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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000026738
Receipt No. R000030696
Scientific Title An open-label, randomized, parallel-group comparison study on the effects of using PHR "e-DM Diary" on self-care ability in Diabetes patients
Date of disclosure of the study information 2017/03/30
Last modified on 2017/03/30

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Basic information
Public title An open-label, randomized, parallel-group comparison study on the effects of using PHR "e-DM Diary" on self-care ability in Diabetes patients
Acronym The effects on the self-care ability of using PHR "e-DM Diary" in Diabetes patients
Scientific Title An open-label, randomized, parallel-group comparison study on the effects of using PHR "e-DM Diary" on self-care ability in Diabetes patients
Scientific Title:Acronym The effects on the self-care ability of using PHR "e-DM Diary" in Diabetes patients
Region
Japan

Condition
Condition 40 diabetics who use their smartphones daily
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objectives is to use the PHR "e-DM Diary" in diabetes care, and measure the effects on diabetes state and self-care.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Measure changes in the diabetes state (HbA1c, weight) after using e-DM Diary for 2 months and 4 months.
Key secondary outcomes Measure changes in the following items after using e-DM Diary for 2 months and 4 months: Self-care(The Summary of Diabetes Self-care Activities Measure), patient's empowerment state(Diabetes Empowerment Scale-Short Form), usability of e-DM Diary (Evaluated usability and assessment criteria for diabetes apps for the elderly), knowledge of treatment goals and progress

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 There is no internvention for the 1st month, and the clinical test data will be taken for comparison.
During the next monthly clinic visit after providing consent, the patient will be provided a e-DM Diary account, self-monitoring devices(digital scale, BP monitor, activity monitor, blood glucose monitor). The patient will be instructed to use these for their self-care for 4 months.
At 2 months and 4 months of e-DM Diary, clinical test data will be obtained and questionaire will be conducted.
At the end of the study, an additional interview on the usability of e-DM Diary will be conducted.
Interventions/Control_2 There is no internvention for the 1st month, and the clinical test data will be taken for comparison.
During the next monthly clinic visit after providing consent, the patient will be provided self-monitoring devices(digital scale, BP monitor, activity monitor, blood glucose monitor) and standard paper logbooks. The patient will be instructed to use these for their self-care for 2 months.
After the 2 months, an e-DM Diary account will be provided. The patient will be instructed to use these for their self-care for the next 2 months.
At 2 months and 4 months of intervention, clinical test data will be obtained and questionaire will be conducted.
At the end of the study, an additional interview on the usability of e-DM Diary will be conducted.
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
18 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Has been diagnosed with diabetes
Uses smartphones daily
Has given written consent to participate in the research
Key exclusion criteria Those whose HbA1c has worsen by more than 1% over the last 3 months, and/or has failed to reach treatment goals and assessed to need immediate care.
Those who are undergoing intensive cardio-vascular, cerebrovascular and kindney disease treatment.
Those who are participating in other interventional clinical trials
Those for other reasons, who have been assessed to be not fit by their doctor,
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Munehide Matsuhisa
Organization Tokushima University
Division name Diabetes Therapeutics and Research Center, Institute of Advanced Medical Sciences
Zip code
Address 3-8-15 Kuramoto-cho, Tokushima-city
TEL 088-633-7587
Email matuhisa@tokushima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Taniguchi
Organization Tokushima University
Division name Diabetes Therapeutics and Research Center, Institute of Advanced Medical Sciences
Zip code
Address 3-8-15 Kuramoto-cho, Tokushima-city
TEL 088-633-7587
Homepage URL
Email satoshi.taniguchi@tokushima-u.ac.jp

Sponsor
Institute Tokushima University
Institute
Department

Funding Source
Organization Ministry of Internal Affairs and Communications
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s) Ministry of Education, Culture, Sports, Science and Technology
Welby Inc
ARKRAY Inc

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 徳島大学病院(徳島県),徳島県立中央病院(徳島県),徳島県鳴門病院(徳島県),たまき青空病院(徳島県)

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 30 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 Preinitiation
Date of protocol fixation
2017 Year 03 Month 13 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 03 Month 28 Day
Last modified on
2017 Year 03 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030696

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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