Comparison of Glycemic Control Among 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 commonly expressed concern by diabetics about beginning insulin
      therapy. A shorter, thinner pen needle that delivers insulin with the safety and efficacy
      profile of currently marketed pen needles may appeal to many diabetic patients as the new
      needle may be perceived as less intimidating and more comfortable. Currently marketed pen
      needles range in length from 5 to 12.7 millimeters (mm).

      The primary purpose of this study was to evaluate whether the investigational 4mm x 32
      Gauge(G) pen needle manufactured by Becton, Dickinson and Company (BD) provides equivalent
      glucose control (as measured by fructosamine levels) as the currently marketed BD 5mm x 31 G
      and BD 8mm x 31 G pen needles (PN)in diabetic subjects with varying insulin dosage regimens.
    

Detailed description: 
      Within each dose group, subjects were randomly assigned at baseline to one of two study arms.
      One study arm (4/5 mm PN) compared the BD 4mm PN to the 5mm PN, and the other arm (4/8 mm PN)
      compared the BD 4mm PN to the 8mm PN, in a crossover fashion. Based on the randomization,
      subjects used either the 4mm or the other assigned PN (5mm or 8mm) for the first 3 weeks,
      then switched to the alternate PN for the next 3 weeks. Glycemic control was assessed by
      serum fructosamine (FRU) levels at the end of each 3 week period.

      Based on their baseline insulin regimen, subjects were also assigned to an insulin dosing
      group (Low or Regular) to help ensure balance among treatment arms. Requirements for each
      group were as follows: Low Dose: largest single dose of insulin each day with a pen device
      must be less than or equal to 20 units. Regular Dose: largest single dose of insulin each
      day, with a pen device, must be 21-40 units.

      Explanation of Visits and Timing of Assessments:

      Visit 1:

        -  Screening

        -  Informed Consent

        -  Demographics

        -  Inclusion /Exclusion

        -  Hemoglobin A1c measurement (HbA1c)

      Visit 2 (Baseline:)

        -  Insulin dose group assignment (Low dose or Regular dose)

        -  Randomization

        -  Fructosamine blood sample collected

        -  Dispense pen needle (PN) assigned first

      Visit 3 (approximately 3 weeks after starting first PN)

        -  Pain rated by subject relative to baseline PN

        -  Review Adverse Events (AEs) and reported events of injection site leakage

        -  Fructosamine blood sample collected

        -  Dispense second assigned PN

      Visit 4 (approximately 3 weeks after starting second PN):

        -  Review AEs and reported events of injection site leakage

        -  Fructosamine blood sample collected

        -  Pain rated relative to previously used PN

        -  Study Completion
    

Intervention name(s): 4mm x 32G pen needle; 8mm x 31G pen needle; 5mm x 31G pen needle
Intervention type(s): Device; Device; Device
Intervention description(s): For 3 weeks, subjects used this pen needle with their own pen device for all daily insulin injections they usually administered themselves with a pen device. Subjects followed their usual insulin regimen and there was no upper limit on total daily insulin dosage or number of injections. Subjects were advised to inject straight in when using the 4mm PN, with no pinch up.; For 3 weeks, subjects used this pen needle with their own pen device for all daily insulin injections they usually administered themselves with a pen device. Subjects followed their usual insulin regimen and there was no upper limit on total daily insulin dosage or number of injections. Subjects were directed to use pinch-up when injecting in the abdomen or thigh with the 8mm PN, and no pinch-up at other injection sites.; For 3 weeks, subjects used this pen needle with their own pen device for all daily insulin injections they usually administered themselves with a pen device. Subjects followed their usual insulin regimen and there was no upper limit on total daily insulin dosage or number of injections. Subjects were advised to inject straight in when using the 5mm PN, with no pinch up.
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™ Mini pen needle, Catalog Number 320119
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Pen Needle; Diabetes; Insulin; Glycemic; Pain; Fructosamine; Leakage; Hypoglycemia; Hyperglycemia