Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 Diabetes
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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:
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150 participants aged 2-5
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300 participants aged 6-13
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300 participants aged 14-17
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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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Device: Omnipod 5
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.
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Outcome Measures
Primary Outcome Measures
- Incidence rate of severe hypoglycemia [From baseline to study completion, up to 12 months.]
Measures frequency of severe hypoglycemia
- Incidence rate of DKA [From baseline to study completion, up to 12 months.]
Measures frequency of DKA
- A1c at 3, 6, 9 and 12 months [Comparing the change in A1c at baseline compared to at 3, 6, 9 and 12 months]
Measures device effectiveness
- Percentage of time < 54 mg/dL [From baseline to study completion, up to 12 months]
Glucose metric from study continuous glucose monitoring system
- Percentage of time < 70 mg/dL [From baseline to study completion, up to 12 months]
Glucose metric from study continuous glucose monitoring system
- Percentage of time > 180 mg/dL [From baseline to study completion, up to 12 months]
Glucose metric from study continuous glucose monitoring system
- Percentage of time > 250 mg/dL [From baseline to study completion, up to 12 months]
Glucose metric from study continuous glucose monitoring system
- Percentage of time in range 70-180 mg/dL [From baseline to study completion, up to 12 months]
Glucose metric from study continuous glucose monitoring system
- Mean Glucose mg/dL [From baseline to study completion, up to 12 months]
Glucose metric from study continuous glucose monitoring system
- Standard deviation of glucose mg/dL [From 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 Usage [From baseline to study completion, up to 12 months]
Measure of insulin requirements
- Body Mass Index (BMI) or BMI z-score [at 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 Feature [From 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/dL [From 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/dL [From baseline to study completion, up to 12 months]
Glucose metric from study CGM
Eligibility Criteria
Criteria
Inclusion Criteria:
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Self-reported type 1 diabetes
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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
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Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novolog, or Admelog
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Able to read and speak English or Spanish (when available) fluently and reside full time in the United States
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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
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Willing and able to complete registry assessments every two weeks
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Willing and able to complete registry outcome questionnaires at baseline, 6 months and end of study (or at withdrawal)
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Is not currently pregnant or planning to become pregnant in the next 12 months and is using a reliable form of birth control
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Access to internet via phone, tablet and/or computer to use the registry online platform
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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)
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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:
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Diagnosed with sickle cell anemia and/or hemoglobinopathy
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Planned blood transfusions over the course of the study or has received a blood transfusion within 3 months prior to starting on Omnipod 5
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Adults that are unable to provide informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Circuit Clinical | Buffalo | New York | United States | 14203 |
Sponsors and Collaborators
- Insulet Corporation
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Post-Market Registry