UMIN-CTR Clinical Trial

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000026024
Receipt No. 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 (Ver. 2)

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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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028935