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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032893
Receipt No. R000035866
Official scientific title of the study 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 2018/06/06

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Basic information
Official scientific title of the study Usefulness of self-monitoring smartphone application for artificial
intelligence-supported nutritional guidance in type 2 diabetes
patients
Title of the study (Brief title) 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 Atsushi Suzuki
Organization Fujita Health University
Division name Department of Endocrinology and Metabolism
Address 1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL 0562939242
Email aslapin@fujita-hu.ac.jp

Public contact
Name of contact person Atsushi Suzuki
Organization Fujita Health University
Division name Department of Endocrinology and Metabolism
Address 1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL 0562939242
Homepage URL
Email aslapin@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University
Institute
Department

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)

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 藤田保健衛生大学病院(愛知県)

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

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2018 Year 03 Month 08 Day
Anticipated trial start date
2018 Year 03 Month 13 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 06 Month 06 Day
Last modified on
2018 Year 06 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035866

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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