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

Abstract

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.

*FlexTouch is a registered trade name of NovoNordisk A/S, Søborg, Denmark.

†InnoLet is a registered trade name of NovoNordisk A/S, Søborg, Denmark.

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.

Keywords::

• Insulin injection
• Patient preference
• Pen device

Transparency

Declaration of funding

This study was funded by a grant from NovoNordisk, Søborg, Denmark.

Declaration of financial/other interests

The sponsor was involved in the planning of the experiment, the discussion of the results and contributed to the manuscript preparation. A.P. received study grants, speaker fees and travel support from NovoNordisk. T.F. received study grants, speaker fees and travel support from NovoNordisk. M.Q. and M.N. have disclosed that they are employees of NovoNordisk. P.M., C.S., and A.L. have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article.

CMRO peer reviewers may have received honoraria for their review work. The peer reviewers on this manuscript have disclosed that they have no relevant financial relationships.

Acknowledgments

The authors acknowledge Julia Heise and Volkmar Schmid from the IKFE-CRO Medical Writing Team for their support with manuscript preparation. The authors would also like to thank the patients, physicians and nurses at IKFE clinic, who were involved in the study.

Notes

*FlexTouch is a registered trade name of NovoNordisk A/S, Søborg, Denmark.

†InnoLet is a registered trade name of NovoNordisk A/S, Søborg, Denmark.

*FlexTouch is a registered trade name of NovoNordisk A/S, Søborg, Denmark.

†InnoLet is a registered trade name of NovoNordisk A/S, Søborg, Denmark.