Type 2 Diabetes MellitusCDCPNCT07885904
Preventive Effectiveness of Primary Care Physician-led CGM-supported Comprehensive Intervention on Cardio-metabolic-immune Diseases in Community Patients With Type 2 Diabetes (Community Diabetes Control Project)
A study testing comprehensive intervention in people with Type 2 Diabetes Mellitus, run by Xiangya Hospital of Central South University at 1 site in China.
Trial summary
This community-based trial evaluates whether primary care physicians, equipped with continuous glucose monitoring (CGM) and trained under a standardized protocol with specialist backup, can improve diabetes outcomes through integrated "medication + exercise + diet" interventions. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- comprehensive intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15,400 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2026to 30 Dec 2030
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-80 years, either sex
- Permanent community residents (residing in the community for at least 6 months per year on average)
- Baseline HbA1c 7.0%-14%, fasting blood glucose <13.9 mmol/L, and 2-hour postprandial blood glucose <16.7 mmol/L
- Own and able to use a smartphone, or have assistance from family members
- Enrolled in the National Basic Medical Insurance scheme (Urban and Rural Resident Medical Insurance or Employee Medical Insurance)
- Participants and their legal representatives are able and willing to sign the informed consent form
Who cannot join
- Type 1 diabetes, specific types of diabetes, or gestational diabetes
- Prior definite myocardial infarction, ischemic stroke, hemorrhagic stroke, or hospitalization for heart failure
- Known severe hepatic or renal insufficiency, or dialysis for any cause. Severe hepatic insufficiency includes alanine aminotransferase (ALT) >3 times the upper limit of normal or aspartate aminotransferase (AST) >3 times the upper limit of normal. Severe renal insufficiency is defined as serum creatinine >3.0 mg/dL (265.2 micromol/L) or glomerular filtration rate (GFR) <30 mL/min/1.73 m2
- Hyperglycemic crisis, diabetic ketoacidosis, or severe hypoglycemic coma requiring assistance within the past 3 months
- History of severe allergy to CGM sensor materials, such as medical adhesive tape
- Definite diagnosis of severe diabetic complications documented in the medical history or medical records
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- Definite active immunodeficiency disease or immune-mediated inflammatory disease, or use of systemic glucocorticoids, conventional disease-modifying antirheumatic drugs, biologics, or targeted immunotherapies within 6 months before enrollment. Examples include systemic lupus erythematosus, rheumatoid arthritis, psoriasis or psoriatic arthritis, inflammatory bowel disease, Sjogren syndrome, systemic sclerosis, systemic vasculitis, autoimmune hepatitis, inflammatory myopathies, and active or thyroid-function-unstable Hashimoto thyroiditis or Graves disease
- Severe mental disorder or dementia that precludes completion of informed consent and follow-up procedures
- Concurrent malignant tumor or severe systemic disease with an estimated life expectancy <90 days
- Participation in another interventional clinical study within 30 days before randomization or current participation in another interventional clinical study
- Pregnancy, breastfeeding, or planned pregnancy within 90 days
- Other conditions deemed by the investigator to make participation unsuitable
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Xiangya hospital
Changsha, Hunan, 410028
Yujing Lin, Doctor, 18765259516, 18765259516@163.com
About this study
Official title: Preventive Effectiveness of Primary Care Physician-led CGM-supported Comprehensive Intervention on Cardio-metabolic-immune Diseases in Community Patients With Type 2 Diabetes (Community Diabetes Control Project) -A Cluster Randomized, Open-label, Controlled Trial
This community-based trial evaluates whether primary care physicians, equipped with continuous glucose monitoring (CGM) and trained under a standardized protocol with specialist backup, can improve diabetes outcomes through integrated "medication + exercise + diet" interventions. Unlike traditional fingerstick testing, CGM reveals full glycemic variability, enabling personalized, real-time adjustments. The study hypothesizes that this approach will lower HbA1c, reduce hypoglycemia risk, and decrease long-term cardiovascular, endocrine, and immune-related complications. With low-cost, reliable Chinese-made CGM devices, the intervention is safe and scalable. A cost-effectiveness analysis will also assess its public health value.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- comprehensive intervention
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comprehensive interventionOther
Medication, diet and exercise intervention
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Medication, diet and exercise intervention Receives: Other: comprehensive intervention |
| no intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving Glycated Hemoglobin (HbA1c) <7.0%
The percentage of participants with glycated hemoglobin (HbA1c) below 7.0% at 6 months after randomization. HbA1c will be measured using high-performance liquid chromatography in a laboratory certified under a national HbA1c standardization program and reported as a percentage (%).
Measured: 6 months after randomization
Time to First Composite Cardio-Metabolic-Immune Clinical Outcome
Time in days from randomization to the first independently adjudicated event: cardiovascular death; nonfatal myocardial infarction; nonfatal ischemic or hemorrhagic stroke; heart failure hospitalization; end-stage kidney disease (long-term dialysis, kidney transplantation, or sustained eGFR <15 mL/min/1.73 m2); hospitalization for diabetic foot ulcer/infection/gangrene or diabetes-related lower-limb amputation; sight-threatening diabetic retinopathy requiring retinal laser, intravitreal therapy, or surgery or new diabetes-related blindness; hospitalization for diabetic ketoacidosis or hyperosmolar hyperglycemic state; or new moderate-to-severe immune-mediated inflammatory disease (rheumatoid arthritis; psoriasis/psoriatic arthritis; Crohn disease/ulcerative colitis; systemic lupus erythematosus; or another disease prespecified in the endpoint charter). An independent blinded endpoint committee will adjudicate events from clinical records.
