UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002992 |
|---|---|
| Receipt number | 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 15:01:29 |
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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
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
shiiinada-tky@umin.ac.jp
Sponsor or person
Institute
Stress Science and Psychosomatic Medicine, Graduate School of Medicine, The University of Tokyo
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003628
