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OpenTrials
Completed

NCT Number: NCT05809843

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

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.

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Key information

Conditions

Type 1 Diabetes Mellitus With Artificial Pancreas Device

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Naples "Federico II"

Naples, 80100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hybrid artificial pancreas systems (CSII)

Device

artificial device that adjust the patient's glycemic levels with insulin doses appropriate to the patient's blood glucose

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 12, 2023
Registry last updated
Apr 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.