Clinical trial NCT00797563: Evaluation of a New Blood Glucose Meter System With Capillary and Venous Blood
Official title: Clinical Evaluation of the Apollo Blood Glucose Monitoring System With Capillary and Venous Blood [Commercial Name is CONTOUR® USB]
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: Ascensia Diabetes Care
Sponsor class: INDUSTRY
First posted: 2008-11-25
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the study was to evaluate the performance of the meter system in the hands of subjects and healthcare professionals (HCPs). It also evaluated the product user guides in the hands of untrained subjects.

Detailed description: The study evaluated the performance of the blood glucose meter system (BGMS) compared to a laboratory glucose method. Subjects and healthcare professionals tested subject capillary blood and healthcare professionals tested subject venous blood. Two meter configurations were evaluated. The study evaluated the acceptability of product labeling in enabling subjects to perform blood glucose testing with the new meter system and for using meter features. Subjects and healthcare professionals provided feedback about the BGMS and its features.

Eligibility criteria: Inclusion Criteria:

* Have type 1 or type 2 diabetes
* Be \> 18, \< 76 year of age at time of consent, with approximately 50% (+10%)being less than 55 years of age
* Be willing to complete all study procedures
* Be routinely testing their blood sugar at home (at least once per day)
* Be able to speak, read, and understand English and understand the Informed Consent document
* Be able to read the labeling instructions

Exclusion Criteria:

* Minors \< 18 years of age and adults \> 75 years of age
* Pregnancy
* Physical (dexterity), visual, or neurological impairments that would make the person unable to perform testing with the BGMS
* Disorders in the fingertip lancing areas
* Acute or chronic infections, particularly skin infections
* Infection with a blood borne pathogen
* Taking prescription anti-coagulants or having clotting problems that may prolong bleeding. Taking aspirin daily (81 mg or 325 mg) is not reason for exclusion
* Hemophilia or any other bleeding disorder
* Having a condition which, in the opinion of the Principal Investigator or designee, would put the person at risk or seriously compromise the integrity of the study
* Working for a competitive medical device company

Primary outcomes:
measure: Number of Capillary and Venous Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method
timeFrame: One hour
Secondary outcomes:
measure: Percentage of Participants Rated as <=3 (Labeling Comprehension)
timeFrame: One hour
measure: Number of Partipants Who Gave These Ratings for Overall Testing Experience With This Meter
timeFrame: One hour
Other outcomes:
Locations:
city: Fairfield
country: United States
facility: Consumer Product Testing Co., Inc.
state: New Jersey
Study officials:
affiliation: Consumer Product Testing Co., Inc.
name: Joy Frank, RN
role: PRINCIPAL_INVESTIGATOR
References: