Status:
RECRUITING
Effects and Safety of Diabetic GUideline Algorithm Implementation Performed by Primary Care Physicians in the Community
Lead Sponsor:
Shanghai Zhongshan Hospital
Conditions:
Type 2 Diabetes
Cardiovascular Complication
Eligibility:
All Genders
65+ years
Phase:
NA
Brief 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 guideli...
Detailed Description
Diabetes is an important public health concern. Elderly diabetic patients are characterized by a long duration and complications, including chronic kidney disease and/or cardiovascular disease. In the...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
November 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2026
Estimated Enrollment :
5600 Patients enrolled
Trial Details
Trial ID
NCT05349955
Start Date
November 21 2022
End Date
November 30 2026
Last Update
May 14 2025
Active Locations (13)
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1
Xiangcheng Second People's Hospital
Suzhou, Jaingsu, China, 215501
2
Caohu Community Healthcare Center
Suzhou, Jiangsu, China, 215006
3
Huangqiao Community Healthcare Center
Suzhou, Jiangsu, China, 215006
4
Xiangcheng People's Hospital.
Suzhou, Jiangsu, China, 215131