Automated Insulin Delivery for Inpatients With Dysglycemia

PHASE3RecruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

January 22, 2025

Primary Completion Date

May 13, 2026

Study Completion Date

May 13, 2026

Conditions
Type 1 DiabetesType 2 Diabetes
Interventions
DEVICE

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."

COMBINATION_PRODUCT

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."

Trial Locations (3)

22903

RECRUITING

University of Virginia School of Medicine, Charlottesville

30322

RECRUITING

Grady Health System (non-CRN), Atlanta

94305

RECRUITING

Stanford University School of Medicine, Stanford

All Listed Sponsors
collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

lead

Emory University

OTHER