Automated Insulin Delivery for INpatients With DysGlycemia (AIDING) Feasibility

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

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.

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. All enrolled participants will be placed on HCL insulin therapy for 10 days or until hospital discharge (if less than 10 days) to determine functional operability of the system and its effect on glycemic control in the hospital setting. This study will generate preliminary data to inform the design of a large multi-institution randomized controlled trial to assess superiority of HCL compared to standard inpatient insulin therapy.

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