UMIN-CTR Clinical Trial

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

40 diabetics who use their smartphones daily

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

Tokushima University

Institute

Department

Personal name

Organization

Ministry of Internal Affairs and Communications

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Ministry of Education, Culture, Sports, Science and Technology
Welby Inc
ARKRAY Inc

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2017

Year

03

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2017

Year

03

Month

28

Day

Last modified on

2017

Year

03

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030696