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Technological Advances
Pen needle design influences ease of insertion, pain, and skin trauma in subjects with type 2 diabetes
  1. Kezia A Præstmark1,2,
  2. Morten L Jensen3,
  3. Nils B Madsen2,
  4. Jonas Kildegaard4,
  5. Bente M Stallknecht1
  1. 1Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark
  2. 2Device R&D Device R&D, Novo Nordisk A/S, Hillerød, Denmark
  3. 3Medical & Science Devices, Novo Nordisk A/S, Søborg, Denmark
  4. 4Insulin Pharmacology, Novo Nordisk A/S, Måløv, Denmark
  1. Correspondence to Dr Kezia A Præstmark; kezj{at}novonordisk.com

Abstract

Objective Pen needles used for subcutaneous injections have gradually become shorter, thinner and more thin walled, and thereby less robust to patient reuse. Thus, different needle sizes, alternative tip designs and needles resembling reuse were tested to explore how needle design influences ease of insertion, pain and skin trauma.

Research design and methods 30 subjects with injection-treated type 2 diabetes and body mass index 25–35 kg/m2 were included in the single-blinded study. Each subject received abdominal insertions with 18 different types of needles. All needles were tested twice per subject and in random order. Penetration force (PF) through the skin, pain perception on 100 mm visual analog scale, and change in skin blood perfusion (SBP) were quantified after the insertions.

Results Needle diameter was positively related to PF and SBP (p<0.05) and with a positive pain trend relation. Lack of needle lubrication and small ‘needle hooks’ increased PF and SBP (p<0.05) but did not affect pain. Short-tip, obtuse needle grinds affected PF and SBP, but pain was only significantly affected in extreme cases. PF in skin and in polyurethane rubber were linearly related, and pain outcome was dependent of SBP increase.

Conclusions The shape and design of a needle and the needle tip affect ease of insertion, pain and skin trauma. Relations are seen across different data acquisition methods and across species, enabling needle performance testing outside of clinical trials.

Trial registration number NCT02531776; results.

  • Devices
  • Medical Device(s)
  • Type 2 Diabetes
  • Pain

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjdrc-2016-000266

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    Footnotes

    • Contributors KAP planned and executed the experiment, carried out data analysis and statistics, and wrote the manuscript. MLJ and NBM helped planning the experiment, contributed to the discussion, and reviewed/edited the manuscript. JK helped with statistics and reviewed/edited the manuscript. BMS helped planning and executing the experiment, contributed to the discussion, and reviewed/edited the manuscript. KAP is the guarantor of this manuscript.

    • Funding This work was supported by the Innovation Fund Denmark as well as Novo Nordisk A/S as part of the Danish Industrial PhD programme.

    • Competing interests KAP, MLJ, NBM, and JK are all employees of Novo Nordisk A/S and hold stock in Novo Nordisk A/S.

    • Ethics approval The study received ethical approval by the Regional Committee of Danish Health Research Ethics (H-6-2014-042) and health authority approval by the Danish Health and Medicines Authority (journal number 2014071250, EUDAMED CIV-ID no. CIV-14-07-012361).

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement No additional data are available.