UMIN-CTR Clinical Trial

Basic information
Public title	Effects of self-supporting ICT system for treating diabetic nephropathy: a randomized controlled trial.
Acronym	Effects of self-supporting ICT system for treating diabetic nephropathy: a randomized controlled trial.
Scientific Title	Effects of self-supporting ICT system for treating diabetic nephropathy: a randomized controlled trial.
Scientific Title:Acronym	Effects of self-supporting ICT system for treating diabetic nephropathy: a randomized controlled trial.
Region	Japan

Condition
Condition	Type 2 diabetes
Classification by specialty	Endocrinology and Metabolism Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aims to clarify the effects of the personal health record system "DialBetesPlus" on preventing progeression of diabetic kidney disease.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	reduction of morning urine albumin/creatinine ratio between two points: start and end of intervention.
Key secondary outcomes	Changes in the following items will be compared between the intervention group and the conventional therapy group at the baseline and at 12 months (some items will be evaluated at 6 months and 18 months.) HbA1c, fasting plasma glucose, albuminuria (except for 12th month), eGFR, BMI, systolic and diastolic blood pressure, HDL-cholesterol, LDL-cholesterol, triglyceride, composite cardiovascular outcomes, all-cause deaths, composite renal end points, diets, self-management scores, medication therapy, QoL, and comparison in the operation of the trial between hospital model and pharmacy model. To ensure safety, we will monitor the number of hypoglycemic events, other adverse events, and troubles with the DialBetesPlus system over the course of the study.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	160 participants will be randomly classified into two groups, 80 in the DialBetesPlus group and 80 in the non-DialBetesPlus control group. Participants in the DialBetesPlus group will use the system for 12 months, and then will be followed for another 6 months.
Interventions/Control_2	the non-DialBetesPlus control group
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	type 2 diabetes HbA1c>=6.5% BMI>=22 DM nephropathy stage 2 (morning urine albumin/creatinine ratio: 30-299mg/gCr) eGFR>=45 mL/min/1.73m2 BP< 180/110mmHg Age:20-74y no previous history of severe hypoglycemia. without history of suspect of hypoglycemia in the most recent 3 months. with voluntary written consent for participation in this study.
Key exclusion criteria	Patients with pacemakers. Patients with hyperthyroidism and under treatment(except for thyroid hormone replacement therapy) in the most recent 1 year. serum Albumin<3.0g/dl Hb<10.0g/dl Patients with preproliferative retinopathy or preproliferative retinopathy in the most recent 1 year. Patients who are enrolled in other clinical trials. Patients who have moderate to severe (requiring restriction on exercise therapy) heart disease. Patients who have moderate to severe (unstable condition and/or requiring restriction on exercise therapy) autoimmune disease, liver disease, digestive disorder, and/or respiratory disease. Patients who are unable to exercise. Patients who are under protein restriction therapy Female patients who are breast-feeding or have possibility or hope of pregnancy. Patients who are considered ineligible by the doctor.
Target sample size	160

Research contact person
Name of lead principal investigator	1st name Kayo Middle name Last name Waki
Organization	the University of Tokyo
Division name	Department of Healthcare Information Management, The University of Tokyo Hospital
Zip code	113-8655
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL	03-3815-5411
Email	dialbetics-office@umin.ac.jp

Public contact
Name of contact person	1st name Kana Middle name Last name Miyake
Organization	the University of Tokyo
Division name	Department of Healthcare Information Management, The University of Tokyo Hospital
Zip code	113-8655
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL	03-3815-5411
Homepage URL
Email	dialbetics-office@umin.ac.jp

Sponsor
Institute	Department of Healthcare Information Management, The University of Tokyo Hospital
Institute
Department

Funding Source
Organization	AMED(Japan Agency for Medical Research and Development)
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	Kawasaki Medical School(Academic juridical person, Kawasaki Gakuen.)
Name of secondary funder(s)	NTT DOCOMO, INC. Nihon Chouzai Co.,Ltd.

IRB Contact (For public release)
Organization	The Office for Human Research Studies (OHRS), Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo
Tel	03-5841-0818
Email	ethics@m.u-tokyo.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	東京大学医学部附属病院（東京都） The University of Tokyo Hospital 横浜市立大学附属病院（神奈川県）　Yokohama City University Hospital 横浜市立大学附属市民総合医療センター（神奈川県）　Yokohama City University Medical Center 横浜労災病院（神奈川県） Yokohama Rosai Hospital 済生会横浜市南部病院（神奈川県） Saiseikai Yokohamashi Nanbu Hospital 藤沢市民病院（神奈川県）Fujisawa City Hospital 茅ヶ崎市立病院（神奈川県）Chigasaki Municipal Hospital 三井記念病院（東京都）Mitsui Memorial Hospital

Other administrative information
Date of disclosure of the study information	2018 Year 07 Month 04 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	159
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2018 Year 06 Month 20 Day
Date of IRB	2018 Year 04 Month 27 Day
Anticipated trial start date	2018 Year 07 Month 04 Day
Last follow-up date	2023 Year 04 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 07 Month 04 Day
Last modified on	2021 Year 04 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037924