CompletedNCT01824355Updated Feb 29, 2016Results posted

Performance of an Investigational Blood Glucose Monitoring System

An interventional study of Ninja 3 PLUS Investigational BG Monitoring System in Diabetes, sponsored by Ascensia Diabetes Care. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-02-29.

Sponsored by Ascensia Diabetes Care · Not applicable, Interventional, and Diagnostic

Phase: Not applicable
Study type: Interventional
Enrollment: 113
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

Diabetes

In context

Lead sponsor

Ascensia Diabetes Care is the lead sponsor of 42 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Males and females, 18 years of age or older.
1. People with type 1 or type 2 diabetes.
2. Able to speak, read and understand English.
3. Willing to complete all study procedures.

Exclusion criteria

Hemophilia or any other bleeding disorder.
1. Pregnancy.
2. Physical, visual or neurological impairments that would make the person unable to perform testing with the BGM.
3. Previously participated in a blood glucose monitoring study using the Ninja 3 Plus BGMS.
4. Working for a medical laboratory, hospital or other clinical setting that involves training on or clinical use of blood glucose meters.
5. Working for a competitive medical device company, or having an immediate family member who works for such a company.
6. A condition, which in the opinion of the investigator or designee, would put the person or study conduct at risk.

Study design

Phase: Not applicable
Primary purpose: Diagnostic
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 113 participants (actual)

Study arms

Experimental
Intended Users of the Monitoring System
Untrained subjects with diabetes used the Ninja 3 PLUS Investigational BG Monitoring System. General enrollment criteria for the 'Intended Users' population: 1. At least 60% of subjects were younger than 65 years of age. 2. At least 20% had type 1 diabetes. 3. At least 50% with type 2 diabetes were insulin users.
Device: Ninja 3 PLUS Investigational BG Monitoring System

Interventions

DeviceNinja 3 PLUS Investigational BG Monitoring System
Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Ninja 3 PLUS Investigational BG Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to a reference laboratory glucose method.

What researchers measure

Primary outcomes

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
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.
Time frame: 1 hour

Secondary outcomes

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
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.
Time frame: 1 hour
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
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.
Time frame: 1 hour
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.
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).
Time frame: 1 hour
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
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.
Time frame: one hour
Number of Subject Responses That 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements
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

Results

Posted Jan 6, 2015

Participant flow

Participant flow — Overall Study
Milestone	Intended Users of the Monitoring System
Started	113
Completed	110
Not completed	3
Withdrew: Adverse event	2
Withdrew: Unevaluable reference method results per	1

Outcome measures

PrimaryPercent 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

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.

Time frame:: 1 hour
Reported as:: Number · percentage of BG results

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
percentage of BG results	Intended Users of the Monitoring System
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	99.09

SecondaryPercent 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

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.

Time frame:: 1 hour
Reported as:: Number · percentage of Blood Glucose Results

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
percentage of Blood Glucose Results	Intended Users of the Monitoring System
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	97.73

SecondaryPercent 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

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.

Time frame:: 1 hour
Reported as:: Number · percentage of Blood Glucose 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
percentage of Blood Glucose Results	Intended Users of the Monitoring System
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	93.64

SecondaryPercent 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.

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).

Time frame:: 1 hour
Reported as:: Number · percentage of AST Blood Glucose 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.
percentage of AST Blood Glucose Results	Intended Users of the Monitoring System
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.	97.13

SecondaryPercent 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

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.

Time frame:: one hour
Reported as:: Number · percentage of Blood Glucose Results

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
percentage of Blood Glucose Results	Intended Users of the Monitoring System
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	100.0

SecondaryNumber of Subject Responses That 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements

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
Reported as:: Number · participants

Number of Subject Responses That 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements
participants	Intended Users of the Monitoring System
I find it easy to do a blood test with this meter	108
The meter display is easy to see and read	108
It was easy to understand my test results	108
I like the overall meter design	106
I find the meter easy to use	106
The instructions (User Guide) easy to understand	105
Instructions clearly explain how to run a test	107
Instructions clearly explain meter error messages	108

Adverse events

Collected over 1 hour subject visit. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Intended Users of the Monitoring System	—	0/113 (0%)	3/113 (2.7%)

Most frequent other events

Most frequent other events
Event	Intended Users of the Monitoring System
HypoglycemiaEndocrine disorders	1/113
DizzyEndocrine disorders	1/113
HeadacheEndocrine disorders	1/113

Baseline characteristics

All enrollees

Age, Customized
Age, Customized(years)	Intended Users of the Monitoring System
Age of enrolled subjects	59.1 (26 to 78)

Sex: Female, Male
Sex: Female, Male(Participants)	Intended Users of the Monitoring System
Female	63
Male	50

Race (NIH/OMB)
Race (NIH/OMB)(responses)	Intended Users of the Monitoring System
American Indian or Alaska Native	1
Asian	0
Native Hawaiian or Other Pacific Islander	0
Black or African American	26
White	84
More than one race	1
Unknown or Not Reported	3

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Intended Users of the Monitoring System
Hispanic or Latino	10
Not Hispanic or Latino	103
Unknown or Not Reported	0

Region of Enrollment
Region of Enrollment(participants)	Intended Users of the Monitoring System
United States	113

Study locations

1 site

Consumer Product Testing Co.
Fairfield, New Jersey 07004, United States

References and documents

Publications

Caswell M, Brown D, Frank J, Wallace JF, Pardo S. Accuracy and user performance evaluation of a blood glucose monitoring system which wirelessly transmits results to compatible insulin pumps. Curr Med Res Opin. 2020 May;36(5):757-764. doi: 10.1080/03007995.2020.1734919. Epub 2020 Mar 17. PubMed 32096654 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 29, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01824355
Lead sponsor: Ascensia Diabetes Care
Responsible party: Sponsor
First posted: Apr 4, 2013
Start date: Mar 2013
Primary completion: Mar 2013
Completion: Mar 2013
Results posted: Jan 6, 2015
Last update: Feb 29, 2016

Study contacts

Michael Caswell, PhD

principal investigator · Consumer Product Testing Co.

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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