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| Name | Class |
|---|---|
| Insulet Corporation | INDUSTRY |
| Jaeb Center for Health Research | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hybrid closed-loop (HCL) automated insulin delivery (AID) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Omnipod 5/Horizon HCL system | Device | 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. |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francisco Pasquel, M.D., M.P.H | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States | ||
| Grady Health System (non-CRN) |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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The baseline analysis population includes participants who completed at least 48 hours of AID device use while hospitalized.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | percentage of time | Up to 10 days (or hospital discharge if before 10 days) |
|
Information on adverse events was collected during exposure to study device, from the time individuals gave consent to participate (up to 10 days of use or hospital discharge if before 10 days).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Francisco J. Pasquel | Emory University | 404-778-1695 | fpasque@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 23, 2020 | Aug 8, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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|
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) |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| University of Virginia School of Medicine | Charlottesville | Virginia | 22903 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Median | Inter-Quartile Range | kg/m^2 |
|
| Highest level of education | Count of Participants | Participants |
|
| Annual household income | Income measured in US Dollars (USD) | Count of Participants | Participants |
|
| Type of diabetes | Count of Participants | Participants |
|
| Duration of diabetes | Median | Inter-Quartile Range | years |
|
| Most recent Hemoglobin A1c (HbA1c) | Mean | Standard Deviation | percent of glycosylated hemoglobin |
|
| Modality of home insulin delivery | Count of Participants | Participants |
|
| Primary reason for hospital admission | Count of Participants | Participants |
|
| Taking supraphysiologic doses of steroids | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | percentage of time in range (TIR) | Up to 10 days (or hospital discharge if before 10 days) |
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | hours | Up to 10 days (or hospital discharge if before 10 days) |
|
|
|
| Secondary | Percentage of Time With CGM Readings | The percentage of time during study participation with CGM readings was calculated. | Posted | Median | Inter-Quartile Range | percentage of time | Up to 10 days (or hospital discharge if before 10 days) |
|
|
|
| Secondary | 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. | This analysis includes 18 participants exposed to the to devices (Patch-pump and CGM device) for 48 hours. | Posted | Mean | Standard Deviation | percentage of CGM values | Up to 10 days (or hospital discharge if before 10 days) |
|
|
|
| Secondary | 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. | This analysis includes 18 participants exposed to the to devices (Patch-pump and CGM device) for 48 hours. | Posted | Mean | Standard Deviation | percentage of CGM values | Up to 10 days (or hospital discharge if before 10 days) |
|
|
|
| Secondary | Number of Hypoglycemic (<70 mg/dL) Episodes Per Patient | The number of hypoglycemic (<70 mg/dL) episodes per patient. | 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. | Posted | Median | Full Range | episodes per patient | Up to 10 days (or hospital discharge if before 10 days) |
|
|
|
| Secondary | Number of Hypoglycemic (<70 mg/dL) Episodes Per Patient-day | The number of hypoglycemic (<70 mg/dL) episodes per patient-day in hospital. | 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. | Posted | Median | Full Range | episodes per patient-day | Up to 10 days (or hospital discharge if before 10 days) |
|
|
|
| Secondary | Number Clinically Important Hypoglycemic (<54 mg/dL) Episodes Per Patient | The number clinically important hypoglycemic (<54 mg/dL) episodes per patient. | 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. | Posted | Median | Full Range | episodes per patient | Up to 10 days (or hospital discharge if before 10 days) |
|
|
|
| Secondary | Percent Time Below Range (TBR) of <70mg/dL | The percent time below range (TBR), defined as blood glucose <70mg/dL. | 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. | Posted | Mean | Standard Deviation | percentage of time below range | Up to 10 days (or hospital discharge if before 10 days) |
|
|
|
| Secondary | Percent Time Below Range (TBR) of <54 mg/dL | The percentage of time below range (TBR) of <54 mg/dL. | 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. | Posted | Mean | Standard Deviation | percentage of time below range | Up to 10 days (or hospital discharge if before 10 days) |
|
|
|
| Secondary | Percent Time Above Range (TAR) of >180 mg/dL | The percentage of time above range (TAR) of >180 mg/dL. | 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. | Posted | Mean | Standard Deviation | percentage of time above range | Up to 10 days (or hospital discharge if before 10 days) |
|
|
|
| Secondary | Percent Time in Severe Hyperglycemia (>250 mg/dL) | The percentage of time in severe hyperglycemia, defined as >250 mg/dL. | 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. | Posted | Mean | Standard Deviation | percentage of time | Up to 10 days (or hospital discharge if before 10 days) |
|
|
|
| Secondary | 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. | Posted | Number | setting adjustments | Up to 10 days (or hospital discharge if before 10 days) |
|
|
|
| Secondary | 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. | Posted | Number | setting adjustments | Up to 10 days (or hospital discharge if before 10 days) |
|
|
|
| Secondary | 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). | Posted | Number | setting adjustments | Up to 10 days (or hospital discharge if before 10 days) |
|
|
|
| Secondary | 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). | Posted | Number | setting adjustments | Up to 10 days (or hospital discharge if before 10 days) |
|
|
|
| Secondary | 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. | Posted | Number | setting adjustments | Up to 10 days (or hospital discharge if before 10 days) |
|
|
|
| Secondary | 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. | Posted | Number | setting adjustments | Up to 10 days (or hospital discharge if before 10 days) |
|
|
|
| Secondary | 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. | Posted | Number | setting adjustments | Up to 10 days (or hospital discharge if before 10 days) |
|
|
|
| Secondary | 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. | Posted | Number | setting adjustments | Up to 10 days (or hospital discharge if before 10 days) |
|
|
|
| Secondary | Total Daily Insulin (TDI) | The total daily insulin (TDI) was calculated. | Posted | Mean | Standard Deviation | units/day | Up to 10 days (or hospital discharge if before 10 days) |
|
|
|
| Secondary | Total Daily Basal Insulin (TBI) | The total daily basal insulin (TBI) was calculated. | Posted | Mean | Standard Deviation | units/day | Up to 10 days (or hospital discharge if before 10 days) |
|
|
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| Secondary | Total Daily Bolus Meal/Correction | The total daily bolus meal/correction was recorded | Posted | Mean | Standard Deviation | units/day | Up to 10 days (or hospital discharge if before 10 days) |
|
|
|
| Secondary | 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. | Posted | Number | hypoglycemic events | Up to 10 days (or hospital discharge if before 10 days) |
|
|
|
| Secondary | Number of Diabetic Ketoacidosis Events | The number of diabetic ketoacidosis (DKA) events across all participants. | Posted | Number | DKA events | Up to 10 days (or hospital discharge if before 10 days) |
|
|
|
| Secondary | 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. | This analysis includes participants who completed the patient survey. Two participants were discharged from the hospital prior to completing the survey. | Posted | Count of Participants | Participants | At time of device discontinuation (up to 10 days of use or hospital discharge if before 10 days) |
|
|
|
| Secondary | 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. | This analysis includes participants who completed the patient survey. Two participants were discharged from the hospital prior to completing the survey. | Posted | Count of Participants | Participants | At time of device discontinuation (up to 10 days of use or hospital discharge if before 10 days) |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
Not provided
Not provided
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| Disagree |
|
| Strongly Disagree |
|
| No |
|
| "Did you find the number of fingersticks burdensome?" |
|
| "Would you prefer to use only the Dexcom sensory without the pump (pod)?" |
|