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Accuracy of continuous glucose monitoring in cardiac surgery

A prospective, single-center, observational study to evaluate the accuracy of "Guardian 4 Standalone System", a continuous blood glucose monitoring system, in cardiac surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0009396
Enrollment
42
Registered
2024-05-03
Start date
2024-09-02
Completion date
Unknown
Last updated
2026-03-23

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

Conditions

None listed

Interventions

None listed

Sponsors

The Catholic University of Korea, Seoul St. Mary's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: A patient or legal representative voluntarily decides to participate in this clinical study and signs and seals the subject's written consent to participate in the study

Exclusion criteria

Exclusion criteria: 1. Patient scheduled for emergency surgery 2. Patient who cannot communicate 3. Patient who is pregnant or nursing 4. Patient who is unable to insert a sensor into the rear of the upper arm 5. Patients taking drugs (Hydroxyurea, acetaminophen, paracetamol) that can affect the sensor

Design outcomes

Primary

MeasureTime frame
Agreement rate 20/20—

Secondary

MeasureTime frame
Agreement rate 15/15;Agreement rate 30/30;Agreement rate 40/40;Mean absolute relative difference;FDA continuous glucose monitoirng system validation criteria;Sensor failture rate;Adverse event rate;Patient satisfaction;Error grid analysis—

Countries

Korea, Republic of

Contacts

Public ContactHoon Choi

The Catholic University of Korea, Seoul St. Mary's Hospital

hoonie83@naver.com+82-2-2258-2236

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Apr 3, 2026