UMIN-CTR Clinical Trial

Basic information
Public title	Verification of vital sign calculation method from FBG sensor signal measured at pulsation point
Acronym	Vital sign calculation from FBG sensor signal measured at pulsation point
Scientific Title	Verification of blood pressure and blood glucose calculation method from arterial strain measured by FBG sensor
Scientific Title:Acronym	Calculation of blood pressure and blood glucose from arterial strain
Region	Japan

Condition
Condition	Hypertension and diabetes mellitus
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose is to construct an analysis method that calculates blood pressure and blood glucose with high accuracy from the strain signal of the pulsation point measured by the Fiber Bragg Grating (FBG) sensor.
Basic objectives2	Others
Basic objectives -Others	The second purpose is to construct an FBG sensor jig that can measure strain signals with a high signal-to-noise ratio.
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase I,II

Assessment
Primary outcomes	Waveform of strain signal by FBG sensor
Key secondary outcomes	Blood pressure, blood glucose, ultrasound echo image, near-infrared transmission image

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	90 years-old >
Gender	Male and Female
Key inclusion criteria	Healthy volunteer and the relatively stable patients with hypertension and diabetes mellitus who are admitted to Shinshu University Hospital and obtained informed consent.
Key exclusion criteria	Subjects having chronic atrial fibrillation, severe arrhythmia, peripheral circulatory failure such as Raynaud's disease, severe deformed nail, and are judged as inappropriate by chief researcher.
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Keisaku Middle name Last name Fujimoto
Organization	Shinshu University School of Health Science
Division name	Department of Clinical Laboratory Sciences
Zip code	390-8621
Address	3-1-1, Asahi, Matsumoto, Nagano, Japan
TEL	+81-263-37-2393
Email	keisaku@shinshu-u.ac.jp

Public contact
Name of contact person	1st name Shouhei Middle name Last name Koyama
Organization	Faculty of Textile Science and Technology, Shinshu University
Division name	Department of Advanced Textile and Kansei Engineering
Zip code	386-8567
Address	3-15-1, Tokida, Ueda, Nagano, Japan
TEL	+81-268-21-5603
Homepage URL
Email	shouhei@shinshu-u.ac.jp

Sponsor
Institute	Shinshu University
Institute
Department

Funding Source
Organization	Japan Science and Technology Agency
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Shinshu University School of Medicine Medical Ethics Committee
Address	3-1-1, Asahi, Matsumoto, Nagano, Japan
Tel	0263-37-2572
Email	mdrinri@shinshu-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

Other administrative information
Date of disclosure of the study information	2020 Year 10 Month 29 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	2020 Year 10 Month 29 Day
Date of IRB	2020 Year 09 Month 14 Day
Anticipated trial start date	2020 Year 10 Month 30 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2022 Year 03 Month 31 Day

Other
Other related information	This study is a prospective observational study with minor invasion. The research period is from October 2020 to December 2021. The subjects of the study were healthy volunteer and the relatively stable patients with hypertension and diabetes mellitus who are admitted to Shinshu University Hospital and obtained informed consent.

Management information
Registered date	2020 Year 10 Month 28 Day
Last modified on	2020 Year 10 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048240