Trial Outcomes & Findings for Automated Insulin Delivery for INpatients With DysGlycemia (AIDING) Feasibility (NCT NCT04714216)

NCT ID: NCT04714216

Last Updated: 2024-04-23

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 22 participants
• Primary outcome timeframe: Up to 10 days (or hospital discharge if before 10 days)
• Results posted on: 2024-04-23

Participant Flow

Participants were recruited from Grady Health System in Atlanta, Georgia, Stanford University School of Medicine, California, and University of Virginia School of Medicine in Charlottesville, Virginia, USA. Participant enrollment began June 29, 2021 and all follow-up assessments were completed by August 11, 2022.

Participant milestones

Measure	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 was deployed to hospitalized patients admitted to the general medical/surgical floor with diabetes (type 1 or type 2) requiring insulin therapy. 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.
Overall Study STARTED	22
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	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 was deployed to hospitalized patients admitted to the general medical/surgical floor with diabetes (type 1 or type 2) requiring insulin therapy. 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.
Overall Study Did not initiate AID due to CGM inaccuracies	2
Overall Study Discharged prior to 48 hours of AID	2

Baseline Characteristics

Automated Insulin Delivery for INpatients With DysGlycemia (AIDING) Feasibility

Baseline characteristics by cohort

Measure	Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) n=18 Participants Hybrid closed-loop (HCL) automated insulin delivery (AID) using the Omnipod 5/Horizon HCL system with remote monitoring and device operation capabilities was deployed to hospitalized patients admitted to the general medical/surgical floor with diabetes (type 1 or type 2) requiring insulin therapy.
Age, Continuous	59 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	7 Participants n=5 Participants
Race/Ethnicity, Customized White	9 Participants n=5 Participants
Race/Ethnicity, Customized More than one race	1 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	1 Participants n=5 Participants
Region of Enrollment United States	18 Participants n=5 Participants
Body Mass Index (BMI)	31.2 kg/m^2 n=5 Participants
Highest level of education Less than high school diploma	8 Participants n=5 Participants
Highest level of education High school completion or equivalent	0 Participants n=5 Participants
Highest level of education Associate degree or some college	6 Participants n=5 Participants
Highest level of education Bachelor's degree	4 Participants n=5 Participants
Annual household income Less than $20,000	5 Participants n=5 Participants
Annual household income $20,000-$49,999	3 Participants n=5 Participants
Annual household income $50,000-$99,999	4 Participants n=5 Participants
Annual household income ≥$100,000	2 Participants n=5 Participants
Annual household income Declined to report	4 Participants n=5 Participants
Type of diabetes Type 1 Diabetes	2 Participants n=5 Participants
Type of diabetes Type 2 Diabetes	16 Participants n=5 Participants
Duration of diabetes	18 years n=5 Participants
Most recent Hemoglobin A1c (HbA1c)	8.2 percent of glycosylated hemoglobin STANDARD_DEVIATION 1.4 • n=5 Participants
Modality of home insulin delivery Injection	15 Participants n=5 Participants
Modality of home insulin delivery Insulin Pump	0 Participants n=5 Participants
Modality of home insulin delivery Not on insulin	3 Participants n=5 Participants
Primary reason for hospital admission Cardiac	6 Participants n=5 Participants
Primary reason for hospital admission Respiratory	2 Participants n=5 Participants
Primary reason for hospital admission Infectious	6 Participants n=5 Participants
Primary reason for hospital admission Glycemic	1 Participants n=5 Participants
Primary reason for hospital admission Other	3 Participants n=5 Participants
Taking supraphysiologic doses of steroids	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) n=18 Participants Hybrid closed-loop (HCL) automated insulin delivery (AID) using the Omnipod 5/Horizon HCL system with remote monitoring and device operation capabilities was deployed to hospitalized patients admitted to the general medical/surgical floor with diabetes (type 1 or type 2) requiring insulin therapy.
Percentage of Time Spent in HCL After CGM Sensor Meets Initial Validation Criteria	91 percentage of time Standard Deviation 11

PRIMARY outcome

Timeframe: Up to 10 days (or hospital discharge if before 10 days)

Population: Glycemic analysis using CGM metrics was prespecified in the study protocol to included participants with at least 48 hours of CGM data, thus, this analysis includes participants with at least 48 hours of CGM data. Although 18 participants used the device for 48 hours, only 16 had full CGM data for 48 hours.

The percentage of time that the sensor glucose measurement is within the target glucose range of 70-180 mg/dL.

