NOT_YET_RECRUITING
Automated Insulin Delivery for Inpatients With Dysglycemia
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
🗓️ Study Start (Actual) 1 July 2024
🗓️ Primary Completion (Estimated) 31 December 2025
✅ Study Completion (Estimated) 31 December 2025
👥 Enrollment (Estimated) 120
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE3
Locations:
📍 Stanford, California, United States
📍 Atlanta, Georgia, United States
📍 Charlottesville, Virginia, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • • 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)

    Exclusion Criteria:

    • * Patients admitted to ICU
    • * Patients anticipated to require less than 48 hours of 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 an outpatient
    • * Patients who previously participated in AIDING feasibility trial or this RCT
    • * Patients with a condition impeding the ability to consent or answer questionnaires
    • * Patients who are pregnant or breastfeeding at the 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
    • * Adults unable to consent
    • * Individuals \<18 years of age
    • * Pregnant women
    • * Prisoners
    • * Cognitively impaired or Individuals with Impaired Decision-Making Capacity
    • * Individuals who are not able to clearly understand English or Spanish will be excluded
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 13 May 2024
  • First Submitted that Met QC Criteria 13 May 2024
  • First Posted 17 May 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 4 June 2024
  • Last Update Posted 5 June 2024
  • Last Verified June 2024