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

Type1diabetes Clinical Trial

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

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06273124
Study type Interventional
Source Tandem Diabetes Care, Inc.
Contact
Status Recruiting
Phase N/A
Start date March 7, 2024
Completion date January 15, 2025
View Details
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