Performance of a New Glucose Meter System

Diabetes Clinical Trial

Official title:

Performance of the TATSU/Tradewind Blood Glucose Monitoring System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01264016
• Other study ID #: CTD-2010-004-01
• Status: Completed
• Phase: N/A
• First received: December 18, 2010
• Last updated: January 29, 2016
• Start date: November 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

The purpose of this study is to evaluate the performance and acceptability of a new blood glucose monitoring system, which includes meter and sensor strip.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• 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:

• Type 1 or 2 diabetes

• Age 18 years or older

• Routinely performs blood glucose self testing at home, at least once per day

• Able to speak, read, and understand English.

• Is willing to complete all study procedures

Exclusion Criteria:

• Currently pregnant

• Hemophilia or any other bleeding disorder

• Taking prescription anticoagulants or has clotting problems that may prolong bleeding. Taking aspirin daily is not excluded

• Subject employee of competitive medical device company

• Cognitive disorder or other condition, which in the opinion of the investigator, would put the person at risk or seriously compromise the integrity of the study

Study Design

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

Related Conditions & MeSH terms

• Diabetes

Intervention

Device:
• Investigational Blood Glucose Monitoring System
Untrained subjects with diabetes performed Blood Glucose (BG) tests with subject's capillary fingerstick using the investigational Tradewind meter and investigational sensor. Study staff tested subject venous blood. All BG Results were compared to a reference laboratory glucose method. Subjects' success at performing basic tasks using only the User Guide were rated by study staff.

Locations

Country	Name	City	State
United States	AMCR Institute	Escondido	California

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 Capillary Blood Glucose (BG) Results Within +/- 5 to 20mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method	Subjects with diabetes used an investigational blood glucose monitoring system (BGMS) with subject capillary blood. 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 +/- 5 to 20 mg/dL (for reference BG results <75mg/dL) or +/- 5 to 20% (for reference BG results >=75mg/dL) of the reference method results.	2 hours	No
Primary	Percent of Venous Blood Glucose (BG) Results Within +/- 5 to 20 mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method	Healthcare professionals (study staff) used an investigational blood glucose monitoring system (BGMS) with subject venous blood. 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 +/- 5 to 20 mg/dL (for reference BG results <75mg/dL) or +/- 5% to 20% (for reference BG results >=75mg/dL) of the reference method results.	2 hours	No
Secondary	Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Comprehension)	Subjects reviewed the instructions for use (User Guide and Quick Reference Guide) to learn to use the system. Study staff then observed and rated the subjects (1 to 4) on their success at performing five tasks. Scale: 1.Success in performing tasks correctly without assistance. 2.Successful with additional review of User Guide. 3.Successful with additional review and study staff assist similar to review of a specific function during a Customer Service call. 4.Subject did not perform task correctly and study staff intervention was required.	2 hours	No