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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

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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
Email 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
Email 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
Email 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 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
2019 Year 09 Month 30 Day
Date of IRB
2019 Year 12 Month 02 Day
Anticipated trial start date
2019 Year 12 Month 09 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2022 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date
2019 Year 12 Month 02 Day
Last modified on
2019 Year 12 Month 02 Day


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


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