LLM-Assisted Diabetes and Hypertension Management by Village Doctors

June 25, 2026 updated by: Jiangsu Taizhou People's Hospital

Large Language Model-Assisted Decision Support for Improving Village Doctors' Integrated Management of Patients With Type 2 Diabetes and Hypertension: A Randomized Controlled Study

This is a prospective, assessor-blinded, randomized controlled study designed to evaluate whether large language model (LLM)-assisted decision support can improve village doctors' abilities in the comprehensive management of patients with type 2 diabetes mellitus and hypertension.

For each standardized clinical case, two village doctors will independently review the same patient information and develop management plans. An independent statistician will randomly assign one doctor to receive LLM-assisted decision support, while the other will complete the assessment without assistance. All management plans and questionnaire responses will be de-identified and evaluated by an independent expert panel blinded to group allocation. The study will compare the quality of clinical decision-making, risk assessment, treatment recommendations, and follow-up planning between the LLM-assisted and control groups.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Certified village doctors or primary care physicians practicing in rural primary healthcare institutions;
  2. At least 1 year of experience in the management of chronic diseases, including type 2 diabetes mellitus and hypertension;
  3. Able to complete the case assessment tasks required by the study;
  4. Willing to participate in the study and provide informed consent.

Exclusion Criteria:

None.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
Experimental: LLM-Assisted Group
Other: LLM
Village doctors receive large language model (LLM)-assisted decision support when assessing standardized patient cases and developing management plans.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of case assessments in which the LLM-assisted management plan is preferred over the non-assisted management plan according to a blinded expert preference assessment form
Time Frame: Immediately after completion of case assessment
Blinded endocrinology experts will independently compare paired management plans using a standardized Expert Preference Assessment Form. For each case, experts will classify the paired plans as "LLM-assisted preferred," "No meaningful difference," or "Non-assisted preferred." The primary outcome is the percentage of non-tied case assessments in which the LLM-assisted management plan is preferred.
Immediately after completion of case assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu Taizhou People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

July 7, 2026

Study Completion (Estimated)

July 14, 2026

Study Registration Dates

First Submitted

June 21, 2026

First Submitted That Met QC Criteria

June 25, 2026

First Posted (Actual)

July 1, 2026

Study Record Updates

Last Update Posted (Actual)

July 1, 2026

Last Update Submitted That Met QC Criteria

June 25, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LSKY 2026-096-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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