NCT07593625
Evaluating Glucose Control Using a Next-Generation AID Algorithm in Individuals With T1D
Recruiting · Not Applicable · Insulet Corporation · registry updated 2026-09-10
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
Feasibility study to evaluate the safety and feasibility of Omnipod automated insulin delivery algorithms in individuals with type 1 diabetes. This study will enroll up to 80 participants to have a minimum of 48 participants to initiate the use of Omnipod. The study will include hotel and outpatient evaluation periods.
Inclusion
- Age at time of consent 2-70 years (inclusive)
- Type 1 diabetes diagnosis for at least 6 months, for those aged 8-70 years, or 3 months for those aged 2-7 years, based on Investigator assessment
- Basal/Bolus insulin delivery via multiple daily injections or insulin pump with or without automation
- Willing to use the following types of U-100 insulin during the study: Humalog U-100, Novorapid or their generic equivalents
- Deemed appropriate for pump therapy per Investigator's assessment considering previous history of severe hypoglycemic and hyperglycemic events, and other comorbidities
- If using noninsulin glucose-lowering medications or weight reduction medications, dose has been stable for 6-weeks prior to screening; and participant is willing to not change the dose unless required for safety purposes.
Exclusion
- Any medical condition, which in the opinion of the Investigator, would put the participant at an unacceptable safety risk. This may include untreated malignancy, unstable cardiac disease, unstable or end-stage renal disease, unstable proliferative retinopathy, unstable psychiatric conditions such as eating disorders, drug or alcohol abuse.
- Current or known history of coronary artery disease that is not stable with medical management, including unstable angina, or a history of myocardial infarction, percutaneous coronary intervention, coronary artery bypass grafting, or arrhythmias requiring intervention within the 12 months prior to screening
- Any planned surgery during the study which could be considered major in the opinion of the Investigator
- History of more than 1 severe hypoglycaemia in the past 6 months. Severe hypoglycaemia is defined as an event that requires the assistance of another person due to altered consciousness, and requires another person to actively administer carbohydrate, glucagon, or other resuscitative actions
- History of more than 1 diabetic ketoacidosis (DKA) in the past 6 months, unrelated to an intercurrent illness; kinked, dislodged, or occluded cannula; or initial diabetes diagnosis Unable to tolerate adhesive tape or has any unresolved skin condition that could impact 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