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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000038753 |
Receipt No. | R000043613 |
Scientific Title | Effect of remote lifestyle intervention by using IoT, ICT, and further AI in diabetic medical cooperation |
Date of disclosure of the study information | 2019/12/02 |
Last modified on | 2019/12/02 |
Basic information | ||
Public title | Effect of remote lifestyle intervention by using IoT, ICT, and further AI in diabetic medical cooperation | |
Acronym | Diabetes remote intervention study | |
Scientific Title | Effect of remote lifestyle intervention by using IoT, ICT, and further AI in diabetic medical cooperation | |
Scientific Title:Acronym | Diabetes remote intervention study | |
Region |
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Condition | ||
Condition | Type 2 diabetes | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | Exploratory research of the effect of remote lifestyle intervention by using IoT and ICT. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | Change of HbA1c after 6 months |
Key secondary outcomes | Change of HbA1c after 3 months.
Change of Blood pressure and body composition after 3 and 6 months. Change of eating habit and physical function after 6 months. |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Uncontrolled |
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 | Instruction of meal and exercise by dietitian and physical therapist every one month, based on the data corrected by IoT and ICT mechanisms. | ||
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 | Type 2 diabetes patients.
Owning personal smartphone and can use it him/herself. Can get his/her own agreement by documents. |
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Key exclusion criteria | Diabetes other than type2.
Under dialysis treatment. Any other reason by decision of Research representative or researchers. |
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Target sample size | 45 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Hiroshima University Graduate School of Biomedical and Health Sciences | ||||||
Division name | Preventive Medicine for Diabetes and Lifestyle-related Diseases | ||||||
Zip code | 734-8553 | ||||||
Address | 1-2-3 Kasumi, Hiroshima city Minami-ward, Hiroshima prefecture | ||||||
TEL | 082-257-5198 | ||||||
masayone17@hiroshima-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Hiroshima University Graduate School of Biomedical and Health Sciences | ||||||
Division name | Preventive Medicine for Diabetes and Lifestyle-related Diseases | ||||||
Zip code | 734-8553 | ||||||
Address | 1-2-3 Kasumi, Hiroshima city Minami-ward, Hiroshima prefecture | ||||||
TEL | 082-257-5198 | ||||||
Homepage URL | |||||||
kazu-kobuke@hiroshima-u.ac.jp |
Sponsor | |
Institute | Hiroshima University Graduate School of Biomedical and Health Sciences
Preventive Medicine for Diabetes and Lifestyle-related Diseases |
Institute | |
Department |
Funding Source | |
Organization | Hiroshima University Graduate School of Biomedical and Health Sciences
Preventive Medicine for Diabetes and Lifestyle-related Diseases donated course |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization | Japan |
Other related organizations | |
Co-sponsor | Aki-Ota Hospital, Mihara City Medical Associations Hospital, Fuchu City Hospital |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Hiroshima University Clinical Research Ethics Review Committee |
Address | 1-2-3 Kasumi, Hiroshima city Minami-ward, Hiroshima prefecture |
Tel | 082-257-1551 |
iryo-seisaku@office.hiroshima-u.ac.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 | 広島大学病院(広島県) |
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 | |
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 | Preinitiation | ||||||
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 |
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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=R000043613 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |