About this trial

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.

Eligibility criteria

Qualifiers

①Males or females aged 65 and above (≥65) receive treatment from the local community health service center;

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);

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Intensive guideline algorithm implementation
  • Conventional guideline algorithm implementation

Treatment groups

5,600 Participants
are divided into 2 treatment groups

Locations

13
Xiangcheng Second People's Hospital215501, SuzhouJaingsu, China
Caohu Community Healthcare Center215006, SuzhouJiangsu, China
Caohu People's Hospital215144, SuzhouJiangsu, China
Chengyang Community Healthcare Center SuzhouJiangsu, China

Sponsors and collaborators

Shanghai Zhongshan Hospital

Lead sponsor