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Evaluation of a Ascensia ONYX NEXT Investigational Blood Glucose Monitoring System

Not Applicable
Completed
Conditions
Diabetes
Registration Number
NCT02390167
Lead Sponsor
Ascensia Diabetes Care
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
376
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 blood glucose monitoring study using the ONYX NEXT or ONYX PLUS BGMS
  • Working for a medical laboratory, hospital, or other clinical setting that involves training on or 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

General enrollment guidelines:

  • At least 70% of subjects will be younger than age 65
  • At least 10% (approximately 10-15%) of subjects will be naive users
  • At least 20% of subjects with diabetes will have type 1 diabetes

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Percent of Self-Test Fingerstick Blood Glucose (BG) Results (From Subjects WITH Diabetes) Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method1 hour

Untrained subjects WITH Diabetes (332) 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 percent of BGMS results within +/- 15 mg/dL (\<100 mg/dL YSI capillary plasma) and +/- 15% (\>=100 mg/dL YSI capillary plasma).

Secondary Outcome Measures
NameTimeMethod
Percent of Venous Blood Glucose (BG) Results (From Subjects WITH Diabetes) Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method When Tested by Study Staff1 hour

Study staff tested venous blood of 332 subjects WITH diabetes 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 percent of BGMS results within +/- 15 mg/dL (\<100 mg/dL YSI venous plasma) and +/- 15% (\>=100 mg/dL YSI venous plasma).

Percent of Alternate Site Palm Blood Glucose (BG) Results (From Subjects WITH Diabetes) Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method1 hour

Untrained subjects WITH Diabetes (332) self-tested Alternate Site (AST) palm 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 percent of BGMS results within +/- 15 mg/dL (\<100 mg/dL YSI capillary plasma) and +/- 15% (\>=100 mg/dL YSI capillary plasma).

Percent of Subject Fingerstick Blood Glucose (BG) Results (From Subjects WITH Diabetes) Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method When Tested by Study Staff1 hour

Study staff tested subject (332 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 Analyzer BG results were used to calculate the percent of BGMS results within +/- 15 mg/dL (\<100 mg/dL YSI capillary plasma) and +/- 15% (\>=100 mg/dL YSI capillary plasma).

Percent of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15% of Laboratory Glucose Method Across the Tested Glucose Range1 hour

Untrained subjects WITH Diabetes (332) and WITHOUT Diabetes (43) 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 percent of BGMS results within +/- 15% of the laboratory reference method across the entire tested YSI glucose range.

Percent of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 12.5mg/dL (<100mg/dL) and Within +/- 12.5% (>=100 mg/dL) of Laboratory Glucose Method1 hour

Untrained subjects WITH Diabetes (332) 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 percent of BGMS results within +/- 12.5 mg/dL (\<100 mg/dL YSI capillary plasma) and +/- 12.5% (\>=100 mg/dL YSI capillary plasma).

Percent of Responses From Persons WITH Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding BGMS1 hour

Staff obtained responses from persons WITH Diabetes (332) using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS. Subjects could respond 'Strongly Agree' or 'Agree' or are 'Neutral' or 'Disagree' or 'Strongly Disagree'.

Percent of Responses From Persons WITH and WITHOUT Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding BGMS1 hour

Staff obtained responses from persons WITH and WITHOUT Diabetes using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS. Subjects could respond 'Strongly Agree' or 'Agree' or are 'Neutral' or 'Disagree' or 'Strongly Disagree'.

Percent of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 20% of Laboratory Glucose Method Across the Tested Glucose Range1 hour

Untrained subjects WITH diabetes (332) and WITHOUT diabetes (43) 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 percent of BGMS results within +/- 20% of the laboratory reference method across the entire tested YSI glucose range.

Percent of Self-Test Alternate Site Palm Blood Glucose (BG) Results Within +/- 15% of Laboratory Glucose Method Across the Tested Glucose Range1 hour

Untrained subjects WITH diabetes (332) and WITHOUT diabetes (43) self-tested AST palm 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 percent of BGMS results within +/- 15% of the laboratory reference method across the entire tested YSI glucose range.

Percent of Self-Test Alternate Site Palm Blood Glucose (BG) Results Within +/- 20% of Laboratory Glucose Method Across the Tested Glucose Range1 hour

Untrained subjects WITH diabetes (332) and WITHOUT diabetes (43) self-tested AST palm 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 percent of BGMS results within +/- 20% of the laboratory reference method across the entire tested YSI glucose range.

Percent of Subject Fingerstick Blood Glucose (BG) Results Within +/- 15% of Laboratory Glucose Method When Tested By Study Staff1 hour

Study staff tested subject (332 WITH and 43 WITHOUT 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 Analyzer BG results were used to calculate the percent of BGMS results within +/- 15% of the laboratory method across the entire tested YSI glucose range.

Percent of Subject Fingerstick Blood Glucose (BG) Results Within +/- 20% of Laboratory Glucose Method When Tested By Study Staff1 hour

Study staff tested subject (332 WITH and 43 WITHOUT 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 Analyzer BG results were used to calculate the percent of BGMS results within +/- 20% of the laboratory method across the entire tested YSI glucose range.

Percent of Responses From Persons WITH Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding Views/Behaviors Related to Self-Monitoring Blood Glucose1 hour

Staff obtained responses from persons WITH Diabetes using short questionnaires to provide feedback on views and behaviors related to managing their diabetes. Subjects could respond 'Strongly Agree' or 'Agree' or are 'Neutral' or 'Disagree' or 'Strongly Disagree' or 'Choose Not to Answer'.

Percent of Self-Test Fingerstick Blood Glucose (BG) Results (From Subjects WITH and WITHOUT Diabetes) Within +/- 15 mg/dL (<75 mg/dL) and Within +/- 15% (>= 75 mg/dL) of Laboratory Glucose Method1 hour

Untrained subject WITH and WITHOUT 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 percent of BGMS results within +/- 15 mg/dL (\< 75 mg/dL YSI capillary plasma) and +/- 15% (\>= 75 mg/dL YSI capillary plasma).

Percent of Self-Test Alternate Site Palm Blood Glucose (BG) Results (From Subjects WITH and WITHOUT Diabetes) Within +/- 15 mg/dL (<75 mg/dL) and Within +/- 15% (>= 75 mg/dL) of Laboratory Glucose Method1 hour

Untrained subject WITH and WITHOUT diabetes self-tested Alternate Site (AST) palm 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 percent of BGMS results within +/- 15 mg/dL (\< 75 mg/dL YSI capillary plasma) and +/- 15% (\>= 75 mg/dL YSI capillary plasma).

Trial Locations

Locations (2)

AMCR Institute

🇺🇸

Escondido, California, United States

Diablo Clinical Research

🇺🇸

Walnut Creek, California, United States

AMCR Institute
🇺🇸Escondido, California, United States

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