Comparative glycemic control, safety and patient ratings for a new 4 mm × 32G insulin pen needle in adults with diabetes

Abstract

Objective:

Pen needles (PN) for subcutaneous insulin therapy have become smaller; 5 mm PNs are now the shortest in use. We evaluated the safety, efficacy and patient ratings of a new 4 mm × 32 gauge (G) PN.

Research design and methods:

Subjects with type 1 and type 2 diabetes and HbA1c 5.5% to 9.5% participated in a randomized non-inferiority cross-over trial, at four U.S. centers. Subjects used 4 mm × 32G PNs and either 5 mm × 31G PNs (4/5 mm) or 8 mm × 31G PNs (4/8 mm) in two, 3-week treatment periods; order of needle use was controlled. Subjects were either ‘low dose’ or ‘regular dose’ users (highest single insulin dose ≤ 20 units and 21–40 units, respectively). Percent absolute change in serum fructosamine (% |Δ Fru|) was the primary endpoint; unexplained, severe hypo- or hyperglycemia was a secondary measure. Leakage at injection sites and pain measured by visual analog scale were tertiary measures. Equivalent glycemic control was defined á priori as % |Δ Fru| (including 95% CI) within 20%; 40 subjects per subgroup provides 90% power at α = 0.05.

Clinical trial registration:

The study was registered on clinicaltrials.gov (identifier: NCT00928057).

Results:

Of 173 subjects randomized, 168 completed the study, and 163 were included in the fructosamine analyses – 83 and 80 in the 4/5 mm and 4/8 mm groups, respectively. Subjects were 56% male, mean 52.6 yrs, 63% type 2. Baseline HbA1c = 7.5 ± 1.0% and fructosamine 301 ± 55.1 μmol/L. Mean % |Δ Fru| was 4.9% (95% CI 3.8, 6.0) and 5.5% (4.5, 6.4), respectively, for the 4/5 mm and 4/8 mm groups, meeting glycemic equivalence criteria; results were similar in both dose groups. The median |Δ Fru| was 11.0 μmol/L (8.0, 13.0) and 13.5 μmol/L (9.8, 18.0) for the 4/5 mm and 4/8 mm groups, respectively. Unexplained, severe hypo- and hyperglycemic episodes were infrequent and not different between PNs. The 4 mm PN was rated significantly less painful and preferred by approximately 2/3 of subjects (p < 0.01). All three PNs had similar reported injection site leakage.

Limitations:

The study was of relatively short duration, in adults in the U.S. Further trials in other patients (e.g., GLP-1 users, pediatrics, obese) should be performed.

Conclusions:

The 4 mm × 32G PN provided equivalent glycemic control compared to 31G, 5 mm and 8 mm PNs with reduced pain, no difference in insulin leakage and was preferred by patients.

Key words::

• Control
• Diabetes
• Fructosamine
• Insulin therapy
• Pen needle

Transparency

Declaration of funding

BD (Becton, Dickinson and Company) provided funding for this study and manufactures all the pen needles tested.

Declaration of financial/other relationships

L.J.H., M.A.G., J.A. and S.Q. have disclosed that they are employees of BD. T.S.B. and L.K. have disclosed that they were investigators in the study and received payments for their work.

Some peer reviewers receive honoraria from CMRO for their review work. The peer reviewers of this paper have disclosed that they have no relevant financial relationships.

Acknowledgments

The authors are grateful to all the BD employees and study staff members that made this study possible. Specifically, they thank Jane Lawrence for study oversight, Katie McNamara for leading the monitoring effort, and Karen Byron for statistical advice. We also acknowledge the efforts of Drs. D. Robertson and G. Connor as other study investigators. Lastly, we thank the patients without whom this study could not have been conducted.