UMIN-CTR Clinical Trial

Basic information
Public title	Cross-sectional study for correlation between blood ketone body and breath acetone concentration in patients with diabetes using breath acetone checker
Acronym	Cross-sectional study for correlation between blood ketone body and breath acetone concentration in patients with diabetes using breath acetone checker
Scientific Title	Cross-sectional study for correlation between blood ketone body and breath acetone concentration in patients with diabetes using breath acetone checker
Scientific Title:Acronym	Cross-sectional study for correlation between blood ketone body and breath acetone concentration in patients with diabetes using breath acetone checker
Region	Japan

Condition
Condition	Diabetes Mellitus
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the correlation between blood ketone body and breath acetone concentration in patients with diabetes using Fat-burning Monitor(FM-001)
Basic objectives2	Others
Basic objectives -Others	Evaluation of correlation between blood ketone bodies and breath acetone concentration measured with Fat-burning Monitor (FM-001)
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Correlation coefficient between breath acetone and blood total ketone body concentration and its 95% confidence interval.
Key secondary outcomes	Linear regression equation to calculating blood total ketone body concentration from breath acetone concentration.

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Among diabetic patients admitted to Diabetic Center of St. Marianna University Hospital, patients whose urinary ketone bodies were positive at the time of application for hospitalization.
Key exclusion criteria	1.Patients requiring intensive care unit management with diabetic ketoacidosis or hyperglycemic hyperosmolar state. 2.Patients who detected blood alcohol at the time of hospitalization. 3.Patients who cannot useFM-001 by difficulty in controlling exhalation due to respiratory disease, cerebrovascular disease or other disease. 4.Patients with severe infections, before and after surgery, and severe trauma.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Nagai Middle name Last name Yoshio
Organization	St.marianna university
Division name	endcrinology and metabolism
Zip code	216-8511
Address	2-16-1 Sugao, Miyamae-ward, Kawasaki-city, Kanagawa
TEL	044-977-8111
Email	ynagai@marianna-u.ac.jp

Public contact
Name of contact person	1st name Shingo Middle name Last name Tsunemi
Organization	St.marianna university
Division name	endcrinology and metabolism
Zip code	216-8511
Address	2-16-1 Sugao, Miyamae-ward, Kawasaki-city, Kanagawa
TEL	044-977-8111
Homepage URL
Email	shingo.tsunemi@marianna-u.ac.jp

Sponsor
Institute	St.marianna university
Institute
Department

Funding Source
Organization	St.marianna university
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	St.marianna university
Address	2-16-1 Sugao, Miyamae-ward, Kawasaki-city, Kanagawa
Tel	044-977-8111
Email	k-sienbu.mail@marianna-u.ac.jp

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	聖マリアンナ医科大学病院

Other administrative information
Date of disclosure of the study information	2019 Year 09 Month 30 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
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	Open public recruiting
Date of protocol fixation	2019 Year 09 Month 17 Day
Date of IRB	2019 Year 10 Month 05 Day
Anticipated trial start date	2019 Year 09 Month 30 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	To evaluate the correlation between blood ketone body concentration and breath acetone concentration in diabetic patients who were positive for urine ketone when they were admitted to hospital, by using Fat-burning Monitor(FM-001)

Management information
Registered date	2019 Year 09 Month 24 Day
Last modified on	2022 Year 01 Month 15 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043406