NCT07325461

Feasibility Study of Extended Wear Insulin Infusion Set Options During Home Use in People With Type 1 Diabetes

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Tandem Diabetes Care, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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)

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DEVICE	SteadiSet Infusion Set	Participants will use the SteadiSet Infusion set with an enhanced filling process for three wear periods and the Steadiset Infusion Set only for three wear periods.

Timeline

• Start date: 2026-02-18
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2026-01-08
• Last updated: 2026-03-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study