Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 2:15 AM
Study NCT ID:
NCT07325461
Status:
RECRUITING
Last Update Posted:
2026-03-05
First Post:
2026-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Study of Extended Wear Insulin Infusion Set Options During Home Use in People With Type 1 Diabetes
Sponsor:
Tandem Diabetes Care, Inc.
Organization:
Study Overview
Official Title:
Feasibility Study of Extended Wear Insulin Infusion Set Options During Home Use in People With Type 1 Diabetes
Status:
RECRUITING
Status Verified Date:
2026-03
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 center, multi-arm study evaluating possible enhancements to the SteadiSet extended wear infusion set.
Detailed Description:
All participants will use the SteadiSet insulin infusion set for 6 wear periods of up to 7 days each.
The 2 treatment arms are:
Existing t:slim X2 Users:
* t:slim X2 insulin pump with SteadiSet (43 inches) and an enhanced filling process (3 wear periods)
* t:slim X2 insulin pump with SteadiSet (43 inches) with no side ports (3 wear periods)
Existing Mobi Users:
* Mobi Insulin Pump with SteadiSet (5 inches) and an enhanced filling process (3 wear periods)
* Mobi Insulin Pump and SteadiSet (5 inches) (3 wear periods)
The 2 treatment arms are:
Existing t:slim X2 Users:
* t:slim X2 insulin pump with SteadiSet (43 inches) and an enhanced filling process (3 wear periods)
* t:slim X2 insulin pump with SteadiSet (43 inches) with no side ports (3 wear periods)
Existing Mobi Users:
* Mobi Insulin Pump with SteadiSet (5 inches) and an enhanced filling process (3 wear periods)
* Mobi Insulin Pump and SteadiSet (5 inches) (3 wear periods)
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: