Efficacy of the Self-management Support System DialBetesPlus for Diabetic Kidney Disease: Protocol for a Randomized Controlled Trial

Yuki Kawai; Akiko Sankoda; Kayo Waki; Kana Miyake; Aki Hayashi; Makiko Mieno; Hiromichi Wakui; Yuya Tsurutani; Jun Saito; Nobuhito Hirawa; Tadashi Yamakawa; Shiro Komiya; Akihiro Isogawa; Shinobu Satoh; Taichi Minami; Uru Osada; Tamio Iwamoto; Tatsuro Takano; Yasuo Terauchi; Kouichi Tamura; Toshimasa Yamauchi; Takashi Kadowaki; Masaomi Nangaku; Naoki Kashihara; Kazuhiko Ohe

doi:10.2196/31061

Efficacy of the Self-management Support System DialBetesPlus for Diabetic Kidney Disease: Protocol for a Randomized Controlled Trial

JMIR Res Protoc. 2021 Aug 17;10(8):e31061. doi: 10.2196/31061.

Authors

Yuki Kawai^#^{1

2}, Akiko Sankoda^#¹, Kayo Waki^{1

3}, Kana Miyake^{1

3}, Aki Hayashi¹, Makiko Mieno⁴, Hiromichi Wakui², Yuya Tsurutani⁵, Jun Saito⁵, Nobuhito Hirawa⁶, Tadashi Yamakawa⁷, Shiro Komiya², Akihiro Isogawa⁸, Shinobu Satoh⁹, Taichi Minami¹⁰, Uru Osada¹⁰, Tamio Iwamoto¹¹, Tatsuro Takano¹², Yasuo Terauchi¹³, Kouichi Tamura², Toshimasa Yamauchi³, Takashi Kadowaki^{14

15}, Masaomi Nangaku¹⁶, Naoki Kashihara¹⁷, Kazuhiko Ohe¹

Affiliations

¹ Department of Planning, Information and Management, University of Tokyo Hospital, Tokyo, Japan.
² Department of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine, Yokohama, Japan.
³ Department of Diabetes and Metabolic Diseases, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
⁴ Department of Medical Informatics, Center for Information, Jichi Medical University, Shimotsuke, Japan.
⁵ Endocrinology and Diabetes Center, Yokohama Rosai Hospital, Yokohama, Japan.
⁶ Department of Nephrology and Hypertension, Yokohama City University Medical Center, Yokohama, Japan.
⁷ Department of Endocrinology and Diabetes, Yokohama City University Medical Center, Yokohama, Japan.
⁸ Division of Diabetes, Mitsui Memorial Hospital, Tokyo, Japan.
⁹ Department of Endocrinology and Metabolism, Chigasaki Municipal Hospital, Chigasaki, Japan.
¹⁰ Department of Diabetes and Endocrinology, Saiseikai Yokohamashi Nanbu Hospital, Yokohama, Japan.
¹¹ Department of Nephrology and Hypertension, Saiseikai Yokohamashi Nanbu Hospital, Yokohama, Japan.
¹² Department of Diabetes and Endocrinology, Fujisawa City Hospital, Fujisawa, Japan.
¹³ Department of Endocrinology and Metabolism, Yokohama City University Graduate School of Medicine, Yokohama, Japan.
¹⁴ Department of Prevention of Diabetes and Lifestyle-Related Diseases, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
¹⁵ Toranomon Hospital, Tokyo, Japan.
¹⁶ Division of Nephrology and Endocrinology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
¹⁷ Department of Nephrology and Hypertension, Kawasaki Medical School, Kurashiki, Japan.

^# Contributed equally.

PMID: 34402802
PMCID: PMC8408755
DOI: 10.2196/31061

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 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.

Objective: The 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.

Methods: This 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.

Results: The 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.

Conclusions: This 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 registration: UMIN-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.

Keywords: albuminuria; behavior; chronic disease; diabetes; diabetes mellitus; diabetic kidney disease; efficacy; intervention; kidney; mHealth; microalbuminuria; protocol; randomized controlled trial; self-care; self-management; self-management support system; support; therapy.

©Yuki Kawai, Akiko Sankoda, Kayo Waki, Kana Miyake, Aki Hayashi, Makiko Mieno, Hiromichi Wakui, Yuya Tsurutani, Jun Saito, Nobuhito Hirawa, Tadashi Yamakawa, Shiro Komiya, Akihiro Isogawa, Shinobu Satoh, Taichi Minami, Uru Osada, Tamio Iwamoto, Tatsuro Takano, Yasuo Terauchi, Kouichi Tamura, Toshimasa Yamauchi, Takashi Kadowaki, Masaomi Nangaku, Naoki Kashihara, Kazuhiko Ohe. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 17.08.2021.