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Name
UMIN ID

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046608
Receipt No. 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

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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
Email 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
Email asao@gunma-u.ac.jp

Sponsor
Institute Gunma University
Institute
Department

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
Email 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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053168

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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