- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01264016
Performance of a New Glucose Meter System
January 29, 2016 updated by: Ascensia Diabetes Care
Performance of the TATSU/Tradewind Blood Glucose Monitoring System
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
96
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Escondido, California, United States, 92026
- AMCR Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intended Users of the Monitoring System
Untrained subjects with diabetes use an 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: 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.
|
2 hours
|
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
Time Frame: 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.
|
2 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Comprehension)
Time Frame: 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.
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2 hours
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2010
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
December 18, 2010
First Submitted That Met QC Criteria
December 18, 2010
First Posted (Estimate)
December 21, 2010
Study Record Updates
Last Update Posted (Estimate)
February 29, 2016
Last Update Submitted That Met QC Criteria
January 29, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- CTD-2010-004-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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