Efficacy of the Omnipod® 6 System Compared With the Omnipod® 5 System
Recruiting · 12 sites across 11 states
Always free
Study care at no cost to you
For your time and travel
Many studies pay you back
Most need no insurance or papers
Legal status usually isn't required; we'll tell you each study's requirements
Interpreters available
Ask for your language
Your choice
Voluntary — you can stop anytime
What is this study?
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.
It is , overseen by an independent and licensed medical staff.
Read the full clinical description
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.
Who this study is looking for
In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.
✅ You may be able to join if…
- •You are between 14 and 75 years old when you agree to join.
- •You have type 1 diabetes for at least 6 months or type 2 diabetes for at least 1 year (decided by the study doctor).
- •You use insulin through multiple daily injections or an insulin pump (with or without automation).
- •Your HbA1c is 7.5% or higher. (HbA1c shows your average blood sugar over time.)
- •You are currently using a continuous glucose monitor. (This device checks blood sugar throughout the day.)
🚫 You may not be able to join if…
- •You have a heart condition that is unstable, including unstable angina, or a history of heart attack, certain heart procedures, or heart bypass surgery within the past 12 months (based on the study doctor).
- •You had severe low blood sugar in the past 6 months. (Severe means it needed another person to help with carbs, glucagon, or other emergency treatment.)
- •You had diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS) in the past 6 months (unless due to a temporary illness or infusion failure).
- •You can’t tolerate adhesive tape or have an unresolved skin problem where the sensor or pump would be placed.
- •You are pregnant or breastfeeding, or could become pregnant and are not using acceptable birth control.
Are you a good fit?
Simplified highlights. The study team always confirms the full details with you.
- ✓Adults roughly 14–75
- ✓Have Type 2 diabetes
- !Some conditions may not be a fit: Heart / cardiovascular disease
- !Not for people who are pregnant or breastfeeding
- !May require a break from current GLP-1 medications
What to expect, step by step
- 1
Usually a few weeks
The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.
- 2
Treatment
If you join and choose to continue, you receive the study treatment and are watched closely by medical staff.
- 3
Follow-up
After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.
Has this treatment been tested before?
The study team can share what safety testing has been done so far.
What you need to know before you apply
What is this study testing?+
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.
Is it safe? Who makes sure of that?+
This is a research study. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.
Will I get a placebo instead of the real treatment?+
Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.
I take a GLP-1 medication (like Ozempic or Wegovy). Can I still join?+
Maybe. This study may ask you to pause certain weight or diabetes medications for a period of time (a 'washout') before joining, or it may be looking for people not currently on them. The coordinator will review your medications with you — don't stop any medication on your own.
Does it cost anything? Will I be paid?+
Study-related care is provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.
Do I need insurance? Will anyone ask about my immigration status?+
No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.
What if English isn't my first language?+
You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.
Is my information private?+
Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.
Some requirements (like specific lab values or timing) are confirmed directly by the study team, not by us.
Source: ClinicalTrials.gov · NCT07579702 · Locations: California · Colorado · Connecticut · Florida · Georgia · Illinois · Indiana · Massachusetts · Michigan · Minnesota · Texas