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)

NCT07885904 | Not Yet Recruiting

• 1 other identifier: 2026082039
• Study Type: interventional
• Target: 15,400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• 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 (%).

  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.

  From randomization through 36 months

Study Arms (2)

intervention group

EXPERIMENTAL

Medication, diet and exercise intervention

Other: comprehensive intervention

no intervention

NO INTERVENTION

Interventions

comprehensive intervention OTHER

Medication, diet and exercise intervention

intervention group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead

Study Sites (1)

Xiangya hospital

Changsha, Hunan, 410028, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Yujing Lin, Doctor

CONTACT

18765259516; 18765259516@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants, care providers, and investigators are aware of the assigned intervention. Clinical endpoint events are adjudicated by an independent committee blinded to intervention assignment. Statistical analysts remain blinded to group codes until database lock.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: October 21, 2026
• Study Start (Estimated): November 30, 2026
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): December 30, 2030
• Last Updated: October 21, 2026

Record last verified: 2026-08

Locations

CN (1)