Omnipod M System for Type 2 Diabetes

Recruiting at 6 trial locations

Overseen By Bonnie Dumais

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Insulet Corporation

Must be taking: Insulin

Must not be taking: Corticosteroids, Hydroxyurea

Disqualifiers: Unstable cardiac disease, Renal disease, Psychiatric conditions, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of the Omnipod M System for individuals with Type 2 Diabetes who already use insulin. It will focus on the ease of use of this new insulin delivery system. The trial seeks participants who have had Type 2 Diabetes for at least six months, use insulin regularly, and are willing to try this new system for six weeks. Participants should also feel comfortable wearing the device continuously during the study. As an unphased trial, this study provides a unique opportunity to contribute to the understanding of innovative diabetes management solutions.

Will I have to stop taking my current medications?

The trial does not require you to stop your current medications, but if you are using non-insulin glucose-lowering or weight-reduction medications, your dose must be stable for 6 weeks before the trial and should not change during the study unless necessary for safety.

What prior data suggests that the Omnipod M System is safe for adults with Type 2 Diabetes?

Research shows that the Omnipod M System, used to manage type 2 diabetes, is likely safe based on knowledge of similar devices. The Omnipod 5, a similar system, has already received FDA approval for type 2 diabetes, indicating it has passed strict safety tests. Studies have found that people using the Omnipod 5 experienced better blood sugar control without major safety issues.

The Omnipod systems, including the M version, regularly perform self-checks to ensure proper function and user safety. While specific safety data for the Omnipod M is still being collected, the strong safety record of similar systems is encouraging. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Omnipod M System is unique because it offers a tubeless, wearable insulin delivery system specifically designed for people with Type 2 diabetes. Unlike traditional insulin injections or pumps that require tubing, the Omnipod M is a discreet, wireless patch that simplifies insulin management. Researchers are excited about its potential to improve convenience and comfort for users, making it easier for them to manage their condition effectively. Additionally, the system's advanced technology allows for more precise insulin dosing, which could lead to better blood sugar control compared to current options.

What evidence suggests that the Omnipod M System is effective for Type 2 Diabetes?

Research has shown that the Omnipod M System, which participants in this trial will use, can help people with type 2 diabetes manage their blood sugar levels more effectively. One study found that adults using a similar system, the Omnipod 5, experienced better blood sugar control and an improved quality of life. Another study found that after starting with an automated insulin delivery system, participants had lower HbA1c levels, a measure of long-term blood sugar. These findings suggest that the Omnipod M System might also improve blood sugar management for people with type 2 diabetes. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with Type 2 Diabetes. It aims to enroll about 40 participants, ensuring at least 20 start using the Omnipod M System and ideally having 16 complete a 6-week treatment period.

Inclusion Criteria

I have been diagnosed with type 2 diabetes for at least 6 months.

I have been on insulin for at least 3 months.

My doctor recommends a pump for my treatment.

Exclusion Criteria

I am scheduled for a blood transfusion during the study.

I have recently used corticosteroids.

I have had severe low blood sugar or diabetic ketoacidosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Omnipod M System for diabetes management

6 weeks

Regular monitoring visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Omnipod M System

Trial Overview

The study is testing the Omnipod M System, which is likely a new device or method for managing Type 2 Diabetes. As it's a single-arm feasibility study, all participants will use this system without comparison to another treatment.

How Is the Trial Designed?

Group I: Experimental- Participants with Type 2 diabetes Experimental Treatment 1 Intervention

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

The SECURE-T2D trial, the first and most racially diverse type 2 diabetes pivotal study4, demonstrated improved clinical outcomes and quality of life in this ...

2.

diabetesjournals.org

diabetesjournals.org/diabetes/article/74/Supplement_1/130-OR/159903/130-OR-Real-World-Glycemic-Outcomes-in-Adults-with

130-OR: Real-World Glycemic Outcomes in Adults with Type 2 ...

Introduction and Objective: A recent trial of the Omnipod® 5 AID System showed improvement in glycemic outcomes following AID initiation in a ...

3.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2830238

Automated Insulin Delivery in Adults With Type 2 Diabetes

The feasibility trial of the Omnipod 5 System used in this study showed similar glycemic improvements in 24 adults with type 2 diabetes. Two ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07276776?term=diabetes

An Evaluation of the Omnipod® M System in Adults With ...

This is a single arm feasibility study to evaluate the Omnipod M System in adults with Type 2 Diabetes with the aim to enroll to 40 participants aged 18-75 ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39951268/

Automated Insulin Delivery in Adults With Type 2 Diabetes

In this nonrandomized clinical trial, HbA1c levels were lower in a diverse cohort of adults with type 2 diabetes following AID initiation.

6.

investors.insulet.com

investors.insulet.com/news/news-details/2024/Insulets-SECURE-T2D-Pivotal-Trial-Results-Demonstrate-Omnipod-5-Improves-Clinical-Outcomes-and-Quality-of-Life-in-Type-2-Diabetes/default.aspx

Insulet's SECURE-T2D Pivotal Trial Results Demonstrate ...

The SECURE-T2D pivotal trial results showed glycemic improvements with the use of Omnipod 5 compared with prior treatment of insulin injections or pump therapy ...

7.

omnipod.com

omnipod.com/safety

Important Safety Information | Insulin Pump Therapy

Safety Features​​ The Omnipod DASH System also performs safety checks on the Personal Diabetes Manager (PDM) whenever the PDM is awake. If it detects any ...

8.

omnipod.com

omnipod.com/hcp/t2d

Healthcare provider | Omnipod® 5 for Type 2 Diabetes

Omnipod 5 is the first and only tubeless automated insulin delivery (AID) system to be FDA-cleared for adults living with type 2 diabetes in the US!

9.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36787903/

Safety and Efficacy of the Omnipod 5 Automated Insulin ...

We tested the feasibility of using AID for type 2 diabetes with the Omnipod 5 System in a multicenter outpatient trial.