Bolus Insulin Dose Error Distributions Based on Results From Two Clinical Trials Comparing Blood Glucose Monitoring...

Area of Science:

• Diabetes Technology
• Clinical Chemistry
• Medical Device Evaluation

Background:

• Previous clinical trials assessed fingertip capillary blood samples using blood glucose monitoring systems (BGMSs) and a YSI glucose analyzer.
• Post hoc analyses calculated hypothetical insulin doses based on BGMS measurements to compare dosing errors.

Purpose of the Study:

• To evaluate the accuracy of different blood glucose monitoring systems (BGMSs) in determining insulin dose errors.
• To compare the range of insulin dose errors across various BGMSs in two clinical trials.

Main Methods:

• Hypothetical premeal bolus insulin doses were calculated for a standardized individual (60-g carbohydrate meal, 100-mg/dL target glucose).
• Insulin sensitivity and carbohydrate ratio were adjusted to account for potential BGMS measurement errors.
• Dosing error was defined as the difference between insulin doses calculated using BGMS readings and a reference YSI glucose analyzer.

Main Results:

• In Clinical Trial 1, the CONTOUR®NEXT EZ BGMS (EZ) showed a 95% dose error range of -0.9 to 0.5 units.
• In Clinical Trial 2, the CONTOUR®NEXT BGMS (CN) exhibited a 95% dose error range of -0.7 to 1.7 units.
• Both EZ and CN BGMSs demonstrated statistically significantly smaller insulin dose error ranges compared to all other evaluated BGMSs (P <0.0001).

Conclusions:

• The CONTOUR®NEXT EZ and CONTOUR®NEXT BGMSs yielded statistically significantly smaller insulin dose errors in post hoc analyses.
• Variations in BGMS accuracy can lead to clinically significant differences in insulin dosing recommendations.