Ignite Creation Date:
2025-12-24 @ 1:30 PM
Ignite Modification Date:
2025-12-26 @ 6:41 PM
Study NCT ID:
NCT01142895
Status:
COMPLETED
Last Update Posted:
2010-06-11
First Post:
2010-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation Study of G4 User Interface
Sponsor:
Tandem Diabetes Care, Inc.
Organization:
Study Overview
Official Title:
Simulated Usability Trial of the T-Slim Ambulatory Insulin Infusion Pump
Status:
COMPLETED
Status Verified Date:
2010-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
G4
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.
* 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: