Automated Insulin Delivery for Inpatients With Dysglycemia

NCT06418880 | Completed Phase 3 DMC FDA Device

• 3 other identifiers: STUDY000070811R01DK138366-012025P012163
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 3

Brief 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

Type 1 Diabetes; Type 2 Diabetes

Keywords

continuous glucose monitoring; automated insulin delivery; Insulin Therapy

Outcome Measures

Primary Outcomes (2)

• Efficacy: Time spent in glucose target range

  This will be captured by the percentage of time spent in glucose target range (TIR 70-180 mg/dl);

  Up to 10 days (or hospital discharge if before 10 days)

• Safety: Time spent below the target glucose range

  This will be captured by the percentage of time spent below glucose range (TBR \<54 mg/dl).

  Up to 10 days (or hospital discharge if before 10 days)

Secondary Outcomes (3)

• TAR >250mg/dl

  Up to 10 days (or hospital discharge if before 10 days)

• TBR <70 mg/dl

  Up to 10 days (or hospital discharge if before 10 days)

• Mean hospitalization glucose

  Up to 10 days (or hospital discharge if before 10 days)

Other Outcomes (7)

• Time spent above 180 mg/dl

  Up to 10 days (or hospital discharge if before 10 days)

• Time spent between 70-99 mg/dl

  Up to 10 days (or hospital discharge if before 10 days)

• Glycemic events above 300 mg/dl

  Up to 10 days (or hospital discharge if before 10 days)

Study Arms (2)

Control

ACTIVE COMPARATOR

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)

Combination Product: Standard of Care Insulin Therapy + CGM

Intervention

EXPERIMENTAL

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)

Device: AID system with Remote Real-Time CGM

Interventions

AID system with Remote Real-Time CGM DEVICE

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.

Intervention

Standard of Care Insulin Therapy + CGM COMBINATION_PRODUCT

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.

Also known as: Multiple Daily Injections +CGM

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Patients admitted to ICU
• Patients anticipated to require less than 48 hours admission.
• Current evidence of hyperglycemic crises (diabetic ketoacidosis or hyperosmolar hyperglycemic state)
• Severe anemia with hemoglobin \<7 g/dL
• Evidence of hemodynamic instability
• Hypoxia (SpO2 \<92% on supplemental oxygen)
• Pre-admission or inpatient total-daily insulin dose \>150 units daily
• T2D patients on sliding scale insulin therapy alone (no scheduled basal or bolus insulin) and with glucose levels below 180 mg/dl
• Patients without diabetes with stress hyperglycemia (not related to steroids or medical nutrition therapy) and with HbA1c \<6.5%
• Patients on AID as outpatient
• Patients who previously participated in AIDING feasibility trial or this RCT
• Patients with a condition impeding their ability to consent or answer questionnaires or notify staff of symptoms.
• Patients who are pregnant time of enrollment
• Patients who are unable or unwilling to use rapid-acting insulin analogs (Humalog, Admelog, or Novolog) during the study
• Use of hydroxyurea, high dose of acetaminophen (\>4 grams/day), or high dose ascorbic acid

Sponsors & Collaborators

• Emory University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (3)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Grady Health System (non-CRN)

Atlanta, Georgia, 30322, United States

Location

University of Virginia School of Medicine

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Francisco Pasquel, M.D., M.P.H

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: May 17, 2024
• Study Start: January 22, 2025
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: November 14, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)