Outcome measures

Measure	Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) n=16 Participants Hybrid closed-loop (HCL) automated insulin delivery (AID) using the Omnipod 5/Horizon HCL system with remote monitoring and device operation capabilities was deployed to hospitalized patients admitted to the general medical/surgical floor with diabetes (type 1 or type 2) requiring insulin therapy.
Percentage of Time Sensor Glucose is Within Target Glucose Range	68 percentage of time in range (TIR) Standard Deviation 16

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) n=18 Participants Hybrid closed-loop (HCL) automated insulin delivery (AID) using the Omnipod 5/Horizon HCL system with remote monitoring and device operation capabilities was deployed to hospitalized patients admitted to the general medical/surgical floor with diabetes (type 1 or type 2) requiring insulin therapy.
Time From Enrollment to Start of HCL Therapy (After Initial CGM Validation)	0 hours Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Up to 10 days (or hospital discharge if before 10 days)

The percentage of time during study participation with CGM readings was calculated.

Outcome measures

Measure	Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) n=18 Participants Hybrid closed-loop (HCL) automated insulin delivery (AID) using the Omnipod 5/Horizon HCL system with remote monitoring and device operation capabilities was deployed to hospitalized patients admitted to the general medical/surgical floor with diabetes (type 1 or type 2) requiring insulin therapy.
Percentage of Time With CGM Readings	99 percentage of time Interval 97.0 to 100.0

SECONDARY outcome

Timeframe: Up to 10 days (or hospital discharge if before 10 days)

Population: This analysis includes 18 participants exposed to the to devices (Patch-pump and CGM device) for 48 hours.

The percentage of CGM values meeting accuracy criteria for bolus/correction insulin dosing was calculated.

Outcome measures

Measure	Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) n=18 Participants Hybrid closed-loop (HCL) automated insulin delivery (AID) using the Omnipod 5/Horizon HCL system with remote monitoring and device operation capabilities was deployed to hospitalized patients admitted to the general medical/surgical floor with diabetes (type 1 or type 2) requiring insulin therapy.
Percentage of CGM Values Meeting Accuracy Criteria for Bolus/Correction Insulin Dosing	85 percentage of CGM values Standard Deviation 14

SECONDARY outcome

Timeframe: Up to 10 days (or hospital discharge if before 10 days)

Population: This analysis includes 18 participants exposed to the to devices (Patch-pump and CGM device) for 48 hours.

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.

Outcome measures

Measure	Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) n=18 Participants Hybrid closed-loop (HCL) automated insulin delivery (AID) using the Omnipod 5/Horizon HCL system with remote monitoring and device operation capabilities was deployed to hospitalized patients admitted to the general medical/surgical floor with diabetes (type 1 or type 2) requiring insulin therapy.
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 %15/15 of POC readings count	71 percentage of CGM values Standard Deviation 19
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 %20/20 of POC readings count	81 percentage of CGM values Standard Deviation 15

SECONDARY outcome

Timeframe: Up to 10 days (or hospital discharge if before 10 days)

Population: Glycemic analyses using CGM metrics were prespecified in the study protocol to included participants with 48 hours or more of CGM data, thus, this analysis includes participants with at least 48 hours of CGM data. Although 18 participants used the device for 48 hours, only 16 had full CGM data for 48 hours.

The number of hypoglycemic (<70 mg/dL) episodes per patient.

Outcome measures

Measure	Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) n=16 Participants Hybrid closed-loop (HCL) automated insulin delivery (AID) using the Omnipod 5/Horizon HCL system with remote monitoring and device operation capabilities was deployed to hospitalized patients admitted to the general medical/surgical floor with diabetes (type 1 or type 2) requiring insulin therapy.
Number of Hypoglycemic (<70 mg/dL) Episodes Per Patient	0 episodes per patient Interval 0.0 to 2.0

SECONDARY outcome

Timeframe: Up to 10 days (or hospital discharge if before 10 days)

Population: Glycemic analyses using CGM metrics were prespecified in the study protocol to included participants with 48 hours or more of CGM data, thus, this analysis includes participants with at least 48 hours of CGM data. Although 18 participants used the device for 48 hours, only 16 had full CGM data for 48 hours.

The number of hypoglycemic (<70 mg/dL) episodes per patient-day in hospital.

