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The Characterization of Blood Volumes of Commercially Available Lancing Devices

F

Facet Technologies

Status

Completed

Conditions

Diabetes

Treatments

Device: Fastclix Lancing Device
Device: Glucoject Lancing Device
Device: Delica Lancing Device
Device: Microlet Lancing Device
Device: Multiclix Lancing Device
Device: Reli-On Lancing Device
Device: Easy Touch Lancing Device
Device: Flash Lancing Device

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT01914302
FT6000682013

Details and patient eligibility

About

Characterize expressed blood volume ≥1μL across representative, commercially available lancing device systems using finger sticks.

Full description

Primary Objective:

• Characterize expressed blood volume ≥1μL across representative, commercially available lancing device systems using finger sticks.

Secondary Objectives: the following characterizations will be performed in the data analysis within each device and across each device:

  • Correlation of Subject pain response to blood volume collected;
  • Proportion of Subjects that produce sufficient blood to fill a 1µl test strip;
  • Proportion of Subjects that generate ≥1µl blood volume;
  • Proportion of Subjects who generate multiple- times the blood volume needed to fill a 1µl test strip
  • Proportion of Subjects who generate multiple- times ≥1µl of blood volume
  • Proportion of Subjects that produce on average (≥1µl) of blood volume on 1st attempt
  • Proportion of Subjects that produce on average (≥1µl) of blood volume on their first and second lancing attempt

Enrollment

64 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Must be diagnosed with type 1 or type 2 diabetes for one (1) or more year(s).
  • Must be currently self-monitoring blood glucose levels for at least 6 months.
  • Must self-test at least 2 times daily.
  • Must be between the ages of 18 and 75 to participate.
  • Subjects must be able to perform all tasks required in this protocol.
  • Subjects must be willing to complete all study procedures.
  • Subjects must be able to speak, read and understand English and understand the Informed Consent document.

Exclusion criteria

  • Subjects with neuropathy or any other nerve damage in the hand or fingers (this will be discovered through the monofilament test)
  • Subjects who are taking prescription anti-coagulants or more than one full aspirin per day during the past week or have clotting problems that may prolong bleeding (persons taking Plavix or a daily low dose aspirin will not be excluded but this will be recorded).
  • Subjects taking pain relievers within 24 hours.
  • Subjects with hemophilia or any other bleeding disorder.
  • Subjects with infection with a blood borne pathogen (e.g., HIV, hepatitis).
  • Subjects having a condition such as a cognitive disorder, which in the opinion of the Investigator would put the person at risk or seriously compromise the integrity of the study (PI will sign Case Report Form if Subject is excluded).
  • Subjects working for Facet, LifeScan Inc., or a competitive company.
  • Subjects with missing digits.
  • Subjects who are pregnant or nursing.
  • Subjects on chemotherapy.

Trial design

64 participants in 8 patient groups

Delica Lancing Device
Description:
Subjects in this group either use the Delica lancing device or a meter that requires 1.0 microliters of blood
Treatment:
Device: Delica Lancing Device
Freestyle Flash Lancing Device
Description:
Subjects in this group either use the Flash lancing device or a meter that requires 0.3/0.6 microliters of blood
Treatment:
Device: Flash Lancing Device
Easy Touch Lancing Device
Description:
Subjects in this group either use the Easy Touch lancing device or a meter that requires 0.3/0.6 microliters of blood
Treatment:
Device: Easy Touch Lancing Device
Glucoject Lancing Device
Description:
Subjects in this group either use the Glucoject lancing device or a meter that requires 0.3/0.6 microliters of blood
Treatment:
Device: Glucoject Lancing Device
Microlet Lancing Device
Description:
Subjects in this group either use the Microlet lancing device or a meter that requires 0.3/0.6 microliters of blood
Treatment:
Device: Microlet Lancing Device
Multiclix Lancing Device
Description:
Subjects in this group either use the Multiclix lancing device or a meter that requires 0.3/0.6 microliters of blood
Treatment:
Device: Multiclix Lancing Device
Fastclix Lancing Device
Description:
Subjects in this group either use the Fastclix lancing device or a meter that requires 0.3/0.6 microliters of blood
Treatment:
Device: Fastclix Lancing Device
Reli-On Lancing Device
Description:
Subjects in this group either use the Reli-On lancing device or a meter that requires 0.3/0.6 microliters of blood
Treatment:
Device: Reli-On Lancing Device

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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