Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 Diabetes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Post Market Registry to Collect Real-World Safety and Effectiveness Data for the Omnipod 5 System in Children and Adults With Type 1 Diabetes

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Device: Omnipod 5


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Self-reported type 1 diabetes Prescribed, obtained, and have been using the Omnipod 5 System for no more than two weeks or plan to start using the system within the next two weeks Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novolog, or Admelog Able to read and speak English or Spanish (when available) fluently and reside full time in the United States Willing to collect A1C samples using a provided home kit and send the samples to the registry specific core laboratory at baseline and 3, 6, 9 and 12 months Willing and able to complete registry assessments every two weeks Willing and able to complete registry outcome questionnaires at baseline, 6 months and end of study (or at withdrawal) Is not currently pregnant or planning to become pregnant in the next 12 months and is using a reliable form of birth control Access to internet via phone, tablet and/or computer to use the registry online platform Willing to provide CGM and insulin delivery data collected prior to using the Omnipod 5 System, if available (participants will not be excluded if data is not provided) Willing and able to provide informed consent (or assent) and/or has a parent/guardian willing and able to provide informed consent as applicable Exclusion Criteria: Diagnosed with sickle cell anemia and/or hemoglobinopathy Planned blood transfusions over the course of the study or has received a blood transfusion within 3 months prior to starting on Omnipod 5 Adults that are unable to provide informed consent

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Omnipod User<br>All new users for the Omnipod 5 System will be required to register with Insulet's Podder Central. Users already in Podder Central will be required to log into their account before logging into the Omnipod 5 Controller if transitioning to the Omnipod 5 System. As part of the onboarding process, users will be invited to participate in this registry. | Device: Omnipod 5<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of severe hypoglycemia | Measures frequency of severe hypoglycemia | From baseline to study completion, up to 12 months. | 
| Incidence rate of DKA | Measures frequency of DKA | From baseline to study completion, up to 12 months. | 
| A1c at 3, 6, 9 and 12 months | Measures device effectiveness | 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 | From baseline to study completion, up to 12 months | 
| Percentage of time < 70 mg/dL | Glucose metric from study continuous glucose monitoring system | From baseline to study completion, up to 12 months | 
| Percentage of time > 180 mg/dL | Glucose metric from study continuous glucose monitoring system | From baseline to study completion, up to 12 months | 
| Percentage of time > 250 mg/dL | Glucose metric from study continuous glucose monitoring system | 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 | From baseline to study completion, up to 12 months | 
| Mean Glucose mg/dL | Glucose metric from study continuous glucose monitoring system | From baseline to study completion, up to 12 months | 
| Standard deviation of glucose mg/dL | measure of the range of glucose readings | 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. | 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% | 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% | 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% | From baseline to study completion, up to 12 months | 
| Insulin Usage | Measure of insulin requirements | From baseline to study completion, up to 12 months | 
| Body Mass Index (BMI) or BMI z-score | Changes in body mass index | at 6 months and at the end of registry participation, up to 12 months. | 
| EQ-5D (inclusive of the Visual Analogue Scale (VAS)) | Questionaire | 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 | at baseline, at 6 months and at the end of registry participation, up to 12 months | 
| System Usability Scale (SUS) | Questionnaire | 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 | From baseline to study completion, up to 12 months | 
| Incidence rate of prolonged hyperglycemia (events per person months) | Measuring the occurrence of prolonged hyperglycemia | 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 | 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 | From baseline to study completion, up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 1 Diabetes, Omnipod, Automated Insulin Delivery, Registry