NCT03767790

Model Predictive Control (MPC) Artificial Pancreas vs. Sensor Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS) With Different Food Choices in the Outpatient Setting

A Randomized Crossover Comparison of Model Predictive Control (MPC) Artificial Pancreas vs. Sensor Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS) With Different Food Choices in the Outpatient Setting

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Sansum Diabetes Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this randomized crossover clinical trial is to 1) assess the efficacy and safety of an automated insulin delivery (AID) system using a Model Predictive Control (MPC) algorithm versus sensor augmented pump therapy (SAP)/Predictive Low Glucose Suspend (PLGS) in people with type 1 diabetes, and 2) assess the impact of different meal macronutrient content on glucose control when using AID and SAP.

Detailed description

The goal of this study is to compare the efficacy and safety of an AID system using a MPC algorithm versus SAP/PLGS therapy with different food choices over a 4 week period. The AID system (iAPS) is comprised of an insulin pump, a Dexcom G6 continuous glucose monitoring sensor, and a smart phone that contains the algorithm and communicates with the other devices. In this study, during each two-week period, subjects will be given pre-weighed portions of different meals to eat (either regular semolina pasta or extra-long grain white rice) with detailed cooking instructions, and will eat these meals on 6 different occasions for dinner. They will bolus as they normally do for these meals. This will allow us to observe the postprandial meal response when using sensor-augmented pump (SAP) or iAPS, showing the importance of nutrition choices with modern technological treatments in T1D.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	iAPS	The AID system (iAPS) is comprised of an insulin pump, a Dexcom G6 continuous glucose monitoring sensor, and a smart phone that contains the algorithm and communicates with the other devices.

Timeline

• Start date: 2019-01-03
• Primary completion: 2019-06-27
• Completion: 2019-06-27
• First posted: 2018-12-07
• Last updated: 2019-08-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study