UMIN-CTR Clinical Trial

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 Kazuyo Middle name Last name Tsushita
Organization	Aichi Health Promotion Public Interest Foundation
Division name	Comprehensive Health Science Center
Zip code	470-2101
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 Eri Middle name Last name Nomura
Organization	Aichi Health Promotion Public Interest Foundation
Division name	Comprehensive Health Science Center
Zip code	470-2101
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	Aichi Health Promotion Public Interest Foundation Institutional Review Board
Address	Gengoyama1-1, Morioka, Higashiura-cho, Chita-gun, Aichi, Japan
Tel	0562-82-0211
Email	so-jinji@grp.ahv.pref.aichi.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	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	203
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	2017 Year 11 Month 10 Day
Date of IRB	2017 Year 11 Month 09 Day
Anticipated trial start date	2018 Year 01 Month 10 Day
Last follow-up date	2020 Year 03 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 01 Month 20 Day
Last modified on	2021 Year 01 Month 22 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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