Pen needle design influences ease of insertion, pain, and skin trauma in subjects with type 2 diabetes

Kezia A Præstmark, Morten L Jensen, Nils B Madsen, Jonas Kildegaard, Bente M Stallknecht, Kezia A Præstmark, Morten L Jensen, Nils B Madsen, Jonas Kildegaard, Bente M Stallknecht

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.

Keywords: Devices; Medical Device(s); Pain; Type 2 Diabetes.

Conflict of interest statement

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

Figures

Figure 1
Figure 1
SBP following insertions of needles with different diameters. Averaged (mean±SEM) SBP profiles measured 0–15 min after needle insertion. Only 1 min of the 3 min baseline is included in the plot. SBP, skin blood perfusion.
Figure 2
Figure 2
LSM scatter plot matrix with linear fits of relations between PF, pain, and SBP. PF and SBP values are log-transformed. LSM, least square mean; PF, penetration force; SBP, skin blood perfusion.

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