Diabetes
Conditions
Brief summary
Subjects with diabetes and study staff used an investigational blood glucose monitoring system.
Interventions
DEVICEContour Link Investigational Blood Glucose Monitoring System
Subjects with diabetes and study staff each performed Blood Glucose tests from the subject's capillary blood obtained from fingerstick using the Contour Link investigational meter.
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 above * Diagnosed as having type 1 or type 2 diabetes * Currently self-testing blood glucose at home for at least three months * Able to speak, read, and understand English * Willing to complete all study procedures
Exclusion criteria
* Gestational Diabetes * Hemophilia or any other bleeding disorder * Employee of competitive medical device company
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Fingerstick Blood Glucose (BG) Results Within +/-20%(>=75 mg/dL) and Within +/- 15mg/dL (<75 mg/dL) of Laboratory Glucose Method | 1 hour | Subjects with diabetes and study staff tested subject fingerstick blood using an investigational blood glucose meter (BGM). BGM results were compared to a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were used to calculate the number of BG results within +/- 20% (for reference BG results \>=75mg/dL) and within +/- 15mg/dL(for reference BG results \<75mg/dL) of the reference method results. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Evaluation) | 1 hour | Subjects read User Guide(UG)to learn to use the system and performed meter tasks. Study staff observed, then rated subjects' success (1 to 4) at performing tasks. Scale: 1.Performed tasks correctly without assistance. 2.Performed tasks correctly, but was directed to a specific part of the UG by the study staff as in a Customer Service call. 3.Performed tasks correctly, but required additional review/assistance similar to review of a specific function during a Customer Service call. 4.Subject incorrectly performed part of the testing regimen and was unaware of the error. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intended Users of the System Subjects with diabetes and study staff used an investigational blood glucose monitoring system. As a result of one subject's low blood sugar (and thus rapidly changing glucose values) during the study, 77 subjects completed the study. | 77 |
| Total | 77 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
Baseline characteristics
| Characteristic | Intended Users of the System |
|---|---|
| Age, Customized | 55 years |
| Region of Enrollment United States | 77 participants |
| Sex: Female, Male Female | 41 Participants |
| Sex: Female, Male Male | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 78 |
| serious Total, serious adverse events | 0 / 78 |
Outcome results
Primary
Percent of Fingerstick Blood Glucose (BG) Results Within +/-20%(>=75 mg/dL) and Within +/- 15mg/dL (<75 mg/dL) of Laboratory Glucose Method
Subjects with diabetes and study staff tested subject fingerstick blood using an investigational blood glucose meter (BGM). BGM results were compared to a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were used to calculate the number of BG results within +/- 20% (for reference BG results \>=75mg/dL) and within +/- 15mg/dL(for reference BG results \<75mg/dL) of the reference method results.
Time frame: 1 hour
Population: As a result of one subject's low blood sugar (and thus rapidly changing glucose values) during the study, one subject did not complete the study. The remaining 77 subjects tested 2 test strip lots on the system. 2x77(154) test results were available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intended Users of the System | Percent of Fingerstick Blood Glucose (BG) Results Within +/-20%(>=75 mg/dL) and Within +/- 15mg/dL (<75 mg/dL) of Laboratory Glucose Method | 95.5 Percentage of BG test results |
Secondary
Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Evaluation)
Subjects read User Guide(UG)to learn to use the system and performed meter tasks. Study staff observed, then rated subjects' success (1 to 4) at performing tasks. Scale: 1.Performed tasks correctly without assistance. 2.Performed tasks correctly, but was directed to a specific part of the UG by the study staff as in a Customer Service call. 3.Performed tasks correctly, but required additional review/assistance similar to review of a specific function during a Customer Service call. 4.Subject incorrectly performed part of the testing regimen and was unaware of the error.
Time frame: 1 hour
Population: Per protocol
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intended Users of the System | Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Evaluation) | Turn meter on and off | 77 Number of Participants |
| Intended Users of the System | Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Evaluation) | Set meter time and date | 77 Number of Participants |
| Intended Users of the System | Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Evaluation) | Perform fingerstick blood test | 77 Number of Participants |
| Intended Users of the System | Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Evaluation) | Perform control test | 77 Number of Participants |