NCT04436796

The International Diabetes Closed Loop (iDCL) Trial: Protocol 4

The International Diabetes Closed Loop (iDCL) Trial: A Randomized Crossover Comparison of Adaptive Model Predictive Control (MPC) Artificial Pancreas Versus Sensor Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS) in the Outpatient Setting in Type 1 Diabetes (DCLP4)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Sansum Diabetes Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigators aim to compare the efficacy and safety of an AID system using an adaptive MPC algorithm versus SAP (which may or may not include PLGS; to be referred to as SAP) in people with type 1 diabetes.

Detailed description

A randomized crossover trial will compare the efficacy and safety of an automated insulin delivery (AID) study system using an adaptive Model Predictive Control (MPC) algorithm versus SAP (which may or may not include PLGS; to be referred to as SAP) therapy in people with type 1 diabetes for 13 weeks in each arm of the study. A Pilot Phase using the study system for 10-14 days will be conducted prior to the crossover trial.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DEVICE	interoperable Artificial Pancreas System (iAPS)	Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.
OTHER	Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS)	Use of personal pump with study CGM \& glucometer at home for 13 weeks.

Timeline

• Start date: 2020-08-05
• Primary completion: 2021-05-10
• Completion: 2021-05-10
• First posted: 2020-06-18
• Last updated: 2022-12-02
• Results posted: 2022-12-02

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study