To assess the safety and effectiveness of a next-generation automated insulin delivery algorithm in participants aged 16+ years with type 1 or type 2 diabetes.
This study is a single-arm, observational clinical study that will enroll a maximum of 72 participants. Participants between the ages of 16+ years with type 1 or type 2 diabetes currently using an insulin pump or receiving basal and bolus multiple daily injections (MDI), with an A1C between 7.5-11.0% at screening, will be recruited for the study. Two participant groups will be recruited and will participate in up to 4 Phases: * Group A (Participants with type 1 diabetes) will participate in Phase 1, Phase 2, Phase 3, and Phase 4 * Group B (Participants with type 2 diabetes) will participate in Phase 1, and Phase 4 Phase 1 (Group A and B) will include: • 14 days of Standard Therapy while using a blinded Dexcom G6 CGM in an outpatient setting Phase 2 (Group A only) will include: • 48 hours of using build 1b.x of the Omnipod 5 System in Manual Mode in an outpatient setting Phase 3 (Group A only) will include: • 3 day/2 night supervised hotel stay using build 1b.x of the Omnipod 5 System in Automated Mode while also participating in meal and exercise challenges at a defined target glucose setting of 5.6 mmol/L (100 mg/dL). During the first 24 hours, participants will be instructed to not bolus for meals. For the following 24 hours, participants will be instructed to bolus for meals. At least 2 meals each day must contain at least 60 grams of carbohydrates. In addition, each day participants will take part in 45 minutes of exercise. Phase 4 (Group A and B) will include: • A total of 6 weeks using the Omnipod 5 System in Automated Mode in an outpatient setting at a defined target glucose setting of 5.6 mmol/L (100 mg/dL). During weeks 1-3, participants will be instructed to bolus for meals. During weeks 4-6, participants will be instructed to not bolus for meals. After completion of a minimum of 10 participants for Group A, Phase 3, the data will be analysed and must meet prespecified criteria for Group A to proceed to Phase 4 and Group B to proceed to Phase 1 followed by Phase 4. If the prespecified criteria are not met, software changes will be made and Group A, Phase 3 may be repeated either with the same participants or additional participants that meet the study criteria. Iterations of Group A, Phase 3 may continue until prespecified criteria are met.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
The Omnipod 5 Automated Glucose Control System will provide automated insulin delivery
University of Otago
Christchurch, New Zealand
Percentage of time in hypoglycemic range (defined as < 3.9 mmol/L (<70 mg/dL))
Glucose metric from CGM
Time frame: At the end of Phase 3 and Phase 4 to compare to baseline values
Percentage of time in hyperglycemic range (defined as > 13.9 mmol/L (>250 mg/dL))
Glucose metric from CGM
Time frame: measured during the 9 week study phase
Mean glucose value of all participants
Glucose metric from study provided continuous glucose monitor (CGM)
Time frame: Measured during the 9 week study phase
Percentage of time < 3.0 mmol/L (<54 mg/dL)
Glucose metric from CGM
Time frame: Measured during the 9 week study phase
Percentage of time > 10.0 mmol/L (>180 mg/dL)
Glucose metric from CGM
Time frame: Measured during the 9 week study phase
Percentage of time > 16.7 mmol/L (>300 mg/dL)
Glucose metric from CGM
Time frame: Measured during the 9 week study phase
Percentage of time between 3.9-10.0 mmol/L (70-180 mg/dL)
Glucose metric from CGM
Time frame: Measured during the 9 week study phase
Standard deviation and coefficient of variation
Glucose metric from CGM measured glucose variability with the coefficient of variation (CV)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Measured during the 9 week study phase
Average total daily insulin (TDI)
measure of insulin
Time frame: Measured during the 9 week study phase
Average TDI/kg
measure of insulin
Time frame: Measured during the 9 week study phase
Average number of manual boluses/day
count of average number of insulin boluses
Time frame: Measured during the 9 week study phase
Average dose of insulin delivered by manual bolus/day
measure of insulin
Time frame: Measured during the 9 week study phase
Average number of hypoglycemic treatments when CGM is less than 3.9mmol/L
Glucose metric from CGM
Time frame: Measured during the 9 week study phase