120
Participants
Start Date
January 22, 2025
Primary Completion Date
May 13, 2026
Study Completion Date
May 13, 2026
AID system with Remote Real-Time CGM
"The Omnipod 5 AID System is comprised of two components:~* Omnipod 5 Pod (insulin infusion pump with SmartAdjust technology)~* Omnipod 5 App (installed on the Controller or smart phone) The Omnipod 5 AID pod is a lightweight, self-adhesive device that the user fills with U-100 rapid-acting insulin and wears directly on their body. The Pod delivers insulin into the user's body through a small flexible tube, called a cannula, based on the commands from the compatible Controller. In the Omnipod 5 AID System, the Pod itself houses the MPC algorithm and communicates directly with the CGM and the Omnipod 5 App. Based on predicted glucose values, the algorithm commands the Pod's insulin delivery through micro-boluses."
Standard of Care Insulin Therapy + CGM
"This includes the usage of subcutaneous insulin for glucose control. Participants will wear a real-time Continuous Monitoring (CGM) for 10 days or until hospital discharge (if \<10 days).~Treatment decisions will be based on POC testing with consideration of daily evaluation of CGM patterns."
RECRUITING
University of Virginia School of Medicine, Charlottesville
RECRUITING
Grady Health System (non-CRN), Atlanta
RECRUITING
Stanford University School of Medicine, Stanford
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Emory University
OTHER