Comparative evaluation of alternative-site capillary, blood glucose systems for accuracy, precision, perceived ease of use, and pain in patients with diabetes

The ability of patients to perform self-monitoring blood glucose tests (SMBG) using the One Touch Ultra, Sof-Tact, and Accu-Check Advantage Blood Glucose Monitoring Systems with blood collected from the forearm was evaluated with 53 patients with type 1 or type 2 diabetes. Patient obtained forearm results were compared to patient-obtained fingertip results. The overall accuracy of the Sof-Tact, One Touch Ultra, and Accu-Check Advantage systems with patient blood from the forearm and finger was established by comparing meter results to results obtained on a Beckman 2 Glucose Analyzer. Research questions that guided the study were the following: (a) Are the three SMBG systems accurate in comparison to a Beckman reference standard? (b) Are the three SMBG systems precise in comparison to a reference standard? (c) Is there a difference in perceived ease of use between three SMBG systems? (d) Is there a difference in perceived pain with sample collection from the forearm and finger stick SMBG system? and (e) Is there a subject preference for site of sample collection and the overall meter preference? Preferences related to the conventional finger-stick SMBG and study SMBG systems were determined by a questionnaire. Regression analysis demonstrated a good correlation existed between the Sof-Tact test results and the Beckman 2 Glucose Analyzer across the range of glucose concentrations with, regression slope 1.025, intercept −1.635, r = .91) followed by the One Touch Ultra (regression slope 0.870 intercept 0.577, r = .90), and the Accu-Check Advantage (regression slope 0.896 and intercept 15.1 and r = 0.935). However, the frequency interval estimation procedure demonstrated that the Accu-Check Advantage system was the most accurate with, 83% of SMBG measurements within the ±10% interval of the reference values followed by the Sof-Tact (63%) and One Touch Ultra (52%) systems. None of the meters met the criteria of 100% concordance < ±10% error between the meter and Beckman glucose analyzer as set by the ADA criteria. The closest to 100% was the Accu-Check Advantage followed by the Sof-Tact and One Touch Ultra. Patients preferred the Sof-Tact as well as alternate site testing and communicated a low level of pain and ease of use.