SmartAdjust 2.0 System With Type 1 and Type 2 Diabetes
NCT Number: NCT06547918
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetes Mellitus
Interventions: DEVICE: Omnipod 5 SA2.0 System
Sponsor: Insulet Corporation
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 75
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-18
Completion Date: 2025-08-28
Locations: University of Otago, Christchurch, Christchurch, 8011, New Zealand|Wellington Regional Hospital, Wellington, 6021, New Zealand

Summary:
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.

Primary Outcome Measures: 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), 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), End of Period 1 which is upto 6 weeks and Period 2 which is upto 6 months (optional) compared to Standard Therapy
Secondary Outcome Measures: Mean glucose (assessed by diabetes type (type 1 and type 2)), Glucose metric from study provided continuous glucose monitor (CGM), 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), 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), 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), 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), 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), 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), 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, 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, 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, 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, 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