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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omnipod User | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omnipod 5 | Device | 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
A minimum of 2,200 Type 1 participants will be recruited.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trang Ly, MBBS, PhD | Contact | 978-600-7000 | APClinical@insulet.com | |
| Julie Perkins | Contact | 978-600-7000 | jperkins@insulet.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Circuit Clinical | Recruiting | Buffalo | New York | 14203 | United States |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
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 |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |