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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
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.
Sansum Diabetes Research Institute
Santa Barbara, California, United States
Time in target glucose range
Time in target glucose range 70-180 mg/dL measured by CGM to determine safety and efficacy of the integrated system
Time frame: 4 weeks
Postprandial glucose peak
Postprandial glucose peak rise (highest measurement in mg/dL) from baseline glucose (mg/dl) for the 5-hour period after the study meals, during both use of SAP/PLGS and when using the iAPS
Time frame: 4 weeks
Time to postprandial glucose peak
Time (minutes) to postprandial glucose (highest measurement in mg/dL) rise from baseline glucose (mg/dl) during the 5-hour period after the study meals, during both use of SAP/PLGS and when using the iAPS
Time frame: 4 weeks
Postprandial Area Under the Curve
Area Under the Curve Glucose (mg/dl x min) for the 5-hour period after the study meals, during both use of SAP/PLGS and when using the iAPS
Time frame: 4 weeks
Postprandial time for glucose to return to baseline
Time (minutes) for CGM glucose to return to baseline (starting value) after the study meals, during both use of SAP/PLGS and when using the iAPS
Time frame: 4 weeks
Glucose < 70 mg/dL
Percent time GGM glucose \< 70 mg/dL
Time frame: 4 weeks
Glucose < 54 mg/dL
Percent time GGM glucose \< 54 mg/dL
Time frame: 4 weeks
Glucose > 180 mg/dL
Percent time GGM glucose \> 180 mg/dL
Time frame: 4 weeks
Glucose > 250 mg/dL
Percent time GGM glucose \> 250 mg/dL
Time frame: 4 weeks
Serious adverse events (SAE)
The total number of serious adverse events during the clinical trial
Time frame: 4 weeks
Serious adverse device events (SADE)
The total number of serious adverse events related to the study device use during the clinical trial
Time frame: 4 weeks
Adverse device effects (ADE)
The total number of adverse device effects (ADE) during the clinical trial
Time frame: 4 weeks
Unanticipated adverse device effects (UADE)
The total number of unanticipated adverse device effects (UADE) during the clinical trial
Time frame: 4 weeks
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