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Prefilled insulin device with reduced injection force: patient perception and accuracy

ABSTRACT Objective: The injection force and the patient perception of the Next Generation FlexPen* (NGFP) with design modifications aimed at reducing injection force was assessed. The accuracy and precision of the NGFP was also tested under standard conditions. * FlexPen is a registered trade name of Novo Nordisk A/S, Bagsværd, Denmark Research design and methods: Dosing accuracy was tested (according to ISO 11608 requirements) at 1 IU, 30 IU and 60 IU doses (acceptable limits were 1 ± 1 IU (0–2 IU), 30 ± 1.5 IU (28.5–31.5 IU), and 60 ± 3 IU (57–63 IU)). Pens were tested at reference conditions (18–28°C and relative humidity 25–75%). Delivered doses were measured on a sensitive balance and corrected for the specific density of the insulin aspart used (according to ISO 11608-1). Precision was calculated from the variance around the mean delivered dose. The injection force of NGFP was measured, and user-preference of NGFP and FlexPen (FP) were compared in 50 patients with type 2 diabetes. Results: The mean injection force with NGFP and FP was 12.57 ± 1.81 N and 17.90 ± 1.51 N ( p < 0.001), respectively. Almost twice as many patients rated the injection force as ‘good’ or ‘very good’ with NGFP (80%, 72% and 38% when delivering 20 IU, 40 IU and 60 IU, respectively) compared with FP (48%, 32% and 20% when delivering 20 IU, 40 IU and 60 IU, respectively) and 76% of patients rated NGFP as superior, in terms of simplicity and comfort, to FP. NGFP accurately delivered the set doses (means [SD] were 0.98 [0.06] IU, 29.98 [0.18] IU, and 59.93 [0.24] IU for the 1 IU, 30 IU and 60 IU doses, respectively). Conclusions: These results show that NGFP has a 30% reduction in injection force compared with FP and was rated as ‘more simple and comfortable to use’ by patients. Furthermore, NGFP was as accurate and as precise as FP.