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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
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 | 2021/01/22 |
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 |
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Condition | |||
Condition | Diabetes | ||
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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Target sample size | 200 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |