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

Becton, Dickinson and Company (BD)

Status: Completed

Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Treatments: Device: BD/33G; Device: OTM / 33G; Device: OTU/28G; Device: ACC/28G; Device: OTM/28G

Study type: Interventional

Funder types: Industry

Identifiers

NCT00741390

BDDC-08-001

Details and patient eligibility

About

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.

Enrollment: 250 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

250 participants in 4 patient groups

Arm A

Other group

Description:

In Visit 1 subjects tested BD/33G, OTM/33G, and OTM/28G devices. In Visit 2 subjects tested BD/33G and OTM/28G. See purpose for additional information.

Treatment:

Device: BD/33G

Device: OTM/28G

Device: OTM / 33G

Arm B

Other group

Description:

In Visit 1 subjects tested BD/33G, OTM/33G and OTU/28G devices. In Visit 2 subjects tested BD/33G and OTU/28G. See purpose for additional information.

Treatment:

Device: BD/33G

Device: OTU/28G

Device: OTM / 33G

Arm C

Other group

Description:

In Visit 1 subjects tested BD/33G, OTM/33G and ACC/28G devices. In Visit 2 subjects tested BD/33G and ACC/28G. See purpose for additional information.

Treatment:

Device: BD/33G

Device: ACC/28G

Device: OTM / 33G

Arm D

Other group

Description:

In Visit 1 subjects tested BD/33G, OTM/33G and OTM/28G devices. In Visit 2 subjects tested OTM/33G and OTM/28G. See purpose for additional information.

Treatment:

Device: BD/33G

Device: OTM/28G

Device: OTM / 33G