Omnipod® System for Type 2 Diabetes

Evaluation of the Fully Closed Loop Omnipod® System in Type 2 Diabetes

Recruiting N/A Interventional Study
Type 2 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
18 – 75
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
350 (estimated)
Sponsor
Insulet Corporation · Industry
Who this trial is looking for

This trial is looking for adults with type 2 diabetes who are currently on insulin therapy. Participants will use the Omnipod® system to manage their diabetes over a 26-week period and may continue using it afterward.

Are You a Good Fit for This Trial?
Must be taking Basal insulin

You may be able to join if

  • I am between 18 and 75 years old.
  • I have been diagnosed with type 2 diabetes for at least 6 months.
  • I have been on insulin therapy for at least 3 months.
  • My A1C level is between 6.0% and 14.0%.
  • I am willing to use only specific types of U-100 insulin during the study.
  • I can wear the system continuously for 26 weeks.
  • I can understand English.
  • I agree to have pregnancy testing if I can become pregnant.

You may not be able to join if

  • I have used an automated insulin delivery pump in the last 3 months.
  • I have any serious medical condition that could put my safety at risk.
  • I have unstable coronary artery disease.
  • I have had more than 1 severe hypoglycemia episode in the past 6 months.
  • I have had more than 1 episode of diabetic ketoacidosis in the past 6 months.
  • I am pregnant or breastfeeding, or I am not using birth control.
  • I have taken systemic steroids in the last 4 weeks.
  • I am involved in another clinical study.

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
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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Age at time of consent 18-75 years (inclusive) 2. Clinical diagnosis, based on investigator assessment, of type 2 diabetes for at least 6 months at time of screening 3. On insulin therapy for at least 3 months at time of screening, with no change to insulin regimen for 6 week…
Contacts

Trang Ly, MBBS, PhD

978-600-7000

APClinical@insulet.com

CONTACT

Bonnie Dumais, RN

978-600-7000

APClinical@insulet.com

CONTACT