The study subjects will be separated into 2 groups, depending on their previous insulin therapy with approximately 50% of subjects from each group, continuous glucose monitoring (CGM) naive. Group A will complete a 2-week Standard Therapy Phase followed by 8 weeks of Omnipod 5 system use. Group B will complete a 2-week Standard Therapy Phase followed by 10 weeks of Omnipod 5 system use. Group A and Group B will have an optional 6-month extension of Omnipod 5 system use
Basal-Bolus - Group A (N=12) * 2 weeks standard therapy - using multiple daily injections (MDI) and Dexcom G6 continuous glucose monitoring (CGM) , followed by: * 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by: * 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus * 6-month optional extension using Automated Mode Basal - Group B (N=12) * 2 weeks standard therapy - using basal injection only and Dexcom G6 continuous glucose monitoring (CGM) , followed by: * 2 weeks Omnipod 5 system use in Manual Mode with Dexcom G6 continuous glucose monitoring (CGM) - with fixed basal rate, no bolus, followed by: * 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by: * If % time in range 70-180 mg/dL during Automated Mode is ≤50%, 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus, OR * If % time in range 70-180 mg/dL during Automated Mode is \>50%, 4 weeks Omnipod 5 system use in Automated Mode with optional bolus * 6-month optional extension using Automated Mode
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
25
The Omnipod 5 is a single hormone insulin delivery system intended for the management of diabetes in persons requiring insulin. Continuous subcutaneous insulin infusion may be delivered by user-defined settings (manual mode) or automatically adjusted in response to feedback from a continuous glucose monitor (CGM). The Omnipod 5 can automatically increase insulin delivery based on sensor glucose values from the continuous glucose monitor (CGM) and can decrease or suspend delivery of insulin when the glucose value falls below or is predicted to fall below predefined threshold values. The Omnipod 5 is designed to assist patients with diabetes in achieving glycemic targets set by their health care providers.
University of California
Los Angeles, California, United States
Emory University
Atlanta, Georgia, United States
Atlanta Diabetes
Atlanta, Georgia, United States
International Diabetes Center
Saint Louis Park, Minnesota, United States
Hyperglycemia
Overall percentage of time ≥250 mg/dL during standard therapy phase and ALL phases of Automated Mode
Time frame: 8-10 weeks and after 6-month optional extension
Hypoglycemia
Overall percentage of time \<54 mg/dL during standard therapy phase and all phases of Automated Mode
Time frame: 8-10 weeks and after 6-month optional extension
Percent of Time in Range 70-180 mg/dL
Glucose metric from study continuous glucose monitoring system
Time frame: Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B
Percent of Time > 180 mg/dL
Glucose metric from study continuous glucose monitoring system
Time frame: Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B
Percent of Time ≥ 300 mg/dL
Glucose metric from study continuous glucose monitoring system
Time frame: Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B
Percent of Time < 70 mg/dL
Glucose metric from study continuous glucose monitoring system
Time frame: Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B
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Standard Deviation
Glucose metric from study continuous glucose monitoring system-measured glucose variability with the standard deviation
Time frame: Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B
Coefficient of Variation (of Glucose)
Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the coefficient of variation (CV). Calculated by dividing the standard deviation of CGM values by the mean CGM values in the observation period.
Time frame: Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B
Mean Glucose
Glucose metric from study continuous glucose monitoring system
Time frame: Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B
Total Daily Insulin (Units)
Measure of insulin requirements
Time frame: Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B
Total Daily Insulin (Units/kg)
Measure of insulin requirements
Time frame: Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B
Change in Hemoglobin A1c (HbA1c)
Measures average blood sugar levels over the past 3 months
Time frame: End of study (8-10 weeks) and during extension (21-23 weeks and 24-26 weeks) compared to baseline (Days 57, 147, and 237 (Group A) or Days 71, 161, and 251 (Group B) compared to Day -30