UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Open-labelled randomized controlled trial of the effect of PDA-based self-care system for type 2 diabetes versus usual care.
Title of the study (Brief title)	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	Kazuhiro Yoshiuchi
Organization	Graduate School of Medicine, The University of Tokyo
Division name	Stress Science and Psychosomatic medicine
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	Shuji Inada
Organization	Graduate School of Medicine, The University of Tokyo
Division name	Stress Science and Psychosomatic Medicine
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2009 Year 09 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000003628