UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An open-label, randomized, parallel-group comparison study on the effects of using PHR "e-DM Diary" on self-care ability in Diabetes patients
Title of the study (Brief title)	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	Munehide Matsuhisa
Organization	Tokushima University
Division name	Diabetes Therapeutics and Research Center, Institute of Advanced Medical Sciences
Address	3-8-15 Kuramoto-cho, Tokushima-city
TEL	088-633-7587
Email	matuhisa@tokushima-u.ac.jp

Public contact
Name of contact person	Satoshi Taniguchi
Organization	Tokushima University
Division name	Diabetes Therapeutics and Research Center, Institute of Advanced Medical Sciences
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

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 03 Month 13 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000030696