Study of an Investigational Glucose Meter System

Diabetes Clinical Trial

Official title:

Performance of the G3 Blood Glucose Monitoring System With TATSU Strip

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01474317
• Other study ID #: CTD-PRO-2010-009-01
• Status: Completed
• Phase: N/A
• First received: November 16, 2011
• Last updated: January 29, 2016
• Start date: November 2011
• Est. completion date: November 2011

Study information

• Verified date: January 2016
• Source: Ascensia Diabetes Care
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 226
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diabetes

Intervention

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.

Locations

Country	Name	City	State
United States	Consumer Product Testing Co.	Fairfield	New Jersey
United States	Southwest Clinical Research Center	Santa Fe	New Mexico

Sponsors (1)

Lead Sponsor	Collaborator
Ascensia Diabetes Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 5to15mg/dL (<100mg/dL) or Within +/- 5to15% (>=100mg/dL) of Laboratory Glucose Method	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.	1 hour	No
Secondary	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	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).	1 hour	No
Secondary	Percent of Venous Blood Glucose Results Within +/- 5to15mg/dL (<75mg/dL) or Within +/- 5to20% (>=75mg/dL) of Laboratory Glucose Method	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).	1 hour	No
Secondary	Number of Subjects Able to Perform Given Tasks Using Product Labeling for Instruction	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?'	1 hour	No