title: 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/m(2)) and non-obese (<30 kg/m(2)).
  
  
  METHODS
  Subjects (BMI 20 to 49 kg/m(2), 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.
  
  
  BACKGROUND
  Clinicaltrials.gov - identifier: NCT00928057.
  
  
  CONCLUSIONS
  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/m(2), respectively; 4/8 mm group 25.2 ± 2.6 and 35.6 ± 4.2 kg/m(2). 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.
authors: Becton, Dickinson & Company Inc., Franklin Lakes, NJ, USA. laurence_hirsch@bd.com
authors: Laurence J
authors: LJ
authors: Hirsch
authors: Michael A
authors: MA
authors: Gibney
authors: Lingzhi
authors: L
authors: Li
authors: Julie
authors: J
authors: Bérubé
mesh_terms: D000328:Adult; D000368:Aged; D000465:Algorithms; D001786:Blood Glucose / Q000187:drug effects / Q000378:metabolism*; D018592:Cross-Over Studies; D048909:Diabetes Complications / Q000453:epidemiology; D003920:Diabetes Mellitus / Q000188:drug therapy* / Q000453:epidemiology; D019544:Equipment Failure Analysis / Q000706:statistics & numerical data; D005260:Female; D006801:Humans; D056865:Ideal Body Weight / Q000502:physiology; D007277:Injections, Jet / Q000009:adverse effects / Q000295:instrumentation; D008297:Male; D008875:Middle Aged; D009339:Needles / Q000009:adverse effects*; D009765:Obesity / Q000150:complications* / Q000188:drug therapy / Q000453:epidemiology; D010146:Pain / Q000209:etiology*; D016032:Randomized Controlled Trials as Topic; D012189:Retrospective Studies; D057566:Self Report
chemical_list: D001786:Blood Glucose