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 range2 Years – 70 Years
SexALL
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Inclusion criteria
âś“. Age at time of consent 2-70 years (inclusive)
âś“. Diabetes diagnosis, based on Investigators clinical judgement, and meets the following:
âś“. Living with a parent or guardian if \< 18 years old
âś“. 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
âś“. 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
âś“. Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novolog, or Admelog or their generic equivalents
âś“. Participant agrees to provide their own insulin for the duration of the study
âś“. 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
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
âś•. Any medical condition, which in the opinion of the investigator, would put the participant at an unacceptable safety risk
âś•. 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
âś•. Any planned surgery during the study which could be considered major in the judgment of the investigator
âś•. 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.
âś•. History of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS) in the past 6 months, unrelated to an intercurrent illness or infusion failure
âś•. Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement
âś•. Blood disorder or dyscrasia within 3 months prior to screening, which in the Investigator's opinion could interfere with determination of HbA1c