DiabetesNCT01859494

Evaluation of an Investigational Blood Glucose Monitoring System

A study testing NINJA 3 Investigational Blood Glucose Monitoring System in people with Diabetes, run by Ascensia Diabetes Care at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes
What is being tested?: NINJA 3 Investigational Blood Glucose Monitoring System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 219 participants
Where: 2 sitesUnited States
Study dates: Apr 2013to May 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Hemophilia or any other bleeding disorder
Pregnancy
Physical, visual, or neurological impairments that would make the person unable to perform testing with the BGM
Previously participated in a BG monitor study using the Ninja 3 BGMS
Working for a medical laboratory, hospital, or other clinical setting that involves training on and clinical use of blood glucose monitors
Working for a competitive medical device company, or having an immediate family member who works for such a company

Show all 11Show fewer

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:
At least 60% of subjects will be younger than age 65
At least 20% of subjects will have type 1 diabetes
At least 50% of subjects with type 2 diabetes wil be insulin users.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

AMCR Institute
Escondido, California, 92026
Rainier Clinical Research Center
Renton, Washington, 98057

Other trials in United States

About this study

Official title: Performance of the Ninja 3 Blood Glucose Monitoring System

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.

Conditions: Diabetes
Being tested: NINJA 3 Investigational Blood Glucose Monitoring System
Medical subject headings: Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NINJA 3 Investigational Blood Glucose Monitoring SystemDevice
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.

Study groups in NCT01859494
Study group	Role	What they receive
Users of the Monitoring System	Experimental	Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System. Receives: Device: NINJA 3 Investigational Blood Glucose Monitoring System

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (5)

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
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)
Measured: 1 hour
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
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)
Measured: 1 hour
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
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)
Measured: 1 hour
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
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)
Measured: 1 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'.
Measured: 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2013May 2013

First posted22 May 2013 (estimated)
Study startApr 2013
Primary completionMay 2013
Study completionMay 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for DiabetesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 219 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01859494
Sponsor's protocol ID: CTD-2012-009-01
Status last verified: Dec 2016
First submitted: 19 May 2013
Last updated: 10 Feb 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: When it is cleared, results data will be provided.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Performance of the Ninja 3 Blood Glucose Monitoring System
ClinicalTrials.gov ID: NCT01859494
Acronym / sponsor ID: CTD-2012-009-01
Conditions: Diabetes
Study type: Interventional
Recruitment status: Completed
Enrolment: 219 participants (actual)
Lead sponsor: Ascensia Diabetes CareIndustry (pharma, biotech, devices)
Study start: Apr 2013
Primary completion: May 2013 (actual)
Study completion: May 2013 (actual)
First posted: 22 May 2013 (estimated)
Results: Posted 31 Oct 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Users of the Monitoring System	Experimental	Device: NINJA 3 Investigational Blood Glucose Monitoring SystemUntrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (11 listed)

Hemophilia or any other bleeding disorder
Pregnancy
Physical, visual, or neurological impairments that would make the person unable to perform testing with the BGM
Previously participated in a BG monitor study using the Ninja 3 BGMS
Working for a medical laboratory, hospital, or other clinical setting that involves training on and clinical use of blood glucose monitors

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NINJA 3 Investigational Blood Glucose Monitoring SystemUntrained 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.	Device	Users of the Monitoring System

Primary outcome

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

5 secondary outcomes

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

Results and safety

Results posted to the registry on 31 Oct 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Users of the Monitoring System	219	218

Primary outcome: Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/-15mg/dL (<75mg/dL) or Within +/-20% (>=75mg/dL) of Laboratory Glucose Method

Time frame: 1 hour. Number. Unit: Blood Glucose results within 15mg/dL/20%

Measure	Users of the Monitoring System n = 218
Value	218

Population analysed: 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.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Subject visits were approximately 1 hour.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Users of the Monitoring System	0 of 219 (0%)	8 of 219 (3.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. When it is cleared, results data will be provided.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Timothy Bailey, MD principal investigator

AMCR Institute

Leslie J Klaff, MD principal investigator

Rainier Clinical Research Center

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing NINJA 3 Investigational Blood Glucose Monitoring System in people with Diabetes, run by Ascensia Diabetes Care at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/-15mg/dL (<75mg/dL) or Within +/-20% (>=75mg/dL) of Laboratory Glucose Method (time frame: 1 hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01859494.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2017.