N/A
Completed N=94
Performance of an Investigational Blood Glucose Monitoring System in a Clinical Setting
Source: ClinicalTrials.gov NCT01268267 ↗Enrolled (actual)
94
Serious AEs
0.0%
Results posted
May 2012
Primary outcomePrimary: Numbers of Fingerstick Blood Glucose (BG) Results Within +/- 5 to 20mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method — 180; 179; 172; 138 Number of BG test results
Summary
The purpose of this study is to evaluate the performance and acceptability of an investigational blood glucose monitoring system, which includes meter and sensor strip.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Numbers of Fingerstick Blood Glucose (BG) Results Within +/- 5 to 20mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method |
180; 179; 172; 138 | — |
| SECONDARY Numbers of Palm Blood Glucose (BG) Results Within +/- 5 to 20 mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method |
166; 161; 143; 82 | — |
| SECONDARY Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Comprehension) |
93; 93; 93; 93; 90; 90 | — |
| SECONDARY Numbers of Forearm Blood Glucose (BG) Results Within +/- 5 to 20 mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method |
158; 145; 125; 74 | — |
Eligibility Criteria
Inclusion Criteria
- Males and females, 18 years of age and above
- Type 1 or type 2 diabetes
- Currently self-testing blood glucose at home at least twice daily
- Able to speak, read, and understand English
- Willing to complete all study procedures
Exclusion Criteria
- Currently Pregnant
- Hemophilia or any other bleeding disorder
- Employee of competitive medical device company
- Cognitive disorder or other condition which, in the opinion of the investigator, would put the person at risk or seriously compromise the integrity of the study
Data sourced from ClinicalTrials.gov (NCT01268267). 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.