NCT05349955Recruiting
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)
Source: ClinicalTrials.gov · Last updated 14 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 5600 (estimated)
- First submitted
- 16 Apr 2022
- Start date
- 21 Nov 2022
- Primary completion date
- 30 Nov 2026
- Lead sponsor
- Shanghai Zhongshan Hospital
- Diseases
- Chronic kidney disease, Type 2 diabetes
- NCT number
- NCT05349955
What you commit to
- Study type: Interventional
- Planned participants: 5600
- From 21 Nov 2022 to the primary completion date, 30 Nov 2026
- 13 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- ③Patient cannot be followed up for 36 months (due to health condition or migration);
- ⑤Type 1 diabetes;
Lab values
- ②eGFR\<30 mL/min/1.73m2 (CKD-EPI formula);
Other
- ①Pregnant women or women planning to become pregnant;
- ④Unwilling or unable to sign the informed consent;
Who the study is looking for
- 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.
Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Taiping Community Healthcare Center Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
| Xiangcheng Second People's Hospital Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
| Health Center of Xiangcheng Tourism Resort Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
| Caohu People's Hospital Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
| Xiangcheng People's Hospital. Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
| Huangqiao Community Healthcare Center Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
| Caohu Community Healthcare Center Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
| Yuanhe Community Healthcare Center Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
| Xiangcheng Third People's Hospital Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
| Xiangcheng Traditional Chinese Medicine Hospital Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
| Dongqiao Community Healthcare Center Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
| Chengyang Community Healthcare Center Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
| Yangchenghu People's Hospital Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.