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
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.
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 →Xiangya Hospital of Central South University is the lead sponsor of 172 studies on the registry; 77 are open to participants now.
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Exclusion Criteria:
Medication, diet and exercise intervention
Other: comprehensive intervention
Medication, diet and exercise intervention
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
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
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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 ↗
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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Xiangya Hospital of Central South University →