NCT03844789

A Study of t:Slim X2 With Control-IQ Technology

The International Diabetes Closed Loop (iDCL) Trial: Clinical Acceptance of the Artificial Pancreas in Pediatrics: A Study of t:Slim X2 With Control-IQ Technology

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 6 Years – 13 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to learn whether an investigational automated insulin delivery system ("study system") for children with type 1 diabetes can safely improve blood glucose (sometimes called blood sugar) control. The system uses continuous glucose monitoring (CGM), an insulin pump, and a software algorithm to automatically give insulin and control blood glucose. This is called a "closed-loop control" system.

Detailed description

After consent is signed, eligibility will be assessed. Eligible participants not currently using an insulin pump and Dexcom CGM with minimum data requirements will initiate a run-in phase of 2-4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) using t:slim X2 with Control-IQ Technology vs. Control Group for 16 weeks. The Control Group will be offered to transition to use CLC and the experimental arm will extend their use of CLC for 12 weeks.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	t:slim X2 with Control-IQ Technology & Dexcom G6 CGM	Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
DEVICE	Control Group	Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.

Timeline

• Start date: 2019-06-06
• Primary completion: 2019-12-20
• Completion: 2020-03-20
• First posted: 2019-02-18
• Last updated: 2023-04-10
• Results posted: 2023-04-10

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study