Validation Study of G4 User Interface

Tandem Diabetes Care

Status: Completed

Conditions: Diabetes Mellitus

Study type: Observational

Funder types: Industry

Identifiers

NCT01142895

TDC-G4

Details and patient eligibility

About

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

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Clinical diagnosis of diabetes mellitus