Effects and Safety of Diabetic GUideline Algorithm Implementation Performed by Primary Care Physicians in the Community

NCT05349955 · tracked via the Priya Life Science China tracker

Sponsor

Shanghai Zhongshan Hospital

Phase

Not applicable

Started

2022-11-21

Last updated

2025-05-14

Condition(s) studied

Type 2 DiabetesCardiovascular ComplicationDiabetic Kidney Disease

Investigational drug(s) / intervention(s)

Intensive guideline algorithm implementationConventional guideline algorithm implementation

Intensive guideline algorithm implementation: 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.

Conventional guideline algorithm implementation: 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.

Study 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

Sex

ALL

Min age

65 Years

Max age

—

Healthy volunteers

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;

Primary outcome measure(s)

Primary Outcome of Phase 1: Comprehensive management effect of various cardiovascular risk factors in T2D，meeting control targets for a combination of A1c, BP, LDL-C. — 18 months since randomization
The proportion of participants with HbA1C\<7.0%, blood pressure\< 130/80 mm Hg，LDL-c\<1.8mmol/L at very high CV risk or \<2.6mmol/L at high CV risk.
Primary Outcome of Phase 2: Composite of 3P MACE and hospitalization for heart failure. — 3 years since randomization
Time to occurrence of cardiovascular and cerebrovascular death, non-fatal myocardial infarction, non-fatal Stroke, hospitalization for heart failure.

Trial sites (13)

Facility	City	Region	Status
Xiangcheng Second People's Hospital	Suzhou	Jaingsu	Recruiting
Caohu Community Healthcare Center	Suzhou	Jiangsu	Recruiting
Huangqiao Community Healthcare Center	Suzhou	Jiangsu	Recruiting
Xiangcheng People's Hospital.	Suzhou	Jiangsu	Recruiting
Yuanhe Community Healthcare Center	Suzhou	Jiangsu	Recruiting
Xiangcheng Third People's Hospital	Suzhou	Jiangsu	Recruiting
Taiping Community Healthcare Center	Suzhou	Jiangsu	Recruiting
Yangchenghu People's Hospital	Suzhou	Jiangsu	Recruiting
Health Center of Xiangcheng Tourism Resort	Suzhou	Jiangsu	Recruiting
Caohu People's Hospital	Suzhou	Jiangsu	Recruiting
Dongqiao Community Healthcare Center	Suzhou	Jiangsu	Recruiting
Xiangcheng Traditional Chinese Medicine Hospital	Suzhou	Jiangsu	Recruiting
Chengyang Community Healthcare Center	Suzhou	Jiangsu	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05349955 on ClinicalTrials.gov ↗ ← All trials in China