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

Plain-language summary

This study examines the effects and safety of a diabetes guideline algorithm implemented by primary care physicians, comparing intensive and conventional implementation. It enrolls patients aged 65 and over with type 2 diabetes who also have chronic kidney disease or high cardiovascular risk. This is a study without a phase and is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Recruiting

Sponsor

Shanghai Zhongshan Hospital

Intervention

Intensive guideline algorithm implementation, Conventional guideline algorithm implementation

Start date

11/21/2022

Estimated completion

11/30/2026

Countries

China

Related genes

Locations

• Suzhou, China
• Suzhou, China
• Suzhou, China
• Suzhou, China
• Suzhou, China
• Suzhou, China
• Suzhou, China
• Suzhou, China
• Suzhou, China
• Suzhou, China
• Suzhou, China
• Suzhou, China
• Suzhou, China

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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;