INTRODUCTION: Self-monitoring of blood glucose (SMBG) is one of the cornerstones of diabetes management. AIM OF THE STUDY: To evaluate the potential for miscoding of a personal glucometer, to define a target population among pediatric patients with diabetes for a non-coding glucometer and the accuracy of the Contour TS non-coding system. MATERIAL AND METHODS: Potential for miscoding during self-monitoring of blood glucose was evaluated by means of an anonymous questionnaire, with worst and best case scenarios evaluated depending on the responses pattern. Testing of the Contour TS system was performed according to guidelines set by the national committee for clinical laboratory standards. RESULTS: Estimated frequency of individuals prone to non-coding ranged from 68.21% (95% 60.70- 75.72%) to 7.95% (95%CI 3.86-12.31%) for the worse and best case scenarios respectively. Factors associated with increased likelihood of non-coding were: a smaller number of tests per day, a greater number of individuals involved in testing and self-testing by the patient with diabetes. The Contour TS device showed intra- and inter-assay accuracy -95%, linear association with laboratory measurements (R2=0.99, p <0.0001) and consistent, but small bias of -1.12% (95% Confidence Interval -3.27 to 1.02%). Clarke error grid analysis showed 4% of values within the benign error zone (B) with the other measurements yielding an acceptably accurate result (zone A). CONCLUSIONS: The Contour TS system showed sufficient accuracy to be safely used in monitoring of pediatric diabetic patients. Patients from families with a high throughput of test-strips or multiple individuals involved in SMBG using the same meter are candidates for clinical use of such devices due to an increased risk of calibration errors.
INTRODUCTION: Self-monitoring of blood glucose (SMBG) is one of the cornerstones of diabetes management. AIM OF THE STUDY: To evaluate the potential for miscoding of a personal glucometer, to define a target population among pediatric patients with diabetes for a non-coding glucometer and the accuracy of the Contour TS non-coding system. MATERIAL AND METHODS: Potential for miscoding during self-monitoring of blood glucose was evaluated by means of an anonymous questionnaire, with worst and best case scenarios evaluated depending on the responses pattern. Testing of the Contour TS system was performed according to guidelines set by the national committee for clinical laboratory standards. RESULTS: Estimated frequency of individuals prone to non-coding ranged from 68.21% (95% 60.70- 75.72%) to 7.95% (95%CI 3.86-12.31%) for the worse and best case scenarios respectively. Factors associated with increased likelihood of non-coding were: a smaller number of tests per day, a greater number of individuals involved in testing and self-testing by the patient with diabetes. The Contour TS device showed intra- and inter-assay accuracy -95%, linear association with laboratory measurements (R2=0.99, p <0.0001) and consistent, but small bias of -1.12% (95% Confidence Interval -3.27 to 1.02%). Clarke error grid analysis showed 4% of values within the benign error zone (B) with the other measurements yielding an acceptably accurate result (zone A). CONCLUSIONS: The Contour TS system showed sufficient accuracy to be safely used in monitoring of pediatric diabeticpatients. Patients from families with a high throughput of test-strips or multiple individuals involved in SMBG using the same meter are candidates for clinical use of such devices due to an increased risk of calibration errors.