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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
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.
Stanford University School of Medicine
Stanford, California, United States
Grady Health System (non-CRN)
Atlanta, Georgia, United States
University of Virginia School of Medicine
Charlottesville, Virginia, United States
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.
Time frame: 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.
Time frame: Up to 10 days (or hospital discharge if before 10 days)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 10 days (or hospital discharge if before 10 days)
Total Daily Insulin (TDI)
The total daily insulin (TDI) was calculated.
Time frame: Up to 10 days (or hospital discharge if before 10 days)
Total Daily Basal Insulin (TBI)
The total daily basal insulin (TBI) was calculated.
Time frame: Up to 10 days (or hospital discharge if before 10 days)
Total Daily Bolus Meal/Correction
The total daily bolus meal/correction was recorded
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At time of device discontinuation (up to 10 days of use or hospital discharge if before 10 days)