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

NCT00741390 | Completed Results

• 1 other identifier: BDDC-08-001
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 4

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.

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Keywords

Diabetes; Lancets; Pain

Outcome Measures

Primary Outcomes (2)

• Blood Sample of Sufficient Volume to Yield a Valid Meter Reading

  Number of subjects in whom valid meter reading was obtained with each device configuration. The primary outcome of a successful lancing is defined as whether or not a technician is able to use the lancing system to yield a blood sample of sufficient volume to yield a valid meter reading.

  Study Day 1 (Visit 1)

• Difference in Lancing Pain for Device Pair at Visit 2. (For Subjects Assigned to Arms A, B, C Only)

  In Visit 2 subjects kept the same group assignment they had in Visit 1. Each subject tested 2 of the 3 systems from Visit 1. Up to 6 pairs of lancings were performed in order to obtain 4 evaluable pairs. After each pair of lancing, the subject was asked to record the pain from the 2nd lancing as compared to the first using a 150mm visual analog scale(0mm = same pain, -75mm = max score for less painful than first lancing,+75mm = max score for more painful). A positive value on the scale (and in table below) indicates that the first device in the pair was more painful than the second.

  Approximately Day 3 (Visit 2)

Secondary Outcomes (2)

• Difference in Lancing Pain for Devices in Visit 2 Only. (For Subjects Assigned to Arm D Only)

  Approximately Day 3 (Visit 2)

• Reported Device Preference Within Lancing Pair at Visit 2

  Approximately Day 3 (Visit 2)

Study Arms (4)

Arm A

OTHER

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.

Device: BD/33G; Device: OTM / 33G; Device: OTM/28G

Arm B

OTHER

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.

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

Arm C

OTHER

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.

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

Arm D

OTHER

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.

Device: BD/33G; Device: OTM / 33G; Device: OTM/28G

Interventions

BD/33G DEVICE

BD Lancet device/BD 33G lancets (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips)

Arm A; Arm B; Arm C; Arm D

OTM / 33G DEVICE

OneTouch® Mini Lancet device / BD 33G lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips)

Arm A; Arm B; Arm C; Arm D

OTU/28G DEVICE

OneTouch® UltraSoft® Lancet device/OneTouch® UltraSoft® 28G Lancet (BGM measured with the OneTouch® UltraMini™ BGM) and OneTouch® Ultra® test strips)

Arm B

ACC/28G DEVICE

Accu-Chek® Softclix Lancet device/Accu-Chek® Softclix 28G Lancet (BGM measured with Accu-Chek® Advantage BGM and Accu-Chek® Comfort Curve test strip)

Arm C

OTM/28G DEVICE

OneTouch® Mini Lancet device / OneTouch® UltraSoft® 28G Lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips)

Arm A; Arm D

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Becton, Dickinson and Company: lead

Study Sites (4)

Thomas J. Stephens & Associates

Colorado Springs, Colorado, 80915-3540, United States

Location

TKL Research, Inc.

Carlstadt, New Jersey, 07072, United States

Location

TKL Research, Inc

Paramus, New Jersey, 07652, United States

Location

TKL Research, Inc.

Ramsey, New Jersey, 07446, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetes Mellitus; Pain

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Kenneth Kassler-Taub, VP Medical Affairs
• Organization: Becton Dickinson

kenneth_kassler_taub@bd.com

201-847-7009

Study Officials

• Michael E Casser, MD

  TKL Research, Inc.

  PRINCIPAL INVESTIGATOR

• Ronald L Rizer, PhD

  Thomas J. Stephens & Associates

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 22, 2008
• First Posted: August 26, 2008
• Study Start: August 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: March 10, 2010
• Results First Posted: March 10, 2010

Record last verified: 2010-03

Locations

US (4)