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

Recruiting

• Conditions: Type 1 Diabetes
• Interventions: Device: Omnipod 5

• Registration Number: NCT06144554
• Lead Sponsor: Insulet Corporation

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.

Study Timeline

• Study Start: 2023-09-25
• Study First Submitted: 2023-11-10
• Study First Submitted QC: 2023-11-16
• Study First Posted: 2023-11-22
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-16
• Primary Completion: 2027-06
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Omnipod User	Omnipod 5	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.

Primary Outcome Measures

Name	Time	Method
Incidence rate of DKA	From baseline to study completion, up to 12 months.	Measures frequency of DKA
Percentage of time < 54 mg/dL	From baseline to study completion, up to 12 months	Glucose metric from study continuous glucose monitoring system
Percentage of time < 70 mg/dL	From baseline to study completion, up to 12 months	Glucose metric from study continuous glucose monitoring system
Percentage of time > 180 mg/dL	From baseline to study completion, up to 12 months	Glucose metric from study continuous glucose monitoring system
Glucose management indicator %	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.
Percentage of participants with time below range (<70mg/dL) of < 4%	From baseline to study completion, up to 12 months	measurement of percentage of participants with time below range (\<70mg/dL) of \< 4%
Insulin Usage	From baseline to study completion, up to 12 months	Measure of insulin requirements
Standard deviation of glucose mg/dL	From baseline to study completion, about 12 months	measure of the range of glucose readings
Percentage of participants achieving A1C < 7%	From baseline to study completion, up to 12 months	measurement of percentage of participants with A1c less than 7%
EQ-5D (inclusive of the Visual Analogue Scale (VAS))	at baseline, at 6 months and at the end of registry participation, up to 12 months.	Questionaire
Insulin Delivery Systems: Perceptions, Ideas, Reflections, and Expectations (INSPIRE)	at baseline, at 6 months and at the end of registry participation, up to 12 months	Questionaire
System Usability Scale (SUS)	at baseline, at 6 months and at the end of registry participation, up to 12 months	Questionnaire
Incidence rate of severe hypoglycemia	From baseline to study completion, up to 12 months.	Measures frequency of severe hypoglycemia
Percentage of time > 250 mg/dL	From baseline to study completion, up to 12 months	Glucose metric from study continuous glucose monitoring system
Percentage of time in range 70-180 mg/dL	From baseline to study completion, up to 12 months	Glucose metric from study continuous glucose monitoring system
Mean Glucose mg/dL	From baseline to study completion, up to 12 months	Glucose metric from study continuous glucose monitoring system
Percentage of participants with time in range > 70%	From baseline to study completion, up to12 months	measurement of percentage of participants with time in range \> 70%
Incidence rate of prolonged hyperglycemia (events per person months) during usage of Activity Feature	From baseline to study completion, up to 12 months	Measuring rate of prolonged high sugar while in activity feature
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	From baseline to study completion, up to 12 months	Glucose metric from study CGM
A1c at 3, 6, 9 and 12 months	Comparing the change in A1c at baseline compared to at 3, 6, 9 and 12 months	Measures device effectiveness
Body Mass Index (BMI) or BMI z-score	at 6 months and at the end of registry participation, up to 12 months.	Changes in body mass index
Incidence rate of prolonged hyperglycemia (events per person months)	From baseline to study completion, up to 12 months	Measuring the occurrence of prolonged hyperglycemia
Incidence rate of prolonged hyperglycemia (events per person months) during usage of a Target Glucose of 140 mg/dL or 150 mg/dL	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

Trial Locations

Locations (1)

Circuit Clinical; 🇺🇸 Buffalo, New York, United States