NCT04503174

Control-IQ Observational (CLIO) Post-Approval Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,157 (actual)
• Sponsor: Tandem Diabetes Care, Inc. · Industry
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

Summary

Post-approval 522 study designed to collect primarily safety data on the US FDA-cleared product, t:slim X2 insulin pump with Control-IQ technology (Control-IQ system).

Detailed description

Post-approval study designed to collect primarily safety data on the US FDA-cleared product, t:slim X2 insulin pump with Control-IQ technology (Control-IQ system), by assessing the rate of severe hypoglycemia (SH) and diabetic ketoacidosis (DKA) during the first 12 months of use. Secondary endpoints assessing the effectiveness of this product in real-world use by assessing the impact on patients' glycemic outcomes and user experience will also be collected. The Control-IQ system will be used as intended and in accordance with FDA-approved labeling.

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DEVICE	t:slim X2 pump with Control-IQ technology	Real-world use

Timeline

• Start date: 2020-08-04
• Primary completion: 2023-06-02
• Completion: 2023-06-26
• First posted: 2020-08-07
• Last updated: 2023-12-08
• Results posted: 2023-12-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study