Monitoring HbA1c levels in individuals affected by diabetes remains the standard of care for ensuring proper management of the condition. Typically, HbA1c is measured by venipuncture or fingerstick blood collection methods at regular intervals, and for nearly all diabetic patients, monitoring HbA1c is a lifelong endeavor. In general, venipuncture and fingerstick are standard blood collection procedures, which are considered inconvenient and painful. Patient surveys have shown that venipuncture induces fear (needle phobia) in more than 20% of adults and in 60% of children. We have designed, developed, and validated an innovative blood sampling device to collect and stabilize capillary blood from the patient’s upper arm. Using small skin incisions and vacuum, the device draws and deposits the blood onto self-contained matrices. The matrices’ cartridge is then shipped at room temperature to a clinical laboratory for HbA1c measurement. We conducted a clinical study at three sites within the U.S. to validate the use of the device on 146 enrolled participants. The primary study objective was to compare HbA1c measurement in samples collected by the device and venipuncture. Pain measurements were conducted to assess the discomfort associated with the use of the device, in comparison to venipuncture and fingerstick. The data demonstrated a strong correlation between the device and venipuncture (y=1.01-0.0131, R2=0.997) over a range of HbA1c values between 4.91 and 13.34%. Device lot-to-lot and operator-to-operator reproducibility studies showed CVs of 0.7% and 0.8%, respectively. Assessment of discomfort showed an average pain score of 1 for the device (on a scale 0 to 10) and the device was preferred over venipuncture and fingerstick by 79% of the subjects. We clinically validated an innovative blood sampling technology that provides a convenient, nearly painless, safe and effective alternative to venipuncture and fingerstick for HbA1c measurement in diabetic individuals.
E. Romeo: Employee; Self; Drawbridge Health, Inc. P.K. Bryant-Greenwood: None. K.N. Castorino: Consultant; Self; Abbott. Research Support; Self; Abbott, Dexcom, Inc., Drawbridge, Novo Nordisk Inc., Sanofi US. D.R. Liljenquist: None. B.L. Jordan: Employee; Self; Drawbridge Health. Employee; Spouse/Partner; Innovation Endeavors, LLC. M. Harrington: Employee; Self; Drawbridge Health. T. Holscher: Employee; Self; Drawbridge Health. C. Alexander: Consultant; Self; CAlexanderConsulting, LLC. V. Dokukin: Employee; Self; Drawbridge Health. M. Nerlekar: Employee; Self; Drawbridge Health. L. Williamson: Other Relationship; Self; Drawbridge Health. J. Sloane: Other Relationship; Self; Drawbridge Health.