Omnipod 5 for Type 2 Diabetes
(SECURE-T2D Trial)

Recruiting in Palo Alto (17 mi)

+22 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Insulet Corporation

No Placebo Group

Trial Summary

What is the purpose of this trial?

This is a single arm, multi-center, prospective study that will evaluate the safety and efficacy of the Omnipod 5 Automated Insulin Delivery System in adults with type 2 diabetes requiring insulin therapy.

Eligibility Criteria

Adults aged 18-75 with type 2 diabetes on insulin therapy are eligible for this trial. They must have an A1C between 7.0% and <12.0%, be able to use specific U-100 insulins, and not plan any major surgeries during the study. Participants should not have had severe hypoglycemia recently, take steroids, or have skin issues affecting device placement.

Inclusion Criteria

I can read and understand either English or Spanish.

I agree to supply my own insulin throughout the study.

I can understand and follow the study's procedures and use its devices.

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Exclusion Criteria

Unable to follow clinical protocol for the duration of the study or is otherwise deemed unacceptable to participate in the study per the investigator's clinical judgment

I plan to receive a blood transfusion during the study.

Participation in another clinical study using an investigational drug or device other than the Omnipod 5 in the 30 days prior to screening or intends to participate during the study period

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Treatment Details

Interventions

Omnipod 5 Automated Glucose Control System (Automated Insulin Delivery System)

Trial OverviewThe Omnipod 5 Automated Insulin Delivery System is being tested for safety and effectiveness in managing blood sugar levels in adults with type 2 diabetes who require insulin therapy. This single-arm study involves continuous system wear throughout the trial period.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment1 Intervention

All subjects wearing the Omnipod 5 Automated Glucose Monitoring System