Effectiveness of a self-management intervention on clinical outcomes among patients with type 2 diabetes at high risk for Diabetic Kidney Disease: A Randomised Controlled Trial

Background: Diabetic kidney disease (DKD) is a common complication of type 2 diabetes mellitus (T2DM) and a leading cause of end-stage renal disease, posing substantial health and economic burdens. Early self-management interventions targeting modifiable risk factors are crucial to prevent or slow DKD progression. However, most studies focus on later stages of DKD, leaving a gap in early prevention for high risk of DKD individuals. Objective: To evaluate the effectiveness of a structured self-management intervention on clinical outcomes among T2DM patients at high risk of DKD. Design: A prospective, two-arm, randomized controlled trial. Setting: A tertiary hospital in Shandong Province, China. Participants: 134 patients with T2DM who were classified as being at high risk of DKD using a validated DKD risk prediction model. Methods: 134 participants were randomized 1:1 to the intervention or control group. The intervention group received a 12-week a structured self-management program and 12-week follow-up. The control group received usual care. Clinical outcomes included hemoglobin A1c (HbA1c), urinary albumin-to-creatinine ratio (UACR), estimated glomerular filtration rate (eGFR), systolic blood pressure (SBP), low-density lipoprotein cholesterol (LDL-C), body mass index (BMI), waist circumference (WC) were collected at baseline (T0), after the 12-week intervention (T1), and at 24 weeks (T2). Generalized estimating equations and intention-to-treat analyses were performed. Sensitivity analyses using multiple imputation were conducted. Results: All participants completed the intervention phase. During the follow-up visits period, 7 participants in the intervention group and 9 participants in the control group were lost to follow-up at T1 (attrition rate: 11.94%), while 5 participants in the intervention group and 4 participants in the control group were lost to follow-up at T2 (attrition rate: 6.71%). No significant differences in baseline sociodemographic or clinical indicators between participants retained and those lost to follow-up (p > 0.05), suggesting data were missing at random. Baseline comparisons between the intervention and control groups revealed no significant differences in demographic or clinical indicators (p > 0.05). Compared with the control group, the intervention group demonstrated significant improvements in HbA1c, eGFR, SBP, and LDL-C, while no significant differences were observed for UACR, BMI, or WC. Sensitivity analyses yielded consistent results. Conclusions: The self-management intervention effectively improved HbA1c, eGFR, SBP and LDL-C among T2DM patients at high risk of DKD. These findings suggest that integrating structured self-management into routine diabetes care may help improve modifiable risk factors and support early DKD prevention. Registration: China Clinical Trial Registry (ChiCTR2400092745; registered on 22 November 2024)