Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 Diabetes

NCT06144554 | Recruiting FDA Device

• 1 other identifier: Post-Market Registry
• Study Type: observational
• Target: 2,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Keywords

Type 1 Diabetes; Omnipod; Automated Insulin Delivery; Registry

Outcome Measures

Primary Outcomes (23)

• 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

  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

Study Arms (1)

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

Interventions

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.

Omnipod User

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insulet Corporation: lead

Study Sites (1)

Circuit Clinical

Buffalo, New York, 14203, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Trang Ly, MBBS, PhD

CONTACT

978-600-7000; APClinical@insulet.com

Julie Perkins

CONTACT

978-600-7000; jperkins@insulet.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: November 22, 2023
• Study Start: September 25, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: May 4, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)