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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000017719
Receipt No. R000020479
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
Date of disclosure of the study information 2015/07/01
Last modified on 2016/06/28

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Basic information
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
Condition 30 Type 2 diabetics who use their smartphones daily
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
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.

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 NO
Concealment Central registration

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

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) 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

Other administrative information
Date of disclosure of the study information
2015 Year 07 Month 01 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 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
Other related information

Management information
Registered date
2015 Year 05 Month 28 Day
Last modified on
2016 Year 06 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020479

Research Plan
Registered date File name
2016/05/28 【当院】臨床研究計画(介入あり)_150910.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name


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