Clinical Evaluation of BD NEXT Pen Needle
Condition: Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      This prospective, multi-center, 2 period cross-over study is designed to determine if people
      who use injection pens for subcutaneous medication delivery prefer the BD NEXT pen needle
      (PN) in comparison with currently marketed pen needles of the same or similar gauge and
      length. Subjects will use the investigational (BD NEXT) PN and their usual conventional PN
      each for one week in a randomly assigned sequence, and will be asked to evaluate and compare
      characteristics of the BD NEXT pen needle versus their usual pen needle when used for all
      their pen injections performed at home. Since injection experience may vary according to the
      type of pen device used, equal numbers of subjects will be recruited who are users of three
      of the most commonly used insulin pen injectors.
    

Detailed description: 
      Using their usual insulin doses, pen and injection routine, subjects will be asked to compare
      two different pen needles (PNs) of corresponding gauge (GA) and length, one being the
      investigational (extra thin wall) pen needle and the other being their most often, currently
      used pen needle. Based on their current pen needle gauge and length, subjects will be
      assigned to the BD NEXT pen needle with the most comparable gauge (G) and length, in
      millimeters (mm). The three possible sizes are BD NEXT 32G x 4mm pen needle, BD NEXT 31G x
      5mm pen needle, or BD NEXT 31G x 8 mm pen needle.

      Both study pen needles will be used by the subject on the same pen device/insulin brand. If
      subjects are using two different pens, comparison data will be collected for both pen
      devices.

      Each subject will participate in three study visits over the course of approximately 3 weeks.
      Study conduct will include two in-home use study periods each lasting approximately (1) one
      week.

      During Visit 1, after subjects are enrolled and assigned to a pen device group, subjects will
      be randomly assigned to use the BD NEXT or their usual PN for use during a 1 week home use
      period (Period 1). After approximately 1 week, at Visit 2, subjects will be crossed-over to
      the other study PN per the randomization schedule.

      After approximately 1 week of home use with the second study PN (Period 2), at Visit 3,
      subjects will be asked to complete Visual Analog Scales (VAS) and answer questions comparing
      their injection experiences with the two different PNs.

      The primary and secondary objectives will be assessed for all pen users combined. In
      addition, preference, thumb force, and confidence in full dose delivery will be compared
      among the subsets of subjects using each of the following pen devices: sanofi-aventis
      SoloSTAR®, Lilly KwikPen™, Novo Nordisk FlexPen®. In order to achieve a minimum of 60
      evaluable subjects in each of these pen user groups approximately 210 subjects will be
      enrolled (70 subjects per pen group).
    

Intervention name(s): BD NEXT 31G x 5 mm pen needle; BD NEXT 31G x 8mm pen needle; BD NEXT 32G x 4mm pen needle
Intervention type(s): Device; Device; Device
Intervention description(s): Each pen needle type will be used for approximately one week. Subjects will use their current pen injector device.; Each pen needle type will be used for approximately one week. Subjects will use their current pen injector device.; Each pen needle type will be used for approximately one week. Subjects will use their current pen injector device.
Keywords: pen needle; insulin