COMPLETED

Automated Insulin Delivery for Inpatients With Dysglycemia

Conditions

Type 1 Diabetes Type 2 Diabetes continuous glucose monitoring automated insulin delivery Insulin Therapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2025-01-22

Study Completion:2025-10-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06418880

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
Age 18 years or older Willing and able to provide informed consent Able to understand and follow study procedures Stable medical condition	* 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

Inclusion Criteria

Exclusion Criteria

Age 18 years or older
Willing and able to provide informed consent
Able to understand and follow study procedures
Stable medical condition

* 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

Contacts and Locations

Principal Investigator

Francisco Pasquel, M.D., M.P.H

PRINCIPAL_INVESTIGATOR

Emory University

Study Locations (Sites)

Stanford University School of Medicine

Stanford, California, 94305

United States

Grady Health System (non-CRN)

Atlanta, Georgia, 30322

United States

University of Virginia School of Medicine

Charlottesville, Virginia, 22903

United States

Collaborators and Investigators

Sponsor: Emory University

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

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

Study Start Date2025-01-22

Study Completion Date2025-10-31

Study Record Updates

Study Start Date2025-01-22

Study Completion Date2025-10-31

Terms related to this study

Keywords Provided by Researchers

continuous glucose monitoring
automated insulin delivery
Insulin Therapy

Additional Relevant MeSH Terms

Type 1 Diabetes
Type 2 Diabetes