Effects and Safety of Diabetic GUideline Algorithm Implementation Performed by Primary Care Physi… (NCT05349955) | Clinical Trial Compass
RecruitingNot Applicable
Effects and Safety of Diabetic GUideline Algorithm Implementation Performed by Primary Care Physicians in the Community
China5,600 participantsStarted 2022-11-21
Plain-language 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.
Who can participate
Age range65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* ①Males or females aged 65 and above (≥65) receive treatment from the local community health service center;
* â‘¡Diagnosed 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;
* â‘¢Complicated 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:
* â‘ Pregnant women or women planning to become pregnant;
* â‘¡eGFR\<30 mL/min/1.73m2 (CKD-EPI formula);
* â‘¢Patient cannot be followed up for 36 months (due to health condition or migration);
* ④Unwilling or unable to sign the informed conse…
What they're measuring
1
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.
Timeframe: 18 months since randomization
2
Primary Outcome of Phase 2: Composite of 3P MACE and hospitalization for heart failure.