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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000002992
Receipt No. R000003628
Scientific Title Open-labelled randomized controlled trial of the effect of PDA-based self-care system for type 2 diabetes versus usual care.
Date of disclosure of the study information 2010/01/08
Last modified on 2019/02/12

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Basic information
Public title Open-labelled randomized controlled trial of the effect of PDA-based self-care system for type 2 diabetes versus usual care.
Acronym The efficacy of PDA based self-care system for type 2 diabetes: a randomized controlled trial.
Scientific Title Open-labelled randomized controlled trial of the effect of PDA-based self-care system for type 2 diabetes versus usual care.
Scientific Title:Acronym The efficacy of PDA based self-care system for type 2 diabetes: a randomized controlled trial.
Region
Japan

Condition
Condition type II DM
Classification by specialty
Endocrinology and Metabolism Psychosomatic Internal Medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 1. To assess the efficacy of PDA based self-care system for diabetes by improving self-care activity of diabetes patients.
2. To assess the relationship between emotion and self-care activity using a ecological momentary assessment technique.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes calorie intake,
self efficacy in diabetes care
Key secondary outcomes body weight, HbA1c, blood lipids,
QOL related to diet therapy,
POMS, PAID

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 NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment Behavior,custom
Interventions/Control_1 Using PDA based self-care system for 6 months including feedback by visualizing records of self-monitoring.
Interventions/Control_2 Usual care.
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

Not applicable
Gender Male and Female
Key inclusion criteria # Patients with type 2 DM receiving outpatient therapy for diabetes at The University of Tokyo Hosipital who give written informed consent
Key exclusion criteria # HbA1c >= 8.0%
# receiving a treatment for any psychiatric diseases
# with severe restriction of salt( <= 5g per day) or protein ( <= 0.5g/kg per day)
# with any other conditions which may prevent using self-care system
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhiro Yoshiuchi
Organization Graduate School of Medicine, The University of Tokyo
Division name Stress Science and Psychosomatic medicine
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo, JAPAN
TEL 03-3815-5411
Email kyoshiuc-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shuji Inada
Organization Graduate School of Medicine, The University of Tokyo
Division name Stress Science and Psychosomatic Medicine
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo, JAPAN
TEL 03-3815-5411
Homepage URL
Email shiiinada-tky@umin.ac.jp

Sponsor
Institute Stress Science and Psychosomatic Medicine, Graduate School of Medicine, The University of Tokyo
Institute
Department

Funding Source
Organization Sharp Corporation
Organization
Division
Category of Funding Organization Profit organization
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 東京大学医学部附属病院(東京都)

Other administrative information
Date of disclosure of the study information
2010 Year 01 Month 08 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Terminated
Date of protocol fixation
2009 Year 09 Month 24 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 01 Day
Last follow-up date
2013 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 01 Month 07 Day
Last modified on
2019 Year 02 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003628

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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