Onset of the Disease and After Optimization of Glycemic Control.

Conditions
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Type 1 Diabetes, Diabetic Retinopathy

Intervention / Treatment
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* Diagnostic Test: Optical Coherence Tomography (OCT) Angiography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with Type 1 Diabetes at diagnosis of the disease (less than 7 days after diagnosis) Age equal to or greater than 18 years Signature of the informed consent by the patient / legal guardian. Exclusion Criteria: Metabolic situation of ketosis or ketoacidosis, according to clinical criteria established in the protocol of the Endocrinology and Nutrition Service. The patient will be a candidate once the ketonemia is absent (value <1 mmol / L). Previous diagnosis of dyslipidemia and any previous lipid-lowering treatment Previous diagnosis of hypertension and any previous hypotensive treatment Previous diagnosis of any form of cardiovascular disease, including heart failure. Previous kidney disease, and presence of advanced kidney failure (estimated glomerular filtration rate <60 ml / min) Presence of diabetic retinopathy identifiable by conventional eye fundus or retinography, or other concomitant retinal vascular pathology (hypertensive retinopathy, venous occlusion, arterial obstruction, etc.) History or presence of retinal pathology that may alter its structure and / or the validity of the measurements (retinal detachment, epiretinal membrane, high myopia -understood as an axial length greater than or equal to 26mm measured by IOL Master biometry-, neovascular membrane, choroidal tumors, etc.) History of posterior uveitis or retinal vasculitis Glaucoma and neuro-ophthalmological pathology that can alter the neuroretinal structures. Refractive media opacity that prevents a correct acquisition of images and, therefore, their evaluation Dementia or intellectual disability that prevent proper collaboration when acquiring images

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Type 1 diabetic patients<br>Recently diagnosed type 1 diabetes patients | Diagnostic Test: Optical Coherence Tomography (OCT) Angiography<br>* Measurement of retinal vessel density and distribution in the macula using new generation OCT device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vessel density | Density of retinal vessels and perfusion in the macula | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vessel density | Density of retinal vessels and perfusion in the macula | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OCT Angiography, OCT-A