This is a decentralized observational clinical registry to collect real-world evidence related to the safety and effectiveness of the Omnipod 5 system in children and adults with Type 1 Diabetes.
This is a decentralized observational clinical registry to collect real-world evidence related to the safety and effectiveness of the Omnipod 5 system in children and adults with Type 1 Diabetes. A minimum of 2,200 Type 1 participants will be recruited to ensure a minimum of 1,650 participants completing 12 months of follow-up. The minimum number of completed participants is as follows: * 150 participants aged 2-5 * 300 participants aged 6-13 * 300 participants aged 14-17 * 900 participants aged 18+ In addition to the enrollment targets above, a minimum of 1100 Omnipod-naïve users, 880 pump-naïve users, and 110 CGM-naïve users will be recruited. Participants are expected to be followed for 12 months.
Study Type
OBSERVATIONAL
Enrollment
2,200
The Omnipod 5 System consists of a tubeless insulin Pod and the Omnipod® 5 App, installed on a designated Controller or compatible Android smartphone. The Omnipod 5 System works with the Dexcom G6® Continuous Glucose Monitoring System to continuously adapt and automatically deliver insulin according to personal needs. Every two weeks while on the Omnipod 5 system, participants will receive a push notification to complete assessments including any severe hypoglycemia or diabetic ketoacidosis events experienced since the prior assessment.
Circuit Clinical
Buffalo, New York, United States
RECRUITINGIncidence rate of severe hypoglycemia
Measures frequency of severe hypoglycemia
Time frame: From baseline to study completion, up to 12 months.
Incidence rate of DKA
Measures frequency of DKA
Time frame: From baseline to study completion, up to 12 months.
A1c at 3, 6, 9 and 12 months
Measures device effectiveness
Time frame: Comparing the change in A1c at baseline compared to at 3, 6, 9 and 12 months
Percentage of time < 54 mg/dL
Glucose metric from study continuous glucose monitoring system
Time frame: From baseline to study completion, up to 12 months
Percentage of time < 70 mg/dL
Glucose metric from study continuous glucose monitoring system
Time frame: From baseline to study completion, up to 12 months
Percentage of time > 180 mg/dL
Glucose metric from study continuous glucose monitoring system
Time frame: From baseline to study completion, up to 12 months
Percentage of time > 250 mg/dL
Glucose metric from study continuous glucose monitoring system
Time frame: From baseline to study completion, up to 12 months
Percentage of time in range 70-180 mg/dL
Glucose metric from study continuous glucose monitoring system
Time frame: From baseline to study completion, up to 12 months
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Mean Glucose mg/dL
Glucose metric from study continuous glucose monitoring system
Time frame: From baseline to study completion, up to 12 months
Standard deviation of glucose mg/dL
measure of the range of glucose readings
Time frame: From baseline to study completion, about 12 months
Glucose management indicator %
MI tells you what your approximate A1C level is likely to be, based on the average glucose level from your CGM readings for 14 or more days.
Time frame: From baseline to study completion, up to 12 months
Percentage of participants achieving A1C < 7%
measurement of percentage of participants with A1c less than 7%
Time frame: From baseline to study completion, up to 12 months
Percentage of participants with time in range > 70%
measurement of percentage of participants with time in range \> 70%
Time frame: From baseline to study completion, up to12 months
Percentage of participants with time below range (<70mg/dL) of < 4%
measurement of percentage of participants with time below range (\<70mg/dL) of \< 4%
Time frame: From baseline to study completion, up to 12 months
Insulin Usage
Measure of insulin requirements
Time frame: From baseline to study completion, up to 12 months
Body Mass Index (BMI) or BMI z-score
Changes in body mass index
Time frame: at 6 months and at the end of registry participation, up to 12 months.
EQ-5D (inclusive of the Visual Analogue Scale (VAS))
Questionaire
Time frame: at baseline, at 6 months and at the end of registry participation, up to 12 months.
Insulin Delivery Systems: Perceptions, Ideas, Reflections, and Expectations (INSPIRE)
Questionaire
Time frame: at baseline, at 6 months and at the end of registry participation, up to 12 months
System Usability Scale (SUS)
Questionnaire
Time frame: at baseline, at 6 months and at the end of registry participation, up to 12 months
Incidence rate of prolonged hyperglycemia (events per person months) during usage of Activity Feature
Measuring rate of prolonged high sugar while in activity feature
Time frame: From baseline to study completion, up to 12 months
Incidence rate of prolonged hyperglycemia (events per person months)
Measuring the occurrence of prolonged hyperglycemia
Time frame: From baseline to study completion, up to 12 months
Incidence rate of prolonged hyperglycemia (events per person months) during usage of a Target Glucose of 140 mg/dL or 150 mg/dL
Measuring the occurrence of prolonged hyperglycemia while at a set target glucose of 140mg/dL or 150mg/dL
Time frame: From baseline to study completion, up to 12 months
Glucose Outcomes during the 4-hour post-bolus period using the SmartBolus Calculator: o Percentage of time < 54 mg/dL o Percentage of time in range 70-180 mg/dL
Glucose metric from study CGM
Time frame: From baseline to study completion, up to 12 months