Study of an Investigational Glucose Meter System

Not Applicable

Completed

Interventions: Device: Apollo Evolution Investigational BG Monitoring System

Brief Summary: The purpose of this study is to demonstrate that untrained subjects who have diabetes or pre-diabetes can operate the investigational Blood Glucose Monitoring System (BGMS) and obtain valid glucose results.

Recruitment & Eligibility

Inclusion Criteria

Have a diagnosis of diabetes or pre-diabetes.
Be 18 years of age or older
Be able to speak, read and understand English and understand the Informed Consent document.
Be willing to complete study procedures

Exclusion Criteria

Pregnancy
Infections or skin disorders at the site of the venipuncture (at the discretion of the phlebotomist).
Hemophilia, bleeding disorder, or clotting problems. Persons taking aspirin (81 mg or 325 mg) daily or Plavix® are not reason for exclusion.
Physical (dexterity), visual, or neurological impairments that would make the person unable to perform testing with the BGM (at the discretion of the site professional staff).
A condition, in the opinion of the Investigator, would put the subject at risk or influence the conduct of the study or interpretation of the results. The reason for exclusion will be documented by the professional staff.
Previously participated in a blood glucose monitoring study using a similar device or use a similar device for personal use when monitoring blood glucose.
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
Working for a medical laboratory, hospital or other clinical setting that involves training on and clinical use of blood glucose monitors

Arm && Interventions

Group	Intervention	Description
Intended Users of the Monitoring System	Apollo Evolution Investigational BG Monitoring System	Untrained subjects with diabetes use the Apollo Evolution Investigational BG Monitoring System.

Primary Outcome Measures

Name	Time	Method
Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method	1 hour	Untrained subjects with diabetes self-test fingerstick blood using the Apollo Evolution 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 +/- 15mg/dL (\<75mg/dL YSI capillary plasma) or +/- 20% (\>=75mg/dL YSI capillary plasma). Site staff tested in parallel after subjects.

Secondary Outcome Measures

Name	Time	Method
Percent of Venous Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=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 +/- 15mg/dL (\<75mg/dL YSI venous plasma) or +/- 20% (\>=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 perform basic tasks considered to be essential for the operation of the system.