NCT06418880CompletedPhase 3
Automated Insulin Delivery for Inpatients With Dysglycemia
Automated Insulin Delivery for Inpatients With Dysglycemia (AIDING) Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 14 Nov 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 130 (actual)
- First submitted
- 13 May 2024
- Start date
- 22 Jan 2025
- Primary completion date
- 31 Oct 2025
- Lead sponsor
- Emory University
- Diseases
- Type 1 diabetes, Type 2 diabetes
- NCT number
- NCT06418880
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 130
- From 22 Jan 2025 to the primary completion date, 31 Oct 2025
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who previously participated in AIDING feasibility trial or this RCT
Other illness
- Patients with a condition impeding their ability to consent or answer questionnaires or notify staff of symptoms.
Lab values
- Severe anemia with hemoglobin \<7 g/dL
- 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%
Other
- Patients admitted to ICU
- Patients anticipated to require less than 48 hours admission.
- Current evidence of hyperglycemic crises (diabetic ketoacidosis or hyperosmolar hyperglycemic state)
- Evidence of hemodynamic instability
- Hypoxia (SpO2 \<92% on supplemental oxygen)
- Pre-admission or inpatient total-daily insulin dose \>150 units daily
- Patients on AID as outpatient
- 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
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Grady Health System (non-CRN) Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| University of Virginia School of Medicine Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
| Stanford University School of Medicine Coordinator of this site? Confirm its status | Stanford | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.