PMID- 34402802
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20210915
IS  - 1929-0748 (Print)
IS  - 1929-0748 (Electronic)
IS  - 1929-0748 (Linking)
VI  - 10
IP  - 8
DP  - 2021 Aug 17
TI  - Efficacy of the Self-management Support System DialBetesPlus for Diabetic Kidney 
      Disease: Protocol for a Randomized Controlled Trial.
PG  - e31061
LID - 10.2196/31061 [doi]
LID - e31061
AB  - 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.
CI  - (c)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.
FAU - Kawai, Yuki
AU  - Kawai Y
AUID- ORCID: 0000-0003-2643-6294
AD  - Department of Planning, Information and Management, University of Tokyo Hospital, 
      Tokyo, Japan.
AD  - Department of Medical Science and Cardiorenal Medicine, Yokohama City University 
      Graduate School of Medicine, Yokohama, Japan.
FAU - Sankoda, Akiko
AU  - Sankoda A
AUID- ORCID: 0000-0002-2578-066X
AD  - Department of Planning, Information and Management, University of Tokyo Hospital, 
      Tokyo, Japan.
FAU - Waki, Kayo
AU  - Waki K
AUID- ORCID: 0000-0003-0046-2523
AD  - Department of Planning, Information and Management, University of Tokyo Hospital, 
      Tokyo, Japan.
AD  - Department of Diabetes and Metabolic Diseases, Graduate School of Medicine, The 
      University of Tokyo, Tokyo, Japan.
FAU - Miyake, Kana
AU  - Miyake K
AUID- ORCID: 0000-0003-2631-7084
AD  - Department of Planning, Information and Management, University of Tokyo Hospital, 
      Tokyo, Japan.
AD  - Department of Diabetes and Metabolic Diseases, Graduate School of Medicine, The 
      University of Tokyo, Tokyo, Japan.
FAU - Hayashi, Aki
AU  - Hayashi A
AUID- ORCID: 0000-0002-5902-2859
AD  - Department of Planning, Information and Management, University of Tokyo Hospital, 
      Tokyo, Japan.
FAU - Mieno, Makiko
AU  - Mieno M
AUID- ORCID: 0000-0002-3510-9941
AD  - Department of Medical Informatics, Center for Information, Jichi Medical 
      University, Shimotsuke, Japan.
FAU - Wakui, Hiromichi
AU  - Wakui H
AUID- ORCID: 0000-0001-8023-922X
AD  - Department of Medical Science and Cardiorenal Medicine, Yokohama City University 
      Graduate School of Medicine, Yokohama, Japan.
FAU - Tsurutani, Yuya
AU  - Tsurutani Y
AUID- ORCID: 0000-0001-5831-3286
AD  - Endocrinology and Diabetes Center, Yokohama Rosai Hospital, Yokohama, Japan.
FAU - Saito, Jun
AU  - Saito J
AUID- ORCID: 0000-0001-5090-5893
AD  - Endocrinology and Diabetes Center, Yokohama Rosai Hospital, Yokohama, Japan.
FAU - Hirawa, Nobuhito
AU  - Hirawa N
AUID- ORCID: 0000-0001-5824-3652
AD  - Department of Nephrology and Hypertension, Yokohama City University Medical 
      Center, Yokohama, Japan.
FAU - Yamakawa, Tadashi
AU  - Yamakawa T
AUID- ORCID: 0000-0001-6329-0939
AD  - Department of Endocrinology and Diabetes, Yokohama City University Medical 
      Center, Yokohama, Japan.
FAU - Komiya, Shiro
AU  - Komiya S
AUID- ORCID: 0000-0002-0462-5038
AD  - Department of Medical Science and Cardiorenal Medicine, Yokohama City University 
      Graduate School of Medicine, Yokohama, Japan.
FAU - Isogawa, Akihiro
AU  - Isogawa A
AUID- ORCID: 0000-0003-1355-5825
AD  - Division of Diabetes, Mitsui Memorial Hospital, Tokyo, Japan.
FAU - Satoh, Shinobu
AU  - Satoh S
AUID- ORCID: 0000-0001-5963-759X
AD  - Department of Endocrinology and Metabolism, Chigasaki Municipal Hospital, 
      Chigasaki, Japan.
FAU - Minami, Taichi
AU  - Minami T
AUID- ORCID: 0000-0003-2056-0980
AD  - Department of Diabetes and Endocrinology, Saiseikai Yokohamashi Nanbu Hospital, 
      Yokohama, Japan.
