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OpenTrials
Completed

NCT Number: NCT01916096

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%.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Facet Technologies

Kennesaw, Georgia, 30144, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Delica Device

Device

Primary outcomes

  1. Blood Volume Measurements

    Time frame: 24 hours

    Lancing events were performed on subjects fingers. After each lancing event blood volume was measure with a scale.

Sponsors and collaborators

Lead sponsor

Facet Technologies

Other

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Aug 5, 2013
Registry last updated
Aug 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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