Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-25 @ 9:49 PM
Study NCT ID:
NCT00892151
Status:
COMPLETED
Last Update Posted:
2016-02-29
First Post:
2009-05-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Evaluation of GLUCOFACTS® Deluxe Diabetes Management System
Sponsor:
Ascensia Diabetes Care
Organization:
Study Overview
Official Title:
Evaluation of GLUCOFACTS® Deluxe Diabetes Management System In a Clinical Setting
Status:
COMPLETED
Status Verified Date:
2016-01
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:
None
Brief Summary:
The purpose of this study is to evaluate a Diabetes management program in the hands of potential users, both health care professionals and lay persons.
Detailed Description:
Diabetes data management programs upload glucose meter results to computers to provide information at home to lay people with diabetes and their healthcare professionals to manage their diabetes. The study evaluated the subjects' success using the software program with a blood glucose meter to perform specific tasks, such as uploading the meter results, changing program and meter settings, and displaying reports. The study also evaluated the system's ease of use and the acceptability of product labeling.
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?: