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Completed

NCT Number: NCT01824355

Performance of an Investigational Blood Glucose Monitoring System

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

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Consumer Product Testing Co.

Fairfield, New Jersey, 07004, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Inclusion Criteria:
  • Males and females, 18 years of age or 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.
  • 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 Ninja 3 Plus BGMS.
  • Working for a medical laboratory, hospital or other clinical setting that involves training on or clinical use of blood glucose meters.
  • 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.

Treatment and study plan

Ninja 3 PLUS Investigational BG Monitoring System

Device

Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Ninja 3 PLUS Investigational BG Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to a reference laboratory glucose method.

Primary outcomes

  1. Percent of Self Test Fingerstick Blood Glucose Results Within ±15 mg/dL (< 75 mg/dL) and Within ±20% (≥ 75 mg/dL) of the Laboratory Glucose Method

    Time frame: 1 hour

    Untrained subjects with diabetes who self-tested fingerstick blood used the Ninja 3 PLUS investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with capillary plasma BG results obtained with a reference laboratory glucose method - YSI Life Sciences (YSI) Analyzer. BG meter results were used to calculate the number of BGMS results within +/- 15mg/dL (for reference BG results <75mg/dL) and within +/- 20% (for reference BG results >=75mg/dL) of the YSI reference method results.

Secondary outcomes

  1. Percent of Self Test Fingerstick Blood Glucose Results Within ±15 mg/dL (< 100 mg/dL) and Within ±15% (≥ 100 mg/dL) of the Laboratory Glucose Method

    Time frame: 1 hour

    Untrained subjects with diabetes who self-tested fingerstick blood used the Ninja 3 PLUS investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with capillary plasma BG results obtained with a reference laboratory glucose method - YSI Life Sciences (YSI) Analyzer. BG meter results were used to calculate the number of BGMS results within +/- 15mg/dL (for reference BG results <100mg/dL) and within +/- 15% (for reference BG results >=100mg/dL) of the YSI reference method results.

  2. Percent of Self Test Fingerstick Blood Glucose Results Within ±12.5 mg/dL (< 100 mg/dL) and Within ±12.5% (≥ 100 mg/dL) of the Laboratory Glucose Method

    Time frame: 1 hour

    Untrained subjects with diabetes who self-tested fingerstick blood used the Ninja 3 PLUS investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with capillary plasma BG results obtained with a reference laboratory glucose method - YSI Life Sciences (YSI) Analyzer. BG meter results were used to calculate the number of BGMS results within +/- 12.5mg/dL (for reference BG results <100mg/dL) and within +/- 12.5% (for reference BG results >=100mg/dL) of the YSI reference method results.

  3. Percent of Blood Glucose Results From Alternative Site Testing (AST) of the Palm Within ±15 mg/dL (< 75 mg/dL) and Within ±20% (≥ 75 mg/dL) of the Laboratory Method.

    Time frame: 1 hour

    Untrained subjects with diabetes self-tested Alternative Site (AST) Palm blood using the Ninja 3 PLUS investigational Blood Glucose Monitoring System (BGMS). BGMS AST results were compared with capillary plasma BG results obtained with a reference laboratory glucose method - YSI Life Sciences (YSI) Analyzer. BG meter results were used to calculate the number of AST BGMS results within +/- 15mg/dL (<75mg/dL YSI capillary plasma) and within +/- 15% (>=75mg/dL YSI capillary plasma).

  4. Percent of Fingerstick Blood Glucose Results Within ±15 mg/dL (< 75 mg/dL) and Within ±20% (≥ 75 mg/dL) of the Laboratory Glucose Method When Tested by Study Staff

    Time frame: one hour

    Study Staff tested subject fingerstick blood using the Ninja 3 PLUS investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with capillary plasma BG results obtained with a reference laboratory glucose method - YSI Life Sciences (YSI) Analyzer. BG meter results were used to calculate the number of BGMS results within +/- 15mg/dL (for reference BG results <75mg/dL) and within +/- 20% (for reference BG results >=75mg/dL) of the YSI reference method results.

  5. Number of Subject Responses That 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements

    Time frame: 1 hour

    Staff obtained subject responses using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS. Subjects could respond 'Strongly Agree' 'Agree' 'Neutral' 'Disagree' or 'Strongly Disagree.'

Sponsors and collaborators

Lead sponsor

Ascensia Diabetes Care

Industry

Registry information

Official study title

Performance of the Ninja 3 Plus Blood Glucose Monitoring System

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Apr 4, 2013
Registry last updated
Feb 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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