Ignite Creation Date:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2025-12-28 @ 11:22 PM
Study NCT ID:
NCT01773668
Status:
COMPLETED
Last Update Posted:
2013-02-05
First Post:
2012-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Study - Integrated Sensor and Infusion Set. Trial III
Sponsor:
Medtronic Diabetes R&D Denmark
Organization:
Study Overview
Official Title:
FEASIBILITY STUDY TO ASSESS PERFORMANCE OF THE INTEGRATED SENSOR AND INFUSION SET. WITH HIGH INSULIN NEED USERS (TRIAL III)
Status:
COMPLETED
Status Verified Date:
2013-01
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 collect performance data on the Integrated sensor and infusion set during 3 days of use and demonstrate performance adequacy of the integrated sensor and infusion set with glucose sensing and insulin delivery functionalities. The hypothesis of this study is that having the infusion of insulin in close proximity to the sensor does not interfere with the sensor accuracy. This study focuses on high bolus patients. A high bolus is defined as 12 units or more.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: