NCT04084171

Safety of Artificial Pancreas Therapy in Preschoolers, Age 2-6

Safety of the Tandem t:Slim X2 With Control-IQ Automated Insulin Delivery System in Preschoolers, Age 2-6 Years Old

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 2 Years – 6 Years
• Healthy volunteers: Not accepted

Summary

A single-arm, multi-center, clinical study to assess the safety profile of the Tandem t:slim X2 with Control-IQ system in children with T1D aged 2-6 years old under free living condition

Detailed description

This clinical trial aims to demonstrate the safety of the Closed-Loop Control (CLC), also known as Artificial Pancreas (AP) named t:slim X2 with Control-IQ Technology and assess usability in a supervised setting for the treatment of type 1 diabetes (T1D) in young children (2-6 years old).

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DEVICE	Tandem t:slim X2 with Control-IQ Technology + Dexcom G6	Subjects will use the Tandem t:slim X2 with Control- IQ Technology and Dexcom G6 CGM to control their glycemia. The Tandem t:slim X2 with Control-IQ device is an automated insulin delivery pump that automatically adjusts insulin delivery to predicted and prevailing glucose levels, as measured by a Dexcom G6 continuous glucose monitor \[CGM\].

Timeline

• Start date: 2019-09-26
• Primary completion: 2019-10-23
• Completion: 2019-10-23
• First posted: 2019-09-10
• Last updated: 2023-03-22
• Results posted: 2023-03-22

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study