Search > Diabetes
200 Participants NeededMy employer runs this trial

Omnipod Systems for Diabetes

(STRIVE 2 Trial)

Recruiting at 11 trial locations
TL
BD
Overseen ByBonnie Dumais, RN
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Insulet Corporation
Must be taking: U-100 insulin
Must not be taking: Sulfonylureas, Systemic steroids
Disqualifiers: Coronary artery disease, Severe hypoglycemia, DKA, 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?

This multi-center, randomized, cross-over trial will evaluate the efficacy of the Omnipod 6 System compared with the Omnipod 5 System in individuals with type 1 or type 2 diabetes and suboptimal glycemia.

Are You a Good Fit for This Trial?

This trial is for people aged 14-75 with type 1 diabetes (for at least 6 months) or type 2 diabetes (for at least a year), who use insulin and have blood sugar levels above target. Participants must already use a continuous glucose monitor, give themselves less than four extra insulin doses per day, and be able to manage the study devices.

Inclusion Criteria

HbA1c ≥ 7.5%
Average number of user-initiated boluses less than 4 per day over the 14 days prior to screening through device data or self-report if non-pump user
Average number of user-initiated boluses less than 4 per day over 14 days during Standard Therapy Phase through device data or self-report if non-pump user
See 12 more

Exclusion Criteria

Participation in another investigational drug or device study within 30 days or intending to participate during study period
Pregnant or lactating or childbearing potential not on acceptable birth control methods
Participant is employee of Insulet, Investigator or study team member, or immediate family member thereof
See 13 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Baseline Therapy

Participants undergo a 2-week standard therapy phase for baseline data collection

2 weeks

Treatment Period 1

Participants are randomly assigned to receive either Omnipod 6 or Omnipod 5 for 13 weeks

13 weeks

Crossover Treatment

Participants switch to the opposite system (Omnipod 6 or Omnipod 5) for an additional 13 weeks

13 weeks

Optional Extension

An optional 4-week extension to assess the response of the Omnipod 6 System with restricted boluses

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Trial Overview

The study compares two automated insulin delivery systems—Omnipod 5 and Omnipod 6—in people with diabetes. Each participant will try both systems in random order to see which one better controls blood sugar.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Omnipod 6 SystemExperimental Treatment1 Intervention
Group II: Omnipod 5 SystemActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Insulet Corporation

Lead Sponsor

Trials
23
Recruited
19,600+

Unbiased Results

We believe in providing patients with all the options.

Your Data Stays Your Data

We only share your information with the clinical trials you're trying to access.

Verified Trials Only

All of our trials are run by licensed doctors, researchers, and healthcare companies.