This study will evaluate the safety and effectiveness of the Omnipod 5 SmartAdjust 2.0 System in individuals aged 2-70 years with type 1 or type 2 diabetes.
This is a single-arm study that will enroll up to 75 participants aged 2-70 years with Type 1 diabetes and aged 16-70 years with Type 2 diabetes in order to have a minimum of 48 participants (24 with Type 1 Diabetes and 24 with Type 2 Diabetes) initiate the use of the Omnipod 5 SA2.0 System. The Study will take part in two periods. Participants who do not have the minimum requirement of CGM data will undergo 2 weeks of Standard Therapy while using a Dexcom G6 in an outpatient setting before proceeding to Period 1. During period 1, all participants will use the Omnipod SmartAdjust 2.0 System in an outpatient setting for up to six weeks. Period 2 is an optional extension of time that allows participants to continue using the Omnipod 2.0 SmartAdjust System for an additional six months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
The Omnipod 5 SA2.0 System provides automated insulin delivery based on Continuous Glucose Monitoring (CGM) values.
University of Otago, Christchurch
Christchurch, New Zealand
Wellington Regional Hospital
Wellington, New Zealand
Percentage of time in hypoglycemic range <3.9 mmol/L (<70 mg/dL) (assessed by diabetes type (type 1 and type 2))
Glucose metric from study provided continuous glucose monitor (CGM)
Time frame: End of Period 1 and Period 2 (optional) compared to Standard Therapy
Percentage of time in hyperglycemic range >13.9 mmol/L (>250 mg/dL) (assessed by diabetes type (type 1 and type 2))
Glucose metric from study provided continuous glucose monitor (CGM)
Time frame: End of Period 1 which is upto 6 weeks and Period 2 which is upto 6 months (optional) compared to Standard Therapy
Mean glucose (assessed by diabetes type (type 1 and type 2))
Glucose metric from study provided continuous glucose monitor (CGM)
Time frame: End of Period 1 which is upto 6 weeks and Period 2 which is upto 6 months (optional) compared to Standard Therapy
Percentage of time < 3.0 mmol/L (<54 mg/dL) (assessed by diabetes type (type 1 and type 2))
Glucose metric from study provided continuous glucose monitor (CGM)
Time frame: End of Period 1 which is upto 6 weeks and Period 2 which is upto 6 months (optional) compared to Standard Therapy
Percentage of time > 10.0 mmol/L (>180 mg/dL) (assessed by diabetes type (type 1 and type 2))
Glucose metric from study provided continuous glucose monitor (CGM)
Time frame: End of Period 1 which is upto 6 weeks and Period 2 which is upto 6 months (optional) compared to Standard Therapy
Percentage of time > 16.7 mmol/L (>300 mg/dL) (assessed by diabetes type (type 1 and type 2))
Glucose metric from study provided continuous glucose monitor (CGM)
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Time frame: End of Period 1 which is upto 6 weeks and Period 2 which is upto 6 months (optional) compared to Standard Therapy
Percentage of time between 3.9-10.0 mmol/L (70-180 mg/dL) (assessed by diabetes type (type 1 and type 2))
Glucose metric from study provided continuous glucose monitor (CGM)
Time frame: End of Period 1 which is upto 6 weeks and Period 2 which is upto 6 months (optional) compared to Standard Therapy
Standard deviation (assessed by diabetes type (type 1 and type 2))
Glucose metric from the continuous glucose monitor (CGM)-measured glucose variability with the standard deviation (SD)
Time frame: End of Period 1 which is upto 6 weeks and Period 2 which is upto 6 months (optional) compared to Standard Therapy
Coefficient of variation (assessed by diabetes type (type 1 and type 2))
Glucose metric from the continuous glucose monitor (CGM)-measured glucose variability with the coefficient of variation (CV)
Time frame: End of Period 1 which is upto 6 weeks and Period 2 which is upto 6 months (optional) compared to Standard Therapy
Average total daily insulin (TDI) (assessed by diabetes type (type 1 and type 2))
Measure of insulin requirements
Time frame: End of Period 1 which is upto 6 weeks and Period 2 which is upto 6 months (optional) compared to Standard Therapy
Average TDI/kg (assessed by diabetes type (type 1 and type 2))
Measure of insulin requirements
Time frame: End of Period 1 which is upto 6 weeks and Period 2 which is upto 6 months (optional) compared to Standard Therapy
Incidence rate of severe hypoglycemia (events per person months) (assessed by diabetes type (type 1 and type 2))
Measure of insulin requirements
Time frame: End of Period 1 upto 6 weeks and Period 2 upto 6 months (optional) compared to participant reported events over the preceding year prior to Visit 4
Incidence rate of diabetic ketoacidosis (DKA) and/or hyperosmolar (assessed by diabetes type (type 1 and type 2)) hyperglycemic state (HHS) (events per person months)
Measure of insulin requirements
Time frame: End of Period 1 which is upto 6 weeks and Period 2 which is upto 6 months (optional) compared to participant reported events over the preceding year prior to Visit 4