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)

Prior treatment

• Prior definite myocardial infarction, ischemic stroke, hemorrhagic stroke, or hospitalization for heart failure
• 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
• 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

Other illness

• Type 1 diabetes, specific types of diabetes, or gestational diabetes
• History of severe allergy to CGM sensor materials, such as medical adhesive tape
• Severe mental disorder or dementia that precludes completion of informed consent and follow-up procedures
• Other conditions deemed by the investigator to make participation unsuitable

Lab values

• 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

Other

• Hyperglycemic crisis, diabetic ketoacidosis, or severe hypoglycemic coma requiring assistance within the past 3 months
• Definite diagnosis of severe diabetic complications documented in the medical history or medical records
• Pregnancy, breastfeeding, or planned pregnancy within 90 days

• 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