Evaluation of a New Blood Glucose Meter System With Capillary and Venous Blood

Diabetes Mellitus Clinical Trial

Official title:

Clinical Evaluation of the Apollo Blood Glucose Monitoring System With Capillary and Venous Blood [Commercial Name is CONTOUR® USB]

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00797563
• Other study ID #: CTD-2008-17
• Status: Completed
• Phase: N/A
• First received: November 24, 2008
• Last updated: January 29, 2016
• Start date: November 2008
• Est. completion date: November 2008

Study information

• Verified date: January 2016
• Source: Ascensia Diabetes Care
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• Apollo Blood Glucose Monitoring System
Subjects with diabetes use a new blood glucose monitoring system with capillary blood; healthcare professionals use the new blood glucose monitoring system with subject capillary and venous blood. All results are compared to a laboratory glucose method - Yellow Springs Instrument (YSI).

Locations

Country	Name	City	State
United States	Consumer Product Testing Co., Inc.	Fairfield	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Ascensia Diabetes Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Capillary and Venous Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method	Subjects with diabetes and healthcare professionals (HCPs) used a new blood glucose monitoring system (BGMS) with subject capillary blood. HCPs used the new bgms with subject venous blood. All results were compared to a lab glucose method. The BGMS has programmed algorithms to provide results equivalent to either serum/plasma or whole blood glucose methods. Number of results were obtained by combining results from three lots of Contour Blood Glucose strips.	One hour	No
Secondary	Percentage of Participants Rated as <=3 (Labeling Comprehension)	Study staff rated participants on their success at performing BG testing and Autolog feature after reading product labeling. The rating scale was: Successful; Successful after being referred to user instructions; Successful with verbal assistance or review of part of user instructions (Similar to review of a specific function during a Customer Service call.); Unsuccessful (Incorrectly performed part of the testing regimen or required intervention by study staff.)	One hour	No
Secondary	Number of Partipants Who Gave These Ratings for Overall Testing Experience With This Meter	Subjects completed a questionnaire rating their overall experience with the Apollo Blood Glucose Monitoring System (User feedback on the system). The rating scale was 0 (Unacceptable) to 4 (Excellent).	One hour	No