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

Trial ID: NCT06418880

Interventional - Phase 3 - Completed

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

Interventions

• AID system with Remote Real-Time CGM
• Standard of Care Insulin Therapy + CGM

Eligibility

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 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

Sponsor

Emory University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Source: ClinicalTrials.gov

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