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Clinical Trials/NCT05809843
NCT05809843CompletedNot Applicable

Deep Learning in Vascular and Structural Retinal Changes in Diabetic Patients Undergoing Artificial Pancreas Device

Federico II University1 site in 1 country11 target enrollmentStarted: January 30, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
11
Locations
1
Primary Endpoint
The measurements of retinal and choriocapillary vessel density in type 1 diabetic patients undergoing artificial pancreas device

Study Overview

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

The measurements of retinal and choriocapillary vessel density in type 1 diabetic patients undergoing artificial pancreas device

Time Frame: 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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Federico II University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ciro Costagliola

professor

Federico II University

Study Sites (1)

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