Type 2 Diabetes MellitusNCT07678658
LLM-Assisted Diabetes and Hypertension Management by Village Doctors
A study testing LLM in people with Type 2 Diabetes Mellitus and Hypertension, run by Jiangsu Taizhou People's Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus, Hypertension
- What is being tested?
- LLM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 14 Jul 2026
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- None.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Large Language Model-Assisted Decision Support for Improving Village Doctors' Integrated Management of Patients With Type 2 Diabetes and Hypertension: A Randomized Controlled Study
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
- Being tested
- LLM
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LLMOther
Village doctors receive large language model (LLM)-assisted decision support when assessing standardized patient cases and developing management plans.
| Study group | Role | What they receive |
|---|---|---|
| LLM-Assisted Group | Experimental | Not described Receives: Other: LLM |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after completion of case assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion7 Jul 2026 (estimated)
- Study completion14 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Taizhou People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07678658
- Sponsor's protocol ID
- LSKY 2026-096-01
- Status last verified
- Jun 2026
- First submitted
- 21 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Large Language Model-Assisted Decision Support for Improving Village Doctors' Integrated Management of Patients With Type 2 Diabetes and Hypertension: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07678658
- Acronym / sponsor ID
- LSKY 2026-096-01
- Conditions
- Type 2 Diabetes Mellitus, Hypertension
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Jiangsu Taizhou People's HospitalUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 7 Jul 2026 (estimated)
- Study completion
- 14 Jul 2026 (estimated)
- First posted
- 1 Jul 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 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LLM-Assisted Group | Experimental | Other: LLM |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- None.
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 |
|---|---|---|
| LLMVillage doctors receive large language model (LLM)-assisted decision support when assessing standardized patient cases and developing management plans. | Other | LLM-Assisted Group |
Primary outcome
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
Time frame: Immediately after completion of case assessment
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.
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 1 Jul 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.
Questions about this trial
What is this clinical trial studying?
A study testing LLM in people with Type 2 Diabetes Mellitus and Hypertension, run by Jiangsu Taizhou People's Hospital.
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 4 inclusion and 1 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: opening soon, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Zhang; Q Zhang (89890300, 18061986120@189.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Immediately after completion of case assessment). 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 1 Jul 2026.