Abstract

Medi-Ject Corporation (now Antares Pharma, Inc.) has been providing delivery devices for the needle-free administration of insulin for over 25 years. This study was one of the final steps in the development and premarket evaluation of Medi-Ject's newest needle-free system, the Medi-Jector Vision. This study was conducted to evaluate the performance of this device in the hands of experienced jet injection users in a home environment. Diabetic subjects currently using a needle-free device for the administration of their insulin were studied. Subjects used the new Medi-Jector Vision for all of their insulin administration during the course of the study. Insulin was injected on schedule and at doses consistent with their standard of practice as directed by their health care provider. All subjects were required to document each injection in a daily diary. Study subjects utilized all common insulin types (rapid, regular, intermediate, and long acting), and injections were administered in all of the common injection sites (arms, thighs, abdomen, and buttocks). Once subjects optimized the system to the most appropriate orifice size based on completeness of injection, average completeness percentages were greater than 94% for all orifice sizes. Most patients using the new Medi-Jector Vision in the home were able to manage their insulin therapy without significant complication. We conclude that the jet delivery of insulin with the new Medi-Jector Vision is well accepted by people with diabetes and offers a reliable alternative to the use of needles.

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