Diabetes
Conditions
Brief summary
The purpose of this study is to demonstrate that untrained subjects who have diabetes can operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain valid glucose results.
Interventions
DEVICECONTOUR® PLUS Investigational BG Monitoring System
Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the CONTOUR® PLUS Investigational BG Monitoring System. Study staff test subject venous blood. All Blood Glucose (BG) results are compared to a reference laboratory glucose method.
Sponsors
Ascensia Diabetes Care
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
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 * Type 1 or type 2 diabetes * Able to speak, read, and understand English * Willing to complete all study procedures
Exclusion criteria
* Pregnancy * Hemophilia or any other bleeding disorder * Previously participated in a study using the CONTOUR PLUS system * 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 or someone who is not a family member but is living within the household of someone who works for such a company. * A condition, which in the opinion of the investigator, would put the person or study conduct at risk (reason for exclusion will be clearly documented by investigator or designee).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method | 1 hour | Untrained subjects with diabetes self-test fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. BG results are used to calculate the number of BGMS results within +/- 15mg/dL (\<75mg/dL YSI capillary plasma) or +/- 20% (\>=75mg/dL YSI capillary plasma) of the reference method results. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Glucose Results From Alternative Site Testing (AST) of the Palm Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method | 1 hour | Untrained subjects with diabetes self-test Alternative Site (AST) Palm blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS AST results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. BG results are used to calculate the number of AST BGMS results within +/- 15mg/dL (\<75mg/dL YSI capillary plasma) or +/- 20% (\>=75mg/dL YSI capillary plasma) of the reference method results. |
| Percent of Venous Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method | 1 hour | Study staff tested subject venous blood using an investigational Blood Glucose Monitoring System (BGMS). Venous BGMS results are compared with venous plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. Venous plasma BG results are used to calculate the number of BGMS results within +/- 15mg/dL (\<75mg/dL YSI venous plasma) or +/- 20% (\>=75mg/dL YSI venous plasma) of the reference method results. |
| Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 5to15mg/dL (<100mg/dL) or Within +/- 5to15% (>=100mg/dL) of Laboratory Glucose Method | 1 hour | Untrained subjects with diabetes self-test fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. BG results are used to calculate the number of BGMS results within +/- 5to15mg/dL (\<100mg/dL YSI capillary plasma) or +/- 5to15% (\>=100mg/dL YSI capillary plasma) of the reference method results. |
| Percent of Subject Fingerstick BG Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method When Tested by Study Staff | 1 hour | Study staff test subject fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. BG results are used to calculate the number of BGMS results within +/- 15mg/dL (\<75mg/dL YSI capillary plasma) or +/- 20% (\>=75mg/dL YSI capillary plasma) of the reference method results. |
| Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements | 1 hour | Subjects respond to statements read by study staff to provide feedback on the labeling materials and system ease of use. 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 Untrained subjects with diabetes use CONTOUR® PLUS Investigational BG Monitoring System. | 220 |
| Total | 220 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
Baseline characteristics
| Characteristic | Intended Users of the Monitoring System |
|---|---|
| Age, Continuous | 60 years |
| Region of Enrollment United States | 220 participants |
| Sex: Female, Male Female | 118 Participants |
| Sex: Female, Male Male | 102 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 220 |
| serious Total, serious adverse events | 0 / 220 |
Outcome results
Primary
Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method
Untrained subjects with diabetes self-test fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. BG results are used to calculate the number of BGMS results within +/- 15mg/dL (\<75mg/dL YSI capillary plasma) or +/- 20% (\>=75mg/dL YSI capillary plasma) of the reference method results.
Time frame: 1 hour
Population: 216 (220-4) blood test results were analyzed. Blood data for 2 subjects were not evaluable because time, defined in protocol, was exceeded between meter test and blood sample preparation for reference method. No fingerstick results were obtained for 2 subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intended Users of the Monitoring System | Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method | 100 percentage of BG Test Results |
Secondary
Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements
Subjects respond to statements read by study staff to provide feedback on the labeling materials and system ease of use. Subjects may respond 'Strongly Agree' 'Agree' 'Neutral' 'Disagree' or 'Strongly Disagree'.
