UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035159 |
|---|---|
| Receipt number | R000040072 |
| Scientific Title | 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 | 2020/06/07 10:07:31 |
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Basic information
Public title
The efficacy of the food record
application to the eating habit
and glucose control of the
patients with Type 2 diabetes.
Acronym
The efficacy of the food record application.
Scientific Title
The efficacy of the food record
application to the eating habit
and glucose control of the
patients with Type 2 diabetes.
Scientific Title:Acronym
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
| 1st name | Junko |
| Middle name | |
| Last name | Sato |
Organization
Juntendo University
The Graduate School of Medicine
Division name
Department of Diabetes, Endocrinology and Metabolism
Zip code
1130033
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
jsato@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Junko |
| Middle name | |
| Last name | Sato |
Organization
Juntendo University, The Graduate School of Medicine
Division name
Department of Diabetes, Endocrinology and Metabolism
Zip code
1130033
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
Homepage URL
jsato@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University, The Graduate School of
Medicine
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
The ethics committee of Juntendo University Hospital
Address
3-1-3 Hongo, Bunkyoku, Tokyo, JAPAN
Tel
03-5802-1584
kenkyu5858@juntendo.ac.jp
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
20
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
Completed
Date of protocol fixation
| 2018 | Year | 11 | Month | 26 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 26 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 06 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 12 | Month | 06 | Day |
Last modified on
| 2020 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040072
