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

Key facts

Where
Suzhou, ChinaSee the 13 sites

Where in China

  • Caohu Community Healthcare CenterSuzhou, ChinaTaking people
  • Caohu People's HospitalSuzhou, ChinaTaking people
  • Chengyang Community Healthcare CenterSuzhou, ChinaTaking people
  • Dongqiao Community Healthcare CenterSuzhou, ChinaTaking people
  • Health Center of Xiangcheng Tourism ResortSuzhou, ChinaTaking people
  • Huangqiao Community Healthcare CenterSuzhou, ChinaTaking people
  • Taiping Community Healthcare CenterSuzhou, ChinaTaking people
  • Xiangcheng People's Hospital.Suzhou, ChinaTaking people
  • Xiangcheng Second People's HospitalSuzhou, ChinaTaking people
  • Xiangcheng Third People's HospitalSuzhou, ChinaTaking people
  • Xiangcheng Traditional Chinese Medicine HospitalSuzhou, ChinaTaking people
  • Yangchenghu People's HospitalSuzhou, ChinaTaking people
  • Yuanhe Community Healthcare CenterSuzhou, ChinaTaking people

Questions to ask the study team

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  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Shanghai Zhongshan Hospital
Trial code
NCT05349955
Record updated
14 May 2025
Original description
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.Read full original descriptionShow less

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)

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.

Inclusion: 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: ③Patient cannot be followed up for 36 months (due to health condition or migration); ⑤Type 1 diabetes; ②eGFR<30 mL/min/1.73m2 (CKD-EPI formula); ①Pregnant women or women planning to become pregnant; ④Unwilling or unable to sign the informed consent.

ClinicalTrials.gov NCT05349955