Automated Insulin Delivery for Inpatients with Dysglycemia

Description

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

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Study Overview

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Study Details

Study overview

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).

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

Automated Insulin Delivery for Inpatients with Dysglycemia

Condition
Type 1 Diabetes
Intervention / Treatment

-

Contacts and Locations

Stanford

Stanford University School of Medicine, Stanford, California, United States, 94305

Atlanta

Grady Health System (non-CRN), Atlanta, Georgia, United States, 30322

Charlottesville

University of Virginia School of Medicine, Charlottesville, Virginia, United States, 22903

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Emory University,

Francisco Pasquel, M.D., M.P.H, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

2026-05-13