RecruitingNot ApplicableNCT05349955

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

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)


Sponsor

Shanghai Zhongshan Hospital

Enrollment

5,600 participants

Start Date

Nov 21, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether having community doctors follow an updated diabetes care algorithm improves health outcomes for older adults with Type 2 diabetes and heart or kidney risks. **You may be eligible if...** - You are 65 years old or older with Type 2 diabetes - You receive care at a local community health center - You have kidney disease, high cardiovascular risk, or a long history of diabetes with risk factors like high blood pressure or obesity **You may NOT be eligible if...** - You are pregnant or planning to become pregnant - Your kidney function is very low (eGFR below 30) - You cannot be followed up for 36 months - You are unwilling or unable to sign informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERIntensive guideline algorithm implementation

Diabetes guideline pharmacological algorithm will be implemented by primary care physicians in community. In brief, SGLT2i or GLP-1RA will be recommended to control blood glucose in priority when subjects at very high/high CV risk and meet the target HbA1C\<7%, control blood pressure \<130/80mmHg, LDL-c\<1.8mmol/L at very high CV risk patients or \<2.6mmol/L at high CV risk patients, and antiplatelet as secondary prevention of ASCVD.

OTHERConventional guideline algorithm implementation

The guideline intervention is based the guidance which the local physicians followed through self learning and education. The management of diabetes paitients will be decided by local physicians.


Locations(13)

Xiangcheng Second People's Hospital

Suzhou, Jaingsu, China

Caohu Community Healthcare Center

Suzhou, Jiangsu, China

Huangqiao Community Healthcare Center

Suzhou, Jiangsu, China

Xiangcheng People's Hospital.

Suzhou, Jiangsu, China

Yuanhe Community Healthcare Center

Suzhou, Jiangsu, China

Xiangcheng Third People's Hospital

Suzhou, Jiangsu, China

Taiping Community Healthcare Center

Suzhou, Jiangsu, China

Yangchenghu People's Hospital

Suzhou, Jiangsu, China

Health Center of Xiangcheng Tourism Resort

Suzhou, Jiangsu, China

Caohu People's Hospital

Suzhou, Jiangsu, China

Dongqiao Community Healthcare Center

Suzhou, Jiangsu, China

Xiangcheng Traditional Chinese Medicine Hospital

Suzhou, Jiangsu, China

Chengyang Community Healthcare Center

Suzhou, Jiangsu, China

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NCT05349955


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