NCT06834568

Tandem Freedom - Feasibility Trial 2

• 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 one week run-in, then will use Tandem Freedom in a supervised hotel setting.

Detailed description

After a one 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 4 nights: 1 day with boluses, and 3 days without boluses, in a supervised hotel setting. Participants will perform 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	t:slim X2 insulin pump with Tandem Freedom System consists of the Tandem t:slim X2 insulin pump and the Freedom algorithm embedded in the pump. Participants will also use the Dexcom G6 continuous glucose monitoring system.

Timeline

• Start date: 2025-03-24
• Primary completion: 2025-04-07
• Completion: 2025-04-07
• First posted: 2025-02-19
• Last updated: 2026-02-06
• Results posted: 2026-02-06

Locations

1 site across 1 country: New Zealand

Regulatory

• FDA-regulated device study