UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033261
Receipt No. R000037924
Official scientific title of the study Effects of self-supporting ICT system for treating diabetic nephropathy: a randomized controlled trial.
Date of disclosure of the study information 2018/07/04
Last modified on 2018/09/13

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Official scientific title of the study Effects of self-supporting ICT system for treating diabetic nephropathy: a randomized controlled trial.
Title of the study (Brief title) 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 "DialbeticsPlus" 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 physical data (BMI, blood pressure,) / input data during the study (physical activity, food intake(energy, salt, carbohydrate, protein, fat,dietary fiber, alcohol intake), exercise record) / clinical laboratory results (fasting blood glucose, HDL cholesterol, LDL cholesterol, triglyceride)/ oral medicine / urinary sodium to potassium ratio / data of food intake records / answer of pre- and post-study interview survey/ MMAS-8 (Morisky Medication Adherence Scale)/a comparison on answer of interview survey on introducing the system in a pharmacy or a hospital.

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 DialBeticsPlus group and 80 in the non-DialBeticsPlus control group. Participante in the DialBeticsPlus group will use the system for 12 months, and then will be followed for another 6 months.
Interventions/Control_2 the non-DialBeticsPlus 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: 30-399mg/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 month.
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 Kayo Waki
Organization the University of Tokyo
Division name Department of Ubisuitous Health Informatics, Graduate School of Medicine
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL 03-3815-5411
Email dialbetics-office@umin.ac.jp

Public contact
Name of contact person Kana Miyake
Organization the University of Tokyo
Division name Department of Ubisuitous Health Informatics, Graduate School of Medicine
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL 03-3815-5411
Homepage URL
Email dialbetics-office@umin.ac.jp

Sponsor
Institute the University of Tokyo
Department of Ubisuitous Health Informatics, Graduate School of Medicine
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.

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

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

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2018 Year 06 Month 20 Day
Anticipated trial start date
2018 Year 07 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 07 Month 04 Day
Last modified on
2018 Year 09 Month 13 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.