Diabetes
Conditions
Brief summary
The purpose of this study is to determine if subjects who have diabetes can operate the Investigational Blood Glucose Monitoring System (BGMS) without training and obtain valid glucose results.
Interventions
DEVICEKarajishi Contour Investigational BG Monitoring System
Subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi Contour Investigational BG Monitoring System with no training. All BG results are compared to reference method results obtained from subject capillary plasma. Also, study staff test subject venous blood and BG results are 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 BGMS (or used a Bayer Contour 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-test fingerstick blood use an investigational Blood Glucose Monitoring System (BGMS) with no training. BGMS results are compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results are 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 test subject venous blood using an investigational Blood Glucose Monitoring System (BGMS). Venous BGMS results are compared with subject venous plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer venous plasma BG results are 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-test Alternative Site (AST) palm blood using an investigational Blood Glucose Monitoring System (BGMS) with no training. BGMS AST palm results are compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results are 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 obtain and test subject fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results are compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma results are 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 will obtain subject responses using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS. Subjects may 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 use the Karajishi Contour Investigational BG Monitoring System with no training. | 136 |
| Total | 136 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
Baseline characteristics
| Characteristic | Intended Users of the Monitoring System |
|---|---|
| Age, Customized Age of enrolled subjects | 52.5 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 130 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 participants |
| Race (NIH/OMB) Asian | 7 participants |
| Race (NIH/OMB) Black or African American | 10 participants |
| Race (NIH/OMB) More than one race | 3 participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 participants |
| Race (NIH/OMB) White | 118 participants |
| Region of Enrollment United States | 136 participants |
| Sex: Female, Male Female | 63 Participants |
| Sex: Female, Male Male | 73 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 4 / 136 |
| serious Total, serious adverse events | 0 / 136 |
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-test fingerstick blood use an investigational Blood Glucose Monitoring System (BGMS) with no training. BGMS results are compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results are 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: 135 (136-1) Blood glucose results were analyzed. One subject discontinued from testing after low BG fingerstick result (hypoglycemia AE), thus no reference result available.
| 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-test Alternative Site (AST) palm blood using an investigational Blood Glucose Monitoring System (BGMS) with no training. BGMS AST palm results are compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results are 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: 130 (136-6) Blood glucose results were analyzed. One subject discontinued from all testing after hypoglycemia AE. One (1) subject with low blood sugar did not attempt AST testing per protocol. No AST palm results were obtained for one (1) subject. Three (3) subjects had low blood sugar; AST results were not evaluable per protocol.
| 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 | 112 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 obtain and test subject fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results are compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma results are 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: 135 (136-1) Blood glucose results were analyzed. One subject discontinued from all testing after hypoglycemia AE.
| 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 | 133 Blood glucose results |
Secondary
Number of Subject Responses That Strongly Agree or Agree or Are Neutral With Questionnaire Statements
Staff will obtain subject responses using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS. Subjects may 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 | I find it easy to do a blood test with this meter. | 136 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. | 136 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. | 136 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. | 136 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. | 136 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. | 136 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. | 136 participants |
| 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 | 136 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 test subject venous blood using an investigational Blood Glucose Monitoring System (BGMS). Venous BGMS results are compared with subject venous plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer venous plasma BG results are 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: 132 (136-4) Blood glucose results were analyzed. One subject discontinued from all testing after hypoglycemia AE. One (1) subject lab reference replicates 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 |