NCT00741390

Evaluation of Blood Volume and Perceived Pain During Fingerstick Monitoring of Blood Glucose

Evaluation of Blood Volume and Perceived Pain During Fingerstick Monitoring of Blood Glucose When Using Different Currently Marketed Lancing Devices and Lancets

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Becton, Dickinson and Company · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DEVICE	BD/33G	BD Lancet device/BD 33G lancets (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips)
DEVICE	OTM / 33G	OneTouch® Mini Lancet device / BD 33G lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips)
DEVICE	OTU/28G	OneTouch® UltraSoft® Lancet device/OneTouch® UltraSoft® 28G Lancet (BGM measured with the OneTouch® UltraMini™ BGM) and OneTouch® Ultra® test strips)
DEVICE	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)
DEVICE	OTM/28G	OneTouch® Mini Lancet device / OneTouch® UltraSoft® 28G Lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips)

Timeline

• Start date: 2008-08-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2008-08-26
• Last updated: 2010-03-10
• Results posted: 2010-03-10

Locations

4 sites across 1 country: United States