Automated Insulin Delivery for Inpatients With Dysglycemia (AIDING) Randomized Controlled Trial

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Combination product, Device
Study Type: Interventional
Study Phase: Phase 3
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• • Any person ≥18 years of age with diabetes mellitus (except cystic fibrosis- and pregnancy-related) admitted to general (non-ICU) medical-surgical hospital services which require inpatient insulin therapy (i.e.,TID or T2D with ≥2 glucose values ≥180mg/dl)

Locations
United States
California
Stanford University School of Medicine
RECRUITING
Stanford
Georgia
Grady Health System (non-CRN)
RECRUITING
Atlanta
Virginia
University of Virginia School of Medicine
RECRUITING
Charlottesville
Contact Information
Primary
Francisco Pasquel, M.D., M.P.H
fpasque@emory.edu
4047781695
Time Frame
Start Date: 2025-01-22
Estimated Completion Date: 2026-05-13
Participants
Target number of participants: 120
Treatments
Active_comparator: Control
The control group will follow the hospital's usual practice for subcutaneous insulin for glucose control. It will be managed by the admitting team with the assistance of an inpatient endocrine team.~Participants will wear a real-time CGM for 10 days or until hospital discharge (if \<10 days)
Experimental: Intervention
Participants in the intervention arm will be assigned to the Omnipod 5 AID system with integrated Dexcom CGM. These devices will communicate with a patient-specific smartphone secured within the patient room and remotely monitored by the nursing station.~Nursing staff on medical-surgical units will provide insulin therapy using the investigational device for participants randomized to the intervention arm, including delivering insulin boluses, monitoring CGM values and trends, validating CGM accuracy against POC glucose, and performing routine device exchanges (Pod or CGM) when indicated AID therapy will continue for 10 days or until hospital discharge (if \<10 days)
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: Emory University

This content was sourced from clinicaltrials.gov