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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035159
Receipt No. R000040072
Official scientific title of the study The efficacy of the food record application to the eating habit and glucose control of the patients with Type 2 diabetes.
Date of disclosure of the study information 2018/12/06
Last modified on 2018/12/06

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Basic information
Official scientific title of the study The efficacy of the food record
application to the eating habit
and glucose control of the
patients with Type 2 diabetes.
Title of the study (Brief title) The efficacy of the food record application.
Region
Japan

Condition
Condition Type 2 diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify whether the application improves
the eating habit and glucose control.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The change of HbA1c from the baseline to the
end of the study.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment Behavior,custom
Interventions/Control_1 The use of smartphone application for 12 weeks
(Food record).
Interventions/Control_2
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
20 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria Type 2 diabetes(HbA1c7.5%-9%)
Patients who agree to attend the study with
informed consent.
Key exclusion criteria 1. Patients with CKD(Stage3-),pregnancy,
Type 1 diabetes, steroid diabetes and cancer.
2. Patients who already used the application
of food record.
3. Patients not suitable for the study.
Target sample size 20

Research contact person
Name of lead principal investigator Junko Sato
Organization Juntendo University
The Graduate School of Medicine
Division name Department of Diabetes, Endocrinology and Metabolism
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL 03-3813-3111
Email jsato@juntendo.ac.jp

Public contact
Name of contact person Junko Sato
Organization Juntendo University, The Graduate School of Medicine
Division name Department of Diabetes, Endocrinology and Metabolism
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL 03-3813-3111
Homepage URL
Email jsato@juntendo.ac.jp

Sponsor
Institute Juntendo University, The Graduate School of
Medicine
Institute
Department

Funding Source
Organization Juntendo University, The Graduate School of
Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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

Other administrative information
Date of disclosure of the study information
2018 Year 12 Month 06 Day

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2018 Year 11 Month 26 Day
Anticipated trial start date
2018 Year 12 Month 06 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
2018 Year 12 Month 06 Day
Last modified on
2018 Year 12 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040072

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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