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350 Participants NeededMy employer runs this trial

Omnipod M System for Type 2 Diabetes

(EVOLVE Trial)

Recruiting at 27 trial locations
TL
BD
Overseen ByBonnie Dumais, RN
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Insulet Corporation
Must be taking: Insulin
Must not be taking: Steroids
Disqualifiers: Unstable cardiac disease, Coronary artery disease, Severe hypoglycemia, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

A multi-center, 26-week randomized controlled trial (RCT) to evaluate the safety and efficacy of the fully closed loop Omnipod M System in adults with type 2 diabetes using basal/bolus insulin therapy or basal-only insulin therapy, with the primary endpoint after 15 weeks and secondary analysis at 26 weeks; followed by an extension phase after completion of the 26-week trial where the Intervention group will continue to use Omnipod M and the Control group will crossover to use Omnipod M for 26 weeks

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with type 2 diabetes for at least 6 months, who have been on a stable insulin regimen (either basal-only or basal-bolus) for at least 3 months. Participants must be willing to use specific insulins and a study-provided glucose sensor.

Inclusion Criteria

I am willing to use only the specified U-100 insulins during the study.
I do not plan to start new diabetes or weight-loss medications during the study period.
I have used the same insulin therapy for at least 3 months, with no changes in the last 6 weeks.
See 13 more

Exclusion Criteria

I have not had a recent blood disorder that affects HbA1c tests.
I do not have any major surgeries planned during the study.
Participation in another investigational drug or device study within 30 days prior or plans to participate in other interventional study during 26-week trial phase
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Omnipod M System or continue their pre-study insulin regimen for 26 weeks

26 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Extension

Intervention group continues with Omnipod M, and Control group crosses over to use Omnipod M for an additional 26 weeks

26 weeks

What Are the Treatments Tested in This Trial?

Trial Overview

The study compares the Omnipod M closed-loop insulin delivery system plus continuous glucose monitoring (CGM) against standard insulin therapy plus CGM in people with type 2 diabetes over about six months. Afterward, all participants will try the Omnipod M system.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Intervention group - Omnipod MExperimental Treatment1 Intervention
Group II: Control group - Pre-study insulin regimenActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Insulet Corporation

Lead Sponsor

Trials
23
Recruited
19,600+

Jaeb Center for Health Research

Collaborator

Trials
162
Recruited
36,200+

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