{ "abstract": "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)", "abstract_shown": true, "affiliations": [ "Department of Nursing, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Selangor, Malaysia", "Department of Biomedical Sciences, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Selangor, Malaysia" ], "article_type": "Research Article", "arxiv": null, "author_total": 5, "authors": [ { "affs": [ 0 ], "name": "Dongmei Chu" }, { "affs": [ 1 ], "name": "Bingyang Liu" }, { "name": "Kim Lam Soh" }, { "name": "Hasni Idayu Saidi" }, { "name": "Salimah Japar" } ], "bibtex": "https://research.draconitic.com/paper/6neptsa1zab31.bib", "cited_by": 0, "doi": "10.1371/journal.pone.0360475", "fulltext_url": null, "id": "6neptsa1zab31", "issns": [ "1932-6203" ], "landing_url": "https://doi.org/10.1371/journal.pone.0360475", "language": null, "licence": "CC-BY-4.0", "licence_label": "CC BY 4.0", "licence_source": "journal", "licence_url": "https://creativecommons.org/licenses/by/4.0/", "metadata_licence": null, "native_subjects": [ [ "openalex", "2727|Chronic Kidney Disease and Diabetes" ], [ "plos", "/Biology and life sciences/Anatomy/Renal system" ], [ "plos", "/Biology and life sciences/Biochemistry/Proteins/Hemoglobin/HbA1c" ], [ "plos", "/Biology and life sciences/Nutrition/Diet" ], [ "plos", "/Medicine and health sciences/Anatomy/Renal system" ], [ "plos", "/Medicine and health sciences/Diagnostic medicine/Diabetes diagnosis and management/HbA1c" ], [ "plos", "/Medicine and health sciences/Endocrinology/Endocrine disorders/Diabetes mellitus" ], [ "plos", "/Medicine and health sciences/Epidemiology/Medical risk factors" ], [ "plos", "/Medicine and health sciences/Health care/Patients" ], [ "plos", "/Medicine and health sciences/Medical conditions/Metabolic disorders/Diabetes mellitus" ], [ "plos", "/Medicine and health sciences/Nutrition/Diet" ], [ "plos", "/Medicine and health sciences/Vascular medicine/Blood pressure" ], [ "plos", "/Physical sciences/Mathematics/Statistics/Statistical methods/Test statistics" ], [ "plos", "/Research and analysis methods/Mathematical and statistical techniques/Statistical methods/Test statistics" ] ], "openalex": "W7221554411", "pdf_url": "https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0360475&type=printable", "pmcid": null, "pmid": null, "published": "2026-10-12", "publisher": "Public Library of Science", "ris": "https://research.draconitic.com/paper/6neptsa1zab31.ris", "sources": [ { "first_seen": "2026-10-30T12:17:30Z", "native_id": "10.1371/journal.pone.0360475", "source": "plos", "url": "https://doi.org/10.1371/journal.pone.0360475" } ], "subjects": [ { "field": "medicine", "origin": "plos:endocrinology", "subfield": "endocrinology-metabolism" }, { "field": "medicine", "origin": "plos:nutrition", "subfield": "nutrition" }, { "field": "medicine", "origin": "plos:anatomy", "subfield": "physiology" } ], "title": "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", "title_text": "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", "type": "peer-reviewed", "updated_at": "2026-10-30T12:17:30Z", "url": "https://research.draconitic.com/paper/6neptsa1zab31", "venue": "PLOS One", "versions": [] }