Cross-sectional study for correlation between blood ketone body and breath acetone concentration in patients with diabetes using breath acetone checker

Cross-sectional study for correlation between blood ketone body and breath acetone concentration in patients with diabetes using breath acetone checker - Cross-sectional study for correlation between blood ketone body and breath acetone concentration in patients with diabetes using breath acetone checker

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000038086

Enrollment

Registered

2019-09-30

Start date

2019-09-30

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Correlation coefficient between breath acetone and blood total ketone body concentration and its 95% confidence interval.	—

Secondary

Measure	Time frame
Linear regression equation to calculating blood total ketone body concentration from breath acetone concentration.	—

Countries

Japan

Contacts

Public ContactShingo Tsunemi

St.marianna university endcrinology and metabolism

shingo.tsunemi@marianna-u.ac.jp044-977-8111

Outcome results