UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012657 |
|---|---|
| Receipt number | R000014803 |
| Scientific Title | 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 16:25:37 |
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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
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
| 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
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
atutovsn@mail.ru
Sponsor or person
Institute
Institute of Automation and Electrometry Siberian Branch of Russian Academy of Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014803
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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