Performance of a New Glucose Meter System

NCT ID: NCT01264016

Last Updated: 2016-02-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2010-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Intended Users of the Monitoring System

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

Group Type: EXPERIMENTAL

Investigational Blood Glucose Monitoring System

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ascensia Diabetes Care

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Timothy Bailey, MD

Role: PRINCIPAL_INVESTIGATOR

AMCR Institute

Locations

AMCR Institute

Escondido, California, United States

Countries

United States

Other Identifiers

CTD-2010-004-01

Identifier Type: -

Identifier Source: org_study_id