Diabetes Mellitus
Conditions
Keywords
Automated insulin delivery, Hybrid closed-loop system, Inpatient insulin therapy
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.
Interventions
DEVICEThe Omnipod 5/Horizon HCL system
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.
Sponsors
Insulet Corporation
Jaeb Center for Health Research
Emory University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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 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. |
| 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. |
| 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 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 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 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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). |
| 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 18 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not initiate AID due to CGM inaccuracies | 2 |
| Overall Study | Discharged prior to 48 hours of AID | 2 |
Baseline characteristics
| Characteristic | Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) |
|---|---|
| Age, Continuous | 59 years STANDARD_DEVIATION 14 |
| Annual household income ≥$100,000 | 2 Participants |
| Annual household income $20,000-$49,999 | 3 Participants |
| Annual household income $50,000-$99,999 | 4 Participants |
| Annual household income Declined to report | 4 Participants |
| Annual household income Less than $20,000 | 5 Participants |
| Body Mass Index (BMI) | 31.2 kg/m^2 |
| Duration of diabetes | 18 years |
| Highest level of education Associate degree or some college | 6 Participants |
| Highest level of education Bachelor's degree | 4 Participants |
| Highest level of education High school completion or equivalent | 0 Participants |
| Highest level of education Less than high school diploma | 8 Participants |
| Modality of home insulin delivery Injection | 15 Participants |
| Modality of home insulin delivery Insulin Pump | 0 Participants |
| Modality of home insulin delivery Not on insulin | 3 Participants |
| Most recent Hemoglobin A1c (HbA1c) | 8.2 percent of glycosylated hemoglobin STANDARD_DEVIATION 1.4 |
| Primary reason for hospital admission Cardiac | 6 Participants |
| Primary reason for hospital admission Glycemic | 1 Participants |
| Primary reason for hospital admission Infectious | 6 Participants |
| Primary reason for hospital admission Other | 3 Participants |
| Primary reason for hospital admission Respiratory | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 7 Participants |
| Race/Ethnicity, Customized Hispanic | 1 Participants |
| Race/Ethnicity, Customized More than one race | 1 Participants |
| Race/Ethnicity, Customized White | 9 Participants |
| Region of Enrollment United States | 18 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 13 Participants |
| Taking supraphysiologic doses of steroids | 3 Participants |
| Type of diabetes Type 1 Diabetes | 2 Participants |
| Type of diabetes Type 2 Diabetes | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 18 |
| other Total, other adverse events | 0 / 18 |
| serious Total, serious adverse events | 0 / 18 |
Outcome results
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) | Percentage of Time Sensor Glucose is Within Target Glucose Range | 68 percentage of time in range (TIR) | Standard Deviation 16 |
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.
Time frame: Up to 10 days (or hospital discharge if before 10 days)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) | Percentage of Time Spent in HCL After CGM Sensor Meets Initial Validation Criteria | 91 percentage of time | Standard Deviation 11 |
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.
Time frame: Up to 10 days (or hospital discharge if before 10 days)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) | Frequency of Setting Adjustments for Clinically-important Hypoglycemia (<54 mg/dL) to Basal Rate | 0 setting adjustments |
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).
Time frame: Up to 10 days (or hospital discharge if before 10 days)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) | Frequency of Setting Adjustments for Clinically-important Hypoglycemia (<54 mg/dL) to Insulin Carb Ratio (ICR) | 3 setting adjustments |
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).
Time frame: Up to 10 days (or hospital discharge if before 10 days)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) | Frequency of Setting Adjustments for Clinically-important Hypoglycemia (<54 mg/dL) to Insulin Sensitivity Factor (ISF) | 0 setting adjustments |
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.
Time frame: Up to 10 days (or hospital discharge if before 10 days)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) | Frequency of Setting Adjustments for Prolonged Hyperglycemia (>250 mg/dL for >1 Hour) to Basal Rate | 6 setting adjustments |
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.
Time frame: Up to 10 days (or hospital discharge if before 10 days)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) | Frequency of Setting Adjustments for Prolonged Hyperglycemia (>250 mg/dL for >1 Hour) to ICR | 25 setting adjustments |
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.
Time frame: Up to 10 days (or hospital discharge if before 10 days)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) | Frequency of Setting Adjustments for Prolonged Hyperglycemia (>250 mg/dL for >1 Hour) to ISF | 14 setting adjustments |
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.
