UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019035 |
|---|---|
| Receipt number | R000021983 |
| Scientific Title | A study on diabetes prevention effect of "the Tacho machi system" |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2016/03/03 18:15:22 |
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Basic information
Public title
A study on diabetes prevention effect of "the Tacho machi system"
Acronym
A study on diabetes prevention effect of "the Tacho machi system"
Scientific Title
A study on diabetes prevention effect of "the Tacho machi system"
Scientific Title:Acronym
A study on diabetes prevention effect of "the Tacho machi system"
Region
| Japan |
Condition
Condition
Pre-diabetes
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to review that "Taco-machi system" is effective in reducing HbA1c.
"Tacho-machi system" is recording of daily amount of activity, body weight, ingested meal and automatically generated advice on exercise, nutrition and taking alcohol these are based on recordings to smart phone, PC with subjects to prevent diabetes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Decreasing of HbA1c are accessed after 3 months of using the system.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Factor 1 (daily body weight recording, daily activity monitor recording, daily meal recording): (+)
Factor 2 (Advice by diabetes prevention application "Tacho-machi system"): (+)
Term of interventions: 3 months
Interventions/Control_2
Factor 1 (daily body weight recording, daily activity monitor recording, daily meal recording): (+)
Factor 2 (Advice by diabetes prevention application "Tacho-machi system"): (-)
Term of interventions: 3 months
Interventions/Control_3
Control group
Factor 1 (daily body weight recording, daily activity monitor recording, daily meal recording): (-)
Factor 2 (Advice by diabetes prevention application "Tacho-machi system"): (-)
Term of interventions: 3 months
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
| 30 | years-old | < |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
5.6=<HbA1c=<6.2 (before trial)
Key exclusion criteria
At start of trial, treatment in diabetes or other lifestyle-related diseases.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Hosokawa |
Organization
Prefectural University of Hiroshima
Division name
Faculty of Health and Welfare
Zip code
Address
Gakuen-machi1-1, Mihara-shi, Hiroshima, Japan
TEL
0848-60-1276
hosokawa@pu-hiroshima.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Hosokawa |
Organization
Prefectural University of Hiroshima
Division name
Faculty of Health and Welfare
Zip code
Address
Gakuen-machi1-1, Mihara-shi, Hiroshima, Japan
TEL
0848-60-1276
Homepage URL
hosokawa@pu-hiroshima.ac.jp
Sponsor or person
Institute
NTT Data Institute if Management Consulting, Inc.
Institute
Department
Personal name
Funding Source
Organization
Ministry if internal affairs and communications of Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 01 | 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
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
Completed
Date of protocol fixation
| 2015 | Year | 09 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2016 | Year | 02 | Month | 29 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 03 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 16 | Day |
Last modified on
| 2016 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021983
