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NOT YET RECRUITING
NCT07684690
NA

AI-Assisted Antidiabetic Drug Consultation System for Glycemic Control in Type 2 Diabetes Patients Managed by Non-Specialist Physicians

Sponsor: National Taiwan University Hospital

View on ClinicalTrials.gov

Summary

This study tests whether an artificial intelligence (AI) tool can help doctors choose better diabetes medicines for their patients. Type 2 diabetes is very common, but there are far more patients than diabetes specialists, so many patients are treated by doctors who are not diabetes specialists. The researchers built an AI consultation system that gives doctors real-time suggestions and predictions about diabetes medicines while they are prescribing. The doctor always makes the final decision. In this trial, patients with type 2 diabetes whose blood sugar is not well controlled will be placed by chance (randomly) into one of two groups. In one group, the doctor uses the AI system when deciding on diabetes medicines. In the other group, the doctor prescribes as usual, without the AI system. All medicines used are already approved in Taiwan and given at approved doses. The study follows each patient for 12 months, with check-ups at the start and at 3, 6, 9, and 12 months. The main goal is to compare how much the patients' long-term blood sugar level (HbA1c) improves between the two groups after one year. The researchers also look at how many patients reach their blood sugar target, how often low blood sugar happens, and whether any side effects occur. The aim is to find out whether using the AI tool leads to better blood sugar control.

Official title: Clinical Validation of AI-assisted Antidiabetic Drug Consultation System-1

Key Details

Gender

All

Age Range

19 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

400

Start Date

2026-07

Completion Date

2027-11

Last Updated

2026-07-06

Healthy Volunteers

No

Interventions

DEVICE

AI-assisted antidiabetic drug consultation system

A machine-learning based clinical decision support software that provides non-specialist physicians with real-time, interactive antidiabetic prescribing recommendations, a drug-prioritization order, and outcome predictions (e.g., the predicted likelihood of reaching glycemic targets and responder/non-responder status for individual drugs). The system was developed and validated using the NTUH integrated medical database platform. It provides advisory recommendations only; the treating physician retains full control over the final prescribing decision. All recommended medications are approved in Taiwan and within approved dose ranges.

OTHER

Manual antidiabetic prescribing (without AI)

Antidiabetic medications prescribed manually by non-specialist physicians according to usual clinical practice, without using the AI consultation system. All medications are approved in Taiwan and prescribed within approved dose ranges.

Locations (1)

National Taiwan University Hospital

Taipei, Taiwan