HypertensionLLM-CoManageNCT07350486
LLM-CoManage: Large Language Model-Enabled Co-Management of Hypertension, Diabetes, and Dyslipidemia
A study testing LLM-Enabled Co-management in people with Hypertension and Diabetes, run by First Hospital of China Medical University at 6 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Hypertension, Diabetes, Dyslipidemia
- What is being tested?
- LLM-Enabled Co-management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,800 participants
- Where
- 6 sitesChina
- Study dates
- 14 May 2026to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 15Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Cangzhou
Cangzhou, Hebei
Yiwu
Jinzhou, Zhejiang
Dawa District
Panjin, Liaoning
Shenyang
Shenyang, Liaoning
Wujiang District
Suzhou, Jiangsu
Binhai New Area
Tianjin
About this study
Official title: 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.
- Conditions
- Hypertension, Diabetes, Dyslipidemia
- Being tested
- LLM-Enabled Co-management
- Keywords
- Large Language Model, Co-Management
- Medical subject headings
- Hypertension, Diabetes Mellitus, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LLM-Enabled Co-managementOther
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.
| Study group | Role | What they receive |
|---|---|---|
| LLM-Enabled Intervention Group | Experimental | LLM-enabled community physicians delivered integrated, guideline-based management Receives: Other: LLM-Enabled Co-management |
| Usual Care Control Group | No intervention | Community physicians provided routine care according to local primary health service standards |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months after baseline
Secondary outcomes (17)
Net changes in estimated 10-year risk for atherosclerotic CVD.
Net change in estimated 10-year atherosclerotic cardiovascular disease risk.
Measured: 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.
Measured: 6 months after baseline
Mean systolic blood pressure changes.
Mean systolic blood pressure changes of participants.
Measured: 6 months after baseline
Mean diastolic blood pressure changes.
Mean diastolic blood pressure changes of participants.
Measured: 6 months after baseline.
Mean HbA1c changes.
Mean HbA1c changes of participants.
Measured: 6 months after baseline.
Mean LDL-C changes.
Mean LDL-C changes of participants.
Measured: 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.
Measured: 6 months after baseline
Awareness and treatment rates for hypertension, diabetes, and dyslipidemia.
Rates of disease awareness and treatment for hypertension, diabetes, and dyslipidemia.
Measured: 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.
Measured: 6 months after baseline
Mean health expenditures and within-trial cost-utility.
Mean health care expenditures and within-trial cost-utility outcomes.
Measured: 6 months after baseline
Changes in treatment adherence.
Change in treatment adherence among participants.
Measured: 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.
Measured: 6 months after baseline
Patient-reported outcomes related to satisfaction.
Patient-reported satisfaction with LLM will be assessed using a structured scale.
Measured: 6 months after baseline
Patient-reported outcomes related to self-management.
Patient-reported self-management will be assessed using a structured scale.
Measured: 6 months after baseline.
Patient-reported outcomes related to quality of life.
Patient-reported quality of life will be assessed using a structured scale.
Measured: 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.
Measured: 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.
Measured: 6 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start14 May 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Hospital of China Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Chao Yang Hospital, Zhejiang University, Shandong Provincial Hospital, Cangzhou Central Hospital
- Responsible party
- Principal investigator, Yingxian Sun, First Hospital of China Medical University
- Investigators
- Yingxian Sun, MD, PhD, Principal investigator, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07350486
- Sponsor's protocol ID
- CMU-HyperMindRCT-2025
- Acronym
- LLM-CoManage
- Status last verified
- Sep 2026
- First submitted
- 25 Dec 2025
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster-Randomized Trial of Large Language Model-Enabled Coordinated Management for Hypertension, Diabetes, and Dyslipidemia in Community Settings (LLM-CoManage Trial)
- ClinicalTrials.gov ID
- NCT07350486
- Acronym / sponsor ID
- LLM-CoManage / CMU-HyperMindRCT-2025
- Conditions
- Hypertension, Diabetes, Dyslipidemia
- Keywords
- Large Language Model, Co-Management
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 6,800 participants (estimated)
- Lead sponsor
- First Hospital of China Medical UniversityUniversity, hospital or other
- Collaborators
- Beijing Chao Yang Hospital, Zhejiang University, Shandong Provincial Hospital, Cangzhou Central Hospital
- Study start
- 14 May 2026 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LLM-Enabled Intervention Group | Experimental | Other: LLM-Enabled Co-managementLLM-enabled community physicians delivered integrated, guideline-based management |
| Usual Care Control Group | No intervention | –Community physicians provided routine care according to local primary health service standards |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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;
- Uncontrolled hypertension, defined as systolic blood pressure (SBP) ≥140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg;
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LLM-Enabled Co-managementThe 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. | Other | LLM-Enabled Intervention Group |
Primary outcome
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).
17 secondary outcomes
Net changes in estimated 10-year risk for atherosclerotic CVD.
Time frame: 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.
Time frame: 6 months after baseline
Mean systolic blood pressure changes.
Time frame: 6 months after baseline
Mean diastolic blood pressure changes.
Time frame: 6 months after baseline.
Mean HbA1c changes.
Time frame: 6 months after baseline.
Mean LDL-C changes.
Time frame: 6 months after baseline.
Proportion of participants achieving simultaneous control of BP, HbA1c, and LDL-C.
Time frame: 6 months after baseline
Awareness and treatment rates for hypertension, diabetes, and dyslipidemia.
Time frame: 6 months after baseline
Proportion of participants receiving integrated, guideline-based management of all indicated conditions.
Time frame: 6 months after baseline
Mean health expenditures and within-trial cost-utility.
Time frame: 6 months after baseline
Changes in treatment adherence.
Time frame: 6 months after baseline
Improvements in behavioral risk factors (e.g., diet, physical activity, tobacco use, lifestyle intervention uptake).
Time frame: 6 months after baseline
Patient-reported outcomes related to satisfaction.
Time frame: 6 months after baseline
Patient-reported outcomes related to self-management.
Time frame: 6 months after baseline.
Patient-reported outcomes related to quality of life.
Time frame: 6 months after baseline.
Adoption and utilization of the LLM system by physicians and patients.
Time frame: 6 months after baseline
Patterns of AI-assisted recommendations and digital interactions.
Time frame: 6 months after baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yingxian Sun, MD, PhD principal investigator
First Hospital of China Medical University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LLM-Enabled Co-management in people with Hypertension and Diabetes, run by First Hospital of China Medical University at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.