NCT05014789

Control-IQ Technology 2.0 Adult and Adolescent Feasibility Study

A Control-IQ Technology 2.0 Feasibility Study in Adult and Adolescent Subjects

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Tandem Diabetes Care, Inc. · Industry
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to obtain preliminary safety and performance data on planned improvements to Control-IQ technology.

Detailed description

This feasibility study is a prospective, single arm, single center study with a run-in phase, followed by a 48-hour supervised phase, followed by a 4-week at home study with sequential interventions (new feature use). Approximately 30 subjects, both male and female, aged 14 and up, will participate in the study, using new features each week with the t:slim X2 insulin pump with Control-IQ technology.

Conditions

• Diabetes Mellitus, Type 1

Interventions

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

Timeline

• Start date: 2021-08-19
• Primary completion: 2021-12-20
• Completion: 2021-12-20
• First posted: 2021-08-20
• Last updated: 2022-01-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study