UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Wearable Vital sign sensing system for noninvasive blood glucose and blood pressue measurement based on optical measuremnt
Title of the study (Brief title)	Wearable Vital sign sensing system
Region	Japan

Condition
Condition	diabetes, high blood pressure
Classification by specialty	Medicine in general Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	By using the optical measutemnt method, nonndestructive detection system of blood glucose level and other vital signs would be studied practically. Near-infrared spectroscopy and Fiber Bragg Grating technologies would be appied in these test for subject set. The stabilities of the measrement system is tested for practical application.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Standard error of the calibration models of the blood glucose contents, blood pressure, and other vitals. Stabilities of the calibration
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	Approximately 5 micro litter blood should be taken by using a medical needle by each subject. After this operation, invasive blood glucose measuremnt is carried out by the blood glucose meter. This value measured will used as the referenve value of the calibration with the near-infrared spectrum measured at the middle finger oh the subject at the same time. The pulse wave and the pulse wave velocity of a subject are measred by using the developed fiber senser. At the sametime, his/her blood pressure is monitored by the conventional blood pressure meter. The correlations between the optical measred values and the conventional method values ere syudied end up to obtaining the calibration models. The stabilities of the calibration models are tested by the same subject one month after the calibration.
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	1. adult 2. consent subject
Key exclusion criteria	1. a person under age 2. person who dose not consent
Target sample size	100

Research contact person
Name of lead principal investigator	Ishizawa HIroaki
Organization	Shinshu University
Division name	Textile Science and Technology
Address	3-15-1 Tokida Ueda-shi
TEL	0268-21-5400
Email	zawa@shinshu-u.ac.jp

Public contact
Name of contact person	Hiroaki Ishizawa
Organization	Shinshu University
Division name	General Management Office of Research and Development
Address	3-15-1 Tokita Ueda-shi Japan 389-8567
TEL	0268-21-5400
Homepage URL
Email	Kazuyuki_Kosaka@su-oasis.jm.shinshu-u.ac.jp

Sponsor
Institute	Shinshu Univerisity
Institute
Department

Funding Source
Organization	Shinshu University
Organization
Division
Category of Funding Organization	Other
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	2012 Year 04 Month 02 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 06 Month 01 Day
Anticipated trial start date	2012 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry	2013 Year 11 Month 30 Day
Date trial data considered complete	2013 Year 12 Month 20 Day
Date analysis concluded	2015 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	The NIR spectroscopy application to blood glucose measurement was difficult to the practicaltesting, because individual difference is inevitable(621 measuring points from 20 subjects). Non-invasive blood pressure measurement is expected to be possible with a adequate error 5 mmHg by a calibration of the pulse waves (810 points from 10 subjects).
Other related information	Paper published: (1)IEEJ Transactions on Sensors and Micromachines,Vol.132, No.12,pp.431-436(2012) (2)Measurement of pulse rate and respiration rate using Fiber Bragg grating sensor.Transaction of SICE,49(12),1101-105(2013) (3)Calibration Model of Individual Optimization in Blood Glucose Measurement,J.Illum. Engng. Inst.Jpn.Vol.98, No2 ,pp. 62-67(2014)

Management information
Registered date	2012 Year 03 Month 30 Day
Last modified on	2017 Year 10 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008986