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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorFirst Hospital of China Medical University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Aged 40 years or older;

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • LLM-Enabled Co-management

    Other intervention

    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.

Treatment groups

6,800 Participants
are divided into 2 treatment groups
Group A: LLM-Enabled Intervention GroupActive comparator 1 intervention
Group B: Usual Care Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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).

Time frame
6 months after baseline

Secondary outcomes

1

Net changes in estimated 10-year risk for atherosclerotic CVD.

Net change in estimated 10-year atherosclerotic cardiovascular disease risk.

Time frame
6 months after baseline
2

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.

Time frame
6 months after baseline
3

Mean systolic blood pressure changes.

Mean systolic blood pressure changes of participants.

Time frame
6 months after baseline
4

Mean diastolic blood pressure changes.

Mean diastolic blood pressure changes of participants.

Time frame
6 months after baseline.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

First Hospital of China Medical University

Lead sponsor

Beijing Chao Yang Hospital

Collaborator

Zhejiang University

Collaborator

Shandong Provincial Hospital

Collaborator

Cangzhou Central Hospital

Collaborator

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