N/A
N=118
User Study of an Investigational Blood Glucose Monitoring System
Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT01447121 ↗Enrolled (actual)
118
Serious AEs
0.0%
Results posted
Oct 2012
Primary outcome: 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 — 115 BG test results
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Tatsu/Tradewind Investigational BG Monitoring System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ascensia Diabetes Care
- Primary completion
- Sep 2011
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 |
115 | — |
| SECONDARY Number of Study Staff Results Within +/- 15mg/dL (<75 mg/dL) or Within +/- 20% (>=75 mg/dL) of Laboratory Glucose Method When Testing Subject Blood Glucose (BG) |
115 | — |
Summary
This clinical trial is designed to assess an investigational blood glucose monitoring system with fingerstick blood in the hands of untrained intended users.
Eligibility Criteria
Inclusion Criteria
- Type 1 or type 2 diabetes
- 18 years of age and older
- Able to speak, read, and understand English
- Willing to complete all study procedures
Exclusion Criteria
- Previously participated in a study using this investigational system
- Working for a medical laboratory, hospital, or other clinical setting that involves training on and clinical use of blood glucose monitors
- Pregnancy
- Hemophilia or any other bleeding disorder
- 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
- 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).
Data sourced from ClinicalTrials.gov (NCT01447121). 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.