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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000018962
Receipt No. R000021892
Scientific Title A clinical trial of non-invasive blood glucose monitoring apparatus
Date of disclosure of the study information 2015/09/14
Last modified on 2015/09/10

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Basic information
Public title A clinical trial of non-invasive blood glucose monitoring apparatus
Acronym A clinical trial of non-invasive blood glucose monitoring apparatus
Scientific Title A clinical trial of non-invasive blood glucose monitoring apparatus
Scientific Title:Acronym A clinical trial of non-invasive blood glucose monitoring apparatus
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 An examination of accuracy of the non-invasive blood glucose monitoring apparatus, which is under development.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes An accuracy evaluation of blood glucose levels derived from wavelength calculations of fingertips, whole blood, and blood plasma measured with the apparatus in a non-invasive manner.
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 Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 We perform 75g oral glucose tolerance tests on examiners, and take blood samples of 0' 30' 60' 90' 120' 180 minutes after glucose load. At the same time, the optical measurements on their fingertips are recorded in each time. Blood glucose levels calculated by the optical measurements are compared with correct blood glucose levels measured with biochemical analyzer. Whole blood and blood plasma taken in each time are also calculated by the optical measurements.
The 75g oral tolerance tests are performed once a week, for 5 weeks. Blood collection amount of one day can be from 70 to 80 mL.
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
60 years-old >
Gender Male
Key inclusion criteria 1) Regular employee of SEIKO EPSON corporation.
2) A or B dicision in glucose metabolism on periodical health examination.
3) A or B or C dicision on synthetic judgement on periodical health examination.
Key exclusion criteria 1) Patients with diabetes mellitus.
2) less than Hb (hemoglobin) 13.0 g/dL.
3) considered to be inappropriate by responsible doctors for this research.
Target sample size 3

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuhisa Komatsu
Organization Shinshu University School of Medicine
Division name Division of Diabetes, Endocrinology and Metabolism, Department of Internal Medicine
Zip code
Address 3-1-1, Asahi Matsumoto-shi, Nagano
TEL 81-263-37-2686
Email mitsuk@shinshu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ako Oiwa
Organization Shinshu University School of Medicine
Division name Division of Diabetes, Endocrinology and Metabolism, Department of Internal Medicine
Zip code
Address 3-1-1, Asahi Matsumoto-shi, Nagano
TEL 81-263-37-2686
Homepage URL
Email akooiwa@shinshu-u.ac.jp

Sponsor
Institute SEIKO EPSON corporation
Institute
Department

Funding Source
Organization SEIKO EPSON 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
Address
Tel
Email

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
2015 Year 09 Month 14 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 No longer recruiting
Date of protocol fixation
2015 Year 08 Month 04 Day
Date of IRB
Anticipated trial start date
2015 Year 09 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 09 Month 10 Day
Last modified on
2015 Year 09 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021892

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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