Clinical trial NCT00741390: Evaluation of Blood Volume and Perceived Pain During Fingerstick Monitoring of Blood Glucose
Official title: Evaluation of Blood Volume and Perceived Pain During Fingerstick Monitoring of Blood Glucose When Using Different Currently Marketed Lancing Devices and Lancets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Keywords: Diabetes
Lancets
Pain
Lead sponsor: Becton, Dickinson and Company
Sponsor class: INDUSTRY
First posted: 2008-08-26
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Must currently be diagnosed with either Type I or Type II diabetes mellitus.
* Must currently be performing self monitoring of blood glucose
* Must be between 18-70 years of age (inclusive).
* Must be able to read and follow study instructions in English.

Exclusion Criteria:

* Pregnant (self reported)
* History of poor blood circulation.
* Any skin condition on his or her fingers that prevents blood sampling.
* History of a bleeding disorder.
* Neuropathy or other condition affecting sensation in the hands.
* Self-reported blood borne infection (e.g., HIV, hepatitis B or C \[non A, non B\], syphilis, malaria, babesiosis, brucellosis, leptospirosis, arboviral infections, relapsing fever, T lymphotropic virus Type 1, Creutzfeldt-Jakob disease).
* Currently participating in another study
* Employed by BD, J\&J, Roche or the Clinical Site.

Primary outcomes:
measure: Blood Sample of Sufficient Volume to Yield a Valid Meter Reading
timeFrame: Study Day 1 (Visit 1)
measure: Difference in Lancing Pain for Device Pair at Visit 2. (For Subjects Assigned to Arms A, B, C Only)
timeFrame: Approximately Day 3 (Visit 2)
Secondary outcomes:
measure: Difference in Lancing Pain for Devices in Visit 2 Only. (For Subjects Assigned to Arm D Only)
timeFrame: Approximately Day 3 (Visit 2)
measure: Reported Device Preference Within Lancing Pair at Visit 2
timeFrame: Approximately Day 3 (Visit 2)
Other outcomes:
Locations:
city: Colorado Springs
country: United States
facility: Thomas J. Stephens & Associates
state: Colorado
city: Carlstadt
country: United States
facility: TKL Research, Inc.
state: New Jersey
city: Paramus
country: United States
facility: TKL Research, Inc
state: New Jersey
city: Ramsey
country: United States
facility: TKL Research, Inc.
state: New Jersey
Study officials:
affiliation: TKL Research, Inc.
name: Michael E Casser, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Thomas J. Stephens & Associates
name: Ronald L Rizer, PhD
role: PRINCIPAL_INVESTIGATOR
References: