UMIN-CTR Clinical Trial

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, Shoubara Red Cross Hospital, Saiseikai Hiroshima 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	Enrolling by invitation
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	2022 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2023 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2019 Year 12 Month 02 Day
Last modified on	2020 Year 12 Month 11 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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