Automated Insulin Delivery for INpatients With DysGlycemia (AIDING) Feasibility

Study Overview
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Brief Summary
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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.

Detailed Description
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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 floorwith 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.

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

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Device: The Omnipod 5/Horizon HCL system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ≥18 years of age with insulin-treated T1 or 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) COVID-19 infection or person under investigation (PUI) on isolation precautions

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hybrid closed-loop (HCL) automated insulin delivery (AID)<br>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. | Device: The Omnipod 5/Horizon HCL system<br>* The Omnipod 5/Horizon HCL system, consists of a disposable insulin infusion pump (or pod), a built-in model predictive control (MPC) insulin dosing algorithm, and a remote Personal Diabetes Manager (PDM) interface, that interact with a Dexcom G6 continuous glucose monitor (CGM) to automatically control insulin delivery based upon real-time glucose values. The PDM component also enables remote interaction with the system, including glucose monitoring as well as insulin dosing management and adjustments.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of time spent in HCL after CGM sensor meets initial validation criteria | Proportion of time spent in HCL after CGM sensor meets initial validation criteria [sensor glucose value is within ±20% of POC values (for glucose levels ≥70 mg/dL) or ±20 mg/dL for POC glucose values <70 mg/dL]. | Until hospital discharge (up to 10 days ) | 
| Percentage of time sensor glucose is within target glucose range | Percentage of time sensor glucose is within target glucose range [time-in-range (TIR)], defined as 70-180 mg/dL. | Until hospital discharge (up to 10 days ) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from enrollment to start of HCL therapy (after initial CGM validation) | Time from enrollment to start of HCL therapy (after initial CGM validation) will be recorded | Until hospital discharge (up to 10 days ) | 
| Percentage of time with CGM readings | Percentage of time with CGM readings will be calculated | Until hospital discharge (up to 10 days ) | 
| Percentage of CGM values meeting accuracy criteria for bolus/correction insulin dosing | Percentage of CGM values meeting accuracy criteria for bolus/correction insulin dosing will be calculated | Until hospital discharge (up to 10 days ) | 
| Number of CGM readings within %15/15 of POC readings and within %20/20 of POC readings with the cut point at 70 mg/dL | Number of CGM readings within %15/15 of POC readings and within %20/20 of POC readings with the cut point at 70 mg/dL will be recorded | Until hospital discharge (up to 10 days ) | 
| Number of hypoglycemic (<70 mg/dL) episodes per patient | Number of hypoglycemic (<70 mg/dL) episodes per patient will be recorded | Until hospital discharge (up to 10 days ) | 
| Number clinically important hypoglycemic (<54 mg/dL) episodes per patient | Number clinically important hypoglycemic (<54 mg/dL) episodes per patient will recorded | Until hospital discharge (up to 10 days ) | 
| Percent time below range (TBR, <70mg/dL) | Percent time below range (TBR, <70mg/dL) will be recorded | Until hospital discharge (up to 10 days ) | 
| Percent time below range (<54 mg/dL) | Percent time below range (<54 mg/dL) will be recorded | Until hospital discharge (up to 10 days ) | 
| Percent time above range (TAR, >180 mg/dL) | Percent time above range (TAR, >180 mg/dL) will be recoreded | Until hospital discharge (up to 10 days ) | 
| Percent time in severe hyperglycemia (>250 mg/dL) | Percent time in severe hyperglycemia (>250 mg/dL) will be recorded | Until hospital discharge (up to 10 days ) | 
| Frequency of setting overall adjustments for clinically-important hypoglycemia (<54 mg/dL) | Frequency of setting overall adjustments for clinically-important hypoglycemia (<54 mg/dL) will be recorded | Until hospital discharge (up to 10 days ) | 
| Frequency of setting adjustments for clinically-important hypoglycemia (<54 mg/dL)to basal rate | Frequency of setting adjustments for clinically-important hypoglycemia (<54 mg/dL)to basal rate will be recorded | Until hospital discharge (up to 10 days ) | 
| Frequency of setting adjustments for clinically-important hypoglycemia (<54 mg/dL) to insulin carb ratio (ICR) | Frequency of setting adjustments for clinically-important hypoglycemia (<54 mg/dL) to insulin carb ratio (ICR) will be recorded | Until hospital discharge (up to 10 days ) | 
| Frequency of setting adjustments for clinically-important hypoglycemia (<54 mg/dL)to insulin sensitivity factor (ISF) | Frequency of setting adjustments for clinically-important hypoglycemia (<54 mg/dL)to insulin sensitivity factor (ISF) will be recorded | Until hospital discharge (up to 10 days ) | 
| Frequency of setting overall adjustments for prolonged hyperglycemia (>250 mg/dL for >1 hour) | Frequency of setting overall adjustments for prolonged hyperglycemia (>250 mg/dL for >1 hour) will be recorded | Until hospital discharge (up to 10 days ) | 
| Frequency of setting adjustments for prolonged hyperglycemia (>250 mg/dL for >1 hour) to basal rate | Frequency of setting adjustments for prolonged hyperglycemia (>250 mg/dL for >1 hour) to basal rate will be recorded | Until hospital discharge (up to 10 days ) | 
| Frequency of setting adjustments for prolonged hyperglycemia (>250 mg/dL for >1 hour) to ICR | Frequency of setting adjustments for prolonged hyperglycemia (>250 mg/dL for >1 hour) to ICR will be recorded | Until hospital discharge (up to 10 days ) | 
| Frequency of setting adjustments for prolonged hyperglycemia (>250 mg/dL for >1 hour) to ISF | Frequency of setting adjustments for prolonged hyperglycemia (>250 mg/dL for >1 hour) to ISF will be recorded | Until hospital discharge (up to 10 days ) | 
| Total daily insulin (TDI) | Total daily insulin (TDI) will be calculated | Until hospital discharge (up to 10 days ) | 
| Total daily basal insulin (TBI) | Total daily basal insulin (TBI) will be calculated | Until hospital discharge (up to 10 days ) | 
| Total daily bolus meal/correction | Total daily bolus meal/correction will be recorded | Until hospital discharge (up to 10 days ) | 
| Number of hypoglycemic events that required assistance of another person due to altered consciousness to actively administer carbohydrate, glucagon, or other resuscitative actions | Number of hypoglycemic events that required assistance of another person due to altered consciousness to actively administer carbohydrate, glucagon, or other resuscitative actions will be recorded | Until hospital discharge (up to 10 days ) | 
| Number of Diabetic ketoacidosis events | Number of Diabetic ketoacidosis events will be recorded | Until hospital discharge (up to 10 days ) | 
| Patient Survey | Patient survey on HCL system use | Until hospital discharge (up to 10 days ) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Automated insulin delivery, Hybrid closed-loop system, Inpatient insulin therapy