Automated Insulin Delivery for INpatients With DysGlycemia (AIDING) Feasibility

Not Recruiting

Trial ID: NCT04714216

Purpose

This single-arm stepwise feasibility study will test initial deployment of hybrid closed-loop (HCL) automated insulin delivery (AID) using the Omnipod 5/Horizon HCL system with remote monitoring and device operation capabilities to hospitalized patients admitted to the general medical/surgical floor with diabetes (type 1 or type 2) requiring insulin therapy.

Official Title

Automated Insulin Delivery for INpatients With DysGlycemia (AIDING) Feasibility Study

Stanford Investigator(s)

Michael Samuel Hughes

Instructor, Medicine - Endocrinology, Gerontology, & Metabolism

Eligibility


Inclusion Criteria:

   - Patients ≥18 years of age with insulin-treated T1 or Type 2 diabetes mellitus (T2DM)
   admitted to general (non-intensive care) medical-surgical hospital service requiring
   inpatient insulin therapy.

Exclusion Criteria:

   - Patients admitted the ICU or anticipated to require ICU transfer

   - Anticipated length of hospital stay <48 hours.

   - Evidence of hyperglycemic crises (diabetic ketoacidosis or hyperosmolar hyperglycemic
   state) at enrollment

   - Severely impaired renal function (eGFR < 30 ml/min/1.73m2) or clinically significant
   liver failure

   - Severe anemia with hemoglobin <7 g/dL

   - Evidence of hemodynamic instability

   - Hypoxia (SpO2 <95% on supplemental oxygen)

   - Pre-admission or inpatient total daily insulin dose >100 units

   - Mental condition rendering the participant unable to consent or answer questionnaires

   - Pregnant or breast feeding at time of enrollment

   - Unable or unwilling to use rapid-acting insulin analogs (Humalog, Admelog, Novolog or
   Apidra) during the study

   - Use of hydroxyurea or high-dose ascorbic acid (>1g/day)

   - Coronavirus Disease 2019 (COVID-19) infection or person under investigation (PUI) on
   isolation precautions

Intervention(s):

device: The Omnipod 5/Horizon HCL system

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305