Dynamic Parameters of Glucose Control in Relation to Biomarkers in Serum and Intraocular Fluid in Patients With Diabetes

Study Overview
=================
Brief Summary
-----------------
Our project investigates the new characteristics of diabetic retinopathy using liquid eye biopsy in combination with novel parameters of glucose control obtained with continuous glucose monitoring. This approach will bring new knowledge and implications for future therapies.

Detailed Description
-----------------
Diabetic retinopathy is one of the most common causes of blindness in developed countries. The short-term glucose fluctuations have been suggested as a factor contributing to the risk of diabetic complications including ocular complications. We hypothesize that modulatory and other biological abilities of miRNAs and inflammatory chemokines/cytokines have a significant impact on the development and the progression of diabetic retinopathy. Our main goal is to identify the biomarkers that will in time be used for new screening, diagnostic, and treatment strategies for patients with diabetic retinopathy, bring a better prevention and early treatment to them and thus improve their quality of life while saving the cost associated with advanced forms of retinopathy.

Official Title
-----------------
Dynamic Parameters of Glucose Control in Relation to Biomarkers in Serum and Intraocular Fluid in Diabetic Patients With Ocular Complications

Conditions
-----------------
Diabetes Complications

Intervention / Treatment
-----------------
* Procedure: Intraocular surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: type 1 or type 2 diabetes ≥ 18 years old treatment with insulin for at least 5 years prior baseline any form of diabetic retinopathy and macular edema HbA1c < 10% written informed consent prior to starting study related activity Exclusion Criteria: any active intraocular or periocular infectious or non-infectious inflammation in study eye uncontrolled glaucoma history of intraocular inflammation or trauma in study eye intravitreal anti-VEGF therapy in study eye during a 3-month perido prior to baseline use of corticosteroid intravitreal implant in study eye at any time

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with DR<br>Adult patients with T1DM or T2DM with any form of diabetic retinopathy and diabetic macular edema, indicated for ocular surgical procedure as standard of care. Blood samples and samples of intraocular fluids will bee taken during the ocular surgery. | Procedure: Intraocular surgery<br>* Pars plana vitrectomy or cataract surgery.<br>|
| Patients without DR<br>Adult patients with T1DM or T2DM without any signs of diabetic retinopathy, indicated for ocular surgical procedure from other reasons as standard of care. Blood samples and samples of intraocular fluids will bee taken during the ocular surgery. | Procedure: Intraocular surgery<br>* Pars plana vitrectomy or cataract surgery.<br>|
| Control group<br>Subjects without diabetes mellitus indicated for ocular surgery from other reasons (cataract, retinal detachment, macular hole, idiopathic epiretinal membrane) as standard of care. Blood samples and samples of intraocular fluids will bee taken during the ocular surgery. | Procedure: Intraocular surgery<br>* Pars plana vitrectomy or cataract surgery.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| miRNA | miRNA expression measuer by real-time PCR method in plasma and vitreous samples (units: threshold cycle) | Year 2025 | 
| TIR | Percentage of time in target ranges | Year 2025 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| miRNA expression differences | miRNA expression differences analysis between diabetic patients with and without diabetic retinopathy (units: fold change) | Year 2025 | 
| Glycemic variability | Expressed as the standard deviation | Year 2025 | 
| Mean sensor glucose concentration | Measured by rtCGM | Year 2025 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
biomarkers, retinopathy, miRNA, diabetes mellitus, glucose variability