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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012657
Receipt No. R000014803
Official scientific title of the study Method and apparatus for noninvasive monitoring of Type 1 diabetes by detection of acetone in breath
Date of disclosure of the study information 2013/12/23
Last modified on 2013/12/26

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Basic information
Official scientific title of the study Method and apparatus for noninvasive monitoring of Type 1 diabetes by detection of acetone in breath
Title of the study (Brief title) Detection of acetone in breath
Region
Asia(except Japan)

Condition
Condition Type 1 diabetes / noninvasive monitoring
Classification by specialty
Endocrinology and Metabolism Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Testing the correlations between the blood glucose levels of diabetic patients and the signal registered by the proposed method and device for detection of acetone in breath.
Basic objectives2 Others
Basic objectives -Others Testing an exhaled air and a blood glucose level.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes As a tentative result we found that the breath acetone level declined linearly with the amount of the blood glucose concentration of all persons examined.
Key secondary outcomes We have demonstrated the possibility of applying the proposed breath analysis method and simple apparatus to the noninvasive monitoring of the blood glucose level.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Type 1 diabetes for about 10 years, early stages of type 1 diabetes, and conditionally healthy patients.
Key exclusion criteria Not applicable
Target sample size 3

Research contact person
Name of lead principal investigator Sergey N. Atutov
Organization Institute of Automation and Electrometry Siberian Branch of Russian Academy of Sciences
Division name Laboratory of physics of lasers
Address Academician V. Koptyug ave., 1, 630090 Novosibirsk, Russian Federarion
TEL +7-383-3306655
Email atutovsn@mail.ru

Public contact
Name of contact person Sergey N. Atutov
Organization Institute of Automation and Electrometry Siberian Branch of Russian Academy of Sciences
Division name Laboratory of physics of lasers
Address Academician V. Koptyug ave., 1, 630090 Novosibirsk, Russian Federarion
TEL +7-383-3306655
Homepage URL
Email atutovsn@mail.ru

Sponsor
Institute Institute of Automation and Electrometry Siberian Branch of Russian Academy of Sciences
Institute
Department

Funding Source
Organization budget
Organization
Division
Category of Funding Organization Outside Japan
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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
2013 Year 12 Month 23 Day

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 08 Month 06 Day
Anticipated trial start date
2012 Year 08 Month 06 Day
Last follow-up date
Date of closure to data entry
2012 Year 08 Month 17 Day
Date trial data considered complete
2012 Year 08 Month 17 Day
Date analysis concluded
2012 Year 08 Month 31 Day

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results We found that the breath acetone level measured by proposed method and device declined linearly with the amount of the blood glucose concentration of all persons examined.
Other related information The measurement of acetone concentration in the breath of 2 patients with Type 1 diabetes and one healthy volunteer was carried out by using an apparatus consisting of a discharge cell connected to a mini-vacuum pump for pumping the expired air through the cell and a mini-spectrograph of visible spectral range connected to computer with specialized programs for decoding and interpreting the emission spectra of the discharge in the expired air. The blood glucose concentration is measured with Yellow Springs Instruments at the same time the breath is tested. These tests were conducted on all patients studied before breakfast on an empty stomach.

Management information
Registered date
2013 Year 12 Month 23 Day
Last modified on
2013 Year 12 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014803

Research Plan
Registered date File name

Research case data specifications
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Research case data
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