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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05809843
Enrollment
11
Registered
2023-04-12
Start date
2023-01-30
Completion date
2023-03-23
Last updated
2023-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes Mellitus With Artificial Pancreas Device

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.

Interventions

DEVICEhybrid artificial pancreas systems (CSII)

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

Sponsors

Federico II University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frameDescription
The measurements of retinal and choriocapillary vessel density in type 1 diabetic patients undergoing artificial pancreas deviceup to 3monthsThe parameters analyzed by optical coherence tomography angiography were: retinal and choriocapillary vessel density matched with clinical parameters resulted from the artificial pancreas device

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026