UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046608 |
|---|---|
| Receipt number | R000053168 |
| Scientific Title | Accuracy verification study of a non-invasive blood glucose meter |
| Date of disclosure of the study information | 2022/01/12 |
| Last modified on | 2022/01/12 12:03:24 |
* 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
Accuracy verification study of a non-invasive blood glucose meter
Acronym
Accuracy verification study of a non-invasive blood glucose meter
Scientific Title
Accuracy verification study of a non-invasive blood glucose meter
Scientific Title:Acronym
Accuracy verification study of a non-invasive blood glucose meter
Region
| Japan |
Condition
Condition
healthy person
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the measurement accuracy of the non-invasive blood glucose meter under development
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To compare blood glucose levels from a non-invasive blood glucose meter being developed in healthy volunteers with those from an invasive blood glucose meter and an outsourced test, and to verify the accuracy of these measurements.
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Measuring blood glucose levels with non-invasive blood glucose meters, invasive blood glucose meters, and outsourced testing
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Adults aged 20 years or older
(2) People who have given written consent for participation in this study.
Key exclusion criteria
1) People who have been diagnosed as diabetic
(2) People who cannot handle their own blood glucose meter
(3) Others who are judged to be inappropriate for the program.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Asao |
Organization
Gunma University Hospital
Division name
Innovative Medical Center
Zip code
371-8511
Address
3-39-15, Showa-machi, Maebashi, Gunma, Japan
TEL
027-220-8222
asao@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Asao |
Organization
Gunma University Hospital
Division name
Innovative Medical Center
Zip code
371-8511
Address
3-39-15, Showa-machi, Maebashi, Gunma, Japan
TEL
027-220-8222
Homepage URL
asao@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
LOOK TEC Corporation
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
Gunma Institutional Review Board
Address
3-39-15, Showa-machi, Maebashi, Gunma, Japan
Tel
027-220-7111
ciru_hitotaisho-irb@ml.gunma-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
| 2022 | Year | 01 | Month | 12 | 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 | 02 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 01 | Month | 12 | Day |
Last modified on
| 2022 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053168
