UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026024 |
|---|---|
| Receipt number | R000028935 |
| Scientific Title | A clinical trials of non-invasive blood glucose monitoring apparatus ~ in use of improved measuring technique ~ |
| Date of disclosure of the study information | 2017/02/07 |
| Last modified on | 2019/08/11 14:17:19 |
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Basic information
Public title
A clinical trials of non-invasive blood glucose monitoring apparatus ~ in use of improved measuring technique ~
Acronym
A clinical trials of non-invasive blood glucose monitoring apparatus
Scientific Title
A clinical trials of non-invasive blood glucose monitoring apparatus ~ in use of improved measuring technique ~
Scientific Title:Acronym
A clinical trials of non-invasive blood glucose monitoring apparatus
Region
| Japan |
Condition
Condition
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 assessment of blood glucose levels calculated by the wavelength apparatus.
Key secondary outcomes
An assessment of fluctuation in concentrations of lipid, electrolytes, hemoglobin, and protein, in glucose and diet tolerance tests.
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 will perform 75g oral glucose tolerance tests 3 times and diet loading tests twice on each subject, and take blood samples of 0'30'60'90'120'180 minutes after glucose and diet loading. At the same time of getting blood sampling, we will perform optical measurements on their fingertips, which will be also recorded every 4 or 5 minute, about 100 times a day. Blood glucose levels calculated by the optical measurements are compared with correct blood glucose levels measured with biochemical analyzer. The loading tests will be performed once a week for 5 weeks. Blood collection amount of one day can be about 40-45 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 and Female
Key inclusion criteria
1) Regular employee of SEIKO EPSON corporation.
2) A person who is judged for entering this research in safety by a participating doctor.
Key exclusion criteria
1) less than Hb (hemoglobin) 13.0 g/dL
2) under taking anticoagulant medicine.
3) A person who is judged for having risk in taking 75g glucose by a participating doctor.
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
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
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
Address
Tel
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
| 2017 | Year | 02 | Month | 07 | 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
20
Results
Blood glucose measurement using a non-invasive blood glucose apparatus, which is being developed by Seiko Epson, is still inadequate in terms of accuracy, and it was judged that clinical application of this device was difficult.
Results date posted
| 2019 | Year | 08 | Month | 11 | Day |
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
| 2017 | Year | 01 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 23 | 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
| 2017 | Year | 02 | Month | 07 | Day |
Last modified on
| 2019 | Year | 08 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028935
