Clinical trial NCT06144554: Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 Diabetes
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type 1 Diabetes
Keywords: Type 1 Diabetes
Omnipod
Automated Insulin Delivery
Registry
Lead sponsor: Insulet Corporation
Sponsor class: INDUSTRY
First posted: 2023-11-22
Enrollment: 2200
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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.

Eligibility criteria: Inclusion Criteria:

1. Self-reported type 1 diabetes
2. 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
3. Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novolog, or Admelog
4. Able to read and speak English or Spanish (when available) fluently and reside full time in the United States
5. 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
6. Willing and able to complete registry assessments every two weeks
7. Willing and able to complete registry outcome questionnaires at baseline, 6 months and end of study (or at withdrawal)
8. Is not currently pregnant or planning to become pregnant in the next 12 months and is using a reliable form of birth control
9. Access to internet via phone, tablet and/or computer to use the registry online platform
10. 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)
11. 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:

1. Diagnosed with sickle cell anemia and/or hemoglobinopathy
2. Planned blood transfusions over the course of the study or has received a blood transfusion within 3 months prior to starting on Omnipod 5
3. Adults that are unable to provide informed consent

Primary outcomes:
measure: Incidence rate of severe hypoglycemia
timeFrame: From baseline to study completion, up to 12 months.
measure: Incidence rate of DKA
timeFrame: From baseline to study completion, up to 12 months.
measure: A1c at 3, 6, 9 and 12 months
timeFrame: Comparing the change in A1c at baseline compared to at 3, 6, 9 and 12 months
measure: Percentage of time < 54 mg/dL
timeFrame: From baseline to study completion, up to 12 months
measure: Percentage of time < 70 mg/dL
timeFrame: From baseline to study completion, up to 12 months
measure: Percentage of time > 180 mg/dL
timeFrame: From baseline to study completion, up to 12 months
measure: Percentage of time > 250 mg/dL
timeFrame: From baseline to study completion, up to 12 months
measure: Percentage of time in range 70-180 mg/dL
timeFrame: From baseline to study completion, up to 12 months
measure: Mean Glucose mg/dL
timeFrame: From baseline to study completion, up to 12 months
measure: Standard deviation of glucose mg/dL
timeFrame: From baseline to study completion, about 12 months
measure: Glucose management indicator %
timeFrame: From baseline to study completion, up to 12 months
measure: Percentage of participants achieving A1C < 7%
timeFrame: From baseline to study completion, up to 12 months
measure: Percentage of participants with time in range > 70%
timeFrame: From baseline to study completion, up to12 months
measure: Percentage of participants with time below range (<70mg/dL) of < 4%
timeFrame: From baseline to study completion, up to 12 months
measure: Insulin Usage
timeFrame: From baseline to study completion, up to 12 months
measure: Body Mass Index (BMI) or BMI z-score
timeFrame: at 6 months and at the end of registry participation, up to 12 months.
measure: EQ-5D (inclusive of the Visual Analogue Scale (VAS))
timeFrame: at baseline, at 6 months and at the end of registry participation, up to 12 months.
measure: Insulin Delivery Systems: Perceptions, Ideas, Reflections, and Expectations (INSPIRE)
timeFrame: at baseline, at 6 months and at the end of registry participation, up to 12 months
measure: System Usability Scale (SUS)
timeFrame: at baseline, at 6 months and at the end of registry participation, up to 12 months
measure: Incidence rate of prolonged hyperglycemia (events per person months) during usage of Activity Feature
timeFrame: From baseline to study completion, up to 12 months
measure: Incidence rate of prolonged hyperglycemia (events per person months)
timeFrame: From baseline to study completion, up to 12 months
measure: Incidence rate of prolonged hyperglycemia (events per person months) during usage of a Target Glucose of 140 mg/dL or 150 mg/dL
timeFrame: From baseline to study completion, up to 12 months
measure: 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
timeFrame: From baseline to study completion, up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Circuit Clinical
state: New York
Study officials:
References: