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

• DOI: 10.2196/31061
• Publication Date: 2021-07-05T17:49:15Z
• Authors: 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
• Keywords: Microalbuminuria; Albuminuria

Background Diabetic kidney disease (DKD) is one of the main complications type 2 diabetes mellitus (T2DM). DKD a known risk factor for end-stage renal disease, cardiovascular and all-cause death. Effective intervention early-stage vital to slowing down progression improve prognoses. Mobile health (mHealth) reportedly effective in supporting patients’ self-care improving glycemic control, but impact mHealth on has yet be shown. Objective The purpose this study evaluate efficacy standard therapy with addition self-management support system, DialBetesPlus, patients microalbuminuria. Methods This prospective, randomized, open-label, multicenter clinical trial. target population consists 160 diagnosed T2DM accompanied by We randomly assigned groups—the group using DialBetesPlus conventional control alone. smartphone application that supports T2DM. period was 12 months, follow-up survey at 18 months. primary outcome change albuminuria levels Secondary outcomes included changes physical parameters, blood test results (glycemic function, lipid metabolism), lifestyle habits, scores, medication therapy, quality life. Results approved April 2018. began recruiting July 2018 completed August 2019. final 18-month conducted March 2021. recruited 159 allocated 70 into 61 group, 28 exclusions due withdrawal consent, refusal continue, or ineligibility. first are expected available Conclusions randomized controlled trial assessing DKD. expect will decrease significantly improved ameliorated 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