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NCT Number: NCT06144554

Post Market Registry for 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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

2 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Circuit Clinical

Buffalo, New York, 14203, United States

Location status: Recruiting

Location contact

Ashok Subramanian, MD

PRINCIPAL_INVESTIGATOR

Carmina VanHAll

CONTACT

[email protected]

603-309-7690

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Incidence rate of severe hypoglycemia

    Time frame: From baseline to study completion, up to 12 months.

    Measures frequency of severe hypoglycemia

  2. Incidence rate of DKA

    Time frame: From baseline to study completion, up to 12 months.

    Measures frequency of DKA

  3. 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

    Measures device effectiveness

  4. Percentage of time < 54 mg/dL

    Time frame: From baseline to study completion, up to 12 months

    Glucose metric from study continuous glucose monitoring system

  5. Percentage of time < 70 mg/dL

    Time frame: From baseline to study completion, up to 12 months

    Glucose metric from study continuous glucose monitoring system

  6. Percentage of time > 180 mg/dL

    Time frame: From baseline to study completion, up to 12 months

    Glucose metric from study continuous glucose monitoring system

  7. Percentage of time > 250 mg/dL

    Time frame: From baseline to study completion, up to 12 months

    Glucose metric from study continuous glucose monitoring system

  8. Percentage of time in range 70-180 mg/dL

    Time frame: From baseline to study completion, up to 12 months

    Glucose metric from study continuous glucose monitoring system

  9. Mean Glucose mg/dL

    Time frame: From baseline to study completion, up to 12 months

    Glucose metric from study continuous glucose monitoring system

  10. Standard deviation of glucose mg/dL

    Time frame: From baseline to study completion, about 12 months

    measure of the range of glucose readings

  11. Glucose management indicator %

    Time frame: 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.

  12. Percentage of participants achieving A1C < 7%

    Time frame: From baseline to study completion, up to 12 months

    measurement of percentage of participants with A1c less than 7%

  13. Percentage of participants with time in range > 70%

    Time frame: From baseline to study completion, up to12 months

    measurement of percentage of participants with time in range > 70%

  14. Percentage of participants with time below range (<70mg/dL) of < 4%

    Time frame: From baseline to study completion, up to 12 months

    measurement of percentage of participants with time below range (<70mg/dL) of < 4%

  15. Insulin Usage

    Time frame: From baseline to study completion, up to 12 months

    Measure of insulin requirements

  16. Body Mass Index (BMI) or BMI z-score

    Time frame: at 6 months and at the end of registry participation, up to 12 months.

    Changes in body mass index

  17. EQ-5D (inclusive of the Visual Analogue Scale (VAS))

    Time frame: at baseline, at 6 months and at the end of registry participation, up to 12 months.

    Questionaire

  18. Insulin Delivery Systems: Perceptions, Ideas, Reflections, and Expectations (INSPIRE)

    Time frame: at baseline, at 6 months and at the end of registry participation, up to 12 months

    Questionaire

  19. System Usability Scale (SUS)

    Time frame: at baseline, at 6 months and at the end of registry participation, up to 12 months

    Questionnaire

  20. Incidence rate of prolonged hyperglycemia (events per person months) during usage of Activity Feature

    Time frame: From baseline to study completion, up to 12 months

    Measuring rate of prolonged high sugar while in activity feature

  21. Incidence rate of prolonged hyperglycemia (events per person months)

    Time frame: From baseline to study completion, up to 12 months

    Measuring the occurrence of prolonged hyperglycemia

  22. Incidence rate of prolonged hyperglycemia (events per person months) during usage of a Target Glucose of 140 mg/dL or 150 mg/dL

    Time frame: 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

  23. 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

    Time frame: From baseline to study completion, up to 12 months

    Glucose metric from study CGM

Study contacts

Contact information is provided by the study sponsor or research team.

Julie Perkins

CONTACT

[email protected]

978-600-7000

Trang Ly, MBBS, PhD

CONTACT

[email protected]

978-600-7000

Sponsors and collaborators

Lead sponsor

Insulet Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Nov 22, 2023
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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