Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Evaluation of Blood Volume and Perceived Pain During Fingerstick Monitoring of Blood Glucose When Using Different Currently Marketed Lancing Devices and Lancets
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.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)
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