Glycemic control, reported pain and leakage with a 4 mm × 32 G pen needle in obese and non-obese adults with diabetes: a post hoc analysis

Abstract

Objective:

The shortest pen needle (PN) for subcutaneous insulin therapy is 4 mm. Clinicians may hesitate to use it in obese patients. We report a post hoc analysis of a previously published study of the 4 mm × 32 G PN, evaluating responses in obese (≥30 kg/m²) and non-obese (<30 kg/m²).

Methods:

Subjects (BMI 20 to 49 kg/m², 52% obese) with diabetes used 4 mm × 32 G PNs and either 5 mm or 8 mm PNs (both 31 G) in two, 3-week treatment periods in a randomized noninferiority cross-over trial. Percentage absolute change in fructosamine (%│Δ Fru│) was the primary endpoint. Equivalent glycemic control was defined as %│Δ Fru│ within 20% (including 95% CI). The impact of obesity on change in fructosamine, pain and reported insulin leakage from the skin is described.

Clinical trial registration:

Clinicaltrials.gov – identifier: NCT00928057.

Limitations:

This report is a post hoc analysis of two BMI subgroups resulting in smaller sample sizes.

Results:

Of 168 who completed the study, 163 were included in the fructosamine analyses − 83 and 80 in the 4/5 mm and 4/8 mm groups, respectively. For the 4/5 mm group, mean BMI ± SD in non-obese and obese groups were 25.9 ± 2.3 and 35.0 ± 4.9 kg/m², respectively; 4/8 mm group 25.2 ± 2.6 and 35.6 ± 4.2 kg/m². BMI group was not significant for %│Δ Fru│ for either 4/5 mm or 4/8 mm. Between BMI groups, the difference of the means in %│Δ Fru│ was 0.4% (4/5 mm) and 0.3% (4/8 mm). The 4 mm PN was significantly less painful in all subject groups, except non-obese in 4/5 mm. Regardless of needle size, obese subjects reported more leakage events. For both BMI groups, there were fewer total reported leakage events when using the 4 mm vs 5 mm and 8 mm needles.

Conclusions:

The 4 mm pen needle provided equivalent glycemic control in both obese and non-obese patients compared to 5 mm and 8 mm needles with no increase in reports of skin leakage, in this post-hoc analysis. These findings should be confirmed in a prospective randomized controlled trial.

Keywords::

• Glucose
• Insulin injection
• Obese
• Pain
• Pen needle

Transparency

Declaration of funding

Becton, Dickinson & Company Inc. provided funding for this study.

Declaration of financial/other relationships

L.J.H., M.A.G., L.L., and J.B. have disclosed that they are employees of Becton, Dickinson & Company. L.J.H. has disclosed that he owns stock in Becton, Dickinson & Company and Merck. M.A.G., L.L., and J.B. have disclosed that they own stock in Becton, Dickinson & Company. L.J.H. and M.A.G. conceived of the analysis; J.B. and L.L. performed the statistical analyses; L.J.H., M.A.G., J.B., and L.L. contributed to the drafting of the manuscript and revisions for substantive content. All authors approved the final manuscript for publication, and all authors vouch for the integrity of the data.

CMRO peer reviewers have received honoraria for their review work. Peer Reviewer 1 has disclosed receiving consultant fees, and or research grants or travel support from the following companies: sanofi, Abbott Medisense, NovaBiomedical, Roche Diagnostics, Bayer and Novo Nordisk. Peer Reviewer 2 has no relevant financial relationships to disclose.

Acknowledgments

The authors thank Karen Byron MS for her assistance with the statistical analyses. The authors are also grateful to all the BD employees and study staff members that made the original study possible. Specifically, they thank Kenneth Kassler-Taub MD and Jane Lawrence for study oversight, and Katie McNamara for leading the monitoring effort. We also acknowledge the efforts of Drs L.J. Klaff, T.S. Bailey, D. Robertson and G. Connor as study investigators. Lastly, we thank the patients without whom this study could not have been conducted.