UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018962 |
|---|---|
| Receipt number | 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 | 2023/03/20 18:00:59 |
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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 | Mitsuhisa |
| Middle name | |
| Last name | Komatsu |
Organization
Shinshu University School of Medicine
Division name
Division of Diabetes, Endocrinology and Metabolism, Department of Internal Medicine
Zip code
390-8621
Address
3-1-1, Asahi Matsumoto-shi, Nagano
TEL
81-263-37-2686
mitsuk@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Ako |
| Middle name | |
| Last name | Oiwa |
Organization
Shinshu University School of Medicine
Division name
Division of Diabetes, Endocrinology and Metabolism, Department of Internal Medicine
Zip code
390-8621
Address
3-1-1, Asahi Matsumoto-shi, Nagano
TEL
81-263-37-2686
Homepage URL
akooiwa@shinshu-u.ac.jp
Sponsor or person
Institute
SEIKO EPSON corporation
Institute
Department
Personal name
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
The ethics committee of the Shinshu University School of Medicine
Address
3-1-1 Asahi Matsumoto, Nagano-ken, Japan
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
| 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
3
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
Completed
Date of protocol fixation
| 2015 | Year | 08 | Month | 04 | Day |
Date of IRB
| 2015 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 11 | Day |
Last follow-up date
| 2015 | Year | 11 | Month | 11 | Day |
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
| 2023 | Year | 03 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021892
