N/A
Completed N=226
Study of an Investigational Glucose Meter System
Source: ClinicalTrials.gov NCT01474317 ↗Enrolled (actual)
226
Serious AEs
0.0%
Results posted
Jan 2013
Primary outcomePrimary: Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 5to15mg/dL (<100mg/dL) or Within +/- 5to15% (>=100mg/dL) of Laboratory Glucose Method — 100; 98.9; 100; 98.4 percentage of meter test results
Summary
The purpose of this study is to demonstrate that untrained subjects who have diabetes can operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain valid glucose results.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 5to15mg/dL (<100mg/dL) or Within +/- 5to15% (>=100mg/dL) of Laboratory Glucose Method |
100; 98.9; 100; 98.4; 100; 95.6 | — |
| SECONDARY Percent of Glucose Results From Alternative Site Testing (AST) of the Palm Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method |
100; 99.1 | — |
| SECONDARY Percent of Venous Blood Glucose Results Within +/- 5to15mg/dL (<75mg/dL) or Within +/- 5to20% (>=75mg/dL) of Laboratory Glucose Method |
100; 99.5; 100; 99.1; 100; 98.6 | — |
| SECONDARY Number of Subjects Able to Perform Given Tasks Using Product Labeling for Instruction |
208; 203; 215 | — |
Eligibility Criteria
Inclusion Criteria
- Males and females, 18 years of age and older
- Type 1 or type 2 diabetes
- Able to speak, read, and understand English
- Willing to complete all study procedures
Exclusion Criteria
- Pregnancy
- Hemophilia or any other bleeding disorder
- Previously participated in a study using the G3 system
- Working for a medical laboratory, hospital or other clinical setting that involves training on and clinical use of blood glucose monitors.
- A condition, which in the opinion of the investigator, would put the person or study conduct at risk (reason for exclusion will be clearly documented by investigator or designee).
- Working for a competitive medical device company, or having an immediate family member or someone who is not a family member but is living within the household of someone who works for such a company.
Data sourced from ClinicalTrials.gov (NCT01474317). 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.