Validation Study of G4 User Interface

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

Completed

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Clinical diagnosis of diabetes mellitus

Sponsors and collaborators

Lead sponsor

Tandem Diabetes Care, Inc.

Industry

Registry information

Official study title

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

Acronym: G4

Important dates

Study start: 2010
Primary completion: 2010
First posted: Jun 11, 2010
Registry last updated: Jun 11, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed