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

INTRODUCTION: 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 marke...

Descripción completa

Detalles Bibliográficos
Autores principales: Whooley, Shahista, Briskin, Toby, Gibney, Michael A., Blank, Lydia R., Berube, Julie, Pflug, Brian K.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Healthcare 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6437253/
https://www.ncbi.nlm.nih.gov/pubmed/30809762
http://dx.doi.org/10.1007/s13300-019-0585-7
_version_ 1783406927975284736
author Whooley, Shahista
Briskin, Toby
Gibney, Michael A.
Blank, Lydia R.
Berube, Julie
Pflug, Brian K.
author_facet Whooley, Shahista
Briskin, Toby
Gibney, Michael A.
Blank, Lydia R.
Berube, Julie
Pflug, Brian K.
author_sort Whooley, Shahista
collection PubMed
description INTRODUCTION: 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. METHODS: 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 visual analog scale (VAS) was used to evaluate overall preference (primary endpoint) and several secondary endpoints, including overall comfort, injection pain, and ease of use. Data from the four PN groups were combined after poolability was verified. Subgroup analyses were also conducted on each PN group. For VAS responses, a two-sided 95% confidence interval (CI) was calculated for average rating. Threshold for non-inferiority or superiority was established at the lower bound CI of >  − 10 mm or > 0 mm, respectively. RESULTS: At baseline, average age of subjects was 55.6 years; 51.6% were female; and 85.1% has type 2 diabetes mellitus. Average diabetes duration was 14.2 years, and average duration of injecting was 7.8 years. The investigational PN demonstrated superiority for all outcomes, both primary and secondary, for all groups combined (p < 0.05). CONCLUSIONS: The investigational PN was rated as being overall preferred, more comfortable, less painful, and easier to use when compared to comparator PNs of similar gauge and length, in all groups combined. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov (NCT03267264). FUNDING: BD (Becton, Dickinson, and Company).
format Online
Article
Text
id pubmed-6437253
institution National Center for Biotechnology Information
language English
publishDate 2019
publisher Springer Healthcare
record_format MEDLINE/PubMed
spelling pubmed-64372532019-04-15 Evaluating the User Performance and Experience with a Re-Engineered 4 mm × 32G Pen Needle: A Randomized Trial with Similar Length/Gauge Needles Whooley, Shahista Briskin, Toby Gibney, Michael A. Blank, Lydia R. Berube, Julie Pflug, Brian K. Diabetes Ther Original Research INTRODUCTION: 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. METHODS: 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 visual analog scale (VAS) was used to evaluate overall preference (primary endpoint) and several secondary endpoints, including overall comfort, injection pain, and ease of use. Data from the four PN groups were combined after poolability was verified. Subgroup analyses were also conducted on each PN group. For VAS responses, a two-sided 95% confidence interval (CI) was calculated for average rating. Threshold for non-inferiority or superiority was established at the lower bound CI of >  − 10 mm or > 0 mm, respectively. RESULTS: At baseline, average age of subjects was 55.6 years; 51.6% were female; and 85.1% has type 2 diabetes mellitus. Average diabetes duration was 14.2 years, and average duration of injecting was 7.8 years. The investigational PN demonstrated superiority for all outcomes, both primary and secondary, for all groups combined (p < 0.05). CONCLUSIONS: The investigational PN was rated as being overall preferred, more comfortable, less painful, and easier to use when compared to comparator PNs of similar gauge and length, in all groups combined. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov (NCT03267264). FUNDING: BD (Becton, Dickinson, and Company). Springer Healthcare 2019-02-27 2019-04 /pmc/articles/PMC6437253/ /pubmed/30809762 http://dx.doi.org/10.1007/s13300-019-0585-7 Text en © The Author(s) 2019 https://creativecommons.org/licenses/by-nc/4.0/This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) ), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
spellingShingle Original Research
Whooley, Shahista
Briskin, Toby
Gibney, Michael A.
Blank, Lydia R.
Berube, Julie
Pflug, Brian K.
Evaluating the User Performance and Experience with a Re-Engineered 4 mm × 32G Pen Needle: A Randomized Trial with Similar Length/Gauge Needles
title Evaluating the User Performance and Experience with a Re-Engineered 4 mm × 32G Pen Needle: A Randomized Trial with Similar Length/Gauge Needles
title_full Evaluating the User Performance and Experience with a Re-Engineered 4 mm × 32G Pen Needle: A Randomized Trial with Similar Length/Gauge Needles
title_fullStr Evaluating the User Performance and Experience with a Re-Engineered 4 mm × 32G Pen Needle: A Randomized Trial with Similar Length/Gauge Needles
title_full_unstemmed Evaluating the User Performance and Experience with a Re-Engineered 4 mm × 32G Pen Needle: A Randomized Trial with Similar Length/Gauge Needles
title_short Evaluating the User Performance and Experience with a Re-Engineered 4 mm × 32G Pen Needle: A Randomized Trial with Similar Length/Gauge Needles
title_sort evaluating the user performance and experience with a re-engineered 4 mm × 32g pen needle: a randomized trial with similar length/gauge needles
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6437253/
https://www.ncbi.nlm.nih.gov/pubmed/30809762
http://dx.doi.org/10.1007/s13300-019-0585-7
work_keys_str_mv AT whooleyshahista evaluatingtheuserperformanceandexperiencewithareengineered4mm32gpenneedlearandomizedtrialwithsimilarlengthgaugeneedles
AT briskintoby evaluatingtheuserperformanceandexperiencewithareengineered4mm32gpenneedlearandomizedtrialwithsimilarlengthgaugeneedles
AT gibneymichaela evaluatingtheuserperformanceandexperiencewithareengineered4mm32gpenneedlearandomizedtrialwithsimilarlengthgaugeneedles
AT blanklydiar evaluatingtheuserperformanceandexperiencewithareengineered4mm32gpenneedlearandomizedtrialwithsimilarlengthgaugeneedles
AT berubejulie evaluatingtheuserperformanceandexperiencewithareengineered4mm32gpenneedlearandomizedtrialwithsimilarlengthgaugeneedles
AT pflugbriank evaluatingtheuserperformanceandexperiencewithareengineered4mm32gpenneedlearandomizedtrialwithsimilarlengthgaugeneedles