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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Device: The Omnipod 5/Horizon HCL system

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Grady Health System (non-CRN)
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Hybrid closed-loop (HCL) automated insulin delivery (AID); 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Time Spent in HCL After CGM Sensor Meets Initial Validation Criteria	The percentage of time spent in HCL after CGM sensor met initial validation criteria of sensor glucose value being within ±20% of point of care (POC) values (for glucose levels ≥70 mg/dL) or ±20 mg/dL for POC glucose values <70 mg/dL.	Up to 10 days (or hospital discharge if before 10 days)
Percentage of Time Sensor Glucose is Within Target Glucose Range	The percentage of time that the sensor glucose measurement is within the target glucose range of 70-180 mg/dL.	Up to 10 days (or hospital discharge if before 10 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time From Enrollment to Start of HCL Therapy (After Initial CGM Validation)	The time from enrollment to start of HCL therapy, after initial CGM validation, was recorded.	Up to 10 days (or hospital discharge if before 10 days)
Percentage of Time With CGM Readings	The percentage of time during study participation with CGM readings was calculated.	Up to 10 days (or hospital discharge if before 10 days)
Percentage of CGM Values Meeting Accuracy Criteria for Bolus/Correction Insulin Dosing	The percentage of CGM values meeting accuracy criteria for bolus/correction insulin dosing was calculated.	Up to 10 days (or hospital discharge if before 10 days)
Percentage of CGM Readings Within %15/15 of POC Readings and Within %20/20 of POC Readings With the Cut Point at 70 mg/dL	The percentage of CGM values within 15% or 15 mg/dL (%15/15) and within 20% or 20 mg/dL (%20/20) of POC reference values for blood glucose, using a cut point at 70 mg/dL. The reference values are derived from a total of 597 paired CGM and reference capillary glucose values.	Up to 10 days (or hospital discharge if before 10 days)
Number of Hypoglycemic (<70 mg/dL) Episodes Per Patient	The number of hypoglycemic (<70 mg/dL) episodes per patient.	Up to 10 days (or hospital discharge if before 10 days)
Number of Hypoglycemic (<70 mg/dL) Episodes Per Patient-day	The number of hypoglycemic (<70 mg/dL) episodes per patient-day in hospital.	Up to 10 days (or hospital discharge if before 10 days)
Number Clinically Important Hypoglycemic (<54 mg/dL) Episodes Per Patient	The number clinically important hypoglycemic (<54 mg/dL) episodes per patient.	Up to 10 days (or hospital discharge if before 10 days)
Percent Time Below Range (TBR) of <70mg/dL	The percent time below range (TBR), defined as blood glucose <70mg/dL.	Up to 10 days (or hospital discharge if before 10 days)
Percent Time Below Range (TBR) of <54 mg/dL	The percentage of time below range (TBR) of <54 mg/dL.	Up to 10 days (or hospital discharge if before 10 days)
Percent Time Above Range (TAR) of >180 mg/dL	The percentage of time above range (TAR) of >180 mg/dL.	Up to 10 days (or hospital discharge if before 10 days)
Percent Time in Severe Hyperglycemia (>250 mg/dL)	The percentage of time in severe hyperglycemia, defined as >250 mg/dL.	Up to 10 days (or hospital discharge if before 10 days)
Frequency of Setting Overall Adjustments for Clinically-important Hypoglycemia (<54 mg/dL)	The frequency of setting adjustments across all participants for clinically-important hypoglycemia, defined as <54 mg/dL.	Up to 10 days (or hospital discharge if before 10 days)
Frequency of Setting Adjustments for Clinically-important Hypoglycemia (<54 mg/dL) to Basal Rate	The frequency of setting adjustments across all participants for clinically-important hypoglycemia (<54 mg/dL) to basal rate.	Up to 10 days (or hospital discharge if before 10 days)
Frequency of Setting Adjustments for Clinically-important Hypoglycemia (<54 mg/dL) to Insulin Carb Ratio (ICR)	The frequency of setting adjustments across all participants for clinically-important hypoglycemia (<54 mg/dL) to insulin carb ratio (ICR).	Up to 10 days (or hospital discharge if before 10 days)
