The purpose is to perform an early investigation on the safety and performance of an Automated Glucose Control (AGC) algorithm using the OmniPod® Insulin Management System and gather clinical data that will be used to make improvements or modifications to the algorithm for subsequent studies in adults, adolescents and children with type 1 diabetes.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
59
Stanford University
Palo Alto, California, United States
William Sansum Diabetes Center
Santa Barbara, 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: 36 hours
Percentage of time in severe hyperglycemic range (defined as >/=250 mg/dL)
Time frame: 36 hours
Mean glucose
Time frame: 36 hours
Percentage of time < 50 mg/dL
Time frame: 36 hours
Percentage of time < 60 mg/dL
Time frame: 36 hours
Percentage of time > 180 mg/dL
Time frame: 36 hours
Percentage of time >/= 300 mg/dL
Time frame: 36 hours
Percentage of time in the broad euglycemic range (defined as 70-180) mg/dL)
Time frame: 36 hours
Percentage of time in the tight euglycemic range (defined as 70-140) mg/dL)
Time frame: 36 hours
Standard deviation and coefficient of variation of CGM values
Time frame: 36 hours
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.