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Metadata

Name
Evaluation of Blood Volume and Perceived Pain During Fingerstick Monitoring of Blood Glucose
Repository
ClinicalTrials.gov
Identifier
clinicaltrials:NCT00741390
Description
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.
Data or Study Types
clinical trial
Keywords
Lancets, Diabetes, Pain
Source Organization
Unknown
Access Conditions
available
Year
2008
Access Hyperlink
https://clinicaltrials.gov/ct2/show/NCT00741390

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