Automated Insulin Delivery for Inpatients With Dysglycemia
- Conditions
- Type 1 DiabetesType 2 Diabetes
- Registration Number
- NCT06418880
- Lead Sponsor
- Emory University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br>• Any person =18 years of age with diabetes mellitus (except cystic fibrosis- and<br>pregnancy-related) admitted to general (non-ICU) medical-surgical hospital services which<br>require inpatient insulin therapy (i.e.,TID or T2D with =2 glucose values =180mg/dl)<br><br>Exclusion Criteria:<br><br> - Patients admitted to ICU<br><br> - Patients anticipated to require less than 48 hours of admission.<br><br> - Current evidence of hyperglycemic crises (diabetic ketoacidosis or hyperosmolar<br> hyperglycemic state)<br><br> - Severe anemia with hemoglobin <7 g/dL<br><br> - Evidence of hemodynamic instability<br><br> - Hypoxia (SpO2 <92% on supplemental oxygen)<br><br> - Pre-admission or inpatient total-daily insulin dose >150 units daily<br><br> - T2D patients on sliding scale insulin therapy alone (no scheduled basal or bolus<br> insulin) and with glucose levels below 180 mg/dl<br><br> - Patients without diabetes with stress hyperglycemia (not related to steroids or<br> medical nutrition therapy) and with HbA1c <6.5%<br><br> - Patients on AID as an outpatient<br><br> - Patients who previously participated in AIDING feasibility trial or this RCT<br><br> - Patients with a condition impeding the ability to consent or answer questionnaires<br><br> - Patients who are pregnant or breastfeeding at the time of enrollment<br><br> - Patients who are unable or unwilling to use rapid-acting insulin analogs (Humalog,<br> Admelog, or Novolog) during the study<br><br> - Use of hydroxyurea, high dose of acetaminophen (>4 grams/day), or high dose ascorbic<br> acid<br><br> - Adults unable to consent<br><br> - Individuals <18 years of age<br><br> - Pregnant women<br><br> - Prisoners<br><br> - Cognitively impaired or Individuals with Impaired Decision-Making Capacity<br><br> - Individuals who are not able to clearly understand English or Spanish will be<br> excluded
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy: Time spent in glucose target range;Safety: Time spent below the target glucose range
- Secondary Outcome Measures
Name Time Method TAR >250mg/dl;TBR <70 mg/dl;Mean hospitalization glucose