LLM-CoManage: Large Language Model-Enabled Co-Management of Hypertension, Diabetes, and Dyslipidemia (LLM-CoManage)

A Cluster-Randomized Trial of Large Language Model-Enabled Coordinated Management for Hypertension, Diabetes, and Dyslipidemia in Community Settings (LLM-CoManage Trial)

This study aims to evaluate the effectiveness of a large language model (LLM)-supported, community-based integrated management model in improving cardiometabolic multimorbidity control among adults with hypertension and coexisting diabetes or dyslipidemia. Adopting an interventional study design, eligible patients will be recruited to compare the disease control indicators between LLM-assisted management and conventional management, so as to verify the effectiveness and safety of the former.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertension; Diabetes; Dyslipidemia
• Intervention / Treatment: Other: LLM-Enabled Co-management

• Study Type: Interventional
• Enrollment (Estimated): 6800
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaofan Guo, PhD; Phone Number: +86 13842078178; Email: guoxiaofan1986@hotmail.com

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110001
      • The First Hospital of China Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Participating communities must meet all of the following criteria:

• Have a designated community physician responsible for primary care who is capable of using a smartphone with stable internet access for clinical communication and LLM-assisted management;
• No plan for administrative merger or restructuring within the next three years;
• Located at least 2 kilometers away from adjacent participating communities (to minimize contamination between clusters).

Eligible participants must fulfill all of the following conditions:

• Aged 40 years or older;
• Uncontrolled hypertension, defined as systolic blood pressure (SBP) ≥140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg;
• Coexisting diabetes (HbA1c ≥ 7.0%) or coexisting dyslipidemia (LDL-C ≥ 3.4 mmol/L[130 mg/dL]);
• Able to use a smartphone independently or with assistance from family members;
• Has resided in the participating community for at least 6 months;
• Has no plan to relocate in the next 3 years;
• Enrolled in basic medical insurance for urban and rural residents, employee medical insurance, or the New Rural Cooperative Medical Scheme;
• Not currently pregnant or planning pregnancy during the study period;
• Free from malignant tumors and deemed to have a life expectancy of at least 3 years, as judged by study physicians;
• Willing and able to provide written informed consent.

Exclusion Criteria:No specific exclusion criteria.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: LLM-Enabled Intervention Group; LLM-enabled community physicians delivered integrated, guideline-based management	Other: LLM-Enabled Co-management; The intervention is a LLM-enabled, community-based integrated management strategy for cardiometabolic multimorbidity. The LLM system functions as the central intelligence layer, integrating multi-condition clinical information, delivering real-time decision support, coordinating care workflows, and facilitating continuous patient engagement. Within this LLM-enabled framework, community physicians-after standardized training-serve as the core executors of care, delivering guideline-based pharmacologic treatment, lifestyle counseling, and structured monitoring of coexisting cardiometabolic conditions. Policy-aligned performance incentives are used to support physician engagement and implementation fidelity, without altering medication access or underlying clinical protocols. The LLM-enabled intervention is implemented through the HyperMind system, an integrated platform that simultaneously supports clinicians, patients, and health-system oversight.
No Intervention: Usual Care Control Group; Community physicians provided routine care according to local primary health service standards

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The between-group difference in the proportion of participants achieving simultaneous control of hypertension and either diabetes or dyslipidemia.	Simultaneous control is defined as BP < 130/80 mmHg and at least one of the following: HbA1c < 7.0% or LDL-C < 2.6 mmol/L (100 mg/dL), with a stricter threshold of < 1.8 mmol/L (70 mg/dL) for participants with cardiovascular disease(CVD).	6 months after baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean systolic blood pressure changes.	Mean systolic blood pressure changes of participants.	6 months after baseline
Mean diastolic blood pressure changes.	Mean diastolic blood pressure changes of participants.	6 months after baseline.
Mean HbA1c changes.	Mean HbA1c changes of participants.	6 months after baseline.
Mean LDL-C changes.	Mean LDL-C changes of participants.	6 months after baseline.
Proportion of participants achieving simultaneous control of BP, HbA1c, and LDL-C.	The proportion of participants achieving simultaneous control of blood pressure, HbA1c, and LDL-C.	6 months after baseline
Awareness and treatment rates for hypertension, diabetes, and dyslipidemia.	Rates of disease awareness and treatment for hypertension, diabetes, and dyslipidemia.	6 months after baseline
Proportion of participants receiving integrated, guideline-based management of all indicated conditions.	The proportion of participants receiving integrated, guideline-based management for indicated conditions.	6 months after baseline
Mean health expenditures and within-trial cost-utility.	Mean health care expenditures and within-trial cost-utility outcomes.	6 months after baseline
Net changes in estimated 10-year risk for atherosclerotic CVD.	Net change in estimated 10-year atherosclerotic cardiovascular disease risk.	6 months after baseline
Changes in treatment adherence.	Change in treatment adherence among participants.	6 months after baseline
Improvements in behavioral risk factors (e.g., diet, physical activity, tobacco use, lifestyle intervention uptake).	Changes in behavioral risk factors including diet, physical activity, and tobacco use.	6 months after baseline
Patient-reported outcomes related to satisfaction.	Patient-reported satisfaction with LLM will be assessed using a structured scale.	6 months after baseline
Patient-reported outcomes related to self-management.	Patient-reported self-management will be assessed using a structured scale.	6 months after baseline.
Patient-reported outcomes related to quality of life.	Patient-reported quality of life will be assessed using a structured scale.	6 months after baseline.
Adoption and utilization of the LLM system by physicians and patients.	The extent of physician and patient adoption and use of the LLM-based system.	6 months after baseline
Patterns of AI-assisted recommendations and digital interactions.	The patterns of Artificial Intelligence(AI)-assisted recommendations and related digital interactions generated during the study.	6 months after baseline
Proportion of participants achieving control of individual risk factors: BP < 130/80 mmHg (or < 140/90 mmHg); HbA1c < 7.0%; and LDL-C < 2.6 mmol/L (100 mg/dL) or < 1.8 mmol/L (70 mg/dL) for those with CVD.	The proportion of participants achieving target control of each individual risk factor, including blood pressure, HbA1c, and LDL-C.	6 months after baseline

Collaborators and Investigators

• Sponsor: First Hospital of China Medical University
• Collaborators: Shandong Provincial Hospital; Beijing Chao Yang Hospital; Zhejiang University; Cangzhou Central Hospital
• Investigators: Principal Investigator: Yingxian Sun, MD, PhD, First Hospital of China Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: December 25, 2025
• First Submitted That Met QC Criteria: January 10, 2026
• First Posted (Actual): January 20, 2026

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 9, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Large Language Model; Co-Management
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Lipid Metabolism Disorders; Nutritional and Metabolic Diseases; Hypertension; Diabetes Mellitus; Dyslipidemias
• Other Study ID Numbers: CMU-HyperMindRCT-2025

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