Clinical trial NCT01859494: Evaluation of an Investigational Blood Glucose Monitoring System
Official title: Performance of the Ninja 3 Blood Glucose Monitoring System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Ascensia Diabetes Care
Sponsor class: INDUSTRY
First posted: 2013-05-22
Enrollment: 219
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/-15mg/dL (<75mg/dL) or Within +/-20% (>=75mg/dL) of Laboratory Glucose Method
timeFrame: 1 hour
Secondary outcomes:
measure: 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
timeFrame: 1 hour
measure: 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
timeFrame: 1 hour
measure: 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
timeFrame: 1 hour
measure: 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
timeFrame: 1 hour
measure: Number of Subject Responses That 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements
timeFrame: 1 hour
Other outcomes:
Locations:
city: Escondido
country: United States
facility: AMCR Institute
state: California
city: Renton
country: United States
facility: Rainier Clinical Research Center
state: Washington
Study officials:
affiliation: AMCR Institute
name: Timothy Bailey, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rainier Clinical Research Center
name: Leslie J Klaff, MD
role: PRINCIPAL_INVESTIGATOR
References: