Validation Study of G4 User Interface

NCT ID: NCT01142895

Last Updated: 2010-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

33 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Diabetes Mellitus

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of diabetes mellitus
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tandem Diabetes Care, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Tandem Diabetes care, Inc.

Other Identifiers

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TDC-G4

Identifier Type: -

Identifier Source: org_study_id

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