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

Type 1 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06144554
• Other study ID #: Post-Market Registry
• Status: Recruiting
• Start date: September 25, 2023
• Est. completion date: January 28, 2026

Study information

• Verified date: November 2023
• Source: Insulet Corporation
• Contact: Trang Ly, MBBS, PhD
• Phone: 978-600-7628
• Email: tly[@]insulet.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2200
• Est. completion date: January 28, 2026
• Est. primary completion date: September 25, 2025
• Gender: All
• Age group: 2 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

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.

Locations

Country	Name	City	State
United States	Circuit Clinical	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Insulet Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence rate of severe hypoglycemia	Measures frequency of severe hypoglycemia	From baseline to study completion, up to 12 months.
Primary	Incidence rate of DKA	Measures frequency of DKA	From baseline to study completion, up to 12 months.
Primary	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
Primary	Percentage of time < 54 mg/dL	Glucose metric from study continuous glucose monitoring system	From baseline to study completion, up to 12 months
Primary	Percentage of time < 70 mg/dL	Glucose metric from study continuous glucose monitoring system	From baseline to study completion, up to 12 months
Primary	Percentage of time > 180 mg/dL	Glucose metric from study continuous glucose monitoring system	From baseline to study completion, up to 12 months
Primary	Percentage of time > 250 mg/dL	Glucose metric from study continuous glucose monitoring system	From baseline to study completion, up to 12 months
Primary	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
Primary	Mean Glucose mg/dL	Glucose metric from study continuous glucose monitoring system	From baseline to study completion, up to 12 months
Primary	Standard deviation of glucose mg/dL	measure of the range of glucose readings	From baseline to study completion, about 12 months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Insulin Usage	Measure of insulin requirements	From baseline to study completion, up to 12 months
Primary	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.
Primary	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.
Primary	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
Primary	System Usability Scale (SUS)	Questionnaire	at baseline, at 6 months and at the end of registry participation, up to 12 months
Primary	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
Primary	Incidence rate of prolonged hyperglycemia (events per person months)	Measuring the occurrence of prolonged hyperglycemia	From baseline to study completion, up to 12 months
Primary	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
Primary	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