Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Omnipod 5.
- Who it may be relevant to
- Registry conditions: Type 1 Diabetes. Basic parameters: from 2 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Post Market Registry to Collect Real-World Safety and Effectiveness Data for the Omnipod 5 System in Children and Adults With Type 1 Diabetes
Overview
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
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.
Interventions
- 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 eve
Primary outcome measures
- Incidence rate of severe hypoglycemia [Time frame: From baseline to study completion, up to 12 months.]
- Incidence rate of DKA [Time frame: From baseline to study completion, up to 12 months.]
- A1c at 3, 6, 9 and 12 months [Time frame: Comparing the change in A1c at baseline compared to at 3, 6, 9 and 12 months]
- Percentage of time < 54 mg/dL [Time frame: From baseline to study completion, up to 12 months]
- Percentage of time < 70 mg/dL [Time frame: From baseline to study completion, up to 12 months]
- Percentage of time > 180 mg/dL [Time frame: From baseline to study completion, up to 12 months]
- Percentage of time > 250 mg/dL [Time frame: From baseline to study completion, up to 12 months]
- Percentage of time in range 70-180 mg/dL [Time frame: From baseline to study completion, up to 12 months]
- Mean Glucose mg/dL [Time frame: From baseline to study completion, up to 12 months]
- Standard deviation of glucose mg/dL [Time frame: From baseline to study completion, about 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Circuit Clinical — Buffalo
Identifiers
NCT: NCT06144554 · Post-Market Registry