NCT05683392

Use of Control-IQ Technology 2.0 in Adults, Children, and Preschoolers With Type 1 Diabetes

Control-IQ 2.0 Feasibility Study #2: Use of Control-IQ Technology 2.0 in Adults, Children, and Preschoolers With Type 1 Diabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Tandem Diabetes Care, Inc. · Industry
• Sex: All
• Age: 2 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to assess safety of and explore glycemic outcomes with Control-IQ technology 2.0 in adults, children and preschoolers with type 1 diabetes.

Detailed description

This feasibility study is a prospective, randomized, two-period crossover multi-center study of Control-IQ technology 2.0. After a two week run-in period, the automated insulin dosing (AID) system will be evaluated in multiple age groups over 4 weeks of use.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DEVICE	t:slim X2 insulin pump with Control-IQ technology 2.0	t:slim X2 insulin pump with Control-IQ technology 2.0, and wearing the Dexcom G6 sensor.

Timeline

• Start date: 2023-02-01
• Primary completion: 2023-12-13
• Completion: 2023-12-13
• First posted: 2023-01-13
• Last updated: 2024-12-20
• Results posted: 2024-12-20

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study