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Active, not recruiting

NCT Number: NCT07350486

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

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Hypertension Cardiovascular Diseases Diabetes Diabetes Mellitus Dyslipidemia Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cangzhou, Hebei, China

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Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

LLM-Enabled Co-management

Other

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.

Primary outcomes

  1. The between-group difference in the proportion of participants achieving simultaneous control of hypertension and either diabetes or dyslipidemia.

    Time frame: 6 months after baseline

    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).

Secondary outcomes

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

    Time frame: 6 months after baseline

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

  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.

    Time frame: 6 months after baseline

    The proportion of participants achieving target control of each individual risk factor, including blood pressure, HbA1c, and LDL-C.

  3. Mean systolic blood pressure changes.

    Time frame: 6 months after baseline

    Mean systolic blood pressure changes of participants.

  4. Mean diastolic blood pressure changes.

    Time frame: 6 months after baseline.

    Mean diastolic blood pressure changes of participants.

  5. Mean HbA1c changes.

    Time frame: 6 months after baseline.

    Mean HbA1c changes of participants.

  6. Mean LDL-C changes.

    Time frame: 6 months after baseline.

    Mean LDL-C changes of participants.

  7. Proportion of participants achieving simultaneous control of BP, HbA1c, and LDL-C.

    Time frame: 6 months after baseline

    The proportion of participants achieving simultaneous control of blood pressure, HbA1c, and LDL-C.

  8. Awareness and treatment rates for hypertension, diabetes, and dyslipidemia.

    Time frame: 6 months after baseline

    Rates of disease awareness and treatment for hypertension, diabetes, and dyslipidemia.

  9. Proportion of participants receiving integrated, guideline-based management of all indicated conditions.

    Time frame: 6 months after baseline

    The proportion of participants receiving integrated, guideline-based management for indicated conditions.

  10. Mean health expenditures and within-trial cost-utility.

    Time frame: 6 months after baseline

    Mean health care expenditures and within-trial cost-utility outcomes.

  11. Changes in treatment adherence.

    Time frame: 6 months after baseline

    Change in treatment adherence among participants.

  12. Improvements in behavioral risk factors (e.g., diet, physical activity, tobacco use, lifestyle intervention uptake).

    Time frame: 6 months after baseline

    Changes in behavioral risk factors including diet, physical activity, and tobacco use.

  13. Patient-reported outcomes related to satisfaction.

    Time frame: 6 months after baseline

    Patient-reported satisfaction with LLM will be assessed using a structured scale.

  14. Patient-reported outcomes related to self-management.

    Time frame: 6 months after baseline.

    Patient-reported self-management will be assessed using a structured scale.

  15. Patient-reported outcomes related to quality of life.

    Time frame: 6 months after baseline.

    Patient-reported quality of life will be assessed using a structured scale.

  16. Adoption and utilization of the LLM system by physicians and patients.

    Time frame: 6 months after baseline

    The extent of physician and patient adoption and use of the LLM-based system.

  17. Patterns of AI-assisted recommendations and digital interactions.

    Time frame: 6 months after baseline

    The patterns of Artificial Intelligence(AI)-assisted recommendations and related digital interactions generated during the study.

Sponsors and collaborators

Lead sponsor

First Hospital of China Medical University

Other

Collaborators

  • Beijing Chao Yang Hospital
  • Cangzhou Central Hospital
  • Shandong Provincial Hospital
  • Zhejiang University

Registry information

Official study title

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

Acronym: LLM-CoManage

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 20, 2026
Registry last updated
Sep 4, 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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