Study of an Investigational Glucose Meter System

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Device: G3 Investigational Blood Glucose Monitoring System

• Registration Number: NCT01474317
• Lead Sponsor: Ascensia Diabetes Care

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Study First Submitted: 2011-11-16
• Study First Submitted QC: 2011-11-16
• Study First Posted: 2011-11-18
• Results First Submitted: 2012-11-30
• Results First Submitted QC: 2012-11-30
• Results First Posted: 2013-01-03
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-29
• Last Update Posted: 2016-02-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 226

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intended Users of the Monitoring System	G3 Investigational Blood Glucose Monitoring System	Untrained subjects with diabetes use the G3 investigational blood glucose monitoring system.

Primary Outcome Measures

Name	Time	Method
Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 5to15mg/dL (<100mg/dL) or Within +/- 5to15% (>=100mg/dL) of Laboratory Glucose Method	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

Name	Time	Method
Percent of Venous Blood Glucose Results Within +/- 5to15mg/dL (<75mg/dL) or Within +/- 5to20% (>=75mg/dL) of Laboratory Glucose Method	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).
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	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).
Number of Subjects Able to Perform Given Tasks Using Product Labeling for Instruction	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?'

Trial Locations

Locations (2)

Consumer Product Testing Co.; 🇺🇸 Fairfield, New Jersey, United States

Southwest Clinical Research Center; 🇺🇸 Santa Fe, New Mexico, United States