Performance of an Investigational Blood Glucose Monitoring System in a Clinical Trial

Diabetes Clinical Trial

Official title:

Clinical Trial Protocol for Contour Link System With Contour Sensor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01328717
• Other study ID #: R&D-2010-2011.09
• Status: Completed
• Phase: N/A
• First received: April 1, 2011
• Last updated: January 29, 2016
• Start date: December 2010
• Est. completion date: December 2010

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

Subjects with diabetes and study staff used an investigational blood glucose monitoring system.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Males and females, 18 years of age and above

• Diagnosed as having type 1 or type 2 diabetes

• Currently self-testing blood glucose at home for at least three months

• Able to speak, read, and understand English

• Willing to complete all study procedures

Exclusion Criteria:

• Gestational Diabetes

• Hemophilia or any other bleeding disorder

• Employee of 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

Intervention

Device:
• Contour Link Investigational Blood Glucose Monitoring System
Subjects with diabetes and study staff each performed Blood Glucose tests from the subject's capillary blood obtained from fingerstick using the Contour Link investigational meter.

Locations

Country	Name	City	State
United States	Bayer HealthCare LLC, Diabetes Care	Mishawaka	Indiana

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	Percent of Fingerstick Blood Glucose (BG) Results Within +/-20%(>=75 mg/dL) and Within +/- 15mg/dL (<75 mg/dL) of Laboratory Glucose Method	Subjects with diabetes and study staff tested subject fingerstick blood using an investigational blood glucose meter (BGM). BGM results were compared to a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were used to calculate the number of BG results within +/- 20% (for reference BG results >=75mg/dL) and within +/- 15mg/dL(for reference BG results <75mg/dL) of the reference method results.	1 hour	No
Secondary	Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Evaluation)	Subjects read User Guide(UG)to learn to use the system and performed meter tasks. Study staff observed, then rated subjects' success (1 to 4) at performing tasks. Scale: 1.Performed tasks correctly without assistance. 2.Performed tasks correctly, but was directed to a specific part of the UG by the study staff as in a Customer Service call. 3.Performed tasks correctly, but required additional review/assistance similar to review of a specific function during a Customer Service call. 4.Subject incorrectly performed part of the testing regimen and was unaware of the error.	1 hour	No