Omnipod 5 System Registry for Type 1 Diabetes
This study is a registry (a type of observational study) looking at how the Omnipod 5 System works in real life for children and adults with Type 1 Diabetes. The Omnipod 5 System is a tubeless insulin pump that works with the Dexcom G6 Continuous Glucose Monitoring System to automatically deliver insulin. Researchers want to see how safe and effective the Omnipod 5 System is. They will track important health measures like severe hypoglycemia (very low blood sugar), DKA (diabetic ketoacidosis, a serious complication), and A1c (a measure of average blood sugar over time) for up to 12 months. You can join if you have Type 1 Diabetes, are at least 2 years old, and are either starting the Omnipod 5 System soon or have been using it for less than two weeks. You also need to use specific types of U-100 insulin (Humalog U-100, Novolog, or Admelog). The study aims to enroll 2,200 participants.
- Study design
- This is an observational registry study involving 2,200 participants with Type 1 Diabetes. It is not a randomized trial and does not have a specified phase.
- What's involved
- You would be followed for 12 months. The study collects real-world information about your use of the Omnipod 5 System.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants are expected to be followed for 12 months after starting the study.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 Diabetes
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Incidence rate of severe hypoglycemiaFrom baseline to study completion, up to 12 months.
Measures frequency of severe hypoglycemia
- Incidence rate of DKAFrom baseline to study completion, up to 12 months.
Measures frequency of DKA
- A1c at 3, 6, 9 and 12 monthsComparing the change in A1c at baseline compared to at 3, 6, 9 and 12 months
Measures device effectiveness
- Percentage of time < 54 mg/dLFrom baseline to study completion, up to 12 months
Glucose metric from study continuous glucose monitoring system
- Percentage of time < 70 mg/dLFrom baseline to study completion, up to 12 months
Glucose metric from study continuous glucose monitoring system
- Percentage of time > 180 mg/dLFrom baseline to study completion, up to 12 months
Glucose metric from study continuous glucose monitoring system
- Percentage of time > 250 mg/dLFrom baseline to study completion, up to 12 months
Glucose metric from study continuous glucose monitoring system
- Percentage of time in range 70-180 mg/dLFrom baseline to study completion, up to 12 months
Glucose metric from study continuous glucose monitoring system
- Mean Glucose mg/dLFrom baseline to study completion, up to 12 months
Glucose metric from study continuous glucose monitoring system
- Standard deviation of glucose mg/dLFrom baseline to study completion, about 12 months
measure of the range of glucose readings
- Glucose management indicator %From baseline to study completion, up to 12 months
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.
- Percentage of participants achieving A1C < 7%From baseline to study completion, up to 12 months
measurement of percentage of participants with A1c less than 7%
- Percentage of participants with time in range > 70%From baseline to study completion, up to12 months
measurement of percentage of participants with time in range \> 70%
- Percentage of participants with time below range (<70mg/dL) of < 4%From baseline to study completion, up to 12 months
measurement of percentage of participants with time below range (\<70mg/dL) of \< 4%
- Insulin UsageFrom baseline to study completion, up to 12 months
Measure of insulin requirements
- Body Mass Index (BMI) or BMI z-scoreat 6 months and at the end of registry participation, up to 12 months.
Changes in body mass index
- EQ-5D (inclusive of the Visual Analogue Scale (VAS))at baseline, at 6 months and at the end of registry participation, up to 12 months.
Questionaire
- Insulin Delivery Systems: Perceptions, Ideas, Reflections, and Expectations (INSPIRE)at baseline, at 6 months and at the end of registry participation, up to 12 months
Questionaire
- System Usability Scale (SUS)at baseline, at 6 months and at the end of registry participation, up to 12 months
Questionnaire
- Incidence rate of prolonged hyperglycemia (events per person months) during usage of Activity FeatureFrom baseline to study completion, up to 12 months
Measuring rate of prolonged high sugar while in activity feature
- Incidence rate of prolonged hyperglycemia (events per person months)From baseline to study completion, up to 12 months
Measuring the occurrence of prolonged hyperglycemia
- Incidence rate of prolonged hyperglycemia (events per person months) during usage of a Target Glucose of 140 mg/dL or 150 mg/dLFrom baseline to study completion, up to 12 months
Measuring the occurrence of prolonged hyperglycemia while at a set target glucose of 140mg/dL or 150mg/dL
- 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/dLFrom baseline to study completion, up to 12 months
Glucose metric from study CGM