No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
2 and older
Sex
Any
Study type
Observational
Participants needed
2,200 (estimated)
Sponsor
Insulet Corporation · Industry
Who this trial is looking for
This trial is looking for people with Type 1 Diabetes who are using or plan to start using the Omnipod 5 system. Participants will track their health data and complete some questionnaires over a year.
Are You a Good Fit for This Trial?
You may be able to join if
I have type 1 diabetes.
I have been using the Omnipod 5 System for no more than two weeks or plan to start using it within two weeks.
I can read and speak English or Spanish.
I am willing to collect A1C blood samples at specific times.
I have reliable internet access to use the online platform.
I can provide informed consent, or my parent/guardian can.
I am using only Humalog U-100, Novolog, or Admelog insulin.
I am not currently pregnant and not planning to become pregnant in the next 12 months.
You may not be able to join if
I have sickle cell anemia or hemoglobinopathy.
I have planned blood transfusions during the study.
I received a blood transfusion in the past 3 months.
I am unable to provide informed consent.
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.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This is a decentralized observational clinical registry to collect real-world evidence related to the safety and effectiveness of the Omnipod 5 system in children and adults with Type 1 Diabetes.
Trial Locations
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City
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Status
Eligibility Criteria
Inclusion Criteria:
1. Self-reported type 1 diabetes
2. Prescribed, obtained, and have been using the Omnipod 5 System for no more than two weeks or plan to start using the system within the next two weeks
3. Willing to use only the following types of U-100 insulin during the study: Humalog U-100, …
Inclusion Criteria:
1. Self-reported type 1 diabetes
2. Prescribed, obtained, and have been using the Omnipod 5 System for no more than two weeks or plan to start using the system within the next two weeks
3. Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novolog, or Admelog
4. Able to read and speak English or Spanish (when available) fluently and reside full time in the United States
5. Willing to collect A1C samples using a provided home kit and send the samples to the registry specific core laboratory at baseline and 3, 6, 9 and 12 months
6. Willing and able to complete registry assessments every two weeks
7. Willing and able to complete registry outcome questionnaires at baseline, 6 months and end of study (or at withdrawal)
8. Is not currently pregnant or planning to become pregnant in the next 12 months and is using a reliable form of birth control
9. Access to internet via phone, tablet and/or computer to use the registry online platform
10. Willing to provide CGM and insulin delivery data collected prior to using the Omnipod 5 System, if available (participants will not be excluded if data is not provided)
11. Willing and able to provide informed consent (or assent) and/or has a parent/guardian willing and able to provide informed consent as applicable
Exclusion Criteria:
1. Diagnosed with sickle cell anemia and/or hemoglobinopathy
2. Planned blood transfusions over the course of the study or has received a blood transfusion within 3 months prior to starting on Omnipod 5
3. Adults that are unable to provide informed consent
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