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

March 5, 2010 updated by: Becton, Dickinson and Company

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Colorado Springs, Colorado, United States, 80915-3540
        • Thomas J. Stephens & Associates
    • New Jersey
      • Carlstadt, New Jersey, United States, 07072
        • TKL Research, Inc.
      • Paramus, New Jersey, United States, 07652
        • TKL Research, Inc
      • Ramsey, New Jersey, United States, 07446
        • TKL Research, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Arm A
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
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: OTM/28G
OneTouch® Mini Lancet device / OneTouch® UltraSoft® 28G Lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips)
Other: Arm B
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
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)
Other: Arm C
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
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: 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)
Other: Arm D
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
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: OTM/28G
OneTouch® Mini Lancet device / OneTouch® UltraSoft® 28G Lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Sample of Sufficient Volume to Yield a Valid Meter Reading
Time Frame: Study Day 1 (Visit 1)
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)
Time Frame: Approximately Day 3 (Visit 2)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in Lancing Pain for Devices in Visit 2 Only. (For Subjects Assigned to Arm D Only)
Time Frame: Approximately Day 3 (Visit 2)

The subjects who participated in Study Visit 2 kept the same group assignment they had in Study Visit 1. Each subject tested 2 of the 3 systems they experienced during 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 difference in the pain they perceive between two lancing systems using the 150 mm visual analog scale. A positive value on the scale (and in the table below) indicates that the first device in the pair was more painful than the second.
Approximately Day 3 (Visit 2)
Reported Device Preference Within Lancing Pair at Visit 2
Time Frame: Approximately Day 3 (Visit 2)
After each pair of 4 lancings, the subject was asked: "Which of the two devices did you find more comfortable, overall?" The choices were: first lancing, second lancing or equivalent. The "Stated Preference" row indicates # of lancing pairs in which one device was preferred over the other device while the 2 rows below indicate the # of pairs in which each device was preferred. First and second device refers to the 1st and 2nd devices identified in column headers, not the device order during testing. The "No Preference" row includes lancing pairs with preference of "equivalent" or no answer.
Approximately Day 3 (Visit 2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Becton, Dickinson and Company

Investigators

  • Principal Investigator: Ronald L Rizer, PhD, Thomas J. Stephens & Associates

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

August 22, 2008

First Submitted That Met QC Criteria

August 25, 2008

First Posted (Estimate)

August 26, 2008

Study Record Updates

Last Update Posted (Estimate)

March 10, 2010

Last Update Submitted That Met QC Criteria

March 5, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BDDC-08-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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