UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032893 |
|---|---|
| Receipt number | R000035866 |
| Scientific Title | Usefulness of self-monitoring smartphone application for artificial intelligence-supported nutritional guidance in type 2 diabetes patients |
| Date of disclosure of the study information | 2018/06/06 |
| Last modified on | 2023/06/10 09:28:00 |
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Basic information
Public title
Usefulness of self-monitoring smartphone application for artificial
intelligence-supported nutritional guidance in type 2 diabetes
patients
Acronym
Usefulness of self-monitoring smartphone application for artificial
intelligence-supported nutritional guidance in type 2 diabetes
patients
Scientific Title
Usefulness of self-monitoring smartphone application for artificial
intelligence-supported nutritional guidance in type 2 diabetes
patients
Scientific Title:Acronym
Usefulness of self-monitoring smartphone application for artificial
intelligence-supported nutritional guidance in type 2 diabetes
patients
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We collecte the information of foods records, the amount of activity, etc. daily from the smartphone application in patients with type 2 diabetes in this study. We provide nutritional guidance based on data from smartphone application. We will examine the improvement of glycemic control.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in HbA1c at months 6 after the start 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
Historical
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
nutritional guidance based on data from smartphone application
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
type 2 diabetes
a daily smartphone user
written consent to participate in the research
Key exclusion criteria
pregnancy
use other implantable medical devices such as pacemakers
eGFR is less than 30 mL/min/1.73 m2
Patients who thought to be inappropriate to enter this study for some reasons by physician's judgments
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Suzuki |
Organization
Fujita Health University
Division name
Department of Endocrinology and Metabolism
Zip code
4701192
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL
0562939242
aslapin@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Suzuki |
Organization
Fujita Health University
Division name
Department of Endocrinology and Metabolism
Zip code
4701192
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL
0562939242
Homepage URL
aslapin@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
The Dai-ichi Life Insurance Company, Limited
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
IBM Japan
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research promotion and support headquarters, Fujita Health University
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
Tel
0562932865
kenshien@fujita-hu.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
藤田医科大学病院(愛知県)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | 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
180
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 | 03 | Month | 08 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 13 | Day |
Last follow-up date
| 2022 | Year | 12 | 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 | 06 | Month | 06 | Day |
Last modified on
| 2023 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035866
