NCT03591354

The International Diabetes Closed Loop (iDCL) Trial: Clinical Acceptance of the Artificial Pancreas (DCLP3 Extension)

An Extension Study of t:Slim X2 With Control-IQ Technology

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 164 (actual)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

Summary

This is a 3-month extension study (DCLP3 Extension) following a primary trial (DCLP3 or NCT03563313) to assess efficacy and safety of a closed loop system (t:slim X2 with Control-IQ Technology) in a large randomized controlled trial. Upon completion of the NIH 3-month extension study, subjects will be invited to participate in a continued use phase with Control-IQ Technology, funded by Tandem Diabetes Care, until the equipment has received FDA approval for commercial use.

Detailed description

Participants in the 6 month primary trial (DCLP3) will be invited to continue in this 3-month extension study (DCLP3 Extension) following completion of the primary trial. The closed-loop control (CLC) Intervention Group participants from the primary trial will be randomly assigned to continue CLC or to switch to Predictive Low-Glucose Suspend (PLGS) therapy with t:slim X2 with Basal-IQ and Dexcom G6 for 3 months. The Sensor-Augmented Pump (SAP) Control Group participants from the primary trial will be assigned to CLC using t:slim X2 with Control-IQ Technology and Dexcom G6 (CGM) for 3 months. Upon completion of the extension study, subjects will be invited to participate in continued use of the Control-IQ Technology until the equipment has received FDA approval for commercial use. This extension phase has two separate objectives: Objective 1: Among participants who used CLC in the primary trial: the primary efficacy outcome for the randomized controlled trial (RCT) is time in target range 70-180 mg/dL measured by CGM in CLC group vs. PLGS group over 3 months. Safety outcomes also will be assessed Objective 2: Among participants who used SAP in the primary trial: the primary outcome is to obtain additional safety data. Efficacy also will be assessed as a pre-post within participant analysis Note: Primary Trial (DCLP3) is NCT03563313

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 insulin pump with Control-IQ Technology \& Dexcom G6 CGM for 3 months.
DEVICE	t:slim X2 with Basal-IQ & Dexcom G6 CGM	Participants will use a Tandem t:slim X2 insulin pump with Basal-IQ and a study CGM (Dexcom G6) for 3 months.

Timeline

• Start date: 2019-01-17
• Primary completion: 2020-02-28
• Completion: 2020-03-09
• First posted: 2018-07-19
• Last updated: 2022-08-31
• Results posted: 2022-08-25

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study