N/A
Completed N=110
User Performance Evaluation of an Investigational Blood Glucose Monitoring System
Source: ClinicalTrials.gov NCT01410773 ↗Enrolled (actual)
110
Serious AEs
0.0%
Results posted
Aug 2012
Primary outcomePrimary: Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/-15mg/dL(<75 mg/dL) or Within +/- 20% (>=75 mg/dL) of Laboratory Glucose Method — 110; 109; 109; 90 participants
Summary
The purpose of this study is to demonstrate that untrained subjects with diabetes can use an investigational Blood Glucose Monitoring System (BGMS) with capillary blood obtained from fingerstick and from Alternative Site (AST) Palm .
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/-15mg/dL(<75 mg/dL) or Within +/- 20% (>=75 mg/dL) of Laboratory Glucose Method |
110; 109; 109; 90 | — |
| SECONDARY Number of Alternative Site (AST) Palm Blood Glucose (BG) Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method |
106; 105; 97; 67 | — |
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
- Able to speak, read, and understand English
- Willing to complete all study procedures
Exclusion Criteria
- Blood Borne infections like hepatitis or HIV or infections such as tuberculosis
- Hemophilia or any other bleeding disorder
- Employee of competitive medical device company, immediate family member of such, or living within the household of such
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT01410773). 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.