Effects and Safety of Diabetic GUideline Algorithm Implementation Performed by Primary Care Physicians in the Community
Effects and Safety of GUideline Algorithm Based Intervention on CaRdiovascular and Renal Outcomes in Elderly Diabetic Patients With High Cardiovascular Risk in the Community- A Cluster Randomized Controlled Trial (GUARD-Community Study)
Shanghai Zhongshan Hospital
5,600 participants
Nov 21, 2022
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria12
- ①Males or females aged 65 and above (≥65) receive treatment from the local community health service center;
- ②Diagnosed type 2 diabetes (ADA criteria):
- 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);
- D. have been treated with antidiabetic drugs;
- Each blood sugar test must be repeated to confirm the diagnosis;
- ③Complicated with chronic kidney disease and/or very high/high risk of cardiovascular disease, meet any one of the following:
- A. ASCVD, including coronary heart disease, cerebral infarction, peripheral vascular disease;
- B. Or target organ damage (albuminuria, renal impairment with eGFR ≥ 30 ml/min/1.73m2, left ventricular hypertrophy or retinopathy);
- C. ≥ 3 major risk factors (age ≥ 65 years old, hypertension, dyslipidemia, smoking, obesity );
- D. Diabetes duration ≥ 10 years, with any one traditional cardiovascular risk factor such as advanced age, obesity, smoking, sedentary, family history of cardiovascular disease, hypertension, abnormal lipid metabolism.
Exclusion Criteria5
- 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;
- ⑤Type 1 diabetes;
Interventions
Diabetes 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.
The 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.
Locations(13)
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NCT05349955