Automated Insulin Delivery for INpatients With DysGlycemia (AIDING) Feasibility

Emory University

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Device: The Omnipod 5/Horizon HCL system

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04714216

STUDY00001835

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

Hybrid closed-loop (HCL) automated insulin delivery (AID)

Experimental group

Description:

Hybrid closed-loop (HCL) automated insulin delivery (AID) using the Omnipod 5/Horizon HCL system with remote monitoring and device operation capabilities will be deployed to hospitalized patients admitted to the general medical/surgical floor with diabetes (type 1 or type 2) requiring insulin therapy.

Treatment:

Device: The Omnipod 5/Horizon HCL system