UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038753 |
|---|---|
| Receipt number | 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 | 2023/03/14 12:14:52 |
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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
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
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
| Behavior,custom | Maneuver |
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
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.
Key exclusion criteria
Diabetes other than type2.
Under dialysis treatment.
Any other reason by decision of Research representative or researchers.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Masayasu |
| Middle name | |
| Last name | Yoneda |
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
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Kobuke |
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 or person
Institute
Hiroshima University Graduate School of Biomedical and Health Sciences
Preventive Medicine for Diabetes and Lifestyle-related Diseases
Institute
Department
Personal name
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, Shoubara Red Cross Hospital, Saiseikai Hiroshima Hospital, Innoshima Ishikai 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
| 2019 | Year | 12 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
39
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
| 2019 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 02 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2023 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2023 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 14 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 12 | Month | 02 | Day |
Last modified on
| 2023 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043613
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