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Half-unit dose accuracy with HumaPen Luxura HD: an insulin pen for patients who need precise dosing
Paula E Clark1, Charles R Okenfuss, Margaret Campbell
1Eli Lilly and Company, Indianapolis, Indiana, USA.
Background:
The HumaPen Luxura HD insulin pen (Eli Lilly and Company, Indianapolis, IN) was originally designed to deliver accurate doses in half-unit increments from 1 to 30 units. Laboratory testing examined the accuracy of the initial 0.5-unit dose within a 95/95% tolerance interval with respect to a specification of +/-0.5 unit (+/-0.005 ml).
Methods:
After priming, operators recorded the first 0.5 unit. Data were analyzed using k-value targets.
Results:
While examining 577 half-unit doses per device lot, test temperature, operator, or test liquid, at least 95% of the doses were accurate with 95% confidence. All data points were within +/-0.5 unit (+/-0.005 ml).
Conclusions:
Dose accuracy of the initial half-unit is achieved with the HumaPen Luxura HD insulin pen.
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