Evaluation of an Investigational Blood Glucose Monitoring System

• Sponsor: Ascensia Diabetes Care (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01859494
• Collaborator: (none)
• Enrollment: 219
• Locations: 2
• Arm: 1
• Duration (Days): 30
• Patients Per Site: 109.5
• Patients Per Site Per Month: 111.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes	Device: NINJA 3 Investigational Blood Glucose Monitoring System	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 219 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Performance of the Ninja 3 Blood Glucose Monitoring System
• Study Start Date: Apr 1, 2013
• Actual Primary Completion Date: May 1, 2013
• Actual Study Completion Date: May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Users of the Monitoring System Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System.	Device: NINJA 3 Investigational Blood Glucose Monitoring System; Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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)

2. 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)

3. 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)

4. 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)

5. 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'.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AMCR Institute	Escondido	California	United States	92026
2	Rainier Clinical Research Center	Renton	Washington	United States	98057

Sponsors and Collaborators

• Ascensia Diabetes Care

Investigators

• Principal Investigator: Timothy Bailey, MD, AMCR Institute
• Principal Investigator: Leslie J Klaff, MD, Rainier Clinical Research Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ascensia Diabetes Care
• ClinicalTrials.gov Identifier: NCT01859494
• Other Study ID Numbers: CTD-2012-009-01
• First Posted: May 22, 2013
• Last Update Posted: Feb 10, 2017
• Last Verified: Dec 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes

Study Results

Participant Flow

Arm/Group Title	Users of the Monitoring System
Arm/Group Description	Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System. NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma.
Period Title: Overall Study
STARTED	219
COMPLETED	218
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Users of the Monitoring System
Arm/Group Description	Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System. NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma.
Overall Participants	221
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	51.8
Gender (Count of Participants)
Female	108 48.9%
Male	113 51.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	22 10%
Not Hispanic or Latino	197 89.1%
Unknown or Not Reported	2 0.9%
Race/Ethnicity, Customized (participants) [Number]
American Indian or Alaska Native	4 1.8%
Asian	9 4.1%
Native Hawaiian or Other Pacific Islander	2 0.9%
Black or African American	10 4.5%
White	194 87.8%
More than one race	3 1.4%
Unknown or Not Reported	5 2.3%
Region of Enrollment (participants) [Number]
United States	221 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

218 (219-1) Blood glucose results were analyzed. One subject discontinued from testing after low Blood Glucose (BG) fingerstick result (hypoglycemia AE), thus no reference result available for that subject.

Arm/Group Title	Users of the Monitoring System
Arm/Group Description	Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System. NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma.
Measure Participants	218
Number [Blood Glucose results within 15mg/dL/20%]	218

2. Secondary Outcome

Title	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
Description	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)
Time Frame	1 hour

Outcome Measure Data

Analysis Population Description

218 (219-1) Blood glucose results were analyzed. One subject discontinued from testing after low BG fingerstick result (hypoglycemia AE), thus no reference result available for that subject.

Arm/Group Title	Users of the Monitoring System
Arm/Group Description	Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System. NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma.
Measure Participants	218
Number [Blood Glucose results within 15mg/dL/15%]	215

3. Secondary Outcome

Title	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
Description	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)
Time Frame	1 hour

Outcome Measure Data

Analysis Population Description

218 (219-1) Blood glucose results were analyzed. One subject discontinued from testing after low BG fingerstick result (hypoglycemia AE), thus no reference result available for that subject.

Arm/Group Title	Users of the Monitoring System
Arm/Group Description	Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System. NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma.
Measure Participants	218
Number [Bld Glucose results w/in 12.5mg/dL/12.5%]	214

4. Secondary Outcome

Title	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
Description	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)
Time Frame	1 hour

Outcome Measure Data

Analysis Population Description

211 (219-8) Blood glucose results were analyzed. One subject discontinued from all testing after hypoglycemia Adverse Event. Three subjects with low blood sugar did not attempt palm testing per protocol. Two subjects had low blood sugar; their palm results were not evaluable per protocol. Two subjects failed to obtain palm blood for testing.

Arm/Group Title	Users of the Monitoring System
Arm/Group Description	Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System. NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma.
Measure Participants	211
Number [Blood Glucose results within 15mg/dL/20%]	209

5. Secondary Outcome

Title	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
Description	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)
Time Frame	1 hour

Outcome Measure Data

Analysis Population Description

218 (219-1) Blood glucose results were analyzed. One subject discontinued from testing after low BG result (hypoglycemia AE), thus no reference result available for that subject.

Arm/Group Title	Users of the Monitoring System
Arm/Group Description	Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System. NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma.
Measure Participants	218
Number [Blood Glucose results within 15mg/dL/20%]	218

6. Secondary Outcome

Title	Number of Subject Responses That 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements
Description	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'.
Time Frame	1 hour

Outcome Measure Data

Analysis Population Description

218 (219-1) responses were analyzed. One subject discontinued from testing after low BG result (hypoglycemia Adverse Event).

Arm/Group Title	Users of the Monitoring System
Arm/Group Description	Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System. NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma.
Measure Participants	218
I find it easy to do a blood test with this meter.	218
The meter display was easy to see and read.	216
It was easy to understand my test results.	218
I like the overall meter design.	215
I find the meter easy to use.	217
The instructions were easy to understand.	213
Instructions clearly explain how to run a test.	216
Instructions clearly explain meter error messages.	217

Adverse Events

Time Frame	Subject visits were approximately 1 hour.
Arm/Group Title	Users of the Monitoring System
Arm/Group Description	Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System. NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma.
All Cause Mortality
	Users of the Monitoring System
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Users of the Monitoring System
	Affected / at Risk (%)	# Events
Total	0/219 (0%)
Other (Not Including Serious) Adverse Events
	Users of the Monitoring System
	Affected / at Risk (%)	# Events
Total	8/219 (3.7%)
Endocrine disorders
Hypoglycemia	8/219 (3.7%)	8

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.