Relationship between glycated haemoglobin (HbA1c) point-of-care and laboratory testing in intensive care unit (ICU) patients with diabetes

Not Applicable

• Conditions: Diabetes; Type 1 Diabetes; Type 2 Diabetes; Hypoglycemia; Critically Ill; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12617000555358
• Lead Sponsor: Dr Palash Kar

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-04-20
• Study Completion: 2017-07-31
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

Participants will include all patients with known diabetes admitted to the Intensive Care Unit (ICU).

Exclusion Criteria

No exclusion criteria aside from opposite of inclusion criteria.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the agreement between point-of-care and laboratory HbA1c testing in critically ill patients with diabetes. Agreement between measures will be analysed by Lin’s concordance correlation coefficient with Bland-Altman plots including 95% confidence limits of agreement. References 1 and 2.<br><br>1.Lin, L. I-K. 1989. A concordance correlation coefficient to evaluate reproducibility. Biometrics 45: 255-268.<br>2.Bland, J. M., and D. G. Altman. 1986. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet I: 307-310.<br>[The timepoint of the primary outcome is the time at which a capillary and arterial sample is taken for HbA1c analysis.]