Omnipod 5 System for Type 1 Diabetes

No longer recruiting at 13 trial locations

Overseen By Bonnie Dumais, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Insulet Corporation

Must be taking: U-100 insulin

Must not be taking: Systemic steroids

Disqualifiers: Severe hypoglycemia, DKA, unstable cardiac, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the Omnipod 5 System, a new insulin pump for people with type 1 diabetes. Participants will either use the Omnipod 5 or continue with their current insulin pump. The goal is to compare how well the Omnipod 5 manages blood sugar levels against current pumps. This trial suits individuals with type 1 diabetes who have used an insulin pump for at least three months and are familiar with managing their insulin. As an unphased trial, participants contribute to valuable research that may enhance diabetes management tools.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you must be on a steady dose of metformin if you are taking it. You cannot be on non-insulin diabetes medications other than metformin, and you should not be on systemic steroids during the study.

What prior data suggests that the Omnipod 5 System is safe for use in managing Type 1 Diabetes?

Research has shown that the Omnipod 5 System is generally safe for people with type 1 diabetes. Studies found that users of this system achieved better blood sugar control and experienced fewer instances of low blood sugar, or hypoglycemia. This indicates that the system is usually well-tolerated. However, individuals taking hydroxyurea, a medication for conditions such as cancer and sickle cell anemia, should avoid using the Omnipod 5 System. Overall, evidence suggests that this automated insulin delivery system is safe when used as directed. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Omnipod 5 System is unique because it integrates an advanced insulin pump with the Dexcom G6 continuous glucose monitoring system, allowing for seamless, automated insulin delivery. Unlike traditional insulin pumps that require manual adjustments, this system automatically adjusts insulin based on real-time glucose readings, offering a more hands-off approach for managing Type 1 Diabetes. Researchers are excited about this treatment because it has the potential to improve glucose control and reduce the burden of diabetes management, making daily life easier for patients.

What evidence suggests that the Omnipod 5 System is effective for Type 1 Diabetes?

Research has shown that the Omnipod 5 System can greatly improve blood sugar control for people with type 1 diabetes. In a study of 37,640 users, those using the system maintained their blood sugar within the target range about 68.8% of the time. Another study found that users of Omnipod 5 reduced their HbA1c levels (which measure average blood sugar over time) by an average of 0.8% compared to those using traditional insulin injections. This trial will compare the Omnipod 5 System, used in the intervention arm, with participants' current insulin pumps in the control arm. The Omnipod 5 System automatically delivers insulin, stabilizing blood sugar levels more effectively than manual methods. Overall, these findings suggest that the Omnipod 5 System could help users manage their diabetes better. ^{6 7 8 9 10}

Who Is on the Research Team?

Eric Renard, Pr

Principal Investigator

Lapeyronie Montpellier University Hospital

Ruth Weinstock, MD

Principal Investigator

State University of New York - Upstate Medical University

Are You a Good Fit for This Trial?

Adults aged 18-70 with Type 1 Diabetes for at least a year, currently on pump therapy, and familiar with insulin delivery concepts. They must be willing to use the Omnipod 5 system or their own pump with continuous glucose monitoring and have an A1C between 7.0-11.0%. Exclusions include severe hypoglycemia history, steroid treatment, skin conditions affecting device placement, certain medication use (except metformin), pregnancy/lactation without birth control, participation in other trials recently.

Inclusion Criteria

Diagnosed with type 1 diabetes for at least 1 year. Diagnosis is based on investigator's clinical judgment.

Willing to wear the system continuously throughout the study

Willing to use and obtain U-100 insulin: (either insulin aspart (Novolog, NovoRapid), or insulin lispro (Humalog, Admelog)), as the primary insulin treatment

Exclusion Criteria

You have experienced very low blood sugar levels in the past 6 months.

Currently on systemic steroids or intends to receive systemic steroid treatment during study participation, including stable treatment for adrenal insufficiency. Inhaled, ophthalmic, topical, joint injection, and other locally applied steroids are allowed.

Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Standard Therapy Phase

Participants undergo a 14-day outpatient phase to collect baseline sensor and insulin data using their usual diabetes management routine

2 weeks

2 visits (in-person or virtual)

Randomized Treatment Phase

Participants are randomized to use either the Omnipod 5 system or their personal insulin pump with the study continuous glucose monitoring system for 90 days

13 weeks

6 visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Omnipod 5 System

Trial Overview The trial is testing the Omnipod 5 System against personal insulin pumps over a period of about three months. Participants will first undergo a standard therapy phase for two weeks before using either the new system or continuing their current pump therapy alongside continuous glucose monitoring.

How Is the Trial Designed?

Group I: Intervention Arm Active Control 1 Intervention

Omnipod 5 System with Dexcom G6 continuous glucose monitoring system

Group II: Control Arm Active Control 1 Intervention

Participant's current insulin pump with Dexcom G6 continuous glucose monitoring system

Who Is Running the Clinical Trial?

Insulet Corporation

Lead Sponsor

Trials

23

Recruited

19,600+

Citations

1. omnipod.com omnipod.com/hcp/c/outcomes

Omnipod® 5 Clinical Outcomes Retrospective analysis of real-world data from 37,640 users with type 1 diabetes using Omnipod 5 who utilized the 6.1 mmol/L or 110 mg/dL glucose target of ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38375861/

Real-World Evidence of Omnipod® 5 Automated Insulin ... The Omnipod 5 Automated Insulin Delivery System was associated with favorable glycemic outcomes for people with type 1 diabetes (T1D) in two pivotal clinical ...

3. diabetesjournals.org diabetesjournals.org/diabetes/article/74/Supplement_1/314-OR/159778/314-OR-Improved-Outcomes-across-Baseline-Time-in

314-OR: Improved Outcomes across Baseline Time-in-Range ... Improved outcomes across baseline time-in-range levels with the Omnipod 5 AID system compared with multiple daily injections (MDI) in type 1 diabetes (T1D).

4. investors.insulet.com investors.insulet.com/news/news-details/2025/Insulets-RADIANT-Trial-Demonstrates-Meaningful-Glycemic-Improvements-with-the-Omnipod-5-Automated-Insulin-Delivery-System-Following-Direct-Transition-from-Multiple-Daily-Injections/default.aspx

Insulet's RADIANT Trial Demonstrates Meaningful ... After three months, people who used the Omnipod 5 System improved their HbA1c by an average of 0.8% compared with those using MDI plus CGM, ...

5. omnipod.com omnipod.com/hcp/blog/clinical-studies/forlenza-24-summary

Real-World Evidence of Omnipod® 5 Shows Glycemic ... 37,640 people with type 1 diabetes using the Omnipod 5 System at the 110 mg/dL Glucose Target had a TIR (70 mg/dL-180 mg/dL) of 68.8% and TBR (< ...

6. omnipod.com omnipod.com/safety

Important Safety Information | Insulin Pump Therapy Warning: Do NOT use Omnipod 5 System if you are taking hydroxyurea, a medication used in the treatment of diseases including cancer and sickle cell anemia. Your ...

7. omnipod.com omnipod.com/sites/default/files/omnipod-5_important-safety-information-guide_us-english.pdf

Important Safety Information The goal of this study was to assess the safety and effectiveness of the Omnipod 5 System in children with type 1 diabetes aged. 2 to 5.9 years. This single ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35678724/

A Single-Arm Multicenter Clinical Trial - PubMed - NIH Use of the automated insulin delivery system was safe, and participants experienced improved glycemic measures and reduced hypoglycemia during the study phase.

9. diabetesjournals.org diabetesjournals.org/care/article/46/4/742/148450/Safety-and-Efficacy-of-the-Omnipod-5-Automated

Safety and Efficacy of the Omnipod 5 Automated Insulin ... Many studies have shown efficacy and safety of AID in type 1 diabetes (13–16), but limited data exist on its use in type 2 diabetes. Nearly all ...

10. omnipod.com omnipod.com/sites/default/files/omnipod-5_summary-of-safety-and-clinical-performance_public-access_uk-english.pdf

Summary of Safety and Clinical Performance The objective of this study is to evaluate the safety and efficacy of the Omnipod 5 System with the FreeStyle Libre 2 continuous glucose monitor ...