Concordance of Central Laboratory Hemoglobin A1c Measurements from Capillary Kits Compared to Venous Draws in the Insulin-Only Bionic Pancreas Pivotal Trial
Authors' conclusion
These results are consistent with previous studies that also reported high concordance between capillary and venous HbA1c values using the same laboratory method, providing further evidence that capillary HbA1c measurements are an accurate alternative to venous measurements.
Study context
- Population
- Participants in the Insulin-Only Bionic Pancreas Trial; samples analyzed at University of Minnesota Advanced Research and Diagnostic Laboratory773 paired samples
- Participants
- 258 participants
- Comparison
- Capillary vs venous hemoglobin A1c (HbA1c)
- Primary endpoint
- HbA1c value congruency between capillary and venous samples
Methodological detailssecondary analysis of the Insulin-Only Bionic Pancreas Pivotal Trial, brief report, paired capillary and venous samples, central laboratory
- Secondary analysis of the Insulin-Only Bionic Pancreas Pivotal Trial
- Brief report
- Paired capillary and venous samples
- Central laboratory
Primary result
As reported in the abstract
Capillary vs venous HbA1c concordance
Capillary samples within 5% of respective venous measurement
97.7%
R2 between the two HbA1c sources
0.95
Original publication
Concordance of Central Laboratory Hemoglobin A1c Measurements from Capillary Kits Compared to Venous Draws in the Insulin-Only Bionic Pancreas Pivotal Trial. Diabetes Technol Ther. Published 2 May 2023. doi:10. 1089/ dia. 2023. 0094
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