Efficacy of the Omnipod® 6 System Compared With the Omnipod® 5 System
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-75
SponsorInsulet Corporation
About this trial
This multi-center, randomized, cross-over trial will evaluate the efficacy of the Omnipod 6 System compared with the Omnipod 5 System in individuals with type 1 or type 2 diabetes and suboptimal glycemia.
Eligibility criteria
Qualifiers
Age at time of consent 14-75 years (inclusive)
Type 1 diabetes diagnosis for at least 6 months or type 2 diabetes diagnosis for at least 1 year, based on Investigator's clinical judgment
Basal/Bolus insulin delivery via multiple daily doses or insulin pump with or without automation
HbA1c ≥ 7.5%
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Omnipod 5 System
- Omnipod 6 System
Treatment groups
200 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov