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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030905
Receipt No. R000035286
Scientific Title Multicenter single-arm intervention study for evaluation of efficacy and feasibility of IoT based self-monitoring system, "Shichifukujin", in Type 2 diabetes mellitus to improve the algorism
Date of disclosure of the study information 2018/01/20
Last modified on 2018/01/20

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Basic information
Public title Multicenter single-arm intervention study for evaluation of efficacy and feasibility of IoT based self-monitoring system, "Shichifukujin", in Type 2 diabetes mellitus to improve the algorism
Acronym Single arm intervention study of IoT based "Shichifukujin" system in Type 2 DM to improve the algorism.
Scientific Title Multicenter single-arm intervention study for evaluation of efficacy and feasibility of IoT based self-monitoring system, "Shichifukujin", in Type 2 diabetes mellitus to improve the algorism
Scientific Title:Acronym Single arm intervention study of IoT based "Shichifukujin" system in Type 2 DM to improve the algorism.
Region
Japan

Condition
Condition Diabetes
Classification by specialty
Medicine in general Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To develop of IoT based automatic feedback software, "Learning type Seven gods for good luck Apps" ,and to verify the effect on type 2 diabetes.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes HbA1c,Completion rate, Utilization of IoT, Improvement of inspection value
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 Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Encourage to improve lifestyle behavior by feedback messages from "Seven gods for good luck" based on IoT information
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
74 years-old >=
Gender Male and Female
Key inclusion criteria Diabetes Mellitus, Impaired Glucose tolerance
Key exclusion criteria The person who is complicated with serious hepatopathy, serious kidney damage, cancer (Recurrence-free period is within five years ), and the infectious disease
The person who receives prescription of an oral diabetes curative beyond 3 drugs
The person who has a medical treatment by an insulin or GLP1 receptor operation medicine
The person who consolidates the active diabetes multiplication retinitis
The person who developed cardiovascular diseas within 6 months
The person who decompensated heart failure
The person who becomes pregnant
The person who needs third person's intervention for hypoglycemic treatment
The person who prohibited from participating the program by doctor in charge
The person loading pacemakers and equipment in the body
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuyo Tsushita
Organization Aichi Health Promotion Public Interest Foundation
Division name Comprehensive Health Science Center
Zip code
Address Gengoyama1-1, Morioka, Higashiura-cho, Chita-gun, Aichi, Japan
TEL 0562-82-0211
Email k-tsushita@grp.ahv.pref.aichi.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eri Nomura
Organization Aichi Health Promotion Public Interest Foundation
Division name Comprehensive Health Science Center
Zip code
Address Gengoyama1-1, Morioka, Higashiura-cho, Chita-gun, Aichi, Japan
TEL 0562-82-0211
Homepage URL
Email e-nomura@grp.ahv.pref.aichi.jp

Sponsor
Institute Aichi Health Promotion Public Interest Foundation
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

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 あいち健康の森健康科学総合センター(愛知県)、聖隷健康診断センター(静岡県)

Other administrative information
Date of disclosure of the study information
2018 Year 01 Month 20 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 Enrolling by invitation
Date of protocol fixation
2017 Year 11 Month 10 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 01 Month 20 Day
Last modified on
2018 Year 01 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035286

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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