Performance of an Investigational Blood Glucose Monitoring System

Not Applicable

Completed

• Conditions: Diabetes

• Registration Number: NCT01824355
• Lead Sponsor: Ascensia Diabetes Care

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Study First Submitted: 2013-04-01
• Study First Submitted QC: 2013-04-01
• Study First Posted: 2013-04-04
• Results First Submitted: 2014-03-28
• Results First Submitted QC: 2015-01-05
• Results First Posted: 2015-01-06
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-29
• Last Update Posted: 2016-02-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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	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 Outcome Measures

Name	Time	Method
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	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.
Number of Subject Responses That 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements	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.'
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	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.
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	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.
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.	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).

Trial Locations

Locations (1)

Consumer Product Testing Co.; 🇺🇸 Fairfield, New Jersey, United States