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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007610
Receipt No. R000008986
Scientific Title Wearable Vital sign sensing system for noninvasive blood glucose and blood pressue measurement based on optical measuremnt
Date of disclosure of the study information 2012/04/02
Last modified on 2017/10/03

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Basic information
Public title Wearable Vital sign sensing system for noninvasive blood glucose and blood pressue measurement based on optical measuremnt
Acronym Wearable Vital sign sensing system
Scientific Title Wearable Vital sign sensing system for noninvasive blood glucose and blood pressue measurement based on optical measuremnt
Scientific Title:Acronym 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
1st name
Middle name
Last name Ishizawa HIroaki
Organization Shinshu University
Division name Textile Science and Technology
Zip code
Address 3-15-1 Tokida Ueda-shi
TEL 0268-21-5400
Email zawa@shinshu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroaki Ishizawa
Organization Shinshu University
Division name General Management Office of Research and Development
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
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).
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
2012 Year 06 Month 01 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000008986

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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