Trial reportPloS one2026
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.
Trial report in PloS one, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Abstract
backgroundDiabetic 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.
objectiveTo evaluate the effectiveness of a structured self-management intervention on clinical outcomes among T2DM patients at high risk of DKD.
designA prospective, two-arm, randomized controlled trial.
settingA tertiary hospital in Shandong Province, China.
participants134 patients with T2DM who were classified as being at high risk of DKD using a validated DKD risk prediction model.
methods134 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.
resultsAll 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.
conclusionsThe 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).
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