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
DEVICEG3 Investigational Blood Glucose Monitoring System
Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the G3 meter and an investigational sensor. Study staff test subject venous blood and all BG results are compared to a reference laboratory glucose method. Untrained subjects utilize some additional features of the meter using the User Guide and provide feedback.
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 G3 system * Working for a medical laboratory, hospital or other clinical setting that involves training on and clinical use of blood glucose monitors. * 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). * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. 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). Site staff tested in parallel after subjects. |
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. YSI capillary plasma 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). |
| Percent of Venous Blood Glucose Results Within +/- 5to15mg/dL (<75mg/dL) or Within +/- 5to20% (>=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. YSI venous plasma results are used to calculate the number of BGMS results within +/- 5to15mg/dL (\<75mg/dL YSI venous plasma) or +/- 5to20% (\>=75mg/dL YSI venous plasma). |
| Number of Subjects Able to Perform Given Tasks Using Product Labeling for Instruction | 1 hour | After reading the instructions for use, and without assistance from the study staff, subjects use the BGMS to utilize some of the additional features of the system. Study staff documents Yes or No 'Did the subject complete the task successfully?' |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intended Users of the Monitoring System Untrained subjects with diabetes use the G3 investigational blood glucose monitoring system. Of 226 subjects enrolled, 224 completed the study
G3 Investigational Blood Glucose Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the G3 meter and an investigational sensor. Study staff test subject venous blood and all BG results are compared to a reference laboratory glucose method. Untrained subjects utilize some additional features of the meter using the User Guide and provide feedback. | 224 |
| Total | 224 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Subject ineligible for study | 1 |
Baseline characteristics
| Characteristic | Intended Users of the Monitoring System |
|---|---|
| Age, Continuous | 54.4 years |
| Region of Enrollment United States | 224 participants |
| Sex: Female, Male Female | 131 Participants |
| Sex: Female, Male Male | 93 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 4 / 224 |
| serious Total, serious adverse events | 0 / 224 |
Outcome results
Primary
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. 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). Site staff tested in parallel after subjects.
Time frame: 1 hour
Population: Blood data for three subjects were not evaluable because time defined in protocol was exceeded between meter test and blood sample preparation for reference method. 221 (224-3) blood test results were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intended Users of the G3 Investigational BG 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 15 mg/dL(<100 mg/dL BG) | 100 percentage of meter test results |
| Intended Users of the G3 Investigational BG 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 15% (>=100 mg/dL BG) | 98.9 percentage of meter test results |
| Intended Users of the G3 Investigational BG 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 12.5% (>=100 mg/dL BG) | 98.4 percentage of meter test results |
| Intended Users of the G3 Investigational BG 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 10 mg/dL (<100 mg/dL BG) | 100 percentage of meter test results |
| Intended Users of the G3 Investigational BG 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 10% (>=100 mg/dL BG) | 95.6 percentage of meter test results |
| Intended Users of the G3 Investigational BG 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 5 mg/dL (<100 mg/dL BG) | 76.9 percentage of meter test results |
| Intended Users of the G3 Investigational BG 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 5% (>=100 mg/dL BG) | 78.6 percentage of meter test results |
| Intended Users of the G3 Investigational BG 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 12.5 mg/dL (<100 mg/dL BG) | 100 percentage of meter test results |
Secondary
Number of Subjects Able to Perform Given Tasks Using Product Labeling for Instruction
After reading the instructions for use, and without assistance from the study staff, subjects use the BGMS to utilize some of the additional features of the system. Study staff documents Yes or No 'Did the subject complete the task successfully?'
Time frame: 1 hour
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intended Users of the G3 Investigational BG Monitoring System | Number of Subjects Able to Perform Given Tasks Using Product Labeling for Instruction | Mark a test result as 'Before Meal' | 208 participants |
| Intended Users of the G3 Investigational BG Monitoring System | Number of Subjects Able to Perform Given Tasks Using Product Labeling for Instruction | Set a reminder | 203 participants |
| Intended Users of the G3 Investigational BG Monitoring System | Number of Subjects Able to Perform Given Tasks Using Product Labeling for Instruction | Access BG trends | 215 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. YSI capillary plasma 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).
