Subjects will use the Omnipod Horizon™ System in Manual Mode in an outpatient setting for 14-days. Subjects will be trained to use the Manual Mode feature of the Omnipod Horizon™ System including how to use the bolus calculator using manual entry of blood glucose values or by using the CGM-informed bolus calculator.
The study schedule consists of two outpatient phases: 1. 7 days of Omnipod Horizon™ use in Manual Mode without a connected CGM using manual entry of BG values to deliver boluses (Phase 1) followed by; 2. 7 days of Omnipod Horizon™ use in Manual Mode with a connected CGM using the CGM-informed bolus calculator to deliver boluses (Phase 2) Following subject screening, system training and enrollment, subjects will commence the first 7-day Manual Mode phase of the study. Subjects will be trained to use the Manual Mode feature of the system including how to use the bolus calculator using manual entry of BG values or by using the CGM-informed bolus calculator. After completion of the first 7 days of the Manual Mode phase using the Omnipod Horizon™ without a connected CGM, subjects will transition to the next 7 days of the Manual Mode phase using the system with a connected CGM using the CGM-informed bolus calculator to deliver boluses.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Omnipod Horizon™ Automated Glucose Control System use in Manual Mode
Sansum Diabetes Research Institute
Santa Barbara, California, United States
University of Colorado Denver
Denver, Colorado, United States
Atlanta Diabetes
Atlanta, Georgia, United States
University of Virginia
Charlottesville, Virginia, United States
Percentage of Time <70 mg/dL
Glucose metric from continuous glucose monitoring system (CGM)
Time frame: Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period)
Percentage of Time >180 mg/dL
Glucose metric from continuous glucose monitoring system (CGM)
Time frame: Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period)
Mean Glucose
Glucose metric from continuous glucose monitoring system (CGM)
Time frame: Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period)
Percentage of Time <54 mg/dL
Glucose metric from continuous glucose monitoring system (CGM)
Time frame: Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period)
Percentage of Time ≥ 250 mg/dL
Glucose metric from continuous glucose monitoring system (CGM)
Time frame: Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period)
Percentage of Time ≥ 300 mg/dL
Glucose metric from continuous glucose monitoring system (CGM)
Time frame: Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period)
Percentage of Time in Range 70-180 mg/dL
Glucose metric from continuous glucose monitoring system (CGM)
Time frame: Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period)
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Mean Glucose
Glucose metric from continuous glucose monitoring system (CGM)
Time frame: Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall
Percentage of Time <54 mg/dL
Glucose metric from continuous glucose monitoring system (CGM)
Time frame: Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall
Percentage of Time <70 mg/dL
Glucose metric from continuous glucose monitoring system (CGM)
Time frame: Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall
Percentage of Time >180 mg/dL
Glucose metric from continuous glucose monitoring system (CGM)
Time frame: Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall
Percentage of Time ≥ 250 mg/dL
Glucose metric from continuous glucose monitoring system (CGM)
Time frame: Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall
Percentage of Time ≥ 300 mg/dL
Glucose metric from continuous glucose monitoring system (CGM)
Time frame: Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall
Percentage of Time in Range 70-180 mg/dL
Glucose metric from continuous glucose monitoring system (CGM)
Time frame: Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall
Percentage of Time in Range 70-140 mg/dL
Glucose metric from continuous glucose monitoring system (CGM)
Time frame: Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall
Standard Deviation
Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the standard deviation (SD)
Time frame: Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall
Coefficient of Variation
Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the coefficient of variation (CV)
Time frame: Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall