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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033845
Receipt No. R000038582
Scientific Title Continuous measurement of blood pressure and blood glucose by a wearable vital sign system using FBG censer and verification of its mechanism.
Date of disclosure of the study information 2018/08/25
Last modified on 2018/08/21

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Basic information
Public title Continuous measurement of blood pressure and blood glucose by a wearable vital sign system using FBG censer and verification of its mechanism.
Acronym Continuous measure of blood pressure and glucose by FBG censer.
Scientific Title Continuous measurement of blood pressure and blood glucose by a wearable vital sign system using FBG censer and verification of its mechanism.
Scientific Title:Acronym Continuous measure of blood pressure and glucose by FBG censer.
Region
Japan

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

Objectives
Narrative objectives1 The purpose is to verify whether the wearable vital sign system can continuously measure blood pressure and glucose by the pulse wave form detected using a FBG (fiber bragg grating) censer developed by Shinshu University.
Basic objectives2 Others
Basic objectives -Others The second purpose is to verify the mechanism how the pulse wave form detected by a FBG censer provide the accuracy of blood pressure and glucose.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase I,II

Assessment
Primary outcomes Pulse wave form detected by a FBG (fiber bragg grating fiber) censor
Key secondary outcomes Blood pressure value, concentration of subcutaneous glucose, ulutrasound echo image of cervical artery

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Continuous blood pressure monitor using a CNAP 500.
Interventions/Control_2 Continuous subcutaneous glucose monitor using iPro2.
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 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keisaku Fujimoto
Organization Shinshu University School of Health Sciences
Division name Department of Clinical Laboratory Sciences
Zip code
Address 3-1-1, Asahi, Matsumoto, Nagano, Japan
TEL +80-263-37-2393
Email fkeisaku@shinshu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroaki Ishizawa
Organization Shinshu University
Division name Institute for Fiber Engineering
Zip code
Address 3-15-1, Tokida, Ueda, Nagano, 386-8567, Japan
TEL +81-268-21-5603
Homepage URL
Email zawa@shinshu-u.ac.jp

Sponsor
Institute Shinshu University
Institute
Department

Funding Source
Organization JSPS KAKENHI Grant Number JP16H01805 and the Wearable vital signs measurement system development project at Shinshu University.
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Institute of Fluid Science, Tohoku University
Name of secondary funder(s) OPERA

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 信州大学医学部医学部付属病院(長野県松本市)、信州大学繊維学部(長野県上田市)、東北大学流体科学研究所(仙台)

Other administrative information
Date of disclosure of the study information
2018 Year 08 Month 25 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
2018 Year 08 Month 07 Day
Date of IRB
Anticipated trial start date
2020 Year 12 Month 31 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
2020 Year 12 Month 31 Day
Date trial data considered complete
2020 Year 12 Month 31 Day
Date analysis concluded
2021 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 08 Month 21 Day
Last modified on
2018 Year 08 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038582

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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