User Study of an Investigational Blood Glucose Monitoring System

Not Applicable

Completed

Brief Summary: This clinical trial is designed to assess an investigational blood glucose monitoring system with fingerstick blood in the hands of untrained intended users.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Previously participated in a study using this investigational system
Working for a medical laboratory, hospital, or other clinical setting that involves training on and clinical use of blood glucose monitors
Pregnancy
Hemophilia or any other bleeding disorder
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
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).

Arm && Interventions

Group	Intervention	Description
Intended Users of the System	Tatsu/Tradewind Investigational BG Monitoring System	Untrained subjects with diabetes use an investigational blood glucose monitoring system (Tatsu/Tradewind Investigational BG Monitoring System) to self-test capillary blood obtained from fingerstick.

Primary Outcome Measures

Name	Time	Method
Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15mg/dL (<75 mg/dL) or Within +/- 20% (>=75 mg/dL) of Laboratory Glucose Method	1 hour	Untrained subjects with diabetes tested self-test fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS), which included an investigational meter and sensor. BGM results were compared with capillary plasm BG results obtained with a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG meter results were used to calculate the number of BG results within +/- 15 mg/dL (for reference BG results \<75mg/dL) or +/- 20% (for reference BG results \>=75mg/dL) of the reference method results (YSI capillary plasma).

Secondary Outcome Measures

Name	Time	Method
Number of Study Staff Results Within +/- 15mg/dL (<75 mg/dL) or Within +/- 20% (>=75 mg/dL) of Laboratory Glucose Method When Testing Subject Blood Glucose (BG)	1 hour	Study staff tested subject fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS), which included an investigational meter and sensor. BGM results were compared with capillary plasma BG results obtained with a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG meter results were used to calculate the number of BG results within +/- 15mg/dL (for reference BG results \<75mg/dL) or +/- 20% (for reference BG results \>=75mg/dL) of the reference method results.