Evaluation of Blood Volume and Perceived Pain During Fingerstick Monitoring of Blood Glucose
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: 
      The procurement of blood for SMBG, usually via a finger stick, is considered by many patients
      to be the most painful portion of diabetes therapy. This has led to the marketing of smaller
      gauge lancets, lancing devices with variable depth settings and blood glucose sensors that
      require less blood for measurement.

      In this study, two main outcomes were evaluated: The first, which was assessed at Visit 1,
      was whether specific combinations of lancets and lancing devices would yield sufficient blood
      volume to allow valid assessment of diabetic subjects' glucose levels. The other outcome,
      assessed at Visit 2, was the level of pain perceived by subjects during lancing with specific
      combinations of lancets and lancing devices. During Visit 2, pain assessment was done using a
      Visual Analog Scale and such that for each lancet/lancing device, the lowest lancing device
      setting that yielded a valid BG reading for each subject during Visit 1 was used. A third
      outcome measure, overall comfort with lancing, was also assessed at Visit 2.

      A total of 5 combinations of lancets and lancing devices were evaluated.

      These were as follows:

        -  BD/33G = BD Lancet device/BD 33G lancets (BGM measured with the OneTouch® UltraMini™
           (BGM) and OneTouch® Ultra® test strips)

        -  OTM/33G =OneTouch® Mini Lancet device / BD 33G lancet (BGM measured with the OneTouch®
           UltraMini™ (BGM) and OneTouch® Ultra® test strips)

        -  OTM/28G =OneTouch® Mini Lancet device / OneTouch® UltraSoft® 28G Lancet (BGM measured
           with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips)

        -  OTU/28G = OneTouch® UltraSoft® Lancet device/OneTouch® UltraSoft® 28G Lancet (BGM
           measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips)

        -  ACC/28G= Accu-Chek® Softclix Lancet device/Accu-Chek® Softclix 28G Lancet (BGM measured
           with Accu-Chek® Advantage BGM and Accu-Chek® Comfort Curve test strip)

      After enrollment and qualification, subjects were assigned to one of 4 intervention arms. The
      arm assignment determined which 3 of the 5 combinations of lancets and lancing devices the
      subjects would evaluate in Visit 1 (for volume adequacy) and of these 3, which 2 they would
      evaluate in Visit 2 (pain during lancing). The lancet/lancing device combinations assigned to
      each arm are shown in the Assigned Interventions Table below.
    


Intervention name(s): BD/33G; OTM / 33G; OTU/28G; ACC/28G; OTM/28G
Intervention type(s): Device; Device; Device; Device; Device
Intervention description(s): BD Lancet device/BD 33G lancets (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips); OneTouch® Mini Lancet device / BD 33G lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips); OneTouch® UltraSoft® Lancet device/OneTouch® UltraSoft® 28G Lancet (BGM measured with the OneTouch® UltraMini™ BGM) and OneTouch® Ultra® test strips); Accu-Chek® Softclix Lancet device/Accu-Chek® Softclix 28G Lancet (BGM measured with Accu-Chek® Advantage BGM and Accu-Chek® Comfort Curve test strip); OneTouch® Mini Lancet device / OneTouch® UltraSoft® 28G Lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Keywords: Diabetes; Lancets; Pain