Omnipod M System for Type 2 Diabetes

Not yet recruiting at 5 trial locations

Overseen By Bonnie Dumais

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Insulet Corporation

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

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 years with type 2 diabetes to have a minimum of 20 participants initiate the use of Omnipod M System and the goal of 16 participants completing the 6-week treatment period.

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.

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+