Automated Insulin Delivery for Inpatients With Dysglycemia

Not Recruiting

Trial ID: NCT06418880

Purpose

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

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

Intervention(s):

device: AID system with Remote Real-Time CGM

combination_product: Standard of Care Insulin Therapy + CGM

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Francisco Pasquel, M.D., M.P.H
4047781695