Validation Study of G4 User Interface

Simulated Usability Trial of the T-Slim Ambulatory Insulin Infusion Pump

The purpose of this simulated useability study is to demonstrate the user interface and software design mitigate potential safety concerns.

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.

Inclusion Criteria:

• Clinical diagnosis of diabetes mellitus