NCT06428591

Tandem Freedom Feasibility Study 1

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Tandem Diabetes Care, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 1 day with boluses, and 1 day without boluses, 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.

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DEVICE	t:slim X2 insulin pump with Tandem Freedom Algorithm	Participants will use the Tandem Freedom system for one day with insulin boluses and one day without insulin boluses.

Timeline

• Start date: 2024-05-29
• Primary completion: 2024-06-10
• Completion: 2024-06-10
• First posted: 2024-05-24
• Last updated: 2025-11-18
• Results posted: 2025-11-18

Locations

1 site across 1 country: New Zealand

Regulatory

• FDA-regulated device study