Evaluating Glucose Control Using a Next-Generation AID Algorithm in Individuals With T1D
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-70
SponsorInsulet Corporation
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Omnipod M System
- Omnipod S
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov