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Efficacy of Using Large Language Model to Assist in Diabetic Retinopathy Detection

Efficacy of Using Large Language Model to Assist in Diabetic Retinopathy Detection

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05231174
Enrollment
535
Registered
2022-02-09
Start date
2023-05-01
Completion date
2023-07-30
Last updated
2024-01-19

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

Conditions

Diabetic Retinopathy, Diagnosis

Brief summary

With the increase in population and the rising prevalence of various diseases, the workload of disease diagnosis has sharply increased. The accessibility of healthcare services and long waiting times have become common issues in the public health medical system, with many primary patients having to wait for extended periods to receive medical services. There is an urgent need for rapid, accurate, and low-cost diagnostic services.

Interventions

OTHERA self-evlaution tool based on Large Language Model

Following the baseline assessment, participants will be guided to use a self-evaluation tool independently to assess their risk of diabetic retinopathy (DR). This tool is a fusion of a conversational AI system based on LLM and an existing logistic diagnostic model. The AI system is designed to collect clinical variables, including age, duration of diabetes, Body Mass Index (BMI), and insulin usage. Additionally, clinical test data such as mean arterial pressure, HbA1c, serum creatinine, and microalbuminuria will be extracted from a local dataset using the patient's name and ID. Once collected, these data will be transmitted to a server-based diagnostic model for further analysis to determine the presence of DR.

Sponsors

Sun Yat-sen University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

The study will include adults aged 18 years and above who have been diagnosed with Type 2 diabetes but have not previously been screened for DR. Participants must demonstrate good compliance with clinical examinations, and provide informed consent.

Exclusion criteria

The study will exclude patients who have previously been diagnosed with DR, those who have recently undergone eye surgery, and those with other significant eye diseases that could potentially confound the results of DR screening. Individuals with ocular, auditory, or cognitive impairments that prevent the use of mobile phones or reading will also be excluded.

Design outcomes

Primary

MeasureTime frameDescription
AUROC of the self-evaluation toolImmediately after using the chatbotThe performance of the self-evaluation tool is evaluated with accuracy with reference to the diagnostic labels by senior ophthalmologists based on fundus photos.

Countries

China

Outcome results

None listed

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