UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007610 |
|---|---|
| Receipt number | 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 14:54:42 |
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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
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
Kazuyuki_Kosaka@su-oasis.jm.shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu Univerisity
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008986