Outcome measures

Measure	Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) n=16 Participants Hybrid closed-loop (HCL) automated insulin delivery (AID) using the Omnipod 5/Horizon HCL system with remote monitoring and device operation capabilities was deployed to hospitalized patients admitted to the general medical/surgical floor with diabetes (type 1 or type 2) requiring insulin therapy.
Number of Hypoglycemic (<70 mg/dL) Episodes Per Patient-day	0 episodes per patient-day Interval 0.0 to 0.3

SECONDARY outcome

Timeframe: Up to 10 days (or hospital discharge if before 10 days)

Population: Glycemic analyses using CGM metrics were prespecified in the study protocol to included participants with 48 hours or more of CGM data, thus, this analysis includes participants with at least 48 hours of CGM data. Although 18 participants used the device for 48 hours, only 16 had full CGM data for 48 hours.

The number clinically important hypoglycemic (<54 mg/dL) episodes per patient.

Outcome measures

Measure	Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) n=16 Participants Hybrid closed-loop (HCL) automated insulin delivery (AID) using the Omnipod 5/Horizon HCL system with remote monitoring and device operation capabilities was deployed to hospitalized patients admitted to the general medical/surgical floor with diabetes (type 1 or type 2) requiring insulin therapy.
Number Clinically Important Hypoglycemic (<54 mg/dL) Episodes Per Patient	0 episodes per patient Interval 0.0 to 2.0

SECONDARY outcome

Timeframe: Up to 10 days (or hospital discharge if before 10 days)

Population: Glycemic analyses using CGM metrics were prespecified in the study protocol to included participants with 48 hours or more of CGM data, thus, this analysis includes participants with at least 48 hours of CGM data. Although 18 participants used the device for 48 hours, only 16 had full CGM data for 48 hours.

The percent time below range (TBR), defined as blood glucose <70mg/dL.

Outcome measures

Measure	Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) n=16 Participants Hybrid closed-loop (HCL) automated insulin delivery (AID) using the Omnipod 5/Horizon HCL system with remote monitoring and device operation capabilities was deployed to hospitalized patients admitted to the general medical/surgical floor with diabetes (type 1 or type 2) requiring insulin therapy.
Percent Time Below Range (TBR) of <70mg/dL	0.17 percentage of time below range Standard Deviation 0.3

SECONDARY outcome

Timeframe: Up to 10 days (or hospital discharge if before 10 days)

Population: Glycemic analyses using CGM metrics were prespecified in the study protocol to included participants with 48 hours or more of CGM data, thus, this analysis includes participants with at least 48 hours of CGM data. Although 18 participants used the device for 48 hours, only 16 had full CGM data for 48 hours.

The percentage of time below range (TBR) of <54 mg/dL.

Outcome measures

Measure	Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) n=16 Participants Hybrid closed-loop (HCL) automated insulin delivery (AID) using the Omnipod 5/Horizon HCL system with remote monitoring and device operation capabilities was deployed to hospitalized patients admitted to the general medical/surgical floor with diabetes (type 1 or type 2) requiring insulin therapy.
Percent Time Below Range (TBR) of <54 mg/dL	0.06 percentage of time below range Standard Deviation 0.2

SECONDARY outcome

Timeframe: Up to 10 days (or hospital discharge if before 10 days)

Population: Glycemic analyses using CGM metrics were prespecified in the study protocol to included participants with 48 hours or more of CGM data, thus, this analysis includes participants with at least 48 hours of CGM data. Although 18 participants used the device for 48 hours, only 16 had full CGM data for 48 hours.

The percentage of time above range (TAR) of >180 mg/dL.

Outcome measures

Measure	Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) n=16 Participants Hybrid closed-loop (HCL) automated insulin delivery (AID) using the Omnipod 5/Horizon HCL system with remote monitoring and device operation capabilities was deployed to hospitalized patients admitted to the general medical/surgical floor with diabetes (type 1 or type 2) requiring insulin therapy.
Percent Time Above Range (TAR) of >180 mg/dL	25 percentage of time above range Standard Deviation 11

SECONDARY outcome

Timeframe: Up to 10 days (or hospital discharge if before 10 days)

Population: Glycemic analyses using CGM metrics were prespecified in the study protocol to included participants with 48 hours or more of CGM data, thus, this analysis includes participants with at least 48 hours of CGM data. Although 18 participants used the device for 48 hours, only 16 had full CGM data for 48 hours.

The percentage of time in severe hyperglycemia, defined as >250 mg/dL.

