This feasibility study is a randomized crossover trial that will compare the efficacy and safety of an automated insulin delivery (AID) system in patients with type 1 diabetes using a Model Predictive Control (MPC) algorithm versus sensor augmented pump therapy (SAP)/Predictive Low Glucose Suspend (PLGS), and will include different stress induction and assessments over a 4 week period.
Eligible participants will be randomly assigned to one of two treatment arms: 1) AID for two weeks and SAP/PLGS for two weeks , or 2) SAP/PLGS for two weeks and AID for two weeks. During the 4-week trial, subjects will wear the Empatica E4 wristband every day to record electrodermal activity, accelerometer and heartrate data. Subjects will also complete logbooks to record activity and stress. During each two-week period, subjects will come to the clinical center twice for stress induction tests in a medically supervised setting.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
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.
Subjects will use their home insulin pump and a Dexcom G6 continuous glucose monitoring sensor.
Sansum Diabetes Research Institute
Santa Barbara, California, United States
Mayo Clinic
Rochester, Minnesota, 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
Change in glucose levels with stress induction
Change in glucose levels with stress induction sessions (mg/dL)
Time frame: 4 weeks
Change in insulin requirements with stress induction
Change in insulin requirements with stress induction sessions (units of insulin)
Time frame: 4 weeks
EDA stress detection
Analysis of EDA to verify stress detection and correlation to glucose changes, both during the stress sessions and in the outpatient setting
Time frame: 4 weeks
Postprandial Time in Target Range
Percent time within the target range of 70-180 mg/dl postprandial within 5 hours following meals
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
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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
Salivary cortisol assessment
Salivary cortisol assessment (nmol/l) during psychologic and physiologic stress induction
Time frame: 4 weeks
Empatica device-based assessment of psychologic and physiologic stress
EDA Measurement of psychologic and physiologic stress from the Empatica E4 Watch
Time frame: 4 weeks
Trier Social Stress Test (TSST)
Trier Social Stress Test (TSST) score at end of each test induction
Time frame: 4 weeks
Socially evaluated cold-pressor test (SECPT)
Socially evaluated cold-pressor test (SECPT) score at end of each test induction
Time frame: 4 weeks