Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| 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. |
Up to 10 days (or hospital discharge if before 10 days) |
|
| 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. |
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. |
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. |
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. |
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. |
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. |
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. |
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. |
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. |
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. |
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. |
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. |
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. |
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. |
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). |
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). |
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. |
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. |
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. |
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. |
Up to 10 days (or hospital discharge if before 10 days) |
|
| Secondary |
Total Daily Insulin (TDI) |
The total daily insulin (TDI) was calculated. |
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. |
Up to 10 days (or hospital discharge if before 10 days) |
|
| Secondary |
Total Daily Bolus Meal/Correction |
The total daily bolus meal/correction was recorded |
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. |
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. |
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. |
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. |
At time of device discontinuation (up to 10 days of use or hospital discharge if before 10 days) |
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