Evaluation of an Investigational Blood Glucose Monitoring System

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Device: NINJA 3 Investigational Blood Glucose Monitoring System

• Registration Number: NCT01859494
• Lead Sponsor: Ascensia Diabetes Care

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Study First Submitted: 2013-05-19
• Study First Submitted QC: 2013-05-19
• Study First Posted: 2013-05-22
• Results First Submitted: 2016-09-09
• Results First Submitted QC: 2016-09-09
• Results First Posted: 2016-10-31
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-20
• Last Update Posted: 2017-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 219

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Users of the Monitoring System	NINJA 3 Investigational Blood Glucose Monitoring System	Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System.

Primary Outcome Measures

Name	Time	Method
Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/-15mg/dL (<75mg/dL) or Within +/-20% (>=75mg/dL) of Laboratory Glucose Method	1 hour	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).

Secondary Outcome Measures

Name	Time	Method
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	1 hour	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)
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	1 hour	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)
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'.
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	1 hour	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)
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	1 hour	Study staff tested subject fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma 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)

Trial Locations

Locations (2)

AMCR Institute; 🇺🇸 Escondido, California, United States

Rainier Clinical Research Center; 🇺🇸 Renton, Washington, United States