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

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ClinicalTrials.gov Identifier: NCT01268267
Recruitment Status : Completed
First Posted : December 30, 2010
Results First Posted : May 31, 2012
Last Update Posted : February 29, 2016
Sponsor:
Information provided by (Responsible Party):
Ascensia Diabetes Care

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Diabetes
Intervention Device: Ninja 2 Investigational Blood Glucose Monitoring System
Enrollment 94
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intended Users of the System
Hide Arm/Group Description Untrained subjects with diabetes use an investigational blood glucose monitoring system.
Period Title: Overall Study
Started 94
Completed 93
Not Completed 1
Reason Not Completed
Protocol Violation             1
Arm/Group Title Intended Users of the System
Hide Arm/Group Description Untrained subjects with diabetes use an investigational blood glucose monitoring system.One subject was found not to meet inclusion/exclusion criteria so subject was withdrawn and no data from this subject was evaluated.
Overall Number of Baseline Participants 93
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 93 participants
38.3
(18 to 74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 93 participants
Female
42
  45.2%
Male
51
  54.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 93 participants
93
1.Primary Outcome
Title Numbers of Fingerstick Blood Glucose (BG) Results Within +/- 5 to 20mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method
Hide Description Subjects with diabetes tested subject fingerstick blood using an investigational blood glucose monitoring system (BGMS), which included an investigational meter and sensor. 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 20 mg/dL (for reference BG results <75mg/dL) or +/- 5 to 20% (for reference BG results >=75mg/dL) of the reference method results.
Time Frame 2 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One subject was withdrawn from the study. One subject YSI reference sample was misidentified. Two subjects were not in steady state, required for the study. Four subjects' blood test data were thus not evaluable. The remaining 90 subjects tested 2 test strip lots on the BGMsystem. 2x90(180) test results were available.
Arm/Group Title Intended Users of the System
Hide Arm/Group Description:
Untrained subjects with diabetes use an investigational blood glucose monitoring system.One subject was found not to meet inclusion/exclusion criteria so subject was withdrawn and no data from this subject were evaluated.
Overall Number of Participants Analyzed 90
Overall Number of Units Analyzed
Type of Units Analyzed: Blood glucose test results
180
Measure Type: Number
Unit of Measure: Number of BG test results
# within +/-15mg/dL(<75mg/dL) or 20% (>=75mg/dL) 180
# within +/-15mg/dL(<75mg/dL) or 15% (>=75mg/dL) 179
# within +/-10mg/dL(<75mg/dL) or 10% (>=75mg/dL) 172
# within +/-5mg/dL(<75mg/dL) or 5% (>=75mg/dL) 138
2.Secondary Outcome
Title Numbers of Palm Blood Glucose (BG) Results Within +/- 5 to 20 mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method
Hide Description Subjects with diabetes used an investigational blood glucose monitoring system (BGMS) 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 20 mg/dL (for reference BG results <75mg/dL) or +/- 5% to 20% (for reference BG results >=75mg/dL) of the reference method results.
Time Frame 2 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Five subjects were hypoglycemic (low blood glucose value). Since alternate-site palm testing by these subjects was not allowed in the study, palm data from these five subjects were not obtained/ not evaluable. The remaining 85 subjects tested 2 test strip lots on the BGM system. 2x85(170)test results were available.
Arm/Group Title Intended Users of the System
Hide Arm/Group Description:
Untrained subjects with diabetes use an investigational blood glucose monitoring system.One subject was found not to meet inclusion/exclusion criteria so subject was withdrawn and no data from this subject was evaluated.
Overall Number of Participants Analyzed 85
Overall Number of Units Analyzed
Type of Units Analyzed: BG test results
170
Measure Type: Number
Unit of Measure: Number of BG test results
# within +/-15mg/dL(<75mg/dL) or 20% (>=75mg/dL) 166
# within +/-15mg/dL(<75mg/dL) or 15% (>=75mg/dL) 161
# within +/-10mg/dL(<75mg/dL) or 10% (>=75mg/dL) 143
# within +/-5mg/dL(<75mg/dL) or 5% (>=75mg/dL) 82
3.Secondary Outcome
Title Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Comprehension)
Hide Description 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.
Time Frame 2 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
For alternate-site palm and forearm testing tasks, 3 subjects with nonevaluable blood glucose data were not included. Only 90 participants were rated for those particular tasks.
Arm/Group Title Intended Users of the System
Hide Arm/Group Description:
Untrained subjects with diabetes use an investigational blood glucose monitoring system.One subject was found not to meet inclusion/exclusion criteria so subject was withdrawn and no data from this subject was evaluated.
Overall Number of Participants Analyzed 93
Measure Type: Number
Unit of Measure: participants
Turn meter on/off 93
Date and time set on meter 93
Normal control testing 93
Subject blood testing - fingerstick 93
Subject blood testing - palm (of 90) 90
Subject blood testing - forearm (of 90) 90
Understand underfill / ability to apply more blood 93
4.Secondary Outcome
Title Numbers of Forearm Blood Glucose (BG) Results Within +/- 5 to 20 mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method
Hide Description Subjects with diabetes used an investigational blood glucose monitoring system (BGMS) 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 20 mg/dL (for reference BG results <75mg/dL) or +/- 5% to 20% (for reference BG results >=75mg/dL) of the reference method results.
Time Frame 2 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Since forearm testing by 5 hypoglycemic subjects (low blood glucose) was not allowed per the protocol, forearm data were not obtained/not evaluable for these subjects. Of the remaining 85 subjects, 83 tested 2 test strip lots(83x2) and 2 subjects tested 1 strip lot(2x1). A total of 168(166+2)test results were available.
Arm/Group Title Intended Users of the System
Hide Arm/Group Description:
Untrained subjects with diabetes use an investigational blood glucose monitoring system.One subject was found not to meet inclusion/exclusion criteria so subject was withdrawn and no data from this subject was evaluated.
Overall Number of Participants Analyzed 85
Overall Number of Units Analyzed
Type of Units Analyzed: BG test results
168
Measure Type: Number
Unit of Measure: Number of BG test results
# within +/-15mg/dL(<75mg/dL) or 20% (>=75mg/dL) 158
# within +/-15mg/dL(<75mg/dL) or 15% (>=75mg/dL) 145
# within +/-10mg/dL(<75mg/dL) or 10% (>=75mg/dL) 125
# within +/-5mg/dL(<75mg/dL) or 5% (>=75mg/dL) 74
Time Frame Each subject participated for approximately 2 hours.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intended Users of the System
Hide Arm/Group Description Untrained subjects with diabetes use an investigational blood glucose monitoring system.One subject was found not to meet inclusion/exclusion criteria so subject was withdrawn and no data from this subject was evaluated.
All-Cause Mortality
Intended Users of the System
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Intended Users of the System
Affected / at Risk (%) # Events
Total   0/94 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Intended Users of the System
Affected / at Risk (%) # Events
Total   7/94 (7.45%)    
Endocrine disorders   
hypoglycemia *  7/94 (7.45%)  7
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Carmine Greene
Organization: Ascensia Diabetes Care
Phone: 574-257-3040
Responsible Party: Ascensia Diabetes Care
ClinicalTrials.gov Identifier: NCT01268267     History of Changes
Other Study ID Numbers: CTD-2010-008-01
First Submitted: December 28, 2010
First Posted: December 30, 2010
Results First Submitted: April 27, 2012
Results First Posted: May 31, 2012
Last Update Posted: February 29, 2016