Effects and Safety of Diabetic GUideline Algorithm Implementation Performed by Primary Care Physicians in the Community
Recruiting · NCT05349955 · Interventional (participants receive a specific treatment) · Lead sponsor: Shanghai Zhongshan Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Conventional guideline algorithm implementationIntensive guideline algorithm implementation
What this trial is about
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.
Who can take part
Age range
65 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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;
Where it is running
26 locations listed.
- Xiangcheng Second People's Hospital - Suzhou, Jaingsu, China
- Xiangcheng Second People's Hospital - Suzhou, Jaingsu, China
- Caohu Community Healthcare Center - Suzhou, Jiangsu, China
- Huangqiao Community Healthcare Center - Suzhou, Jiangsu, China
- Xiangcheng People's Hospital. - Suzhou, Jiangsu, China
- Yuanhe Community Healthcare Center - Suzhou, Jiangsu, China
- Xiangcheng Third People's Hospital - Suzhou, Jiangsu, China
- Taiping Community Healthcare Center - Suzhou, Jiangsu, China
- Yangchenghu People's Hospital - Suzhou, Jiangsu, China
- Health Center of Xiangcheng Tourism Resort - Suzhou, Jiangsu, China
- Caohu People's Hospital - Suzhou, Jiangsu, China
- Dongqiao Community Healthcare Center - Suzhou, Jiangsu, China
- Xiangcheng Traditional Chinese Medicine Hospital - Suzhou, Jiangsu, China
- Chengyang Community Healthcare Center - Suzhou, Jiangsu, China
- Caohu Community Healthcare Center - Suzhou, Jiangsu, China
- Huangqiao Community Healthcare Center - Suzhou, Jiangsu, China
- Xiangcheng People's Hospital. - Suzhou, Jiangsu, China
- Yuanhe Community Healthcare Center - Suzhou, Jiangsu, China
- Xiangcheng Third People's Hospital - Suzhou, Jiangsu, China
- Taiping Community Healthcare Center - Suzhou, Jiangsu, China
- Yangchenghu People's Hospital - Suzhou, Jiangsu, China
- Health Center of Xiangcheng Tourism Resort - Suzhou, Jiangsu, China
- Caohu People's Hospital - Suzhou, Jiangsu, China
- Dongqiao Community Healthcare Center - Suzhou, Jiangsu, China
- Xiangcheng Traditional Chinese Medicine Hospital - Suzhou, Jiangsu, China
- Chengyang Community Healthcare Center - Suzhou, Jiangsu, China