FAU - Osada, Uru
AU  - Osada U
AUID- ORCID: 0000-0002-0790-5529
AD  - Department of Diabetes and Endocrinology, Saiseikai Yokohamashi Nanbu Hospital, 
      Yokohama, Japan.
FAU - Iwamoto, Tamio
AU  - Iwamoto T
AUID- ORCID: 0000-0002-0265-4791
AD  - Department of Nephrology and Hypertension, Saiseikai Yokohamashi Nanbu Hospital, 
      Yokohama, Japan.
FAU - Takano, Tatsuro
AU  - Takano T
AUID- ORCID: 0000-0002-5422-3790
AD  - Department of Diabetes and Endocrinology, Fujisawa City Hospital, Fujisawa, 
      Japan.
FAU - Terauchi, Yasuo
AU  - Terauchi Y
AUID- ORCID: 0000-0002-8872-3697
AD  - Department of Endocrinology and Metabolism, Yokohama City University Graduate 
      School of Medicine, Yokohama, Japan.
FAU - Tamura, Kouichi
AU  - Tamura K
AUID- ORCID: 0000-0002-0660-5372
AD  - Department of Medical Science and Cardiorenal Medicine, Yokohama City University 
      Graduate School of Medicine, Yokohama, Japan.
FAU - Yamauchi, Toshimasa
AU  - Yamauchi T
AUID- ORCID: 0000-0003-4827-6404
AD  - Department of Diabetes and Metabolic Diseases, Graduate School of Medicine, The 
      University of Tokyo, Tokyo, Japan.
FAU - Kadowaki, Takashi
AU  - Kadowaki T
AUID- ORCID: 0000-0002-5428-3582
AD  - Department of Prevention of Diabetes and Lifestyle-Related Diseases, Graduate 
      School of Medicine, The University of Tokyo, Tokyo, Japan.
AD  - Toranomon Hospital, Tokyo, Japan.
FAU - Nangaku, Masaomi
AU  - Nangaku M
AUID- ORCID: 0000-0001-7401-2934
AD  - Division of Nephrology and Endocrinology, Graduate School of Medicine, The 
      University of Tokyo, Tokyo, Japan.
FAU - Kashihara, Naoki
AU  - Kashihara N
AUID- ORCID: 0000-0002-9487-984X
AD  - Department of Nephrology and Hypertension, Kawasaki Medical School, Kurashiki, 
      Japan.
FAU - Ohe, Kazuhiko
AU  - Ohe K
AUID- ORCID: 0000-0002-4296-9536
AD  - Department of Planning, Information and Management, University of Tokyo Hospital, 
      Tokyo, Japan.
LA  - eng
PT  - Journal Article
DEP - 20210817
PL  - Canada
TA  - JMIR Res Protoc
JT  - JMIR research protocols
JID - 101599504
PMC - PMC8408755
OTO - NOTNLM
OT  - albuminuria
OT  - behavior
OT  - chronic disease
OT  - diabetes
OT  - diabetes mellitus
OT  - diabetic kidney disease
OT  - efficacy
OT  - intervention
OT  - kidney
OT  - mHealth
OT  - microalbuminuria
OT  - protocol
OT  - randomized controlled trial
OT  - self-care
OT  - self-management
OT  - self-management support system
OT  - support
OT  - therapy
COIS- Conflicts of Interest: The author(s) disclose receipt of the external financial 
      support for the research, authorship, and publication of this article: In 
      addition to the AMED grant, this research was supported by NTT DOCOMO Inc. and 
      Nihon Chouzai Co, Ltd. KM was a member of a cooperative program between the 
      University of Tokyo and NTT DOCOMO.
EDAT- 2021/08/18 06:00
MHDA- 2021/08/18 06:01
PMCR- 2021/08/17
CRDT- 2021/08/17 12:19
PHST- 2021/06/08 00:00 [received]
PHST- 2021/07/05 00:00 [accepted]
PHST- 2021/07/05 00:00 [revised]
PHST- 2021/08/17 12:19 [entrez]
PHST- 2021/08/18 06:00 [pubmed]
PHST- 2021/08/18 06:01 [medline]
PHST- 2021/08/17 00:00 [pmc-release]
AID - v10i8e31061 [pii]
AID - 10.2196/31061 [doi]
PST - epublish
SO  - JMIR Res Protoc. 2021 Aug 17;10(8):e31061. doi: 10.2196/31061.