Implementing diabetes treatment guidelines by primary care physicians in the community

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• 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

Study contacts

• Principal investigator: Xiaoying Li, MD — Fudan University
• Study coordinator: Xiaoying Li, MD
• Email: li.xiaoying@zs-hospital.sh.cn
• Phone: 13651913857

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.