UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042274
Receipt number R000048240
Scientific Title Verification of blood pressure and blood glucose calculation method from arterial strain measured by FBG sensor
Date of disclosure of the study information 2020/10/29
Last modified on 2020/10/29 08:39:35

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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 or person

Institute

Shinshu University

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048240


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name