LLM-Assisted Diabetes and Hypertension Management by Village Doctors

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hypertension Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

None.

Treatment and study plan

LLM

Other

Village doctors receive large language model (LLM)-assisted decision support when assessing standardized patient cases and developing management plans.

Primary outcomes

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Zhang; Q Zhang

CONTACT

[email protected]

89890300

Sponsors and collaborators

Lead sponsor

Jiangsu Taizhou People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Jul 1, 2026
Registry last updated: Jul 1, 2026

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.

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