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Cited by 54Diabetes Management and ResearchDiabetes Treatment and ManagementIntramuscular injections and effects

Safety and efficacy of insulin therapy delivered via a 4mm pen needle in obese patients with diabetes

Bergenstal, Richard M., Strock, Ellie S., Peremislov, Diana, Gibney, Michael A., Parvu, Valentin, Hirsch, Laurence J.·2015·Mayo Clinic Proceedings
DOI 10.1016/j.mayocp.2014.12.014
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Abstract

Objective To determine whether insulin delivered via a 4-mm × 32-gauge pen needle (PN) provides equivalent glycemic control as 8-mm × 31-gauge and 12.7-mm × 29-gauge PNs in obese (body mass index ≥30) patients with diabetes. Patients and methods This prospective, multicenter, randomized, open-label, 2-period, crossover, equivalence, home-based study was conducted from October 26, 2010, through May 31, 2012. After a 3-week wash-in period, eligible patients aged 18 to 80 years with a hemoglobin A1c (HbA1c) level of 5.5% to 9.5% (37-80 mmol/mol) were randomized to compare either 4- vs 8-mm PNs or 4- vs 12.7-mm PNs, using each of the 2 assigned PNs for 12 weeks in random order. The primary outcome was change in HbA1c level, with equivalence limits of ±0.4%. Results The 274 patients randomized (mean ± SD age, 56.7±11.0 years) had a mean ± SD body mass index of 37.0±6.1 (range, 29.1-59.9) and took up to 350 U of insulin daily; 226 patients were included in the modified intention-to-treat analysis. Mean (95% CI) changes in HbA1c levels with the 4-mm PN were -0.08% (-0.21 to 0.06) and -0.10% (-0.19 to 0.00) vs the 8- and 12.7-mm PNs, respectively, within equivalence margins. The 4-mm PN was less painful than the larger PNs (P Conclusion The 4-mm × 32-gauge PN provides equivalent glycemic control as 8- and 12.7-mm PNs in obese patients with diabetes, with less pain and no increase in leakage. Shorter PNs should be considered in all insulin-requiring patients with diabetes, including t…

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  • Recent evidence supports the use of short needles (e.g., 4-mm pen needles) as effective and well tolerated compared with longer needles, including a study performed in adults with obesity.

    “Recent evidence supports the use of short needles (e.g., 4-mm pen needles) as effective and well tolerated compared with longer needles, including a study performed in adults with obesity (67).”

    From 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes—2025 (2025) · cites this paper as [67]

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Authors
Bergenstal, R. M., Strock, E. S., Peremislov, D., Gibney, M. A., Parvu, V., & Hirsch, L. J.
Affiliations
  • Park Nicollet Health Services (US)
  • Becton Dickinson (United States) (US)
Corresponding author
Bergenstal, Richard M.
ORCID
Venue
Mayo Clinic Proceedings
Publisher
Elsevier BV
Published
2015-03
Volume
90
Issue
3
Pages
329-338
ISSN
0025-6196 (ISSN-L)
DOI
10.1016/j.mayocp.2014.12.014
OpenAlex
W2072469810
Cited by
54
References
5
Citations by year
2026: 6 · 2025: 4 · 2024: 3 · 2023: 3 · 2022: 3 · 2021: 4 · 2020: 6 · 2019: 6 · 2018: 6 · 2017: 7 · 2016: 5 · 2014: 1
FWCI
5.21
Type
journal article
Language
en
Open access
closed
Licence
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations
  • Mayo Clinic Proceedings (publishedVersion)
  • PubMed (publishedVersion)
Funders
Mayo Foundation for Medical Education and Research
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
  • Health Sciences › Medicine › Emergency Medicine › Intramuscular injections and effects
Keywords
insulin pen needles, needle gauge, needle length, obesity, type 2 diabetes, glycemic control, HbA1c, insulin delivery, injection pain, patient preferences, hypoglycemia, hyperglycemia, insulin dose adjustment
MeSH terms
Adolescent, Adult, Aged, Aged, 80 and over, Diabetes Mellitus, Female, Humans, Hypoglycemic Agents, Insulin, Male, Middle Aged, Needles, Obesity, Prospective Studies, Treatment Outcome, Cross-Over Studies, Patient Safety

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