Performance of an Investigational Blood Glucose Monitoring System

Ascensia Diabetes Care113 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

113

Conditions

Diabetes

Interventions

Ninja 3 PLUS Investigational BG Monitoring SystemDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

* Inclusion Criteria: 1. Males and females, 18 years of age or 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 blood glucose monitoring study using the Ninja 3 Plus BGMS. 5. Working for a medical laboratory, hospital or other clinical setting that involves training on or clinical use of blood glucose meters. 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.

Locations (1)

Consumer Product Testing Co.

Fairfield, New Jersey, United States

Outcomes

Primary Outcomes

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

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.

Time frame: 1 hour

Secondary Outcomes

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

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.

Time frame: 1 hour

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

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.

Time frame: 1 hour

Data from ClinicalTrials.gov

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