Evaluation of an Investigational Blood Glucose Monitoring System

Ascensia Diabetes Care219 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

219

Conditions

Diabetes

Interventions

NINJA 3 Investigational Blood Glucose Monitoring SystemDEVICE

Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Males and females, 18 years of age and older 2. People with type 1 or type 2 diabetes 3. Able to speak, read, and understand English 4. Willing to complete all study procedures Exclusion Criteria: 1. Hemophilia or any other bleeding disorder 2. Pregnancy 3. Physical, visual, or neurological impairments that would make the person unable to perform testing with the BGM 4. Previously participated in a BG monitor study using the Ninja 3 BGMS 5. Working for a medical laboratory, hospital, or other clinical setting that involves training on and clinical use of blood glucose monitors 6. Working for a competitive medical device company, or having an immediate family member who works for such a company 7. 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: 1. At least 60% of subjects will be younger than age 65 2. At least 20% of subjects will have type 1 diabetes 3. At least 50% of subjects with type 2 diabetes wil be insulin users.

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 +/-15mg/dL (<75mg/dL) or Within +/-20% (>=75mg/dL) of Laboratory Glucose Method

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).

Time frame: 1 hour

Secondary Outcomes

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

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 BG results were used to calculate the number of BGMS results within +/- 15mg/dL (\<100mg/dL YSI capillary plasma) or +/- 15% (\>=100mg/dL YSI capillary plasma)

Time frame: 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

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 BG results were used to calculate the number of BGMS results within +/- 12.5mg/dL (\<100mg/dL YSI capillary plasma) or +/- 12.5% (\>=100mg/dL YSI capillary plasma)

Time frame: 1 hour

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

Untrained subjects with diabetes self-tested Alternative Site (AST) palm blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS AST results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma BG results were used to calculate the number of AST BGMS results within +/- 15mg/dL (\<75mg/dL YSI capillary plasma) or +/- 20% (\>=75mg/dL YSI capillary plasma)

Data from ClinicalTrials.gov

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