NCT06273124

Investigational Extended Wear Insulin Infusion Set in People With Type 1 Diabetes

Open, Single Arm, Prospective, Multicenter Study of an Investigational Extended Wear Insulin Infusion Set During Home Use in People With Type 1 Diabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 260 (actual)
• Sponsor: Tandem Diabetes Care, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to collect clinical data to support a 7-day wear of the Extended Wear Infusion Set (EWIS). Participants will be asked to: 1. Wear the EWIS for up to 7 consecutive days for 12 consecutive wear periods 2. Perform blood glucose and ketone measurements if continuous glucose meter is ≥250mg/dL for one hour

Detailed description

This is a multi-center, single-arm, prospective study of an extended wear infusion set in adults with Type 1 diabetes using a Tandem t:slim X2 insulin pump with Control-IQ technology with continuous Glucose Monitoring (CGM). Up to 300 participants across the United States age 18-80 will be enrolled in up to 20 investigational centers. Participants will change insulin cartridge every 48 to 72 hours as recommended by their health care provider. Participants will be expected to participate in the study for approximately 12-16 weeks.

Conditions

• Type1diabetes

Interventions

Type	Name	Description
DEVICE	SteadiSet Extended Wear Infusion Set	Each participant will be given 12 Extended Wear Infusion Sets to wear over 12 wear periods up to 168 hours each.

Timeline

• Start date: 2024-03-07
• Primary completion: 2024-12-11
• Completion: 2024-12-11
• First posted: 2024-02-22
• Last updated: 2025-09-24
• Results posted: 2025-09-24

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated device study