UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033845 |
|---|---|
| Receipt number | 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 | 2023/08/25 15:01:32 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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 | Keisaku |
| Middle name | |
| Last name | Fujimoto |
Organization
Shinshu University School of Health Sciences
Division name
Department of Clinical Laboratory Sciences
Zip code
3908621
Address
3-1-1, Asahi, Matsumoto, Nagano, Japan
TEL
0263372393
fkeisaku@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Ishizawa |
Organization
Shinshu University
Division name
Institute for Fiber Engineering
Zip code
386-8567
Address
3-15-1, Tokida, Ueda, Nagano, 386-8567, Japan
TEL
+81-268-21-5603
Homepage URL
zawa@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
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
Clinical Research Review Board/Life Science/Medical Research Ethics Committee
Address
Shinshu University School of Medicine, Research Center
Tel
0263-37-2572
byouin_soumu@gm.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
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
IEEE Sensors Journal, vol.19, Issue.24, 11946-11954, 2019.
Publication of results
Published
Result
URL related to results and publications
IEEE Sensors Journal, vol.19, Issue.24, 11946-11954, 2019.
Number of participants that the trial has enrolled
120
Results
FBG sensor signal supported the diameter of radial artery conjugation, and it became clear that this accorded with the pressure of the fluid, and the shape of the pulsation distortion signal changed by age and was an estimate in blood vessel age or arteriosclerotic possibility from a wave pattern shape. Blood pressure calculation was possible as a parameter with the size of the vertical axis direction of the pulsation distortion wave pattern.
Results date posted
| 2023 | Year | 08 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy adults and tha patients with hypertension and diabetes mellitus visiting the hospital of Shinshu University Hospital.
Participant flow
It recruited participants by a poster and an appeal and obtained informed consent using an explanation document. I measured in another room.
Adverse events
none
Outcome measures
Blood pressure and blood sugar.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2018 | Year | 08 | Month | 07 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 07 | Day |
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
| 2023 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038582
