Validation Study of G4 User Interface
Completed
- Conditions
- Diabetes Mellitus
- Registration Number
- NCT01142895
- Lead Sponsor
- Tandem Diabetes Care, Inc.
- Brief Summary
The purpose of this simulated useability study is to demonstrate the user interface and software design mitigate potential safety concerns.
- Detailed Description
These are the detailed descriptive planned outcomes of this useability study.
* To demonstrate that human-interface design mitigations lead to effective, efficient, and safe use.
* Validate that foreseeable misuse does not lead to a safety hazard or patient injury.
* Validate the effectiveness and comprehension of critical warnings and alerts, including vibratory, auditory, and textual cues.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
Inclusion Criteria
- Clinical diagnosis of diabetes mellitus
Exclusion Criteria
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method