At a glance
ClinicalIndex Comparison Record- ✓Age 18-70 years at time of consent
- ✓Type 1 diabetes diagnosed for at least 1 year
- ✓On pump therapy for ≥3 months prior to screening, familiar with basal/bolus insulin delivery and carbohydrate counting
- ✓A1C 7.0-11.0% at screening
- ✕Medical conditions including untreated malignancy, unstable cardiac disease, unstable/end-stage renal failure, eating disorders that pose unacceptable safety risk
- ✕History of severe hypoglycemia in past 6 months
- ✕History of diabetic ketoacidosis (DKA) in past 6 months, unrelated to intercurrent illness or infusion set failure
- ✕Blood disorder or dyscrasia within 3 months prior to screening, including use of hydroxyurea that could interfere with HbA1C determination
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Efficacy and Safety of the Omnipod 5 System Compared to Pump Therapy in the Treatment of Type 1 Diabetes: a Randomized, Parallel-group Clinical Trial
In Brief
A clinical study evaluating Omnipod 5 System for Type 1 Diabetes. Completed, enrolled 196 participants across 14 sites in 2 countries.
Detailed Summary
Subject will undergo a 14-day outpatient, standard therapy phase during which sensor and insulin data will be collected. This will be followed by a 90-day outpatient phase where subjects will either use the Omnipod 5 system or continue to use their personal insulin pump with the study provided continuous glucose monitoring system. Participants in France will be offered an optional extension of 12 months of Omnipod 5 System use.
Study Details
Timeline
Interventions
Omnipod 5 System automates insulin delivery based on information received from the continuous glucose monitoring system every 5 minutes.