Evaluating the User Performance and Experience with a Re-Engineered 4 mm × 32G Pen Needle: A Randomized Trial with Similar Length/Gauge Needles

Diabetes Therapy : Research, Treatment and Education of Diabetes and Related Disorders
Shahista WhooleyBrian K Pflug

Abstract

Since insulin pens were first introduced in 1985, many advances have been made in pen needles (PNs). In this study we evaluated patient-reported outcomes of an investigational newly re-engineered 4 mm × 32G PN, the BD Nano™ 2nd Gen (also known by its "PRO" brand extension in many markets outside of the USA). In place of a conventional cylindrical posted hub, the investigational PN's hub is contoured with an expanded surface area. The investigational PN also includes a redesigned inner shield that includes tactile ridges and a remodeled outer cover with improved proportions and attachment grips. This was a multi-site, prospective, open-label, two-period crossover trial. Individuals with type 1 and type 2 diabetes using 32G PNs of ≤ 6 mm in length for ≥ 4 months were eligible. Subjects using     31G PNs of a similar length were eligible after a 2-week wash-in period. Subjects were assigned to one of four groups, with each group using a commercially available PN to which the investigational PN was compared. Each of the two study periods were 15 days: one with the investigational PN and the other with a comparator PN. After completing both study periods, subjects compared experiences between the two PN types. A 150-mm comparative v...Continue Reading

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Citations

Sep 8, 2020·Diabetes Therapy : Research, Treatment and Education of Diabetes and Related Disorders·Basel BariLori Berard
May 16, 2020·Diabetes Therapy : Research, Treatment and Education of Diabetes and Related Disorders·Jothydev KesavadevGopika Krishnan
Jul 30, 2020·Current Medical Research and Opinion·Michael A GibneyStanislav Glezer
Dec 11, 2021·Journal of Diabetes Science and Technology·Lutz HeinemannJulia K Mader

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Clinical Trials Mentioned

NCT03267264

Software Mentioned

IntegReview

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