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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000023651
Receipt No. 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

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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
Email 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
Email tomohisa@med.uoeh-u.ac.jp

Sponsor
Institute Department of Occupational Health Practice and Management, Institute of Industrial Ecological Scienc, University of Occupational and Environmental Health, Japan
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027244

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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