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

Launched by SHANGHAI ZHONGSHAN HOSPITAL · Apr 22, 2022

Keywords

ClinConnect Summary

The GUARD-Community study is a clinical trial designed to see how effective and safe a new treatment plan is for elderly patients with type 2 diabetes, especially those at risk for heart and kidney problems. The study involves primary care doctors using specific guidelines to help manage patients' diabetes and monitor their health outcomes over time. It aims to find out if this approach can improve the overall health of these patients, particularly their heart and kidney function.

To participate in this study, you need to be at least 65 years old and diagnosed with type 2 diabetes. You should also have additional health concerns, such as chronic kidney disease or a high risk of heart disease. If you decide to join, you will work closely with your primary care physician, who will guide you through the treatment plan over a period of 36 months. It's important to note that this trial is currently recruiting participants, and it's a great opportunity to contribute to research that could help improve diabetes care in the community.

Gender

ALL

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;