Time frame: 1 hour
Population: Per protocol
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intended Users of the Monitoring System | Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements | Easy to handle the individual test strips. | 218 participants |
| Intended Users of the Monitoring System | Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements | Instructions (User Guide) easy to understand. | 218 participants |
| Intended Users of the Monitoring System | Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements | Instructions clearly explain how to run a test. | 220 participants |
| Intended Users of the Monitoring System | Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements | Instructions clearly explain meter error messages. | 218 participants |
| Intended Users of the Monitoring System | Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements | I found it easy to do a blood test with this meter | 215 participants |
| Intended Users of the Monitoring System | Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements | Meter display(test result) is easy to see and read | 220 participants |
| Intended Users of the Monitoring System | Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements | It was easy to understand my test results. | 218 participants |
| Intended Users of the Monitoring System | Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements | I like the overall meter design. | 218 participants |
| Intended Users of the Monitoring System | Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements | I find the meter easy to handle. | 218 participants |
Secondary
Percent of Glucose Results From Alternative Site Testing (AST) of the Palm Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method
Untrained subjects with diabetes self-test Alternative Site (AST) Palm blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS AST results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. BG results are used to calculate the number of AST BGMS results within +/- 15mg/dL (\<75mg/dL YSI capillary plasma) or +/- 20% (\>=75mg/dL YSI capillary plasma) of the reference method results.
Time frame: 1 hour
Population: 213 (220-7) blood test results were analyzed. Four(4) subjects had low blood sugar and AST results were not evaluable per protocol. One(1) subject with low blood sugar (AE) 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 | Percent of Glucose Results From Alternative Site Testing (AST) of the Palm Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method | 98.1 percentage of BG Test Results |
Secondary
Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 5to15mg/dL (<100mg/dL) or Within +/- 5to15% (>=100mg/dL) of Laboratory Glucose Method
Untrained subjects with diabetes self-test fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. BG results are used to calculate the number of BGMS results within +/- 5to15mg/dL (\<100mg/dL YSI capillary plasma) or +/- 5to15% (\>=100mg/dL YSI capillary plasma) of the reference method results.
Time frame: 1 hour
Population: 108 (110-2) blood test results from one test strip lot were analyzed. Blood data for 1 subject was not evaluable because time, defined in protocol, was exceeded between meter test and blood sample preparation for reference method. No fingerstick result was obtained for 1 subject.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intended Users of the Monitoring System | Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 5to15mg/dL (<100mg/dL) or Within +/- 5to15% (>=100mg/dL) of Laboratory Glucose Method | w/in +/-10mg/dL(<100mg/dL) or +/- 10% (>=100mg/dL) | 86.1 percentage of BG Test Results |
| Intended Users of the Monitoring System | Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 5to15mg/dL (<100mg/dL) or Within +/- 5to15% (>=100mg/dL) of Laboratory Glucose Method | w/in +/-5mg/dL(<100mg/dL) or +/- 5% (>=100mg/dL) | 53.7 percentage of BG Test Results |
| Intended Users of the Monitoring System | Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 5to15mg/dL (<100mg/dL) or Within +/- 5to15% (>=100mg/dL) of Laboratory Glucose Method | % within +/-15mg/dL(<100mg/dL) or 15% (>=100mg/dL) | 98.2 percentage of BG Test Results |
| Intended Users of the Monitoring System | Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 5to15mg/dL (<100mg/dL) or Within +/- 5to15% (>=100mg/dL) of Laboratory Glucose Method | w/in +/-12.5mg/dL(<100mg/dL) or 12.5% (>=100mg/dL) | 93.5 percentage of BG Test Results |
Secondary
Percent of Subject Fingerstick BG Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method When Tested by Study Staff
Study staff test subject fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. BG results are used to calculate the number of BGMS results within +/- 15mg/dL (\<75mg/dL YSI capillary plasma) or +/- 20% (\>=75mg/dL YSI capillary plasma) of the reference method results.
Time frame: 1 hour
Population: 217 (220-3) blood test results were analyzed. Blood data for 2 subjects were not evaluable because time, defined in protocol, was exceeded between meter test and blood sample preparation for reference method. No fingerstick results were obtained for 1 subject.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intended Users of the Monitoring System | Percent of Subject Fingerstick BG Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method When Tested by Study Staff | 99.5 percentage of BG Test Results |
Secondary
Percent of Venous Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method
Study staff tested subject venous blood using an investigational Blood Glucose Monitoring System (BGMS). Venous BGMS results are compared with venous plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. Venous plasma BG results are used to calculate the number of BGMS results within +/- 15mg/dL (\<75mg/dL YSI venous plasma) or +/- 20% (\>=75mg/dL YSI venous plasma) of the reference method results.
Time frame: 1 hour
Population: 213 (220-7) blood test results were analyzed. Venipuncture was unsuccessful for 6 subjects. Blood data for 1 subject was not evaluable because time, defined in protocol, was exceeded between meter test and blood sample preparation for reference method.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intended Users of the Monitoring System | Percent of Venous Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method | 99.5 percentage of BG Test Results |