Diabetes MellitusNCT04714216
Automated Insulin Delivery for INpatients With DysGlycemia (AIDING) Feasibility
A study testing The Omnipod 5/Horizon HCL system in people with Diabetes Mellitus, run by Emory University at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- The Omnipod 5/Horizon HCL system
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 3 sitesUnited States
- Study dates
- 29 Jun 2021to 11 Aug 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Grady Health System (non-CRN)
Atlanta, Georgia, 30322
University of Virginia School of Medicine
Charlottesville, Virginia, 22903
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Automated Insulin Delivery for INpatients With DysGlycemia (AIDING) Feasibility Study
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.
Read the 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.
- Conditions
- Diabetes Mellitus
- Being tested
- The Omnipod 5/Horizon HCL system
- Keywords
- Automated insulin delivery, Hybrid closed-loop system, Inpatient insulin therapy
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Omnipod 5/Horizon HCL systemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: The Omnipod 5/Horizon HCL system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 10 days (or hospital discharge if before 10 days)
Secondary outcomes (26)
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.
Measured: Up to 10 days (or hospital discharge if before 10 days)
Percentage of Time With CGM Readings
The percentage of time during study participation with CGM readings was calculated.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 10 days (or hospital discharge if before 10 days)
Total Daily Insulin (TDI)
The total daily insulin (TDI) was calculated.
Measured: Up to 10 days (or hospital discharge if before 10 days)
Total Daily Basal Insulin (TBI)
The total daily basal insulin (TBI) was calculated.
Measured: Up to 10 days (or hospital discharge if before 10 days)
Total Daily Bolus Meal/Correction
The total daily bolus meal/correction was recorded
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At time of device discontinuation (up to 10 days of use or hospital discharge if before 10 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start29 Jun 2021
- Primary completion11 Aug 2022
- Study completion11 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Insulet Corporation, Jaeb Center for Health Research
- Responsible party
- Principal investigator, Francisco Pasquel, Emory University
- Investigators
- Francisco Pasquel, M.D., M.P.H, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04714216
- Sponsor's protocol ID
- STUDY00001835
- Status last verified
- Mar 2024
- First submitted
- 14 Jan 2021
- Last updated
- 23 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Insulin Delivery for INpatients With DysGlycemia (AIDING) Feasibility Study
- ClinicalTrials.gov ID
- NCT04714216
- Acronym / sponsor ID
- STUDY00001835
- Conditions
- Diabetes Mellitus
- Keywords
- Automated insulin delivery, Hybrid closed-loop system, Inpatient insulin therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Insulet Corporation, Jaeb Center for Health Research
- Study start
- 29 Jun 2021 (actual)
- Primary completion
- 11 Aug 2022 (actual)
- Study completion
- 11 Aug 2022 (actual)
- First posted
- 19 Jan 2021 (actual)
- Results
- Posted 23 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hybrid closed-loop (HCL) automated insulin delivery (AID) | Experimental | Device: The Omnipod 5/Horizon HCL systemHybrid 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Omnipod 5/Horizon HCL systemThe 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. | Device | Hybrid closed-loop (HCL) automated insulin delivery (AID) |
Primary outcome
Percentage of Time Spent in HCL After CGM Sensor Meets Initial Validation Criteria
Time frame: 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
Time frame: 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.
26 secondary outcomes
Time From Enrollment to Start of HCL Therapy (After Initial CGM Validation)
Time frame: Up to 10 days (or hospital discharge if before 10 days)
Percentage of Time With CGM Readings
Time frame: Up to 10 days (or hospital discharge if before 10 days)
Percentage of CGM Values Meeting Accuracy Criteria for Bolus/Correction Insulin Dosing
Time frame: Up to 10 days (or hospital discharge if before 10 days)
Percentage of CGM Readings Within %15/15 of POC Readings and Within %20/20 of POC Readings With the Cut Point at 70 mg/dL
Time frame: Up to 10 days (or hospital discharge if before 10 days)
Number of Hypoglycemic (<70 mg/dL) Episodes Per Patient
Time frame: Up to 10 days (or hospital discharge if before 10 days)
Number of Hypoglycemic (<70 mg/dL) Episodes Per Patient-day
Time frame: Up to 10 days (or hospital discharge if before 10 days)
Number Clinically Important Hypoglycemic (<54 mg/dL) Episodes Per Patient
Time frame: Up to 10 days (or hospital discharge if before 10 days)
Percent Time Below Range (TBR) of <70mg/dL
Time frame: Up to 10 days (or hospital discharge if before 10 days)
Percent Time Below Range (TBR) of <54 mg/dL
Time frame: Up to 10 days (or hospital discharge if before 10 days)
Percent Time Above Range (TAR) of >180 mg/dL
Time frame: Up to 10 days (or hospital discharge if before 10 days)
Percent Time in Severe Hyperglycemia (>250 mg/dL)
Time frame: Up to 10 days (or hospital discharge if before 10 days)
Frequency of Setting Overall Adjustments for Clinically-important Hypoglycemia (<54 mg/dL)
Time frame: Up to 10 days (or hospital discharge if before 10 days)
Frequency of Setting Adjustments for Clinically-important Hypoglycemia (<54 mg/dL) to Basal Rate
Time frame: Up to 10 days (or hospital discharge if before 10 days)
Frequency of Setting Adjustments for Clinically-important Hypoglycemia (<54 mg/dL) to Insulin Carb Ratio (ICR)
Time frame: Up to 10 days (or hospital discharge if before 10 days)
Frequency of Setting Adjustments for Clinically-important Hypoglycemia (<54 mg/dL) to Insulin Sensitivity Factor (ISF)
Time frame: Up to 10 days (or hospital discharge if before 10 days)
Frequency of Setting Overall Adjustments for Prolonged Hyperglycemia (>250 mg/dL for >1 Hour)
Time frame: Up to 10 days (or hospital discharge if before 10 days)
Frequency of Setting Adjustments for Prolonged Hyperglycemia (>250 mg/dL for >1 Hour) to Basal Rate
Time frame: Up to 10 days (or hospital discharge if before 10 days)
Frequency of Setting Adjustments for Prolonged Hyperglycemia (>250 mg/dL for >1 Hour) to ICR
Time frame: Up to 10 days (or hospital discharge if before 10 days)
Frequency of Setting Adjustments for Prolonged Hyperglycemia (>250 mg/dL for >1 Hour) to ISF
Time frame: Up to 10 days (or hospital discharge if before 10 days)
Total Daily Insulin (TDI)
Time frame: Up to 10 days (or hospital discharge if before 10 days)
Total Daily Basal Insulin (TBI)
Time frame: Up to 10 days (or hospital discharge if before 10 days)
Total Daily Bolus Meal/Correction
Time frame: Up to 10 days (or hospital discharge if before 10 days)
Number of Hypoglycemic Events That Required Assistance of Another Person
Time frame: Up to 10 days (or hospital discharge if before 10 days)
Number of Diabetic Ketoacidosis Events
Time frame: Up to 10 days (or hospital discharge if before 10 days)
Patient Acceptability of HCL System
Time frame: At time of device discontinuation (up to 10 days of use or hospital discharge if before 10 days)
Patient Perceptions of HCL System Use
Time frame: At time of device discontinuation (up to 10 days of use or hospital discharge if before 10 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francisco Pasquel, M.D., M.P.H principal investigator
Emory University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Omnipod 5/Horizon HCL system in people with Diabetes Mellitus, run by Emory University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Time Spent in HCL After CGM Sensor Meets Initial Validation Criteria (time frame: Up to 10 days (or hospital discharge if before 10 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.