Lancet Blood Volume Comparison Study

Diabetes Clinical Trial

Official title:

Lancet Blood Volume Comparison Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01916096
• Other study ID #: FT-837-068-BV
• Status: Completed
• Phase: N/A
• First received: August 1, 2013
• Last updated: August 1, 2013
• Start date: February 2012
• Est. completion date: February 2012

Study information

• Verified date: August 2013
• Source: Facet Technologies
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes

Intervention

Device:
• Delica Device

Locations

Country	Name	City	State
United States	Facet Technologies	Kennesaw	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Facet Technologies

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Volume Measurements	Lancing events were performed on subjects fingers. After each lancing event blood volume was measure with a scale.	24 hours	No