Safety and Effects of Guideline-Based Diabetes Treatment by Primary Care Physicians on Heart and Kidney Health in Older Adults with High Cardiovascular Risk

What this Trial Is About

This research evaluates the effects and safety of implementing a diabetic guideline algorithm by primary care physicians in a community setting. It focuses on elderly patients aged 65 and older with type 2 diabetes who have high or very high cardiovascular risk and complications such as chronic kidney disease or cardiovascular disease. The study aims to see if the guideline-based intervention can reduce major cardiovascular events and improve cardiovascular and renal outcomes over time. The trial is a cluster-randomized controlled study with two groups one receiving intensive guideline algorithm implementation prioritizing drugs like SGLT2 inhibitors or GLP-1 receptor agonists for high-risk patients, targeting specific blood sugar, blood pressure, and cholesterol goals and the other receiving conventional guideline-based care managed by local physicians with education support. The intervention targets include HbA1C under 7%, blood pressure below 13080 mmHg, and LDL cholesterol below certain thresholds depending on risk level. The study duration is four years, with Phase 1 assessing control of risk factors at 18 months and Phase 2 evaluating cardiovascular and kidney outcomes at three years. Participants will undergo assessments to monitor blood sugar control, blood pressure, cholesterol levels, kidney function, cardiovascular events, and other health markers such as heart function, retinopathy, cognitive function, and frailty over the study period. Data collection includes measuring primary outcomes like combined cardiovascular events and hospitalization for heart failure, as well as secondary outcomes including changes in glycemic control, kidney disease progression, and body weight. Safety and adherence to treatment guidelines will be tracked throughout. The study involves regular follow-up to evaluate the impact of guideline implementation on health outcomes in elderly diabetics with high cardiovascular risk.

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