UMIN-CTR Clinical Trial

Basic information
Public title	Method and apparatus for noninvasive monitoring of Type 1 diabetes by detection of acetone in breath
Acronym	Detection of acetone in breath
Scientific Title	Method and apparatus for noninvasive monitoring of Type 1 diabetes by detection of acetone in breath
Scientific Title:Acronym	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
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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	1st name Middle name Last name Sergey N. Atutov
Organization	Institute of Automation and Electrometry Siberian Branch of Russian Academy of Sciences
Division name	Laboratory of physics of lasers
Zip code
Address	Academician V. Koptyug ave., 1, 630090 Novosibirsk, Russian Federarion
TEL	+7-383-3306655
Email	atutovsn@mail.ru

Public contact
Name of contact person	1st name Middle name Last name Sergey N. Atutov
Organization	Institute of Automation and Electrometry Siberian Branch of Russian Academy of Sciences
Division name	Laboratory of physics of lasers
Zip code
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)

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	2013 Year 12 Month 23 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	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.
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	2012 Year 08 Month 06 Day
Date of IRB
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

Other

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://center6.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
Registered date	File name

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