Omnipod® SmartAdjust 2.0 System Compared to the Omnipod® 5 System in Individuals With Type 1 or T… (NCT06865989) | Clinical Trial Compass
CompletedNot Applicable
Omnipod® SmartAdjust 2.0 System Compared to the Omnipod® 5 System in Individuals With Type 1 or Type 2 Diabetes
United States132 participantsStarted 2025-03-26
Plain-language summary
The goal of this multi-center, randomized, cross-over study is to evaluate the safety and effectiveness of the Omnipod 5 SmartAdjust 2.0 System in individuals with type 1 or type 2 diabetes.
Study participants will complete about 5 in-person visits and be expected to treat their diabetes per their usual routine using the system at the lowest available target setting.
Each participant will begin the study using either the Omnipod 5 SmartAdjust 2.0 System or the Omnipod 5 System for 4 weeks (Period 1) then switch to the opposite system for the next 4 weeks (Period 2). Everyone will use the Omnipod 5 SmartAdjust 2.0 System for the last 4-6 weeks (Period 3). During Period 3, participants will have a goal of administering no more than 3 meal or snack boluses per day.
Who can participate
Age range
2 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age at time of consent 2-70 years (inclusive)
. Diabetes diagnosis, based on Investigators clinical judgement, and meets the following:
. Living with a parent or guardian if \< 18 years old
. Omnipod 5 user who has used U-100 insulin or their generic equivalents with the Omnipod 5 system for at least 3 months prior to screening
. Must have used the target of 110mg/dl for at least 30% of the time for 2-13 year olds and for at least 50% of the time for 14-70 year olds for the 2 weeks preceding the screening visit
. Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novolog, or Admelog or their generic equivalents
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percent of time in range <54 mg/dL (non-inferiority margin of 0.75%)
Timeframe: End of Period 2 (Day 56) compared to Baseline
2
Percent of time in range <70 mg/dL (non-inferiority margin of 3.0%)
Timeframe: End of Period 2 (Day 56) compared to Baseline
3
Percent of time in range 70-180 mg/dL (non-inferiority margin of 3.0%)
Timeframe: End of Period 2 (Day 56) compared to Baseline
4
Mean Glucose (non-inferiority margin of 8 mg/dL)
Timeframe: End of Period 2 (Day 56) compared to Baseline
. Participant agrees to provide their own insulin for the duration of the study
. Stable doses over the preceding 4 weeks of non-insulin glucose lowering or weight loss medications that have a meaningful effect on glycemia, as determined by the investigator
Exclusion criteria
. Any medical condition, which in the opinion of the investigator, would put the participant at an unacceptable safety risk
. Current or known history of coronary artery disease that is not stable with medical management per investigator judgment, including unstable angina, or angina that prevents moderate exercise despite medical management, or a history of myocardial infarction, percutaneous coronary intervention, or coronary artery bypass grafting within the 12 months prior to screening
. Any planned surgery during the study which could be considered major in the judgment of the investigator
. History of severe hypoglycemia in the past 6 months. Severe hypoglycemia is defined as an event that requires the assistance of another person due to altered mental and/or physical status, and requires another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
. History of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS) in the past 6 months, unrelated to an intercurrent illness or infusion failure
. Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement
. Blood disorder or dyscrasia within 3 months prior to screening, which in the Investigator's opinion could interfere with determination of HbA1c