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

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 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


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

Value
https://center6.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