Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06428591
Status:
COMPLETED
Last Update Posted:
2024-06-14
First Post:
2024-05-20
Brief Title:
Tandem Freedom - Feasibility Trial 1
Sponsor:
Tandem Diabetes Care Inc
Organization:
Tandem Diabetes Care Inc
Study Overview
Official Title:
Tandem Freedom - Feasibility Trial 1
Status:
COMPLETED
Status Verified Date:
2024-06
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:
None
Brief Summary:
This feasibility study is a prospective single arm study evaluating the Tandem Freedom system in adults with type 1 diabetes Existing Control-IQ technology users will use Control-IQ technology at home for a 1 week run-in then will use Tandem Freedom in a supervised hotel setting for 3 daysnights
Detailed Description:
After a 1 week Control-IQ run-in at home 10 adults who are existing Control-IQ users with type 1 diabetes will use the Tandem Freedom System for 3 daysnights in a supervised hotel setting Participants will perform meal and exercise challenges The primary outcome is safety events CGM time in ranges will also be evaluated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1307-6267 | OTHER | ICTRP | None |