UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023651 |
|---|---|
| Receipt number | R000027244 |
| Scientific Title | Randomized Trial of Wearable tracker-based physical activity intervention for diabetic subjects |
| Date of disclosure of the study information | 2016/08/17 |
| Last modified on | 2016/08/17 14:29:15 |
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Basic information
Public title
Randomized Trial of Wearable tracker-based physical activity intervention for diabetic subjects
Acronym
Randomized Trial of Wearable tracker-based physical activity intervention for diabetic subjects
Scientific Title
Randomized Trial of Wearable tracker-based physical activity intervention for diabetic subjects
Scientific Title:Acronym
Randomized Trial of Wearable tracker-based physical activity intervention for diabetic subjects
Region
| Japan |
Condition
Condition
diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate, within an RCT, the feasibility and preliminary efficacy of integrating self-monitoring of physical activity by wearable trackers and plasma glucose level by self-examination of the blood for diabetic subjects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
BMI
HbA1c(NGSP)
Key secondary outcomes
exercise, smoking, sleep
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
self-monitoring of physical activity by wearable trackers for 3 months
Interventions/Control_2
self-monitoring of plasma glucose level by self-examination once a month for 3 months
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
HbA1c(NGSP) >=6.5
HbA1c(NGSP) =<7.0
Key exclusion criteria
person requiring dialysis
people who take antihyperglycemic drug or insulin
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomohisa Nagata |
Organization
University of Occupational and Environmental Health, Japan
Division name
Department of Occupational Health Practice and Management, Institute of Industrial Ecological Sciences
Zip code
Address
1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu, 807-8555, Japan
TEL
093-603-1611
tomohisa@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomohisa Nagata |
Organization
University of Occupational and Environmental Health, Japan
Division name
Department of Occupational Health Practice and Management, Institute of Industrial Ecological Scienc
Zip code
Address
1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu, 807-8555, Japan
TEL
093-603-1611
Homepage URL
tomohisa@med.uoeh-u.ac.jp
Sponsor or person
Institute
Department of Occupational Health Practice and Management, Institute of Industrial Ecological Scienc, University of Occupational and Environmental Health, Japan
Institute
Department
Personal name
Funding Source
Organization
Ministry of Economy, Trade and Industry
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
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 | 08 | Month | 17 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 17 | Day |
Last follow-up date
| 2017 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 17 | Day |
Last modified on
| 2016 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027244
