DiabetesNCT02041377
Evaluation of an Karajishi TS Investigational Blood Glucose Monitoring System
A study testing Karajishi TS Investigational Blood Glucose Monitoring System in people with Diabetes, run by Ascensia Diabetes Care at 2 sites in United States.
Trial summary
The purpose of this study was to determine if subjects who have diabetes can operate the Investigational Blood Glucose Monitoring System (BGMS) with no training 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?
- Karajishi TS Investigational Blood Glucose Monitoring System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2014to Jan 2014
- 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 Karajishi TS BGMS (or used a Bayer Contour TS meter)
- 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
- A condition which, in the opinion of the investigator or designee, would put the person or study conduct at risk
Trial locations and contacts
2 sites in 1 country.
United States2 sites
AMCR Institute
Escondido, California, 92026
Rainier Clinical Research Center
Renton, Washington, 98057
About this study
Official title: User Performance of the Karajishi Contour TS Blood Glucose Monitoring System
The purpose of this study was to determine if subjects who have diabetes can operate the Investigational Blood Glucose Monitoring System (BGMS) with no training and obtain valid glucose results.
- Conditions
- Diabetes
- Being tested
- Karajishi TS 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.
Karajishi TS Investigational Blood Glucose Monitoring SystemDevice
Subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi TS Investigational Blood Glucose Monitoring System with no training. All BG results were compared to reference method results obtained from subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma.
| Study group | Role | What they receive |
|---|---|---|
| Intended Users of the Monitoring System | Experimental | Subjects with diabetes used the Karajishi TS Investigational Blood Glucose Monitoring System with no training. The criteria for the intended use population:
1. At least 60% of subjects will be younger than age 65
2. At least 10% of subjects will have type 1 diabetes Receives: Device: Karajishi TS 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 +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method
Subjects with diabetes self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS) with no training. 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 +/-15 mg/dL (<100 mg/dL YSI capillary plasma) and +/-15% (>=100 mg/dL YSI capillary plasma).
Measured: 1 hour
Secondary outcomes (4)
Number of Venous Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method
Study staff tested subject venous blood using an investigational Blood Glucose Monitoring System (BGMS). Venous BGMS results were compared with subject venous plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer venous plasma BG results were used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI venous plasma) and +/-15% (>=100 mg/dL YSI venous plasma).
Measured: 1 hour
Number of Blood Glucose (BG) Results From Alternative Site Testing (AST) Palm Blood Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method
Subjects with diabetes self-tested Alternative Site (AST) palm blood using an investigational Blood Glucose Monitoring System (BGMS) with no training. BGMS AST palm 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 +/-15 mg/dL (<100 mg/dL YSI capillary plasma) and +/-15% (>=100 mg/dL YSI capillary plasma).
Measured: 1 hour
Number of Subject Fingerstick Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method When Obtained and Tested by Study Staff
Study staff obtained and tested subject 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 capillary plasma results were used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI capillary plasma) and +/-15% (>=100 mg/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.
- First posted22 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionJan 2014
- Study completionJan 2014
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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ascensia Diabetes Care
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leslie J Klaff, MD, Principal investigator, Rainier Clinical Research CenterTimothy Bailey, MD, Principal investigator, AMCR Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02041377
- Sponsor's protocol ID
- GCA-2013-002-01
- Status last verified
- Jan 2016
- First submitted
- 17 Jan 2014
- Last updated
- 29 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- User Performance of the Karajishi Contour TS Blood Glucose Monitoring System
- ClinicalTrials.gov ID
- NCT02041377
- Acronym / sponsor ID
- GCA-2013-002-01
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Ascensia Diabetes CareIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 22 Jan 2014 (estimated)
- Results
- Posted 16 Feb 2015
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 subjects who have diabetes can operate the Investigational Blood Glucose Monitoring System (BGMS) with no training and obtain valid glucose results.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intended Users of the Monitoring System | Experimental | Device: Karajishi TS Investigational Blood Glucose Monitoring SystemSubjects with diabetes used the Karajishi TS Investigational Blood Glucose Monitoring System with no training. The criteria for the intended use population: 1. At least 60% of subjects will be younger than age 65 2. At least 10% of subjects will have type 1 diabetes |
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 (7 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 Karajishi TS BGMS (or used a Bayer Contour TS meter)
- 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 |
|---|---|---|
| Karajishi TS Investigational Blood Glucose Monitoring SystemSubjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi TS Investigational Blood Glucose Monitoring System with no training. All BG results were compared to reference method results obtained from subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma. | Device | Intended Users of the Monitoring System |
Primary outcome
Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method
Time frame: 1 hour
Subjects with diabetes self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS) with no training. 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 +/-15 mg/dL (<100 mg/dL YSI capillary plasma) and +/-15% (>=100 mg/dL YSI capillary plasma).
4 secondary outcomes
Number of Venous Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method
Time frame: 1 hour
Number of Blood Glucose (BG) Results From Alternative Site Testing (AST) Palm Blood Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method
Time frame: 1 hour
Number of Subject Fingerstick Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method When Obtained and 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
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Leslie J Klaff, MD principal investigator
Rainier Clinical Research Center
Timothy Bailey, MD principal investigator
AMCR Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Karajishi TS 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 7 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 29 Feb 2016. 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 16 Feb 2015). 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 +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/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?
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 29 Feb 2016.