Frequency of Setting Adjustments for Clinically-important Hypoglycemia (<54 mg/dL) to Insulin Sensitivity Factor (ISF)	The frequency of setting adjustments across all participants for clinically-important hypoglycemia (<54 mg/dL) to insulin sensitivity factor (ISF).	Up to 10 days (or hospital discharge if before 10 days)
Frequency of Setting Overall Adjustments for Prolonged Hyperglycemia (>250 mg/dL for >1 Hour)	The frequency of setting adjustments across all participants for prolonged hyperglycemia, defined as blood glucose >250 mg/dL for over one hour.	Up to 10 days (or hospital discharge if before 10 days)
Frequency of Setting Adjustments for Prolonged Hyperglycemia (>250 mg/dL for >1 Hour) to Basal Rate	The frequency of setting adjustments across all participants for prolonged hyperglycemia, defined as blood glucose >250 mg/dL for over one hour, to basal rate.	Up to 10 days (or hospital discharge if before 10 days)
Frequency of Setting Adjustments for Prolonged Hyperglycemia (>250 mg/dL for >1 Hour) to ICR	The frequency of setting adjustments across all participants for prolonged hyperglycemia, defined as >250 mg/dL for over one hour, to ICR.	Up to 10 days (or hospital discharge if before 10 days)
Frequency of Setting Adjustments for Prolonged Hyperglycemia (>250 mg/dL for >1 Hour) to ISF	The frequency of setting adjustments across all participants for prolonged hyperglycemia, defined as blood glucose >250 mg/dL for over one hour, to ISF.	Up to 10 days (or hospital discharge if before 10 days)
Total Daily Insulin (TDI)	The total daily insulin (TDI) was calculated.	Up to 10 days (or hospital discharge if before 10 days)
Total Daily Basal Insulin (TBI)	The total daily basal insulin (TBI) was calculated.	Up to 10 days (or hospital discharge if before 10 days)
Total Daily Bolus Meal/Correction	The total daily bolus meal/correction was recorded	Up to 10 days (or hospital discharge if before 10 days)
Number of Hypoglycemic Events That Required Assistance of Another Person	The number of hypoglycemic events across all participants that required assistance of another person due to altered consciousness to actively administer carbohydrate, glucagon, or other resuscitative actions.	Up to 10 days (or hospital discharge if before 10 days)
Number of Diabetic Ketoacidosis Events	The number of diabetic ketoacidosis (DKA) events across all participants.	Up to 10 days (or hospital discharge if before 10 days)
Patient Acceptability of HCL System	To assesses acceptability of the HCL system participants responded to the statement "Overall, I liked using the Omnipod 5/Horizon system to treat my blood sugar in the hospital" with five (5) options to choose from: Strongly Agree, Agree, Neither Agree nor Disagree, Disagree, and Strongly Disagree. The responses were not assigned a score, rather the number of participants for each response were examined.	At time of device discontinuation (up to 10 days of use or hospital discharge if before 10 days)
Patient Perceptions of HCL System Use	Participants were asked to provide their perceptions of the HCL system with four questions that were responded to with "Yes" or "No". Responses are assigned a score and a summary score is not calculated, rather the number of participants responding "Yes" or "No" to each of the individual questions is examined.	At time of device discontinuation (up to 10 days of use or hospital discharge if before 10 days)

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: Jaeb Center for Health Research; Insulet Corporation
• Investigators: Principal Investigator: Francisco Pasquel, M.D., M.P.H, Emory University

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2021
• Primary Completion (Actual): August 11, 2022
• Study Completion (Actual): August 11, 2022

Study Registration Dates

• First Submitted: January 14, 2021
• First Submitted That Met QC Criteria: January 14, 2021
• First Posted (Actual): January 19, 2021

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Automated insulin delivery; Hybrid closed-loop system; Inpatient insulin therapy
• Other Study ID Numbers: STUDY00001835

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No