Lancet Blood Volume Comparison Study

Facet Technologies

Status: Completed

Conditions: Diabetes

Treatments: Device: Delica Device

Study type: Observational

Funder types: Other

Identifiers

NCT01916096

FT-837-068-BV

Details and patient eligibility

About

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%.

Enrollment: 180 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

180 participants in 6 patient groups

Delica 28g Depth 3 vs Delica 30g Depth 3

Description:

30 subjects with diabetes

Treatment:

Device: Delica Device

Delica 28g Depth 5 vs Delica 30g Depth 5

Description:

30 subjects with diabetes

Treatment:

Device: Delica Device

Delica 28g Depth 7 vs Delica 30g Depth 7

Description:

30 subjects with diabetes

Treatment:

Device: Delica Device

Delica 28g Depth 3 vs Delica 33g Depth 3

Description:

30 subjects with diabetes

Treatment:

Device: Delica Device

Delica 28g Depth 5 vs Delica 33g Depth 5

Description:

30 subjects with diabetes

Treatment:

Device: Delica Device

Delica 28g Depth 7 vs Delica 33g Depth 7

Description:

30 subjects with diabetes

Treatment:

Device: Delica Device