Diabetes
Conditions
Brief 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.
Interventions
DEVICEKarajishi TS Investigational Blood Glucose Monitoring System
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.
Sponsors
Ascensia Diabetes Care
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Venous Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method | 1 hour | 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). |
| 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 | 1 hour | 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). |
| 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 | 1 hour | 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). |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intended Users of the Monitoring System 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
Karajishi TS Investigational Blood Glucose Monitoring System: 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. | 134 |
| Total | 134 |
Baseline characteristics
| Characteristic | Intended Users of the Monitoring System |
|---|---|
| Age, Customized Age of enrolled subjects | 53.8 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 121 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 responses |
| Race (NIH/OMB) Asian | 8 responses |
| Race (NIH/OMB) Black or African American | 11 responses |
| Race (NIH/OMB) More than one race | 5 responses |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 responses |
| Race (NIH/OMB) Unknown or Not Reported | 6 responses |
| Race (NIH/OMB) White | 108 responses |
| Region of Enrollment United States | 134 participants |
| Sex: Female, Male Female | 71 Participants |
| Sex: Female, Male Male | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 134 |
| serious Total, serious adverse events | 0 / 134 |
Outcome results
Primary
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).
Time frame: 1 hour
Population: 132 (134-2)Blood glucose results were analyzed. Lab reference replicates for one subject were discrepant and not evaluable per protocol. One subject had no fingerstick result.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intended Users of the Monitoring System | 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 | 127 Blood glucose results |
Secondary
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).
Time frame: 1 hour
Population: 129 (134-5) Blood glucose results were analyzed. Lab reference replicates for one subject were discrepant and not evaluable per protocol. One subject had low blood sugar and AST result was not evaluable per protocol. One subject with low blood sugar did not attempt AST testing per protocol. No AST palm results were obtained for 2 subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intended Users of the Monitoring System | 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 | 121 Blood glucose results |
Secondary
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).
Time frame: 1 hour
Population: 133 (134-1) Blood glucose results were analyzed. Lab reference replicates for one subject were discrepant and not evaluable per protocol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intended Users of the Monitoring System | 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 | 131 Blood glucose results |
Secondary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intended Users of the Monitoring System | Number of Subject Responses That Strongly Agree or Agree or Are Neutral With Questionnaire Statements | The instruction (User Guide) is easy to understand | 132 participants |
| Intended Users of the Monitoring System | Number of Subject Responses That Strongly Agree or Agree or Are Neutral With Questionnaire Statements | I find it easy to do a blood test with this meter. | 132 participants |
| Intended Users of the Monitoring System | Number of Subject Responses That Strongly Agree or Agree or Are Neutral With Questionnaire Statements | The meter display is easy to see and read. | 133 participants |
| Intended Users of the Monitoring System | Number of Subject Responses That Strongly Agree or Agree or Are Neutral With Questionnaire Statements | It is easy to understand my test results. | 133 participants |
| Intended Users of the Monitoring System | Number of Subject Responses That Strongly Agree or Agree or Are Neutral With Questionnaire Statements | I like the overall meter design. | 134 participants |
| Intended Users of the Monitoring System | Number of Subject Responses That Strongly Agree or Agree or Are Neutral With Questionnaire Statements | I find the meter easy to use. | 132 participants |
| Intended Users of the Monitoring System | Number of Subject Responses That Strongly Agree or Agree or Are Neutral With Questionnaire Statements | Instructions clearly explain how to run a test. | 134 participants |
| Intended Users of the Monitoring System | Number of Subject Responses That Strongly Agree or Agree or Are Neutral With Questionnaire Statements | Instructions clearly explain meter error messages. | 134 participants |
Secondary
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).
Time frame: 1 hour
Population: 131 (134-3) Blood glucose results were analyzed. Lab reference replicates for one subject were discrepant and not evaluable per protocol. Venipuncture was not successful for 2 subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intended Users of the Monitoring System | Number of Venous Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method | 131 Blood glucose results |