Time frame: 1 hour
Population: Blood data for 3 subjects were not evaluable because time defined in protocol was exceeded between meter test and blood sample preparation for reference method. 221 (224-3) blood test results were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intended Users of the G3 Investigational BG 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 | % within 15 mg/dL (<75 mg/dL BG) | 100 percentage of meter test results |
| Intended Users of the G3 Investigational BG 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 | % within 20% (>=75 mg/dL BG) | 99.1 percentage of meter test results |
Secondary
Percent of Venous Blood Glucose Results Within +/- 5to15mg/dL (<75mg/dL) or Within +/- 5to20% (>=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. YSI venous plasma results are used to calculate the number of BGMS results within +/- 5to15mg/dL (\<75mg/dL YSI venous plasma) or +/- 5to20% (\>=75mg/dL YSI venous plasma).
Time frame: 1 hour
Population: Venipuncture was unsuccessful for one subject. 223 (224-1) venous blood test results were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intended Users of the G3 Investigational BG Monitoring System | Percent of Venous Blood Glucose Results Within +/- 5to15mg/dL (<75mg/dL) or Within +/- 5to20% (>=75mg/dL) of Laboratory Glucose Method | % within 20% (>=75 mg/dL BG) | 100 percentage of meter test results |
| Intended Users of the G3 Investigational BG Monitoring System | Percent of Venous Blood Glucose Results Within +/- 5to15mg/dL (<75mg/dL) or Within +/- 5to20% (>=75mg/dL) of Laboratory Glucose Method | % within 15% (>=75 mg/dL BG) | 99.5 percentage of meter test results |
| Intended Users of the G3 Investigational BG Monitoring System | Percent of Venous Blood Glucose Results Within +/- 5to15mg/dL (<75mg/dL) or Within +/- 5to20% (>=75mg/dL) of Laboratory Glucose Method | %within 15 mg/dL (<75 mg/dL BG) | 100 percentage of meter test results |
| Intended Users of the G3 Investigational BG Monitoring System | Percent of Venous Blood Glucose Results Within +/- 5to15mg/dL (<75mg/dL) or Within +/- 5to20% (>=75mg/dL) of Laboratory Glucose Method | % within 12.5% (>=75 mg/dL BG) | 99.1 percentage of meter test results |
| Intended Users of the G3 Investigational BG Monitoring System | Percent of Venous Blood Glucose Results Within +/- 5to15mg/dL (<75mg/dL) or Within +/- 5to20% (>=75mg/dL) of Laboratory Glucose Method | % within 12.5 mg/dL (<75 mg/dL BG) | 100 percentage of meter test results |
| Intended Users of the G3 Investigational BG Monitoring System | Percent of Venous Blood Glucose Results Within +/- 5to15mg/dL (<75mg/dL) or Within +/- 5to20% (>=75mg/dL) of Laboratory Glucose Method | % within 10% (>=75 mg/dL BG) | 98.6 percentage of meter test results |
| Intended Users of the G3 Investigational BG Monitoring System | Percent of Venous Blood Glucose Results Within +/- 5to15mg/dL (<75mg/dL) or Within +/- 5to20% (>=75mg/dL) of Laboratory Glucose Method | % within 10 mg/dL (<75 mg/dL BG) | 100 percentage of meter test results |
| Intended Users of the G3 Investigational BG Monitoring System | Percent of Venous Blood Glucose Results Within +/- 5to15mg/dL (<75mg/dL) or Within +/- 5to20% (>=75mg/dL) of Laboratory Glucose Method | % within 5 mg/dL (<75 mg/dL BG) | 83.3 percentage of meter test results |
| Intended Users of the G3 Investigational BG Monitoring System | Percent of Venous Blood Glucose Results Within +/- 5to15mg/dL (<75mg/dL) or Within +/- 5to20% (>=75mg/dL) of Laboratory Glucose Method | % within 5% (>=75 mg/dL BG) | 71.4 percentage of meter test results |