UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030905 |
|---|---|
| Receipt number | 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 | 2021/01/22 17:13:41 |
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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 | 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
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
e-nomura@grp.ahv.pref.aichi.jp
Sponsor or person
Institute
Aichi Health Promotion Public Interest Foundation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035286
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