Accuracy and preference assessment of prefilled insulin pen versus vial and syringe with diabetes patients, caregivers, and healthcare professionals

Abstract

Objectives:

The primary objective of this study was to investigate the dosing accuracy of the new prefilled FlexTouch insulin pen (FT) in comparison to conventional vial and syringe (V&S) when used by patients (Pts), caregivers (CG) and healthcare professionals (HCPs).

Methods:

A total of 120 subjects participated in the trial (40 diabetes patients aged 61 ± 11 [mean ± SD] yrs, 20 caregivers [parents and other relatives], 20 physicians, and 40 nurses/certified diabetes educators). The participants were introduced to the devices in randomized order and were asked to perform injections of 5, 25, 43 and 79 IU doses into laboratory tubes. Dosing accuracy was analyzed by weighing the tubes on a pharmaceutical balance and calculating the mean absolute deviation (MAD) from the intended doses. After completing a device assessment questionnaire, Patient Perception Questionnaire (PPQ), with questions regarding device design and performance, the procedure was repeated for the other device, and the patients were finally asked to complete a device preference questionnaire (DPQ).

Results:

Dosing accuracy was significantly better for FT when used by any of the cohorts at all doses. (MAD ± SD for FT/V&S; 5 IU: 0.4 ± 0.4/0.6 ± 0.6 IU; 25 IU: 0.3 ± 0.4/0.7 ± 0.9 IU; 43 IU: 0.4 ± 0.4/0.9 ± 1.2 IU; 79 IU: 0.5 ± 0.5/1.7 ± 1.6 IU, p < 0.005 for all doses). Dosing accuracy with FT for all three subgroups was comparable (patients: 0.35–0.59 IU; HCP&CG: 0.29–0.54 IU; n.s.). Dosing accuracy with V&S for all three subgroups was not comparable: HCP and CG performed much better with V&S than patients and delivered the doses with significantly higher accuracy (range of mean MAD; patients: 0.81–2.54 IU; HCP&CG: 0.51–1.30 IU, p < 0.005 at all doses). FT was ranked superior to V&S for all aspects of the PPQ. In the DPQ, 93% of the patients voted for FT (neutral: 5%, V&S: 2%), (CG: 100%/0%/0%; HCPs: 85%/2%/13%; p < 0.001 in all cases).

Conclusion:

FT, compared to V&S, was more accurate at all tested doses and was used with similar accuracy by patients, HCPs, and CGs. Using questionnaires only, and without dexterity assessment, study participants rated FT higher than V&S in every component of the PPQ and the vast majority of them preferred FT. These findings may point to a better alternative for dosing accuracy and improved adherence when using the new prefilled insulin pen compared to V&S for insulin delivery in patients with diabetes.

Keywords::

• Diabetes
• Insulin treatment
• Patient preference
• Pen injection device
• Vial and syringe

Transparency

Declaration of funding

This study was funded by a grant from Novo Nordisk, Denmark. The sponsor participated in the final review of this manuscript and two authors (M.N. and G.G.) are employed by the sponsor.

Declaration of financial/other relationships

A.P. has received sponsorship, consultant fees and speakers bureau fees from Novo Nordisk and Sanofi-Aventis, and has received grant research funding from Novo Nordisk, Sanofi-Aventis and Eli Lilly. T.B. has received sponsorship and grant research funding from Novo Nordisk. C.C. has received sponsorship and speakers bureau fees from Novo Nordisk. D.Ka. serves on the speakers bureaus for and has received sponsorship and grant research funding from Novo Nordisk and Sanofi-Aventis, and serves as a consultant for Sanofi-Aventis. D.Kl. has received sponsorship and grant research funding from Novo Nordisk, and has received grant research funding from Sanofi-Aventis. G.G. and M.N. are employees of Novo Nordisk. EA has disclosed that she has 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 would like to thank Julia Heise from the IKFE-CRO, Mainz medical writing group for her assistance in preparing and editing the manuscript, and Andreas Löffler, statistician at IKFE-CRO, Mainz for her support in analyzing the data.

Notes

*FlexTouch is a registered trade name of Novo Nordisk A/S, Bagsværd, Denmark.

*FlexTouch is a registered trade name of Novo Nordisk A/S, Bagsværd, Denmark.

*FlexPen is a registered trade name of NovoNordisk

†InnoLet is a registered trade name of NovoNordisk.