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

April 30, 2026 updated by: Insulet Corporation

Post Market Registry to Collect Real-World Safety and Effectiveness Data 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

2200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14203
        • Recruiting
        • Circuit Clinical
        • Contact:
        • Principal Investigator:
          • Ashok Subramanian, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence rate of severe hypoglycemia
Time Frame: From baseline to study completion, up to 12 months.
Measures frequency of severe hypoglycemia
From baseline to study completion, up to 12 months.
Incidence rate of DKA
Time Frame: From baseline to study completion, up to 12 months.
Measures frequency of DKA
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
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
Time Frame: From baseline to study completion, up to 12 months
Glucose metric from study continuous glucose monitoring system
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
Glucose metric from study continuous glucose monitoring system
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
Glucose metric from study continuous glucose monitoring system
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
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
Time Frame: From baseline to study completion, up to 12 months
Glucose metric from study continuous glucose monitoring system
From baseline to study completion, up to 12 months
Mean Glucose mg/dL
Time Frame: From baseline to study completion, up to 12 months
Glucose metric from study continuous glucose monitoring system
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
measure of the range of glucose readings
From baseline to study completion, about 12 months
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.
From baseline to study completion, up to 12 months
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%
From baseline to study completion, up to 12 months
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%
From baseline to study completion, up to12 months
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%
From baseline to study completion, up to 12 months
Insulin Usage
Time Frame: From baseline to study completion, up to 12 months
Measure of insulin requirements
From baseline to study completion, up to 12 months
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
at 6 months and at the end of registry participation, up to 12 months.
System Usability Scale (SUS)
Time Frame: at baseline, at 6 months and at the end of registry participation, up to 12 months
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
Time Frame: From baseline to study completion, up to 12 months
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)
Time Frame: From baseline to study completion, up to 12 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
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
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
Time Frame: From baseline to study completion, up to 12 months
Glucose metric from study CGM
From baseline to study completion, up to 12 months
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
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)
Time Frame: at baseline, at 6 months and at the end of registry participation, up to 12 months
Questionaire
at baseline, at 6 months and at the end of registry participation, up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Insulet Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2023

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

November 10, 2023

First Submitted That Met QC Criteria

November 16, 2023

First Posted (Actual)

November 22, 2023

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Post-Market Registry

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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