Implementing diabetes treatment guidelines 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)

This study is testing whether following new diabetes treatment guidelines can help older adults with diabetes avoid serious heart and kidney problems compared to regular care.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 5600 (estimated)
• Ages: 65 Years and up
• Sex: All
• Sponsor: Shanghai Zhongshan Hospital (other)
• Locations: 13 sites (Suzhou, Jaingsu and 12 other locations)
• Trial ID: NCT05349955 on ClinicalTrials.gov

What this trial studies

The GUARD-Community study is a cluster-randomized controlled trial aimed at evaluating the effects and safety of implementing diabetes treatment guidelines by primary care physicians on cardiovascular and renal outcomes in elderly patients with type 2 diabetes. The study will enroll over 5,600 participants aged 65 and older who have diabetes and are at high risk for cardiovascular complications and chronic kidney disease. Participants will be divided into two groups: one receiving intensive guideline implementation and the other receiving conventional care. The primary goal is to determine if the guideline intervention can significantly reduce major adverse cardiovascular events over an 18-month period.

Who should consider this trial

Good fit: Ideal candidates are males and females aged 65 and older with type 2 diabetes and complications such as chronic kidney disease or high cardiovascular risk.

Not a fit: Patients who are younger than 65 or do not have type 2 diabetes or related complications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved cardiovascular and renal health outcomes for elderly patients with type 2 diabetes.

How similar studies have performed: Other studies have shown promising results with similar guideline implementation approaches, suggesting potential for success in this trial.

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;

Where this trial is running

Suzhou, Jaingsu and 12 other locations

• Xiangcheng Second People's Hospital — Suzhou, Jaingsu, China (RECRUITING)
• Caohu Community Healthcare Center — Suzhou, Jiangsu, China (RECRUITING)
• Huangqiao Community Healthcare Center — Suzhou, Jiangsu, China (RECRUITING)
• Xiangcheng People's Hospital. — Suzhou, Jiangsu, China (RECRUITING)
• Yuanhe Community Healthcare Center — Suzhou, Jiangsu, China (RECRUITING)
• Xiangcheng Third People's Hospital — Suzhou, Jiangsu, China (RECRUITING)
• Taiping Community Healthcare Center — Suzhou, Jiangsu, China (RECRUITING)
• Yangchenghu People's Hospital — Suzhou, Jiangsu, China (RECRUITING)
• Health Center of Xiangcheng Tourism Resort — Suzhou, Jiangsu, China (RECRUITING)
• Caohu People's Hospital — Suzhou, Jiangsu, China (RECRUITING)
• Dongqiao Community Healthcare Center — Suzhou, Jiangsu, China (RECRUITING)
• Xiangcheng Traditional Chinese Medicine Hospital — Suzhou, Jiangsu, China (RECRUITING)
• Chengyang Community Healthcare Center — Suzhou, Jiangsu, China (RECRUITING)

Study contacts

• Principal investigator: Xiaoying Li, MD — Fudan University
• Study coordinator: Xiaoying Li, MD

Conditions: Type 2 Diabetes, Cardiovascular Complication, Diabetic Kidney Disease, Diabetes implementation study, Diabetes guideline algorithm, Cardiovascular disease, Chronic kidney disease