UMIN-CTR Clinical Trial

Public title

An open-label, randomized, parallel-group comparison study on the effects of the "e-Diabetes Diary" on self-management efficacy for type 2 diabetics

Acronym

Study on the effects of "e-Diabetes Diary" on self-management efficacy for type 2 diabetics

Scientific Title

An open-label, randomized, parallel-group comparison study on the effects of the "e-Diabetes Diary" on self-management efficacy for type 2 diabetics

Scientific Title:Acronym

Study on the effects of "e-Diabetes Diary" on self-management efficacy for type 2 diabetics

Region

Japan

Condition

30 Type 2 diabetics who use their smartphones daily

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The objective is to measure the effects of using "e-Diabetes Diary" in the diabetes care program has on type 2 diabetics' understanding and knowledge of their self-management activities.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

After receiving instructions from their doctor, patients will self-manage their diabetes using the "e-diabetes diary" for 3 months. At the end of 3 months, the changes in the patients' understanding and knowledge of their self-management activities will be measured by interview and questionnaire.

Key secondary outcomes

After receiving instructions from their doctor, patients will self-manage their diabetes using the "e-diabetes diary" for 3 months. At the end of 3 months, the following items will be measured.
The changes in the patients' self-management activities will be measured by interview and questionnaire.
The changes in diet will be measured by food frequency questionnaire.
The changes in exercise will be measured using a pedometer.
The changes in blood glucose level management will be assessed by measuring HbA1c.
The changes in obesity level will be assessed by measuring weight, BMI and body composition.
The changes in diabetes related complications will be assessed by measuring triglyceride, total cholesterol, HDL cholesterol, BUN, Creatinine, AST, ALT, urinary albumin excretion rate and e-GFR.

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

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

The intervention group will be provided access to "e-Diabetes Diary" as well as instructions based on the web-service.
On the first visit, patients will receive guidance on how to use the "e-Diabetes Diary" and the personal ID and password for access. Also, patients will be provided self-recording devices (digital-scale, digital pedometer, automated sphygmomanometer, self monitoring blood glucose meter) if they are assigned by the doctor and does not have one that will digitally connect to the "e-Diabetes Diary".
The patient will then be instructed to reference the "e-Diabetes Diary" in their self-treatment and record their progress according to the doctor's instructions for the next 3 months.
The treatment goals, test results and assessments on diabetes and complications provided by the doctor will be recorded in the e-Diabetes Diary". The doctor will use the "e-Diabetes Diary" in consulting and providing guidance to the patient at each visit during the 3 months intervention.

Interventions/Control_2

The control group will be provided standard care using the standard "Diabetes Logbook" issued by the Japan Association for Diabetes Education and Care. The control group will be offered self-recording devices (scale, pedometer, automated sphygmomanometer, self monitoring blood glucose meter) if they are assigned by the doctor to level conditions with the intervention group.
Then, the patient will be instructed to reference the "Diabetes Logbook" for their self-treatment over the next 3 months.
The doctor will note the treatment goals, test results and assessments on diabetes and complications in the "Diabetes Logbook". It will be use in consulting and providing guidance to the patient at each visit during the 3 months intervention.

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 Type 2 Diabetes
HbA1c(NGSP) is more than 6.0%
Is a daily smartphone user
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

30

Name of lead principal investigator

1st name
Middle name
Last name	Matsuhisa Munehide

Organization

Tokushima University

Division name

Diabetes Therapeutics and Research Center

Zip code

Address

3-8-15 Kuramoto-cho, Tokushima-city 770-8503

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

Zip code

Address

3-8-15 Kuramoto-cho, Tokushima-city 770-8503

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）　Tokushima University Hospital
天満病院(徳島県）　　Tenma Hospital
南徳島クリニック(徳島県） Minami-Tokushima Clinc
阿南天満病院(徳島県） Anan Tenama Hospital

Date of disclosure of the study information

2015

Year

07

Month

01

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

No longer recruiting

Date of protocol fixation

2015

Year

05

Month

28

Day

Date of IRB

Anticipated trial start date

2015

Year

07

Month

01

Day

Last follow-up date

2016

Year

04

Month

30

Day

Date of closure to data entry

Date trial data considered complete

2016

Year

04

Month

30

Day

Date analysis concluded

Other related information

Registered date

2015

Year

05

Month

28

Day

Last modified on

2016

Year

06

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020479