The Effects and Safety of Diabetic GUideline Algorithm Implementation in the Community (GUARD-Community) study is a 2-arm, cluster-randomized control trial to evaluate the effect and safety of guideline algorithm intervention performed by primary care physicians on cardiovascular and renal outcomes in elderly patients with high risk in community.
①Males or females aged 65 and above (≥65) receive treatment from the local community health service center;
A. Typical symptoms of diabetes + random blood sugar ≥ 11.1mmol/L;
B. Fasting blood glucose (FPG) ≥ 7.0mmol/L (fasting blood glucose is defined as no caloric intake within 8 hours);
C. Oral glucose tolerance test 2h blood glucose (OGTT) ≥ 11.1mmol/L (2h after meal);
①Pregnant women or women planning to become pregnant;
②eGFR<30 mL/min/1.73m2 (CKD-EPI formula);
③Patient cannot be followed up for 36 months (due to health condition or migration);
④Unwilling or unable to sign the informed consent;
Parallel
Intensive guideline algorithm implementation
Other interventionDiabetes guideline pharmacological algorithm will be implemented by primary care physicians in community. In brief, SGLT2i or GLP-1RA will be recommended to control blood glucose in priority when subjects at very high/high CV risk and meet the target HbA1C\<7%, control blood pressure \<130/80mmHg， LDL-c\<1.8mmol/L at very high CV risk patients or \<2.6mmol/L at high CV risk patients, and antiplatelet as secondary prevention of ASCVD.
Conventional guideline algorithm implementation
Other interventionThe guideline intervention is based the guidance which the local physicians followed through self learning and education. The management of diabetes paitients will be decided by local physicians.
Primary Outcome of Phase 1: Comprehensive management effect of various cardiovascular risk factors in T2D，meeting control targets for a combination of A1c, BP, LDL-C.
The proportion of participants with HbA1C\<7.0%, blood pressure\< 130/80 mm Hg，LDL-c\<1.8mmol/L at very high CV risk or \<2.6mmol/L at high CV risk.
Primary Outcome of Phase 2: Composite of 3P MACE and hospitalization for heart failure.
Time to occurrence of cardiovascular and cerebrovascular death, non-fatal myocardial infarction, non-fatal Stroke, hospitalization for heart failure.
Secondary Outcome of Phase 1: Glycemic control rate
The proportion of participants with tight glucose control, targeting HbA1c \<7.0%
Secondary Outcome of Phase 1: Mean HbA1C changes
Mean HbA1C changes of participants
Secondary Outcome of Phase 1: Mean systolic and diastolic pressure changes
Mean systolic and diastolic pressure changes of participants
Secondary Outcome of Phase 1: Mean LDL-c changes
Mean LDL-c changes of participants
Health Economics Indicators
Cost-effectiveness analysis： quantification of Incremental Cost Ratio Life Cycle (ICER) and Quality Adjusted Years (QALYs)
Changes in cardiovascular risk indicators
Framingham score
Serology and urine testing
Biomarkers associated with diagnosis or prognosis: using "omics" screening.
Genomics testing
Gene polymorphism testing for drug response or prognosis: using genome-wide association study(GWAS) screening.
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