Type 1 Diabetes Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People who have type 1 diabetes (based on self-reporting)
- People who have recently been prescribed the Omnipod 5 System and have been using it for no more than two weeks, or who plan to start using it within the next two weeks
- People who are willing to use only one of these specific insulin types during the study: Humalog U-100, Novolog, or Admelog (all U-100 strength)
- People who can read and speak English or Spanish (where available) fluently and who live full-time in the United States
- People who are willing to collect blood samples at home using a provided kit and send them to a laboratory at set time points (at the start, and at 3, 6, 9, and 12 months)
- People who are willing and able to complete short check-ins through the registry every two weeks
- People who are willing and able to complete questionnaires at the start of the study, at 6 months, and at the end of the study (or if they leave early)
- People who are not currently pregnant, not planning to become pregnant in the next 12 months, and who are using a reliable form of birth control
- People who have internet access through a phone, tablet, or computer to use the online registry platform
- People who are willing to share any continuous glucose monitor (CGM) and insulin delivery data from before they started using the Omnipod 5 System, if that data is available (not having this data will not prevent someone from joining)
- People who are able to give informed consent themselves, or — where applicable — people who have a parent or guardian willing and able to give consent on their behalf
Who may not be able to join:
- People who have been diagnosed with sickle cell anemia and/or a condition affecting hemoglobin (a blood protein)
- People who are planning to have a blood transfusion during the study, or who have received a blood transfusion within the 3 months before starting on the Omnipod 5 System
- Adults who are not able to provide informed consent on their own
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Phone: 978-600-7000
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Incidence rate of severe hypoglycemia; Incidence rate of DKA; A1c at 3, 6, 9 and 12 months; Percentage of time < 54 mg/dL; Percentage of time < 70 mg/dL; Percentage of time > 180 mg/dL; Percentage of time > 250 mg/dL; Percentage of time in range 70-180 mg/dL; Mean Glucose mg/dL; Standard deviation of glucose mg/dL; Glucose management indicator %; Percentage of participants achieving A1C < 7%; Percentage of participants with time in range > 70%; Percentage of participants with time below range (<70mg/dL) of < 4%; Insulin Usage; Body Mass Index (BMI) or BMI z-score; EQ-5D (inclusive of the Visua...
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Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.