Effectiveness of Intensively Integrated Care of Microvascular Risk Factors to Prevent Diabetic Kidney Disease Incidences in Community Clinics in Xiamen, China: An Open-label Randomized Controlled Trial

Most patients with diabetes, which has reached epidemic proportions in China, have multiple uncontrolled microvascular risk factors due to suboptimal care. Diabetic kidney disease events (DKD) is one of the most common microvascular complications and has been becoming the leading cause of end-stage renal disease (ESRD).

The overall objective of the proposed randomized trial is to test whether implementation of intensively integrated care of microvascular risk factors (glycated hemoglobin [HbA1C], urinary albumin-to-creatinine ratio [ACR], blood pressure [BP], estimated glomerular filtration rate [eGFR], uric acid [UA] and low-density lipoprotein cholesterol [LDL]) will improve and reduce diabetic kidney disease events (DKD morbidity and mortality) among patients with diabetes and additional microvascular risk factors compared to usual care in public primary care setting (community health service center) in Xiamen, China.

The Prevention In Community Clinics From Diabetic Kidney Disease (PICK) study is an open-label randomized controlled trial which will be conducted in one public primary care setting (Lianqian community health service center) in Xiamen, China. The proposed trial will recruit 1240 patients with diabetes and additional microvascular risk factors but without DKD at baseline. Approximately 620 participants will be randomly assigned to the intervention group and similar participants to the control group.

The intensively integrated care, which will provide a standardized, combined, multi-component intervention according to clinical guideline treatment for diabetes and comorbidities in a primary care setting, will be delivered by trained primary care physicians, health managers and diabetes specialists. Diabetic microvascular risk factors (glycated hemoglobin [HbA1C], urinary albumin-to-creatinine ratio [ACR], blood pressure [BP], estimated glomerular filtration rate [eGFR], uric acid [UA] and low-density lipoprotein cholesterol [LDL]) will be tested every 3 month for the intervention group and clinical treatment decisions based on the test results will be implemented accordingly when necessary. The intensively integrated care intervention will last for 36 months. HbA1C, ACR, BP, eGFR, UA, LDL, other variables and co-morbidities will be measured at baseline and follow-up visits every 3 month. Meanwhile management of the diabetic microvascular risk factors for the control group will be conducted as usual.

In Phase 1, the primary outcomes are mean reductions in HbA1C, ACR, BP, eGFR, UA and LDL levels over the 18-month intervention between intervention and control groups. Net change in HbA1C, ACR, BP, eGFR, UA and LDL levels will be simultaneously modeled using a scaled marginal model which allows estimation of a single overall intervention effect.