Lancet Blood Volume Comparison Study

The primary objective of the study examines the success rate of various OneTouch Delica lancet sizes across depth settings of the OneTouch Delica lancing device. The sample size is based on 30 subjects per lancet size for a given depth setting. Each subject is lanced 4 times with two lancet sizes at a single depth setting. There will be 120 paired lancing events for each lancet size within the group.

Null hypothesis (H0): there is a 90% success rate of attaining a minimum blood volume of 1.0μL for the 28g lancet across all depth settings.

Alternate hypothesis (H1): the success rate of attaining a minimum blood volume of 1.0μL for the 28g lancet across all depth settings is less than 90%.

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Device: Delica Device

• Study Type: Observational
• Enrollment (Actual): 180

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Kennesaw, Georgia, United States, 30144
      • Facet Technologies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

People with diabetes from the surrounding communitu

Description

Inclusion Criteria:

• Must have been diagnosed with type 1 or type 2 diabetes for at least 1 year
• Must be doing Blood Glucose Monitoring, at least twice daily for at least 6 months
• Subjects must be between 18 and 85 years of age.
• 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
• 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 prescription medications for neuropathy.
• 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.
• Subjects with poor circulation to the hands as judged by a refill time of more than 5 seconds

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Delica 28g Depth 3 vs Delica 30g Depth 3; 30 subjects with diabetes	Device: Delica Device
Delica 28g Depth 5 vs Delica 30g Depth 5; 30 subjects with diabetes	Device: Delica Device
Delica 28g Depth 7 vs Delica 30g Depth 7; 30 subjects with diabetes	Device: Delica Device
Delica 28g Depth 3 vs Delica 33g Depth 3; 30 subjects with diabetes	Device: Delica Device
Delica 28g Depth 5 vs Delica 33g Depth 5; 30 subjects with diabetes	Device: Delica Device
Delica 28g Depth 7 vs Delica 33g Depth 7; 30 subjects with diabetes	Device: Delica Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Volume Measurements	Lancing events were performed on subjects fingers. After each lancing event blood volume was measure with a scale.	24 hours

Collaborators and Investigators

• Sponsor: Facet Technologies
• Investigators: Study Chair: Barry Ginsberg, MD, Facet Technologies

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: August 1, 2013
• First Submitted That Met QC Criteria: August 1, 2013
• First Posted (Estimate): August 5, 2013

Study Record Updates

• Last Update Posted (Estimate): August 5, 2013
• Last Update Submitted That Met QC Criteria: August 1, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: FT-837-068-BV