UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033261 |
|---|---|
| Receipt number | R000037924 |
| Scientific Title | 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 | 2021/04/21 11:30:49 |
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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
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
dialbetics-office@umin.ac.jp
Sponsor or person
Institute
Department of Healthcare Information Management, The University of Tokyo Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037924
