Omnipod 6 System vs Omnipod 5 System for Diabetes

Efficacy of the Omnipod® 6 System Compared With the Omnipod® 5 System

Recruiting N/A Interventional Study
Type 2 Diabetes Mellitus Type 1 Diabetes Mellitus
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
14 – 75
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
200 (estimated)
Sponsor
Insulet Corporation · Industry
Who this trial is looking for

This trial is looking for people aged 14 to 75 with type 1 or type 2 diabetes who have trouble controlling their blood sugar. Participants will use the Omnipod 6 System to see how well it works compared to the Omnipod 5 System.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am between 14 and 75 years old.
  • I have type 1 diabetes for at least 6 months or type 2 diabetes for at least 1 year.
  • I currently use a continuous glucose monitor.
  • I have an HbA1c level of 7.5% or higher.
  • I average less than 4 user-initiated boluses per day.
  • I am willing to use approved types of U-100 insulin during the study.
  • I can read and understand English.
  • I am willing to sign a consent form.

You may not be able to join if

  • I have had a severe hypoglycemia event in the past 6 months.
  • I have a history of diabetic ketoacidosis or hyperosmolar hyperglycemic state in the past 6 months.
  • I have any medical condition that would put me at an unacceptable safety risk.
  • I have a current or known history of unstable coronary artery disease.
  • I cannot tolerate adhesive tape or have a skin condition in the area of sensor or pump placement.
  • I am pregnant or breastfeeding.
  • I have taken systemic steroids in the past 4 weeks.
  • I am an employee of Insulet or related to someone on the study team.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About 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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Age at time of consent 14-75 years (inclusive) * Type 1 diabetes diagnosis for at least 6 months or type 2 diabetes diagnosis for at least 1 year, based on Investigator's clinical judgment * Basal/Bolus insulin delivery via multiple daily doses or insulin pump with or without …
Contacts

Trang Ly, MBBS, PhD

978-600-7000

APClinical@insulet.com

CONTACT

Bonnie Dumais, RN

APClinical@insulet.com

CONTACT