Measured: From randomization through 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start30 Nov 2026 (estimated)
- Primary completion30 Jun 2030 (estimated)
- Study completion30 Dec 2030 (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.
- More trials run by Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07885904
- Sponsor's protocol ID
- 2026082039
- Acronym
- CDCP
- Status last verified
- Aug 2026
- First submitted
- 14 Sep 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventive Effectiveness of Primary Care Physician-led CGM-supported Comprehensive Intervention on Cardio-metabolic-immune Diseases in Community Patients With Type 2 Diabetes (Community Diabetes Control Project) -A Cluster Randomized, Open-label, Controlled Trial
- ClinicalTrials.gov ID
- NCT07885904
- Acronym / sponsor ID
- CDCP / 2026082039
- Conditions
- Type 2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15,400 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 21 Oct 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 community-based trial evaluates whether primary care physicians, equipped with continuous glucose monitoring (CGM) and trained under a standardized protocol with specialist backup, can improve diabetes outcomes through integrated "medication + exercise + diet" interventions. Unlike traditional fingerstick testing, CGM reveals full glycemic variability, enabling personalized, real-time adjustments. The study hypothesizes that this approach will lower HbA1c, reduce hypoglycemia risk, and decrease long-term cardiovascular, endocrine, and immune-related complications. With low-cost, reliable Chinese-made CGM devices, the intervention is safe and scalable. A cost-effectiveness analysis will also assess its public health value.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: comprehensive interventionMedication, diet and exercise intervention |
| no intervention | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18-80 years, either sex
- Permanent community residents (residing in the community for at least 6 months per year on average)
- Baseline HbA1c 7.0%-14%, fasting blood glucose <13.9 mmol/L, and 2-hour postprandial blood glucose <16.7 mmol/L
- Own and able to use a smartphone, or have assistance from family members
- Enrolled in the National Basic Medical Insurance scheme (Urban and Rural Resident Medical Insurance or Employee Medical Insurance)
Key exclusion criteria (12 listed)
- Type 1 diabetes, specific types of diabetes, or gestational diabetes
- Prior definite myocardial infarction, ischemic stroke, hemorrhagic stroke, or hospitalization for heart failure
- Known severe hepatic or renal insufficiency, or dialysis for any cause. Severe hepatic insufficiency includes alanine aminotransferase (ALT) >3 times the upper limit of normal or aspartate aminotransferase (AST) >3 times the upper limit of normal. Severe renal insufficiency is defined as serum creatinine >3.0 mg/dL (265.2 micromol/L) or glomerular filtration rate (GFR) <30 mL/min/1.73 m2
- Hyperglycemic crisis, diabetic ketoacidosis, or severe hypoglycemic coma requiring assistance within the past 3 months
- History of severe allergy to CGM sensor materials, such as medical adhesive tape
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 |
|---|---|---|
| comprehensive interventionMedication, diet and exercise intervention | Other | intervention group |
Primary outcome
Percentage of Participants Achieving Glycated Hemoglobin (HbA1c) <7.0%
Time frame: 6 months after randomization
The percentage of participants with glycated hemoglobin (HbA1c) below 7.0% at 6 months after randomization. HbA1c will be measured using high-performance liquid chromatography in a laboratory certified under a national HbA1c standardization program and reported as a percentage (%).
Time to First Composite Cardio-Metabolic-Immune Clinical Outcome
Time frame: From randomization through 36 months
Time in days from randomization to the first independently adjudicated event: cardiovascular death; nonfatal myocardial infarction; nonfatal ischemic or hemorrhagic stroke; heart failure hospitalization; end-stage kidney disease (long-term dialysis, kidney transplantation, or sustained eGFR <15 mL/min/1.73 m2); hospitalization for diabetic foot ulcer/infection/gangrene or diabetes-related lower-limb amputation; sight-threatening diabetic retinopathy requiring retinal laser, intravitreal therapy, or surgery or new diabetes-related blindness; hospitalization for diabetic ketoacidosis or hyperosmolar hyperglycemic state; or new moderate-to-severe immune-mediated inflammatory disease (rheumatoid arthritis; psoriasis/psoriatic arthritis; Crohn disease/ulcerative colitis; systemic lupus erythematosus; or another disease prespecified in the endpoint charter). An independent blinded endpoint committee will adjudicate events from clinical records.
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 21 Oct 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing comprehensive intervention in people with Type 2 Diabetes Mellitus, run by Xiangya Hospital of Central South University at 1 site 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 6 inclusion and 12 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 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Yujing Lin, Doctor (18765259516, 18765259516@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving Glycated Hemoglobin (HbA1c) <7.0% (time frame: 6 months after randomization). The study lists 2 primary outcomes in all. 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 21 Oct 2026.