To assess the safety and performance of the Insulet AP (artificial pancreas) system, using the Omnipod® insulin management system, Dexcom G4 Share® AP System and personalized model predictive control algorithm in adults with type 1 diabetes consuming high fat meals and undertaking moderate intensity exercise.
The two-part study schedule consists of a 7±1 day outpatient, open-loop phase, followed by one 54-hour, hybrid closed-loop phases conducted in a supervised CRC or hotel/rental house setting.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
24
Insulet AP (artificial pancreas) system, using the Omnipod® insulin management system, Dexcom G4 Share® AP System and personalized model predictive control algorithm.
Stanford University
Palo Alto, California, United States
Diablo Clinical Research
Walnut Creek, California, United States
University of Colorado Denver
Denver, Colorado, United States
Percentage of time in hypoglycemic range (defined as < 70 mg/dL)
Time frame: 54 hours
Percentage of time in hyperglycemic range(defined as ≥ 250 mg/dL)
Time frame: 54 hours
Mean glucose
Time frame: 54 hours
Percentage of time < 50 mg/dL
Time frame: 54 hours
Percentage of time < 60 mg/dL
Time frame: 54 hours
Percentage of time > 180 mg/dL
Time frame: 54 hours
Percentage of time ≥ 300 mg/dL
Time frame: 54 hours
Percentage of time between 70-180 mg/dL
Time frame: 54 hours
Percentage of time between 70-140 mg/dL
Time frame: 54 hours
Standard deviation
Time frame: 54 hours
Coefficient of variation
Time frame: 54 hours
Meal challenge-12 hour PPG dinner
The post-prandial glucose response including time to peak glucose, peak glucose concentration, and peak glucose excursion and the 12-hour post-prandial period following dinner.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 54 hours
Meal challenge-4 hour PPG breakfast
The post-prandial glucose response including time to peak glucose, peak glucose concentration, and peak glucose excursion for the 4-hour post-prandial period following breakfast.
Time frame: 54 hours
Meal challenge-4 hour PPG lunch
The post-prandial glucose response including time to peak glucose, peak glucose concentration, and peak glucose excursion for the 4-hour post-prandial period following lunch.
Time frame: 54 hour
Exercise challenge-immediate and delayed glucose response
The immediate (2 hours) and delayed (24 hours) glucose response to moderate intensity exercise.
Time frame: 54 hour
Effect of changing setpoints
Effect of changing setpoints to overall performance.
Time frame: 54 hour