Performance of the Ninja 3 Blood Glucose Monitoring System

Ascensia Diabetes Care2 sites in 1 country219 target enrollmentApril 2013

ConditionsDiabetes

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diabetes
Sponsor: Ascensia Diabetes Care
Enrollment: 219
Locations: 2
Primary Endpoint: Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/-15mg/dL (<75mg/dL) or Within +/-20% (>=75mg/dL) of Laboratory Glucose Method
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study was to determine if untrained subjects who have diabetes can operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain valid glucose results.

Registry

clinicaltrials.gov

Start Date

April 2013

End Date

May 2013

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Ascensia Diabetes Care

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Males and females, 18 years of age and older
•People with type 1 or type 2 diabetes
•Able to speak, read, and understand English
•Willing to complete all study procedures

Exclusion Criteria

•Hemophilia or any other bleeding disorder
•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 Ninja 3 BGMS
•Working for a medical laboratory, hospital, or other clinical setting that involves training on and clinical use of blood glucose monitors
•Working 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.
•The enrollment criteria for the study population:
•At least 60% of subjects will be younger than age 65
•At least 20% of subjects will have type 1 diabetes
•At least 50% of subjects with type 2 diabetes wil be insulin users.

Outcomes

Primary Outcomes

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

Time Frame: 1 hour

Untrained subjects with diabetes 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 +/- 15mg/dL (\<75mg/dL YSI capillary plasma) or +/- 20% (\>=75mg/dL YSI capillary plasma).

Secondary Outcomes

Number of Glucose Results From Alternative Site Testing (AST) of the Palm Within +/- 15mg/dL (<75mg/L YSI) or Within +/- 20% (>=75mg/dL YSI) of Laboratory Glucose Method(1 hour)
Number of Self-Test Fingerstick Blood Glucose (BG)Results Within +/- 15mg/dL (<100mg/L YSI) or Within +/- 15% (>=100mg/dL YSI) of Laboratory Glucose Method(1 hour)
Number of Subject Responses That 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements(1 hour)
Number of Self-Test Fingerstick Blood Glucose (BG)Results Within +/- 12.5mg/dL (<100mg/L YSI) or Within +/- 12.5% (>=100mg/dL YSI) of Laboratory Glucose Method(1 hour)
Number of Subject Fingerstick BG Results Within +/- 15mg/dL (<75mg/L YSI) or Within +/- 20% (>=75mg/dL YSI) of Laboratory Glucose Method When Tested by Study Staff(1 hour)