LLM-Assisted Diabetes and Hypertension Management by Village Doctors

NCT07678658 | Not Yet Recruiting

• 1 other identifier: LSKY 2026-096-01
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Type 2 Diabetes Mellitus; Hypertension

Outcome Measures

Primary Outcomes (1)

• 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

  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

Study Arms (2)

LLM-Assisted Group

EXPERIMENTAL

Other: LLM

Control Group

NO INTERVENTION

Interventions

LLM OTHER

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

LLM-Assisted Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• None.

Sponsors & Collaborators

• Jiangsu Taizhou People's Hospital: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypertension

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Zhang; Q Zhang

CONTACT

89890300; 18061986120@189.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2026
• First Posted: July 1, 2026
• Study Start: July 1, 2026
• Primary Completion: July 7, 2026
• Study Completion: July 14, 2026
• Last Updated: July 1, 2026

Record last verified: 2026-06