Performance of an Investigational Blood Glucose Monitoring System

Diabetes Clinical Trial

Official title:

Performance of the Ninja 3 Plus Blood Glucose Monitoring System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01824355
• Other study ID #: CTD-2012-010-01
• Status: Completed
• Phase: N/A
• First received: April 1, 2013
• Last updated: January 29, 2016
• Start date: March 2013
• Est. completion date: March 2013

Study information

• Verified date: January 2016
• Source: Ascensia Diabetes Care
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

• 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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diabetes

Intervention

Device:
• Ninja 3 PLUS Investigational BG Monitoring System
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.

Locations

Country	Name	City	State
United States	Consumer Product Testing Co.	Fairfield	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Ascensia Diabetes Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 hour	No
Secondary	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.	1 hour	No
Secondary	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.	1 hour	No
Secondary	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.	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).	1 hour	No
Secondary	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	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.	one hour	No
Secondary	Number of Subject Responses That 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements	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.'	1 hour	No