Automated Insulin Delivery for INpatients With DysGlycemia (AIDING) Feasibility

Not Applicable

Completed

Conditions: Diabetes Mellitus

Interventions: Device: The Omnipod 5/Horizon HCL system

Registration Number: NCT04714216

Lead Sponsor: Emory University

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 22

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hybrid closed-loop (HCL) automated insulin delivery (AID)	The Omnipod 5/Horizon HCL system	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Time Sensor Glucose is Within Target Glucose Range	Up to 10 days (or hospital discharge if before 10 days)	The percentage of time that the sensor glucose measurement is within the target glucose range of 70-180 mg/dL.
Percentage of Time Spent in HCL After CGM Sensor Meets Initial Validation Criteria	Up to 10 days (or hospital discharge if before 10 days)	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.

Secondary Outcome Measures

Name	Time	Method
Number Clinically Important Hypoglycemic (<54 mg/dL) Episodes Per Patient	Up to 10 days (or hospital discharge if before 10 days)	The number clinically important hypoglycemic (\<54 mg/dL) episodes per patient.
Percent Time Below Range (TBR) of <70mg/dL	Up to 10 days (or hospital discharge if before 10 days)	The percent time below range (TBR), defined as blood glucose \<70mg/dL.
Percent Time Above Range (TAR) of >180 mg/dL	Up to 10 days (or hospital discharge if before 10 days)	The percentage of time above range (TAR) of \>180 mg/dL.
Percent Time in Severe Hyperglycemia (>250 mg/dL)	Up to 10 days (or hospital discharge if before 10 days)	The percentage of time in severe hyperglycemia, defined as \>250 mg/dL.
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	Up to 10 days (or hospital discharge if before 10 days)	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.
Frequency of Setting Adjustments for Clinically-important Hypoglycemia (<54 mg/dL) to Insulin Carb Ratio (ICR)	Up to 10 days (or hospital discharge if before 10 days)	The frequency of setting adjustments across all participants for clinically-important hypoglycemia (\<54 mg/dL) to insulin carb ratio (ICR).
Percentage of Time With CGM Readings	Up to 10 days (or hospital discharge if before 10 days)	The percentage of time during study participation with CGM readings was calculated.
Time From Enrollment to Start of HCL Therapy (After Initial CGM Validation)	Up to 10 days (or hospital discharge if before 10 days)	The time from enrollment to start of HCL therapy, after initial CGM validation, was recorded.
Percentage of CGM Values Meeting Accuracy Criteria for Bolus/Correction Insulin Dosing	Up to 10 days (or hospital discharge if before 10 days)	The percentage of CGM values meeting accuracy criteria for bolus/correction insulin dosing was calculated.
Number of Hypoglycemic (<70 mg/dL) Episodes Per Patient	Up to 10 days (or hospital discharge if before 10 days)	The number of hypoglycemic (\<70 mg/dL) episodes per patient.
Number of Hypoglycemic (<70 mg/dL) Episodes Per Patient-day	Up to 10 days (or hospital discharge if before 10 days)	The number of hypoglycemic (\<70 mg/dL) episodes per patient-day in hospital.
Frequency of Setting Overall Adjustments for Clinically-important Hypoglycemia (<54 mg/dL)	Up to 10 days (or hospital discharge if before 10 days)	The frequency of setting adjustments across all participants for clinically-important hypoglycemia, defined as \<54 mg/dL.
Frequency of Setting Adjustments for Clinically-important Hypoglycemia (<54 mg/dL) to Basal Rate	Up to 10 days (or hospital discharge if before 10 days)	The frequency of setting adjustments across all participants for clinically-important hypoglycemia (\<54 mg/dL) to basal rate.
Frequency of Setting Adjustments for Prolonged Hyperglycemia (>250 mg/dL for >1 Hour) to ISF	Up to 10 days (or hospital discharge if before 10 days)	The frequency of setting adjustments across all participants for prolonged hyperglycemia, defined as blood glucose \>250 mg/dL for over one hour, to ISF.
Percent Time Below Range (TBR) of <54 mg/dL	Up to 10 days (or hospital discharge if before 10 days)	The percentage of time below range (TBR) of \<54 mg/dL.
Frequency of Setting Adjustments for Clinically-important Hypoglycemia (<54 mg/dL) to Insulin Sensitivity Factor (ISF)	Up to 10 days (or hospital discharge if before 10 days)	The frequency of setting adjustments across all participants for clinically-important hypoglycemia (\<54 mg/dL) to insulin sensitivity factor (ISF).
Frequency of Setting Adjustments for Prolonged Hyperglycemia (>250 mg/dL for >1 Hour) to Basal Rate	Up to 10 days (or hospital discharge if before 10 days)	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.
Frequency of Setting Adjustments for Prolonged Hyperglycemia (>250 mg/dL for >1 Hour) to ICR	Up to 10 days (or hospital discharge if before 10 days)	The frequency of setting adjustments across all participants for prolonged hyperglycemia, defined as \>250 mg/dL for over one hour, to ICR.
Number of Diabetic Ketoacidosis Events	Up to 10 days (or hospital discharge if before 10 days)	The number of diabetic ketoacidosis (DKA) events across all participants.
Frequency of Setting Overall Adjustments for Prolonged Hyperglycemia (>250 mg/dL for >1 Hour)	Up to 10 days (or hospital discharge if before 10 days)	The frequency of setting adjustments across all participants for prolonged hyperglycemia, defined as blood glucose \>250 mg/dL for over one hour.
Total Daily Insulin (TDI)	Up to 10 days (or hospital discharge if before 10 days)	The total daily insulin (TDI) was calculated.
Total Daily Basal Insulin (TBI)	Up to 10 days (or hospital discharge if before 10 days)	The total daily basal insulin (TBI) was calculated.
Patient Perceptions of HCL System Use	At time of device discontinuation (up to 10 days of use or hospital discharge if before 10 days)	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.
Total Daily Bolus Meal/Correction	Up to 10 days (or hospital discharge if before 10 days)	The total daily bolus meal/correction was recorded
Number of Hypoglycemic Events That Required Assistance of Another Person	Up to 10 days (or hospital discharge if before 10 days)	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.
Patient Acceptability of HCL System	At time of device discontinuation (up to 10 days of use or hospital discharge if before 10 days)	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.

Trial Locations

Locations (3): Stanford University School of Medicine
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Stanford, California, United States
Grady Health System (non-CRN)
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Atlanta, Georgia, United States
University of Virginia School of Medicine
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Charlottesville, Virginia, United States