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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