OCT and OCT-A Deep Learning in Diabetic Patients Wiht Artificial Pancreas Device

Completed

• Conditions: Type 1 Diabetes Mellitus With Artificial Pancreas Device
• Interventions: Device: hybrid artificial pancreas systems (CSII)

• Registration Number: NCT05809843
• Lead Sponsor: Federico II University

Brief Summary

This study evaluates the ability of deep learning to improve the knowledge about structural and vascular retinal changes in diabetic patients undergoing artificial pancreas device, using optical coherence tomography angiography.

Detailed Description

hybrid artificial pancreas systems (CSII) are able to adjust the type 1 diabetic patient's glycemic levels with insulin doses appropriate to the patient's blood glucose.

The optical coherence tomography angiography represents a novel and noninvasive diagnostic technique that allows a detailed and quantitative analysis of retinal and choriocapillary vascular features.

The study evaluates the changes in optical coherence tomography angiography features in diabetic patients undergoing artificial pancreas device, elaborating these data with artificial intelligence.

Study Timeline

• Study Start: 2023-01-30
• Primary Completion: 2023-03-23
• Study Completion: 2023-03-23
• Study First Submitted: 2023-03-27
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-11
• Last Update Submitted: 2023-04-11
• Study First Posted: 2023-04-12
• Last Update Posted: 2023-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• • age older than 18 years

  • diagnosis of type 1 diabetes
  • treatment with artificial pancreas device
  • absence of previous ocular surgery and congenital eye diseases.
  • absence of errors of refraction
  • absence of lens opacities
  • absence of low-quality OCT and OCTA images

Exclusion Criteria

• age younger than 18 years
• previous ocular surgery and congenital eye diseases
• errors of refraction
• lens opacities
• low-quality OCT and OCTA images

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
rype 1 diabetc patients with artificial pancreas device	hybrid artificial pancreas systems (CSII)	-

Primary Outcome Measures

Name	Time	Method
The measurements of retinal and choriocapillary vessel density in type 1 diabetic patients undergoing artificial pancreas device	up to 3months	The parameters analyzed by optical coherence tomography angiography were: retinal and choriocapillary vessel density matched with clinical parameters resulted from the artificial pancreas device

Trial Locations

Locations (1)

University of Naples "Federico II"; 🇮🇹 Naples, Italy