User Study of an Investigational Blood Glucose Monitoring System

Ascensia Diabetes Care118 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

118

Conditions

Diabetes

Interventions

Tatsu/Tradewind Investigational BG Monitoring SystemDEVICE

Tradewind is a Bayer investigational meter that used an investigational sensor.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Type 1 or type 2 diabetes * 18 years of age and older * Able to speak, read, and understand English * Willing to complete all study procedures 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).

Locations (1)

AMCR Institute

Escondido, California, United States

Outcomes

Primary Outcomes

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

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).

Time frame: 1 hour

Secondary Outcomes

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)

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.

Time frame: 1 hour

Data from ClinicalTrials.gov

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