Comparison of Glycemic Control in Obese Diabetics Using Three Different Pen Needles
Condition: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Anxiety about needles is a concern commonly expressed by diabetics when beginning insulin
      therapy. A shorter, thinner pen needle that delivers insulin with the safety and efficacy
      profile of longer pen needles may appeal to many diabetic patients as the shorter needle may
      be perceived as less intimidating and more comfortable. While pen needles of 4 to 8 mm in
      length are generally used for insulin injection in patients considered thin or normal weight,
      longer (12.7 mm) needles are still often prescribed for overweight or obese patients with
      diabetes. Since skin thickness is nearly constant across a range of body mass index (BMI), a
      clear rationale exists for the use of shorter needles in obese patients. (Gibney et al., CMRO
      2010)

      The primary purpose of this study is to evaluate whether the BD Ultra-Fine™ Nano 4mm x 32
      Gauge(G) pen needle manufactured by Becton, Dickinson and Company (BD) provides equivalent
      glucose control (as measured by hemoglobin A1c levels) as the BD Ultra-Fine™ 8mm x 31G and
      the BD Ultra-Fine™ 12.7mm x 29G pen needles in obese subjects with diabetes.
    

Detailed description: 
      Each subject's participation is expected to last a total of 7 months and includes a screening
      visit, a three-week wash-in period (one week with each of the three different size pen
      needles) followed by two consecutive 12 week study periods. The purpose of the three week
      wash-in period is to minimize the number of dropouts during the following study periods by
      ensuring that subjects have experience using each of the three study needles and find them
      generally acceptable for use during the study.

      Only subjects who complete the wash-in period and confirm their agreement to continue
      participating will be randomized into one of the two study arms. Subjects will be randomly
      assigned to use the BD Ultra-Fine™ 4mm pen needle and either the BD Ultra-Fine™ 8mm pen
      needle or the BD Ultra-Fine™ 12.7mm pen needle. The randomization will also specify which of
      the two study pen needles to be used first. Half of the study subjects will use the BD
      Ultra-Fine™ 4mm and BD Ultra-Fine™ 8mm pen needles (4mm/8mm arm) and the other half will use
      the BD Ultra-Fine™ 4mm and the BD Ultra-Fine™ 12.7mm pen needles (4mm/12.7mm arm). At the end
      of the first 12 week study period subjects will switch to the other assigned pen needle for
      the second and final study period.

      Glycemic control (based on HbA1c concentrations) will be assessed at baseline and at the end
      of each 12 week study period.
    

Intervention name(s): 4 mm x 32G Pen Needle; 8mm x 31G Pen Needle; 12.7mm x 29G Pen Needle
Intervention type(s): Device; Device; Device
Intervention description(s): During the 12 week study period, subjects use this pen needle with their own pen device for all daily insulin injections they usually administered themselves with a pen device. Subjects follow their usual insulin regimen and there is no upper limit on total daily insulin dosage or number of injections. Subjects are advised to inject straight in when using the 4mm PN, with no pinch up.; During the 12 week study period, subjects will use this pen needle with their own pen device for all daily insulin injections they usually administered themselves with a pen device. Subjects follow their usual insulin regimen and there is no upper limit on total daily insulin dosage or number of injections. Subjects are directed to use pinch-up when injecting in the abdomen or thigh with the 8mm PN, and no pinch-up at other injection sites.; During the 12 week study period, subjects will use this pen needle with their own pen device for all daily insulin injections they usually administered themselves with a pen device. Subjects follow their usual insulin regimen and there is no upper limit on total daily insulin dosage or number of injections. When using the 12.7mm PN, subjects are instructed to insert either at an angle of 45 degrees, or to pinch up and hold the pen device at a 90 degree angle (straight in).
Other intervention name(s): BD Ultra-Fine™ Nano pen needle, Catalog number 320122; BD Ultra-Fine™ Short pen needle, Catalog number 320109; BD Ultra-Fine™ Original pen needle, BD Catalog Number 328203
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: diabetes; obesity; hypoglycemia; hyperglycemia; pen needle