Performance of a New Glucose Meter System

NCT01264016 | Completed Results

• 1 other identifier: CTD-2010-004-01
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (1)

• Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Comprehension)

  2 hours

Study Arms (1)

Intended Users of the Monitoring System

EXPERIMENTAL

Untrained subjects with diabetes use an investigational blood glucose monitoring system.

Device: Investigational Blood Glucose Monitoring System

Interventions

Investigational Blood Glucose Monitoring System DEVICE

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.

Intended Users of the Monitoring System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ascensia Diabetes Care: lead

Study Sites (1)

AMCR Institute

Escondido, California, 92026, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Jane Wallace
• Organization: Ascensia Diabetes Care

jane.wallace@ascensia.com

574-257-3063

Study Officials

• Timothy Bailey, MD

  AMCR Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2010
• First Posted: December 21, 2010
• Study Start: November 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: February 29, 2016
• Results First Posted: May 1, 2012

Record last verified: 2016-01

Locations

US (1)