Patient device assessment evaluation of two insulin injection devices in a mixed cohort of insulin-treated patients with type 1 or type 2 diabetes mellitus.

Objective: FT (FlexTouch*) is a new disposable insulin injection pen device for use in insulin-treated patients with diabetes mellitus. The aim of this study was to evaluate patient perception of FT versus IL (InnoLet†) with respect to the ease of use and patient preference in a mixed patient cohort with different kinds and degrees of visual or dexterity impairments.

Methods: Ninety patients were included into this investigation (54 male/36 female, age [mean ± SD]: 62 ± 8 yrs, disease duration: 18 ± 11 yrs, HbA1c: 7.2 ± 1.0%). After assessment of visual acuity and dexterity skills (by Jebsen-Taylor Hand Function Test), the patients were introduced to the two pen devices in random order, and were asked to perform mock injections with 10 IU, 30 IU and 50 IU doses before completing a 41 item standardized device assessment questionnaire. The questions asked were covering five topics of pen use (confidence in delivering a correct dose, dose setting, performance of the injection, general handling, and others) and could be answered with a rank scale from '1 = very easy' to '5 = very difficult'.

Results: FT was ranked superior to IL with respect to the injection procedure (FT: 1.2 ± 0.1 vs. IL: 2.1 ± 0.4, p < 0.001) and general handling (1.3 ± 0.2 vs. 2.3 ± 0.7, p < 0.001), and numerically better with respect to confidence in correct dosing (1.4 ± 0.2 vs. 2.1 ± 0.9, n.s.). The two devices were ranked equally for ease of dose setting (1.6 ± 0.3 vs. 1.7 ± 0.4, n.s.). When ranked individually, FT use was recommended by 92.2% of the patients (IL: 30.0%).

Key Limitations: Patients of this investigation were from one local area (San Jose, CA, USA) only. The subgroups may be considered small for the performed analysis.

Conclusions: In summary, FT was perceived to be easier to use than IL in this investigation.