NCT03563313

The International Diabetes Closed Loop (iDCL) Trial: Clinical Acceptance of the Artificial Pancreas

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 168 (actual)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

Summary

The objective of the study is to assess efficacy and safety of a closed loop system (t:slim X2 with Control-IQ Technology) in a large randomized controlled trial.

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 to 8 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 2:1 to the use of closed-loop control (CLC group) using t:slim X2 with Control-IQ Technology vs. SAP for 6 months.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	t:slim X2 with Control-IQ Technology & Dexcom G6 CGM	Participants will use the Tandem t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months at home.
DEVICE	Sensor-augmented pump (SAP)	Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology.

Timeline

• Start date: 2018-06-28
• Primary completion: 2019-04-08
• Completion: 2019-04-08
• First posted: 2018-06-20
• Last updated: 2020-04-28
• Results posted: 2020-04-28

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study