JMIR Publications

ABSTRACT

Background:

Diabetic 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 important to slow the progression of kidney disease and improve prognoses. Whereas mobile health (mHealth) is reportedly effective in supporting diabetic patients’ self-care and improving glycemic control, the impact of mHealth on DKD has not yet been shown.

Objective:

The purpose of this study is to evaluate the efficacy of a standard therapy with addition of a self-management support system, DialBeticsPlus, in DKD patients with microalbuminuria.

Methods:

This study is a prospective, randomized, open-label, multicenter clinical trial. The target population consists of 160 patients diagnosed with T2DM accompanied with microalbuminuria. We randomized the patients between two groups—the intervention group employing DialBetesPlus in addition to conventional therapy and the control group with conventional therapy alone. DialBetesPlus is a smartphone application that supports patients’ self-management of T2DM. The study period is 12 months, with a follow-up survey at 18 months. The primary outcome is change in albuminuria levels at 12 months. Secondary outcomes include 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.

Results:

The study was approved in April 2018. We began recruiting patients in July 2018, and completed recruiting in August 2019. The final 18-months follow-up will be done in March 2021. We recruited 159 patients and randomly allocated 70 into the intervention group and 61 into the control group, with 28 exclusions for withdrawal of consent, refusal to continue, or ineligibility. The first results are expected to be available in 2021.

Conclusions:

This is the first randomized controlled trial to assess 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. Clinical Trial: University Hospital Medical Information Network Clinical Trials Registry (UMIN000033261). https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000037924