Automated Insulin Delivery for Inpatients With Dysglycemia

Completed · Phase 3

Conditions studied: Type 1 Diabetes, Type 2 Diabetes

In brief

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).

Key facts

Study ID

NCT06418880

Run by

Emory University

People needed

130

Starts

2025-01-22

Expected to finish

2025-10-31

Last updated by the study team

2025-11-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Stanford University School of Medicine — Stanford, California, United States
• Grady Health System (non-CRN) — Atlanta, Georgia, United States
• University of Virginia School of Medicine — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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