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ABSTRACT
Objective: SoloSTAR* † (SR) is a new pre-filled insulin pen device for administration of insulin glargine and insulin glulisine. This article reports on the usability of SR, as reported by healthcare professionals (HCPs) and participants, in clinical practice in Australia.
* This article is based on the outcomes of a Working Group meeting convened 18 April 2008, by the European Society on Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO), in Cannes, France. The Working Group was co-ordinated by Prof. Steven Boonen
† SoloSTAR is a registered trade name of sanofi-aventis, Paris, France
Methods: Individuals with Type 1 or Type 2 diabetes were eligible for this 3-month observational survey. Participants were supplied with the insulin glargine SR pens, the instruction leaflet and a toll-free helpline number. Training was offered to all participants. Independent telephone interviews were conducted with participants and HCPs after 6–10 weeks of use of SR.
Results: Overall, 150 HCPs across 93 sites supported this survey. Of these, 65 HCPs (14 doctors; 51 diabetes educators, covering 1669 patients) provided feedback, with the remaining 85 HCPs not responding. All HCPs rated participant training as ‘very easy’ or ‘easy’, and most reported that SR had, in their opinion, made training easier (85%) and quicker (98%). Most of the 536 participants reported that ease of learning to use (98%), ease of using (98%) and features (≥ 89%) of SR were ‘excellent’ or ‘good’. SR had positive impacts on various psychological aspects for people with diabetes, including helping overcome reluctance to use insulin, and increasing confidence in their ability to manage their diabetes using insulin.
Conclusions: In this non-randomized, non-interventional, open-label, observational survey of clinical practice, HCPs reported that SR was easy to teach and easy to use for people with diabetes. People with diabetes reported that SR was easy to use and rated specific features of SR highly. Further follow-up surveys and comparative studies in clinical practice are needed to confirm these findings and to determine the impact of SR in diabetes management.
Acknowledgements
Declaration of interest: This survey was supported by sanofi-aventis. Editorial support for this article from Medicus International (Nicholas Smith, PhD) was funded by sanofi-aventis. The sponsors coordinated the study and monitored investigator sites. International SOS collected the data and managed participant contact. Data processing and statistical analyses were performed by StatProcess. The authors had access to the data and had the final responsibility for the decision to submit for publication.
A.R. serves on advisory boards for sanofi-aventis and Novo Nordisk, and has received financial support for research from sanofi-aventis, Novo Nordisk, Eli Lilly and Company, Merck Sharpe & Dohme and Novartis. J.C. has received financial support from sanofi-aventis and Novo Nordisk to attend congresses.
The authors would like to thank all of the investigators for their commitment to this study.
Notes
* Selected data from this study have been presented as a poster at the Diabetes Technology Meeting 2007, 25-27 October 2007, and in abstract form in J Diabetes Sci Technology 2008;2:A21. Selected data from this study have also been presented as a poster at the American Diabetes Association's 68th Scientific Sessions, 6 -10 June 2008 and in abstract form in Diabetes 2008;57 (Suppl. 1): A126.
* This article is based on the outcomes of a Working Group meeting convened 18 April 2008, by the European Society on Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO), in Cannes, France. The Working Group was co-ordinated by Prof. Steven Boonen
† SoloSTAR is a registered trade name of sanofi-aventis, Paris, France
‡ NovoPen and FlexPen are registered trade names of Novo Nordisk, Bagsvaerd, Denmark
† SoloSTAR, LANTUS and Apidra are registered trade names of sanofi-aventis, Paris, France
¶ The Lilly disposable pen is manufactured by Eli Lilly for the administration of Humulin and Humalog, which are registered trade names of Eli Lilly and Company, Indianapolis, USA