Outcome measures

Measure	Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) n=16 Participants Hybrid closed-loop (HCL) automated insulin delivery (AID) using the Omnipod 5/Horizon HCL system with remote monitoring and device operation capabilities was deployed to hospitalized patients admitted to the general medical/surgical floor with diabetes (type 1 or type 2) requiring insulin therapy.
Percent Time in Severe Hyperglycemia (>250 mg/dL)	6.9 percentage of time Standard Deviation 7.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) n=18 Participants Hybrid closed-loop (HCL) automated insulin delivery (AID) using the Omnipod 5/Horizon HCL system with remote monitoring and device operation capabilities was deployed to hospitalized patients admitted to the general medical/surgical floor with diabetes (type 1 or type 2) requiring insulin therapy.
Frequency of Setting Overall Adjustments for Clinically-important Hypoglycemia (<54 mg/dL)	3 setting adjustments

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) n=18 Participants Hybrid closed-loop (HCL) automated insulin delivery (AID) using the Omnipod 5/Horizon HCL system with remote monitoring and device operation capabilities was deployed to hospitalized patients admitted to the general medical/surgical floor with diabetes (type 1 or type 2) requiring insulin therapy.
Frequency of Setting Adjustments for Clinically-important Hypoglycemia (<54 mg/dL) to Basal Rate	0 setting adjustments

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) n=18 Participants Hybrid closed-loop (HCL) automated insulin delivery (AID) using the Omnipod 5/Horizon HCL system with remote monitoring and device operation capabilities was deployed to hospitalized patients admitted to the general medical/surgical floor with diabetes (type 1 or type 2) requiring insulin therapy.
Frequency of Setting Adjustments for Clinically-important Hypoglycemia (<54 mg/dL) to Insulin Carb Ratio (ICR)	3 setting adjustments

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) n=18 Participants Hybrid closed-loop (HCL) automated insulin delivery (AID) using the Omnipod 5/Horizon HCL system with remote monitoring and device operation capabilities was deployed to hospitalized patients admitted to the general medical/surgical floor with diabetes (type 1 or type 2) requiring insulin therapy.
Frequency of Setting Adjustments for Clinically-important Hypoglycemia (<54 mg/dL) to Insulin Sensitivity Factor (ISF)	0 setting adjustments

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) n=18 Participants Hybrid closed-loop (HCL) automated insulin delivery (AID) using the Omnipod 5/Horizon HCL system with remote monitoring and device operation capabilities was deployed to hospitalized patients admitted to the general medical/surgical floor with diabetes (type 1 or type 2) requiring insulin therapy.
Frequency of Setting Overall Adjustments for Prolonged Hyperglycemia (>250 mg/dL for >1 Hour)	6 setting adjustments

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) n=18 Participants Hybrid closed-loop (HCL) automated insulin delivery (AID) using the Omnipod 5/Horizon HCL system with remote monitoring and device operation capabilities was deployed to hospitalized patients admitted to the general medical/surgical floor with diabetes (type 1 or type 2) requiring insulin therapy.
Frequency of Setting Adjustments for Prolonged Hyperglycemia (>250 mg/dL for >1 Hour) to Basal Rate	6 setting adjustments

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) n=18 Participants Hybrid closed-loop (HCL) automated insulin delivery (AID) using the Omnipod 5/Horizon HCL system with remote monitoring and device operation capabilities was deployed to hospitalized patients admitted to the general medical/surgical floor with diabetes (type 1 or type 2) requiring insulin therapy.
Frequency of Setting Adjustments for Prolonged Hyperglycemia (>250 mg/dL for >1 Hour) to ICR	25 setting adjustments

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) n=18 Participants Hybrid closed-loop (HCL) automated insulin delivery (AID) using the Omnipod 5/Horizon HCL system with remote monitoring and device operation capabilities was deployed to hospitalized patients admitted to the general medical/surgical floor with diabetes (type 1 or type 2) requiring insulin therapy.
Frequency of Setting Adjustments for Prolonged Hyperglycemia (>250 mg/dL for >1 Hour) to ISF	14 setting adjustments

SECONDARY outcome

Timeframe: Up to 10 days (or hospital discharge if before 10 days)

The total daily insulin (TDI) was calculated.

Outcome measures

Measure	Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) n=18 Participants Hybrid closed-loop (HCL) automated insulin delivery (AID) using the Omnipod 5/Horizon HCL system with remote monitoring and device operation capabilities was deployed to hospitalized patients admitted to the general medical/surgical floor with diabetes (type 1 or type 2) requiring insulin therapy.
Total Daily Insulin (TDI)	0.41 units/day Standard Deviation 0.21

SECONDARY outcome

Timeframe: Up to 10 days (or hospital discharge if before 10 days)

The total daily basal insulin (TBI) was calculated.

