NCT05349955 Effects and Safety of Diabetic GUideline Algorithm Implementation Performed by Primary Care Physicians in the Community
| NCT ID | NCT05349955 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai Zhongshan Hospital |
| Condition | Type 2 Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 5,600 participants |
| Start Date | 2022-11-21 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 5,600 participants in total. It began in 2022-11-21 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 guideline algorithm intervention performed by primary care physicians on cardiovascular and renal outcomes in elderly patients with high risk in community.
Eligibility Criteria
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;
Contact & Investigator
Xiaoying Li, MD
PRINCIPAL INVESTIGATOR
Fudan University
Frequently Asked Questions
Who can join the NCT05349955 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Type 2 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05349955 currently recruiting?
Yes, NCT05349955 is actively recruiting participants. Contact the research team at li.xiaoying@zs-hospital.sh.cn for enrollment information.
Where is the NCT05349955 trial being conducted?
This trial is being conducted at Suzhou, China, Suzhou, China, Suzhou, China, Suzhou, China and 9 additional locations.
Who is sponsoring the NCT05349955 clinical trial?
NCT05349955 is sponsored by Shanghai Zhongshan Hospital. The principal investigator is Xiaoying Li, MD at Fudan University. The trial plans to enroll 5,600 participants.
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