Type 1 diabetes

Concordance of Central Laboratory Hemoglobin A1c Measurements from Capillary Kits Compared to Venous Draws in the Insulin-Only Bionic Pancreas Pivotal Trial

Diabetes Technol TherPublished Method comparison study

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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