Outcome measures

Measure	Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) n=18 Participants Hybrid closed-loop (HCL) automated insulin delivery (AID) using the Omnipod 5/Horizon HCL system with remote monitoring and device operation capabilities was deployed to hospitalized patients admitted to the general medical/surgical floor with diabetes (type 1 or type 2) requiring insulin therapy.
Total Daily Basal Insulin (TBI)	0.21 units/day Standard Deviation 0.12

SECONDARY outcome

Timeframe: Up to 10 days (or hospital discharge if before 10 days)

The total daily bolus meal/correction was recorded

Outcome measures

Measure	Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) n=18 Participants Hybrid closed-loop (HCL) automated insulin delivery (AID) using the Omnipod 5/Horizon HCL system with remote monitoring and device operation capabilities was deployed to hospitalized patients admitted to the general medical/surgical floor with diabetes (type 1 or type 2) requiring insulin therapy.
Total Daily Bolus Meal/Correction	0.23 units/day Standard Deviation 0.13

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) n=18 Participants Hybrid closed-loop (HCL) automated insulin delivery (AID) using the Omnipod 5/Horizon HCL system with remote monitoring and device operation capabilities was deployed to hospitalized patients admitted to the general medical/surgical floor with diabetes (type 1 or type 2) requiring insulin therapy.
Number of Hypoglycemic Events That Required Assistance of Another Person	0 hypoglycemic events

SECONDARY outcome

Timeframe: Up to 10 days (or hospital discharge if before 10 days)

The number of diabetic ketoacidosis (DKA) events across all participants.

Outcome measures

Measure	Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) n=18 Participants Hybrid closed-loop (HCL) automated insulin delivery (AID) using the Omnipod 5/Horizon HCL system with remote monitoring and device operation capabilities was deployed to hospitalized patients admitted to the general medical/surgical floor with diabetes (type 1 or type 2) requiring insulin therapy.
Number of Diabetic Ketoacidosis Events	0 DKA events

SECONDARY outcome

Timeframe: At time of device discontinuation (up to 10 days of use or hospital discharge if before 10 days)

Population: This analysis includes participants who completed the patient survey. Two participants were discharged from the hospital prior to completing the survey.

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.

Outcome measures

Measure	Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) n=16 Participants Hybrid closed-loop (HCL) automated insulin delivery (AID) using the Omnipod 5/Horizon HCL system with remote monitoring and device operation capabilities was deployed to hospitalized patients admitted to the general medical/surgical floor with diabetes (type 1 or type 2) requiring insulin therapy.
Patient Acceptability of HCL System Strongly Agree	8 Participants
Patient Acceptability of HCL System Agree	8 Participants
Patient Acceptability of HCL System Neither Agree nor Disagree	0 Participants
Patient Acceptability of HCL System Disagree	0 Participants
Patient Acceptability of HCL System Strongly Disagree	0 Participants

SECONDARY outcome

Timeframe: At time of device discontinuation (up to 10 days of use or hospital discharge if before 10 days)

Population: This analysis includes participants who completed the patient survey. Two participants were discharged from the hospital prior to completing the survey.

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.

Outcome measures

Measure	Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) n=16 Participants Hybrid closed-loop (HCL) automated insulin delivery (AID) using the Omnipod 5/Horizon HCL system with remote monitoring and device operation capabilities was deployed to hospitalized patients admitted to the general medical/surgical floor with diabetes (type 1 or type 2) requiring insulin therapy.
Patient Perceptions of HCL System Use "If you have diabetes, would you want to use this system to manage your diabetes at home?" · Yes	15 Participants
Patient Perceptions of HCL System Use "If you have diabetes, would you want to use this system to manage your diabetes at home?" · No	1 Participants
Patient Perceptions of HCL System Use "Did you find the number of alarms burdensome?" · Yes	0 Participants
Patient Perceptions of HCL System Use "Did you find the number of alarms burdensome?" · No	16 Participants
Patient Perceptions of HCL System Use "Did you find the number of fingersticks burdensome?" · Yes	6 Participants
Patient Perceptions of HCL System Use "Did you find the number of fingersticks burdensome?" · No	10 Participants
Patient Perceptions of HCL System Use "Would you prefer to use only the Dexcom sensory without the pump (pod)?" · Yes	3 Participants
Patient Perceptions of HCL System Use "Would you prefer to use only the Dexcom sensory without the pump (pod)?" · No	13 Participants

Adverse Events

Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Francisco J. Pasquel

Emory University

Phone: 404-778-1695

Email: fpasque@emory.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place