Evaluation of an Karajishi Contour Investigational Blood Glucose Monitoring System (ISO/FDA Study)

Ascensia Diabetes Care372 enrolled

Overview

The purpose of this study was to determine if untrained persons with diabetes and without diabetes could operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain valid blood glucose results.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

372

Conditions

Diabetes

Interventions

Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMSDEVICE

Untrained subjects WITH and WITHOUT diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood (and study staff tested subject fingerstick blood) using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma.

Subjects WITH Diabetes Use Karajishi Contour BGMSDEVICE

Untrained subjects WITH diabetes use the Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood (and study staff tested subject fingerstick blood) using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Males and females, 18 years of age and older * Able to speak, read, and understand English * Willing to complete all study procedures Exclusion Criteria: * Hemophilia or any other bleeding disorder * Pregnancy * Physical, visual, or neurological impairments that would make the person unable to perform testing with the BGM * Previously participated in a BG monitor study using the Karajishi Contour BGMS (or used a Bayer Contour meter) * Work for a medical laboratory, hospital, or other clinical setting that involves training on and clinical use of blood glucose monitors * Work for a competitive medical device company, or having an immediate family member who works for such a company * A condition which, in the opinion of the investigator or designee, would put the person or study conduct at risk General enrollment guidelines: * Most subjects will be persons with type 1 or type 2 diabetes * At least 10% of subjects with diabetes will have type 1 diabetes * Approximately 10% of subjects will be persons without diabetes * At least 60% of subjects will be younger than age 65

Locations (2)

AMCR Institute

Escondido, California, United States

Rainier Clinical Research Center

Renton, Washington, United States

Outcomes

Primary Outcomes

Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method

Untrained subjects WITH diabetes (329) self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the number of BGMS results within +/-15 mg/dL (\<100 mg/dL YSI capillary plasma) and +/-15% (\>=100 mg/dL YSI capillary plasma).

Time frame: 1 hour

Secondary Outcomes

Number of Venous Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method

Study staff tested venous blood of subjects WITH diabetes (329) using an investigational Blood Glucose Monitoring System (BGMS). Venous BGMS results were compared with subject venous plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer venous plasma BG results were used to calculate the number of BGMS results within +/-15 mg/dL (\<100 mg/dL YSI venous plasma) and +/-15% (\>=100 mg/dL YSI venous plasma).

Time frame: 1 hour

Number of Fingerstick Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method When Obtained and Tested by Study Staff

Study staff obtained and tested subject (329 WITH diabetes) fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma results were used to calculate the number of BGMS results within +/-15 mg/dL (\<100 mg/dL YSI capillary plasma) and +/-15% (\>=100 mg/dL YSI capillary plasma).

Time frame: 1 hour

Number of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.