UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exploratory study to estimate blood parameter by sensor. ID:SHD-2018-03-SENSE
Title of the study (Brief title)	Exploratory study to estimate blood parameter by sensor.
Region	Japan

Condition
Condition	Not applicable
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the correlation between amounts of sensor measurement and blood parameter
Basic objectives2	Others
Basic objectives -Others	Method of measurement
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Correlation between amounts of sensor measurement and blood parameter
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Confirming the blood parammater level change until about two hours after food load.
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	20 years-old <=
Age-upper limit	70 years-old >
Gender	Male and Female
Key inclusion criteria	(1)BMI less than 30 (2)Subjects who are able to submit the written informed consents.
Key exclusion criteria	(1)Subjects who are with treatment. (2)Females in pregnancy, lactation and scheduled pregnancy period. (3)Subjects who are; (a)With present heart disorder, liver disorder, or kidney disorder, (b)With history of cardiac disorder, (c)With diabetes mellitus, or (4)Subjects who habitually intake drugs. (5)Subjects who experienced unpleasant feeling during drawing blood. (6)Subjects who are deemed to be unsuitable by the investigator.
Target sample size	200

Research contact person
Name of lead principal investigator	Mitsuhiro Zeida
Organization	Suntory holdings Limited
Division name	Research Strategy Planning Department
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL	050-3182-0464
Email	Mitsuhiro_Zeida@suntory.co.jp

Public contact
Name of contact person	Mitsuhiro Zeida
Organization	Suntory holdings Limited
Division name	Research Strategy Planning Department
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL	050-3182-0464
Homepage URL
Email	Mitsuhiro_Zeida@suntory.co.jp

Sponsor
Institute	Suntory holdings Limited
Institute
Department

Funding Source
Organization	Suntory holdings Limited
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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

Other administrative information
Date of disclosure of the study information	2019 Year 10 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 09 Month 06 Day
Anticipated trial start date	2018 Year 09 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 09 Month 10 Day
Last modified on	2019 Year 02 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038860