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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001898
Receipt No. R000002297
Scientific Title Study on the correlation between the spectroscopic information and the invasive blood glucose values in order to develop the non-invasive blood glucose measurement calibration model mainly for the self monitoring blood glucose monitoring of diabetics.
Date of disclosure of the study information 2009/04/20
Last modified on 2012/03/30

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Basic information
Public title Study on the correlation between the spectroscopic information and the invasive blood glucose values in order to develop the non-invasive blood glucose measurement calibration model mainly for the self monitoring blood glucose monitoring of diabetics.
Acronym Spectroscopic study on the non-invasive measurement of blood glucose based on the optical information, the reference blood glucose values, and the calibration method.
Scientific Title Study on the correlation between the spectroscopic information and the invasive blood glucose values in order to develop the non-invasive blood glucose measurement calibration model mainly for the self monitoring blood glucose monitoring of diabetics.
Scientific Title:Acronym Spectroscopic study on the non-invasive measurement of blood glucose based on the optical information, the reference blood glucose values, and the calibration method.
Region
Japan

Condition
Condition diabetics
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The object of this study is developing the non-invasive blood glucose based on the infrared absorbance spectrum.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes 1.Relative error of the calibration model
2.Error Grid analysis for the for the evaluation of the clinical implications
Key secondary outcomes Efficiency of the measurement

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Uncontrolled
Stratification
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Invasive blood glucose measurement would be carried out each subject by the AntsenseII of which values would be used as the reference method values.
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 Grouwn-up, who would give their consent to this study after understanding the object, method, and the risk management of this study.
Key exclusion criteria Under age person
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ishizawa Hiroaki
Organization Shinshu University
Division name Faculty of Textile Science and Technology
Zip code
Address 3-15-1Tokita Ueda-shi Nagano-ken
TEL 0268-21-5400
Email

Public contact
Name of contact person
1st name
Middle name
Last name Ishizawa Hiroaki
Organization Shinshu University
Division name Faculty of Textile Science and Technology
Zip code
Address 3-15-1Tokita Ueda-shi Nagano-ken
TEL 0268-21-5400
Homepage URL
Email zawa@shinshu-u.ac.jp

Sponsor
Institute Shinshu university
Institute
Department

Funding Source
Organization CLUSTER(the second stage) of Ministry of Education, Culture, Sports Science and Technology, Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor NEC SystemTechnologies, Ltd
Nishizawa Electric Meters Manufacturing Co.Ltd
Name of secondary funder(s) none

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
2009 Year 04 Month 20 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
The condition of the spectroscopy has been determined.
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
2009 Year 04 Month 06 Day
Date of IRB
Anticipated trial start date
2009 Year 05 Month 01 Day
Last follow-up date
2012 Year 03 Month 01 Day
Date of closure to data entry
2012 Year 03 Month 01 Day
Date trial data considered complete
2012 Year 03 Month 01 Day
Date analysis concluded
2012 Year 03 Month 01 Day

Other
Other related information none

Management information
Registered date
2009 Year 04 Month 20 Day
Last modified on
2012 Year 03 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002297

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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