A Comparison of Bolus Insulin Dose Errors Based on Results of a Clinical Trial of Five Blood Glucose Monitoring Systems

Abstract

Aim: Inaccurate blood glucose monitoring system (BGMS) results may lead to insulin dosing errors and adverse clinical outcomes. Results & methodology: This post-hoc analysis used a model to estimate the bolus insulin dose error associated with each of the five BGMSs, for a hypothetical person with diabetes (assuming a standardized meal and target blood glucose of 100 mg/dl). Differences in dose-error distribution between BGMSs were statistically tested. The 95% dose-error range for each BGMS was (insulin units): CONTOUR^®PLUS, -1.1–0.7; Accu-Chek^® Active, -2.4–0.7; Accu-Chek^® Performa, -2.9–0.8; FreeStyle Freedom, from -5.5 to -0.5; OneTouch^® SelectSimple^™, -4.1−3.0. Conclusion: The CONTOUR^®PLUS BGMS was associated with a statistically significantly smaller model-estimated median bolus insulin dose-error and dosing error range, compared with the other BGMSs.

Keywords:

• accuracy
• blood glucose monitoring system
• diabetes management
• dosing errors
• insulin dose
• self-monitoring of blood glucose

Financial & competing interests disclosure

The previous clinical study and the analyses presented here were supported by Bayer HealthCare, the predecessor-in-interest of Ascensia Diabetes Care, Parsippany, NJ, USA. S Pardo is a full time employee of Ascensia Diabetes Care. N Dunne and DA Simmons were employees of Ascensia Diabetes Care during the development of the work reported here. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Medical writing assistance was provided by A Michaelis of MedErgy and B Andrews and J Currie of CircleScience (an Ashfield Healthcare company) and was funded in part by Ascensia Diabetes Care and in part by Bayer HealthCare as Ascensia’s predecessor-in-interest.

Data sharing statement

The authors certify that this manuscript reports a secondary analysis of clinical trial data that have been shared with them and that the use of this shared data is in accordance with the terms (if any) agreed upon their receipt. The source of these data is: clinicaltrials.gov identifier, NCT01714232; sponsor, Ascensia Diabetes Care Holdings AG. Individual, deidentified participant data for NCT01714232 (completed 2012) will not be shared. Data were available to the authors in their capacity as Ascensia employees: the secondary analyses reported here used anonymized data from the original study database and were conducted by S Pardo, PStat^® in his capacity as an employee of Bayer HealthCare (the predecessor-in-interest of Ascensia Diabetes Care Holdings AG). The primary analysis of these data has been reported previously [9].