An interventional study of Contour Link Investigational Blood Glucose Monitoring System in Diabetes, sponsored by Ascensia Diabetes Care. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-02-29.
Sponsored by Ascensia Diabetes Care · Not applicable, Interventional, and Diagnostic
Subjects with diabetes and study staff used an investigational blood glucose monitoring system.
Ascensia Diabetes Care is the lead sponsor of 42 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects with diabetes used Contour Link Investigational Blood Glucose Monitoring System
Device: Contour 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.
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
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
| Milestone | Intended Users of the System |
|---|---|
| Started | 78 |
| Completed | 77 |
| Not completed | 1 |
| Withdrew: Adverse event | 1 |
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.
| Percentage of BG test results | 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 |
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.
| Number of Participants | Intended Users of the System |
|---|---|
| Turn meter on and off | 77 |
| Set meter time and date | 77 |
| Perform fingerstick blood test | 77 |
| Perform control test | 77 |
Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intended Users of the System | — | 0/78 (0%) | 2/78 (2.6%) |
| Event | Intended Users of the System |
|---|---|
| hypoglycemiaEndocrine disorders | 2/78 |
| Age, Customized(years) | Intended Users of the System |
|---|---|
| Mean | 55 (20 to 85) |
| Sex: Female, Male(Participants) | Intended Users of the System |
|---|---|
| Female | 41 |
| Male | 36 |
| Region of Enrollment(participants) | Intended Users of the System |
|---|---|
| United States | 77 |
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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Ascensia Diabetes Care