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Not yet recruitingNCT07885904CDCPUpdated Oct 21, 2026

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)

An interventional study of comprehensive intervention in Type 2 Diabetes Mellitus, sponsored by Xiangya Hospital of Central South University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-21.

Sponsored by Xiangya Hospital of Central South University · Not applicable, Interventional, and Prevention

Updated Oct 21, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
15,400
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Type 2 Diabetes Mellitus
03

In context

Diabetes Mellitus, Type 2

9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.

This study's planned enrollment of 15,400 is above the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Xiangya Hospital of Central South University is the lead sponsor of 172 studies on the registry; 77 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
15,400 participants (estimated)

Study arms

  • Experimental
    intervention group

    Medication, diet and exercise intervention

    Other: comprehensive intervention

  • No intervention
    no intervention

Interventions

  • Othercomprehensive intervention

    Medication, diet and exercise intervention

06

What researchers measure

Primary outcomes

  1. 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 (%).

    Time frame: 6 months after randomization

  2. 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.

    Time frame: From randomization through 36 months

07

Study locations

1 site
  • Xiangya hospital
    Changsha, Hunan 410028, China
08

References and documents

Study documents

  • Protocol and informed consent form · Aug 10, 2026
  • Informed consent form · Apr 13, 2026

Documents are hosted by the registry — open the source record to download them.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 21, 2026
Show all 1 update
  1. Oct 21, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07885904
Responsible party
Sponsor
First posted
Oct 21, 2026
Start date
Nov 30, 2026 (estimated)
Primary completion
Jun 30, 2030 (estimated)
Completion
Dec 30, 2030 (estimated)
Last update
Oct 21, 2026

Study contacts

Yujing Lin, Doctor
Contact
18765259516@163.com
18765259516

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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