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Study of an Investigational Glucose Meter System

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01474317
First Posted: November 18, 2011
Last Update Posted: February 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ascensia Diabetes Care
  Purpose
The purpose of this study is to demonstrate that untrained subjects who have diabetes can operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain valid glucose results.

Condition Intervention
Diabetes Device: G3 Investigational Blood Glucose Monitoring System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Performance of the G3 Blood Glucose Monitoring System With TATSU Strip

Resource links provided by NLM:


Further study details as provided by Ascensia Diabetes Care:

Primary Outcome Measures:
  • Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 5to15mg/dL (<100mg/dL) or Within +/- 5to15% (>=100mg/dL) of Laboratory Glucose Method [ Time Frame: 1 hour ]
    Untrained subjects with diabetes self-test fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results are used to calculate the number of BGMS results within +/- 5to15mg/dL (<100mg/dL YSI capillary plasma) or +/- 5to15% (>=100mg/dL YSI capillary plasma). Site staff tested in parallel after subjects.


Secondary Outcome Measures:
  • Percent of Glucose Results From Alternative Site Testing (AST) of the Palm Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method [ Time Frame: 1 hour ]
    Untrained subjects with diabetes self-test Alternative Site (AST) Palm blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS AST results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma BG results are used to calculate the number of AST BGMS results within +/- 15mg/dL (<75mg/dL YSI capillary plasma) or +/- 20% (>=75mg/dL YSI capillary plasma).

  • Percent of Venous Blood Glucose Results Within +/- 5to15mg/dL (<75mg/dL) or Within +/- 5to20% (>=75mg/dL) of Laboratory Glucose Method [ Time Frame: 1 hour ]
    Study staff tested subject venous blood using an investigational Blood Glucose Monitoring System (BGMS). Venous BGMS results are compared with venous plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI venous plasma results are used to calculate the number of BGMS results within +/- 5to15mg/dL (<75mg/dL YSI venous plasma) or +/- 5to20% (>=75mg/dL YSI venous plasma).

  • Number of Subjects Able to Perform Given Tasks Using Product Labeling for Instruction [ Time Frame: 1 hour ]
    After reading the instructions for use, and without assistance from the study staff, subjects use the BGMS to utilize some of the additional features of the system. Study staff documents Yes or No 'Did the subject complete the task successfully?'


Enrollment: 226
Study Start Date: November 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intended Users of the Monitoring System
Untrained subjects with diabetes use the G3 investigational blood glucose monitoring system.
Device: G3 Investigational Blood Glucose Monitoring System
Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the G3 meter and an investigational sensor. Study staff test subject venous blood and all BG results are compared to a reference laboratory glucose method. Untrained subjects utilize some additional features of the meter using the User Guide and provide feedback.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females, 18 years of age and older
  • Type 1 or type 2 diabetes
  • Able to speak, read, and understand English
  • Willing to complete all study procedures

Exclusion Criteria:

  • Pregnancy
  • Hemophilia or any other bleeding disorder
  • Previously participated in a study using the G3 system
  • Working for a medical laboratory, hospital or other clinical setting that involves training on and clinical use of blood glucose monitors.
  • A condition, which in the opinion of the investigator, would put the person or study conduct at risk (reason for exclusion will be clearly documented by investigator or designee).
  • Working for a competitive medical device company, or having an immediate family member or someone who is not a family member but is living within the household of someone who works for such a company.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01474317


Locations
United States, New Jersey
Consumer Product Testing Co.
Fairfield, New Jersey, United States, 07004
United States, New Mexico
Southwest Clinical Research Center
Santa Fe, New Mexico, United States, 87505
Sponsors and Collaborators
Ascensia Diabetes Care
Investigators
Principal Investigator: Robert Bernstein, MD, FACE Southwest Clinical Research Center
Principal Investigator: Michael Caswell, PhD Consumer Product Testing Co.
  More Information

Responsible Party: Ascensia Diabetes Care
ClinicalTrials.gov Identifier: NCT01474317     History of Changes
Other Study ID Numbers: CTD-PRO-2010-009-01
First Submitted: November 16, 2011
First Posted: November 18, 2011
Results First Submitted: November 30, 2012
Results First Posted: January 3, 2013
Last Update Posted: February 29, 2016
Last Verified: January 2016