UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034125 |
|---|---|
| Receipt number | R000038899 |
| Scientific Title | Study on blood sugar level estimation with the light vital signs sensor using an electric photoplethysmography. |
| Date of disclosure of the study information | 2018/10/01 |
| Last modified on | 2023/09/26 18:28:45 |
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Basic information
Public title
Study on blood sugar level estimation with the light vital signs sensor using an electric photoplethysmography.
Acronym
Blood sugar estimation using an photoplethysmography.
Scientific Title
Study on blood sugar level estimation with the light vital signs sensor using an electric photoplethysmography.
Scientific Title:Acronym
Blood sugar estimation using an photoplethysmography.
Region
| Japan |
Condition
Condition
Diabetes Mellitus
Classification by specialty
| Medicine in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to compare the blood sugar level using the self-blood sugar measuring instrument with the blood sugar level estimated from the pulse wave form using an electric photoplethysmography, and to inspect and verify the algorithm of the measurement.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pulse wave form detected by an electric photoplrthysmography.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Blood sugar level measured by a self-blood sugar measuring instrument.
Interventions/Control_2
The blood sugar level estimated from the pulse wave form detected by an electric photoplethysmography.
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 volunteers and the relatively controled patients with diabeted mellitus (HbA1c<8.0% and FBS<200mg/dl).
Key exclusion criteria
Subjects having chronic arterial fibrillation, severe arrhythmia, perpheral circulatory failure such as Raynaud's disease, severe deformed nail, and are judged as inappropriate by chief researcher.
Target sample size
40
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
390-8621
Address
3-1-1, Asahi, Matsumoto, Naganoken, 390-8621, Japan
TEL
+81-263-37-2393
fkeisaku@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Keisaku |
| Middle name | |
| Last name | Fujimoto |
Organization
Shinshu University School of Health Sciences
Division name
Department of Clinical Laboratory Sciences
Zip code
390-8621
Address
3-1-1, Asahi, Matsumoto, Naganoken, 390-8621, Japan
TEL
+81-263-37-2393
Homepage URL
fkeisaku@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Murata Manufacturing Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
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
| 2018 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
none
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
46
Results
38 healthy subjects were able to measure the pulse wave signals by the photoelectric plethysmograph. The coefficient of correlation of the blood sugar level measured by the estimated blood sugar level due to the photoelectric plethysmograph of pulse wave and the puncture of the conventional finger-tip showed 0.88 and a high equilateral correlation in 0.83, women in men.
Results date posted
| 2023 | Year | 09 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy adult subjects
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 sugar
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2018 | Year | 09 | Month | 04 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 04 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 10 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 10 | Month | 13 | Day |
Other
Other related information
As for 8 of 46 physically unimpaired people, the photoelectric expression capacity pulse wave is accurate for the cold of the finger-tip; excluded it from analysis without being able to measure. The coefficient of correlation of the blood sugar level measured by the estimated blood sugar level due to the photoelectric expression capacity pulse wave and the puncture of the conventional finger-tip showed 0.88 and a high equilateral correlation in 0.83, women in men. Furthermore, 99% of estimated blood sugar level were distributed over A zone and the B zone in the consensus error grid analysis and met a clinical precision-related condition. [conclusion] The measurement of the noninvasive blood sugar level using the photoelectric expression capacity pulse wave device had validity about standard, and it became clear by this study to meet a condition to guarantee the clinical precise nature of the ISO15197 standard. However, the contract with the company was finished before leading to the number of the planned samples, and the examination was called off.
Management information
Registered date
| 2018 | Year | 09 | Month | 13 | Day |
Last modified on
| 2023 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038899
