Performance of a New Glucose Meter System

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Device: Investigational Blood Glucose Monitoring System

• Registration Number: NCT01264016
• Lead Sponsor: Ascensia Diabetes Care

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Study First Submitted: 2010-12-18
• Study First Submitted QC: 2010-12-18
• Study First Posted: 2010-12-21
• Results First Submitted: 2012-04-04
• Results First Submitted QC: 2012-04-04
• Results First Posted: 2012-05-01
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-29
• Last Update Posted: 2016-02-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intended Users of the Monitoring System	Investigational Blood Glucose Monitoring System	Untrained subjects with diabetes use an investigational blood glucose monitoring system.

Primary Outcome Measures

Name	Time	Method
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	2 hours	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.
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	2 hours	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.

Secondary Outcome Measures

Name	Time	Method
Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Comprehension)	2 hours	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.

Trial Locations

Locations (1)

AMCR Institute; 🇺🇸 Escondido, California, United States