Recruiting

Observational Study

Sponsor:

Insulet Corporation

Code:

NCT06144554

Conditions

Type 1 Diabetes

Eligibility Criteria

Sex: All

Age: 2+

Healthy Volunteers: Not accepted

Interventions

Omnipod 5

Study Details

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

Study ID

NCT06144554

Start date

Sep 25, 2023

Status verified date

Jun, 2026

Completion date

Sep, 2028

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2+

Healthy Volunteers: Not accepted

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

Enrollment

2200 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Incidence rate of severe hypoglycemia [ Time Frame: From baseline to study completion, up to 12 months. ]
  • Incidence rate of DKA [ Time Frame: 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 ]
  • Percentage of time < 54 mg/dL [ Time Frame: 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 ]
  • Percentage of time > 180 mg/dL [ Time Frame: 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 ]
  • Percentage of time in range 70-180 mg/dL [ Time Frame: From baseline to study completion, up to 12 months ]
  • Mean Glucose mg/dL [ Time Frame: 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 ]
  • Glucose management indicator % [ Time Frame: 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 ]
  • Percentage of participants with time in range > 70% [ Time Frame: 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 ]
  • Insulin Usage [ Time Frame: 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. ]
  • 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. ]
  • 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 ]
  • System Usability Scale (SUS) [ Time Frame: 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 ]
  • Incidence rate of prolonged hyperglycemia (events per person months) [ Time Frame: 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Trang Ly, MBBS, PhD

978-600-7000APClinical@insulet.com

Julie Perkins

978-600-7000jperkins@insulet.com

Locations

Circuit Clinical

Recruiting

Buffalo, New York, United States, 14203

Contacts

Carmina VanHAll

603-309-7690cvanhall@circuitclinical.com

Principal Investigator:

Ashok Subramanian, MD

More Information

Sponsor

Insulet Corporation

Last update posted

Jul 1, 2026

Last verified

Jun, 2026

Keywords

  • Type 1 Diabetes
  • Omnipod
  • Automated Insulin Delivery
  • Registry

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Insulet Corporation on 2026-07-01.