Performance of an Investigational Blood Glucose Monitoring System in a Clinical Setting

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Device: Ninja 2 Investigational Blood Glucose Meter

• Registration Number: NCT01268488
• Lead Sponsor: Ascensia Diabetes Care

Brief Summary

The purpose of this study is to evaluate the performance of an investigational blood glucose meter with the Contour sensor strip. It was decided that this investigational monitoring system would not be part of a regulatory submission and it will not proceed to marketed product.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Study First Submitted: 2010-12-29
• Study First Submitted QC: 2010-12-29
• Study First Posted: 2010-12-31
• Results First Submitted: 2012-09-14
• Results First Submitted QC: 2012-09-14
• Results First Posted: 2012-10-16
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-28
• Last Update Posted: 2016-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

• Males and females, 18 years of age and above
• Type 1 or type 2 diabetes
• Currently self-testing blood glucose at home at least twice daily
• Able to speak, read, and understand English
• Willing to complete all study procedures

Exclusion Criteria

• Currently Pregnant
• Hemophilia or any other bleeding disorder
• Employee of competitive medical device company
• Cognitive disorder or other condition which, in the opinion of the investigator, would put the person at risk or seriously compromise the integrity of the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intended Users of the System	Ninja 2 Investigational Blood Glucose Meter	Untrained subjects with diabetes obtained capillary fingerstick, palm, and forearm blood and performed Blood Glucose (BG) tests using a Ninja 2 investigational blood glucose meter and the Contour® sensor. This BG monitoring system will not proceed to marketed product.

Primary Outcome Measures

Name	Time	Method
Numbers of Fingerstick Blood Glucose (BG) Results Within +/- 5 to 15mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method	2 hours	Subjects with diabetes tested subject fingerstick blood using an investigational blood glucose meter (BGM). BGM results were compared to a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were used to calculate the number of BG results within +/- 5 to 15 mg/dL (for reference BG results \<75mg/dL) or +/- 5 to 20% (for reference BG results \>=75mg/dL) of the reference method results.

Secondary Outcome Measures

Name	Time	Method
Numbers of Palm Blood Glucose (BG) Results Within +/- 5 to 15 mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method	2 hours	Subjects with diabetes used an investigational blood glucose meter (BGM) with subject capillary blood obtained from the palm. BGM results were compared to a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were used to calculate the number of BG results within +/- 5 to 15 mg/dL (for reference BG results \<75mg/dL) or +/- 5% to 20% (for reference BG results \>=75mg/dL) of the reference method results.
Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Comprehension)	2 hours	Subjects reviewed the instructions for use (User Guide and Quick Reference Guide) to learn to use the system. Study staff then observed and rated the subjects(1 to 4) on their success at performing the tasks. Scale: 1.Success in performing tasks correctly without assistance. 2.Successful with additional review of User Guide. 3.Successful with additional review and study staff assist similar to review of a specific function during a Customer Service call. 4.Subject did not perform task correctly and study staff intervention was required.
Numbers of Forearm Blood Glucose (BG) Results Within +/- 5 to 15 mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method	2 hours	Subjects with diabetes used an investigational blood glucose meter (BGM) with subject capillary blood obtained from the forearm. BGM results were compared to a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were used to calculate the number of BG results within +/- 5 to 15 mg/dL (for reference BG results \<75mg/dL) or +/- 5% to 20% (for reference BG results \>=75mg/dL) of the reference method results.

Trial Locations

Locations (1)

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