Study of an Investigational Glucose Meter System

Ascensia Diabetes Care207 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

207

Conditions

Diabetes

Interventions

Apollo Evolution Investigational BG Monitoring SystemDEVICE

Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and Alternative Site Testing (AST) of the palm using the Apollo Evolution 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 complete basic tasks using the User Guide and provide feedback.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Bayer HealthCare LLC, Diabetes Care

Mishawaka, Indiana, United States

Outcomes

Primary Outcomes

Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method

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.

Time frame: 1 hour

Secondary Outcomes

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).

Time frame: 1 hour

Percent of Venous Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=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 +/- 15mg/dL (\<75mg/dL YSI venous plasma) or +/- 20% (\>=75mg/dL YSI venous plasma).

Time frame: 1 hour

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 perform basic tasks considered to be essential for the operation of the system.

Data from ClinicalTrials.gov

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