ArticleJMIR research protocols2021
Efficacy of the Self-management Support System DialBetesPlus for Diabetic Kidney Disease: Protocol for a Randomized Controlled Trial.
Article in JMIR research protocols, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.
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Who cites it
10 citing papers in PubMed, 1 synthesis or guideline pooled it, 15 citations in OpenAlex.
- Education programmes for people with chronic kidney disease and diabetes.The Cochrane database of systematic reviews · 2024Pooled it
- Efficacy of Save Medical Corporation (SMC)-01, a Smartphone App Designed to Support Type 2 Diabetes Self-Management Based on Established Guidelines: Randomized Controlled Trial.Journal of medical Internet research · 2024Trial
- Effects of a device-measured physical activity intervention on visual outcomes, including contrast sensitivity, and glycaemic control in individuals with abnormal glucose tolerance: a pilot randomised trial post-CarMeR study.Pilot and feasibility studies · 2026Article
- Emerging New Era of Artificial Intelligence and Digital Medicine-directed Management of Chronic Kidney Disease.JMA journal · 2025Article
- Telemedicine in nephrology: future perspective and solutions.Clinical kidney journal · 2024Article
- Prevalence and Risk Factors of Chronic Kidney Disease in Patients With Type 2 Diabetes in China: Cross-Sectional Study.JMIR public health and surveillance · 2024Observational
- Effectiveness of DialBetesPlus, a self-management support system for diabetic kidney disease: Randomized controlled trial.NPJ digital medicine · 2024Article
- Efficacy of StepAdd, a Personalized mHealth Intervention Based on Social Cognitive Theory to Increase Physical Activity Among Patients With Type 2 Diabetes Mellitus: Protocol for a Randomized Controlled Trial.JMIR research protocols · 2024Article
- Lifestyle interventions delivered by eHealth in chronic kidney disease: A scoping review.PloS one · 2024Article
- Effect of Digital Health Among People With Type 2 Diabetes Mellitus During the COVID-19 Pandemic in Japan.Journal of diabetes science and technology · 2022Article
Corrections and comments
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Authors and funding
25 authors at 11 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDiabetic kidney disease (DKD) is one of the main complications of type 2 diabetes mellitus (T2DM). DKD is a known risk factor for end-stage renal disease, cardiovascular disease, and all-cause death. Effective intervention for early-stage DKD is vital to slowing down the progression of kidney disease and improve prognoses. Mobile health (mHealth) is reportedly effective in supporting patients' self-care and improving glycemic control, but the impact of mHealth on DKD has yet to be shown.
objectiveThe purpose of this study is to evaluate the efficacy of standard therapy with the addition of a self-management support system, DialBetesPlus, in patients with DKD and microalbuminuria.
methodsThis study is a prospective, randomized, open-label, multicenter clinical trial. The target population consists of 160 patients diagnosed with T2DM accompanied by microalbuminuria. We randomly assigned the patients to 2 groups-the intervention group using DialBetesPlus in addition to conventional therapy and the control group using conventional therapy alone. DialBetesPlus is a smartphone application that supports patients' self-management of T2DM. The study period was 12 months, with a follow-up survey at 18 months. The primary outcome was a change in albuminuria levels at 12 months. Secondary outcomes included changes in physical parameters, blood test results (glycemic control, renal function, and lipid metabolism), lifestyle habits, self-management scores, medication therapy, and quality of life.
resultsThe study was approved in April 2018. We began recruiting patients in July 2018 and completed recruiting in August 2019. The final 18-month follow-up was conducted in March 2021. We recruited 159 patients and randomly allocated 70 into the intervention group and 61 into the control group, with 28 exclusions due to withdrawal of consent, refusal to continue, or ineligibility. The first results are expected to be available in 2021.
conclusionsThis is the first randomized controlled trial assessing the efficacy of mHealth on early-stage DKD. We expect that albuminuria levels will decrease significantly in the intervention group due to improved glycemic control with ameliorated self-care behaviors.
trial registrationUMIN-CTR UMIN000033261; https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000037924. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/31061.
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