N/A
Completed N=78
Performance of an Investigational Blood Glucose Monitoring System in a Clinical Trial
Source: ClinicalTrials.gov NCT01328717 ↗Enrolled (actual)
78
Serious AEs
0.0%
Results posted
May 2012
Primary outcomePrimary: 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
Summary
Subjects with diabetes and study staff used an investigational blood glucose monitoring system.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 | — |
| SECONDARY Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Evaluation) |
77; 77; 77; 77 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01328717). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.