Time frame: Up to 10 days (or hospital discharge if before 10 days)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) | Frequency of Setting Overall Adjustments for Clinically-important Hypoglycemia (<54 mg/dL) | 3 setting adjustments |
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.
Time frame: Up to 10 days (or hospital discharge if before 10 days)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) | Frequency of Setting Overall Adjustments for Prolonged Hyperglycemia (>250 mg/dL for >1 Hour) | 6 setting adjustments |
Secondary
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)
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) | Number Clinically Important Hypoglycemic (<54 mg/dL) Episodes Per Patient | 0 episodes per patient |
Secondary
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)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) | Number of Diabetic Ketoacidosis Events | 0 DKA events |
Secondary
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)
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) | Number of Hypoglycemic (<70 mg/dL) Episodes Per Patient | 0 episodes per patient |
Secondary
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)
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) | Number of Hypoglycemic (<70 mg/dL) Episodes Per Patient-day | 0 episodes per patient-day |
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.
Time frame: Up to 10 days (or hospital discharge if before 10 days)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) | Number of Hypoglycemic Events That Required Assistance of Another Person | 0 hypoglycemic events |
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.
Time frame: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) | Patient Acceptability of HCL System | Strongly Agree | 8 Participants |
| Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) | Patient Acceptability of HCL System | Agree | 8 Participants |
| Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) | Patient Acceptability of HCL System | Neither Agree nor Disagree | 0 Participants |
| Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) | Patient Acceptability of HCL System | Disagree | 0 Participants |
| Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) | Patient Acceptability of HCL System | Strongly Disagree | 0 Participants |
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.
Time frame: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) | Patient Perceptions of HCL System Use | Would you prefer to use only the Dexcom sensory without the pump (pod)? | Yes | 3 Participants |
| Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) | 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 |
| Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) | 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 |
| Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) | Patient Perceptions of HCL System Use | Did you find the number of alarms burdensome? | Yes | 0 Participants |
| Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) | Patient Perceptions of HCL System Use | Did you find the number of alarms burdensome? | No | 16 Participants |
| Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) | Patient Perceptions of HCL System Use | Did you find the number of fingersticks burdensome? | Yes | 6 Participants |
| Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) | Patient Perceptions of HCL System Use | Did you find the number of fingersticks burdensome? | No | 10 Participants |
| Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) | Patient Perceptions of HCL System Use | Would you prefer to use only the Dexcom sensory without the pump (pod)? | No | 13 Participants |
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) | 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 |
| Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) | 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
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)
Population: This analysis includes 18 participants exposed to the to devices (Patch-pump and CGM device) for 48 hours.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) | Percentage of CGM Values Meeting Accuracy Criteria for Bolus/Correction Insulin Dosing | 85 percentage of CGM values | Standard Deviation 14 |
Secondary
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)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) | Percentage of Time With CGM Readings | 99 percentage of time |
Secondary
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)
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) | Percent Time Above Range (TAR) of >180 mg/dL | 25 percentage of time above range | Standard Deviation 11 |
Secondary
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)
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) | Percent Time Below Range (TBR) of <54 mg/dL | 0.06 percentage of time below range | Standard Deviation 0.2 |
Secondary
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)
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) | Percent Time Below Range (TBR) of <70mg/dL | 0.17 percentage of time below range | Standard Deviation 0.3 |
Secondary
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)
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) | Percent Time in Severe Hyperglycemia (>250 mg/dL) | 6.9 percentage of time | Standard Deviation 7 |
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.
Time frame: Up to 10 days (or hospital discharge if before 10 days)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) | Time From Enrollment to Start of HCL Therapy (After Initial CGM Validation) | 0 hours |
Secondary
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) | Total Daily Basal Insulin (TBI) | 0.21 units/day | Standard Deviation 0.12 |
Secondary
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) | Total Daily Bolus Meal/Correction | 0.23 units/day | Standard Deviation 0.13 |
Secondary
Total Daily Insulin (TDI)
The total daily insulin (TDI) was calculated.
Time frame: Up to 10 days (or hospital discharge if before 10 days)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hybrid Closed-loop (HCL) Automated Insulin Delivery (AID) | Total Daily Insulin (TDI) | 0.41 units/day | Standard Deviation 0.21 |