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Automated Insulin Delivery for Inpatients With Dysglycemia

NCT06418880 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2025-11-14

No results posted yet for this study

Summary

This randomized controlled trial will test the efficacy and safety of automated insulin delivery (AID) in hospitalized patients with diabetes (type 1 or type 2) requiring insulin therapy who are admitted to general medical/surgical floors.

The main objectives of this study are:

* To test the efficacy and safety of AID versus multiple daily insulin injections (MDI) + CGM in the inpatient setting
* To determine differences in CGM-derived metrics between AID and MDI plus CGM in the hospital and explore differences in treatment effect according to individual characteristics.

Participants will be:

* Randomized to AID + remote CGM (intervention) or multiple daily insulin injections (MDI) + CGM (control group)
* Followed for a total of 10 days or until hospital discharge (if less than 10 days).

Conditions

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.

Sponsors & Collaborators

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

    collaborator NIH

  • Emory University

    lead OTHER

Principal Investigators

  • Francisco Pasquel, M.D., M.P.H · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-22
Primary Completion
2025-10-31
Completion
2025-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06418880 on ClinicalTrials.gov