Glucose Control Through a Bihormonal Artificial Pancreas in Patients After Total Pancreatectomy (PANORAMA)

March 28, 2024 updated by: M.G. Besselink, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Glucose Control Through a Bihormonal Artificial Pancreas in Patients After Total Pancreatectomy (PANORAMA): Randomized Controlled Crossover Trial

In recent years total pancreatectomy is increasingly performed in selected patients due to the increasing use of preoperative chemotherapy, making more patients operable. After total pancreatectomy, all patients develop insulin dependent diabetes mellitus (IDDM). Glucose control in these patients is challenging due to the complete absence of both pancreatic insulin and glucagon secretion, and most patients report decreased quality of life due to fear of hypoglycemic events and the need for continuous glucose monitoring.

The CE marked bihormonal artificial pancreas (BIHAP) provides continuous fully automatic glucose monitoring and administration of insulin and glucagon using a self-learning algorithm. In a recent pilot study (APPEL5+, NL.8871) the BIHAP was being compared to current diabetes treatment in 10 patients after total pancreatectomy. This trial demonstrated that treatment with BIHAP was safe and improved time spent in euglycemia significantly during one week treatment (78.30%, [IQR 71.05%-82.61%] vs. 57.38% [IQR 52.38%-81.35%], p=0.03).

Now, larger randomized studies with a longer treatment period are necessary to confirm safety and efficacy of BIHAP for the treatment of diabetes in patients after total pancreatectomy, with sufficient attention for long-term glycemic control (HbA1c) and patient-reported outcomes.

The PANORAMA trial will evaluate the efficacy of a 3-month treatment with BIHAP in 40 patients after total pancreatectomy as compared to a 3-month treatment period with current diabetes care in a randomized cross-over trial. Patients will be randomized to start with the BIHAP (after a training period) or current diabetes care (i.e. insulin pen or pump). Hereafter, all patients will cross over.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Rationale:

Insulin dependent diabetes after total pancreatectomy (TP) is difficult to manage due to the complete absence of alfa and beta cells. In a recent pilot study in 10 patients after total pancreatectomy, treatment with a bihormonal closed loop system was safe and resulted in better glucose control compared to current open loop therapy.

Objective:

To assess the efficacy of a 3-month treatment with a bihormonal artificial pancreas (BIHAP) in patients after total pancreatectomy compared to current diabetes care.

Secondary objectives are to assess the safety of BIHAP treatment; quality of life during BIHAP treatment and additional efficacy parameters.

Study design:

PANORAMA is a randomized, cross-over trial performed in an outpatient setting comparing closed loop diabetes treatment with BIHAP to open loop with current diabetes care (i.e., insulin pump or pen therapy) in 40 adults after TP. Patients will be recruited from Dutch Pancreatic Cancer Group hospitals and randomized to a 3-month treatment period with the BIHAP (preceded by a 5-day training period) or a 3-month treatment with their current diabetes care. Hereafter, all 40 patients will cross over. Study population: This trial will comprise in total 40 adult patients with insulin dependent diabetes at least three months after total pancreatectomy.

Intervention: The intervention is 3 months closed loop control of blood glucose with the BIHAP. Patients complete a 5-day training period before the intervention period will start. The BIHAP contains a self-learning algorithm which automatically maintains the glucose levels within target limits via subcutaneous administration of insulin (Humalog®) and glucagon. The control arm (open loop) consists of standard treatment for diabetes with continuous subcutaneous insulin infusion or insulin injections for 3 months. After a wash-out period of 3 months, all patients will crossover to the other study arm.

Main study parameters/endpoints:

The primary endpoint will be time (in %) spent in the normal glucose range (3.9 mmol/l - 10.0 mmol/l).

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

Patients will have to wear the prototype with two subcutaneous sensors and infusion sets continuously. There are no major risks associated with this study. The most prominent risk is failure of the BIHAP to regulate the plasma glucose concentration properly, which can result in hypo- or hyperglycemia. This may be caused by failure of the algorithm, technical failure or due to incorrect glucose measurements. However, with multiple risk control measures the risk for the patients is minimized. The system comprises a controller, a separate safety processor, as well as multiple alerts that are built in the system.

The potential benefits for each patient include a significantly better glycemic control, as well as improved quality of life because the BIHAP system completely takes over the glucose regulation, thereby minimizing the burden of life with diabetes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
        • Amsterdam UMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Informed consent
  • Age ≥18 years
  • Insulin dependent diabetes after total pancreatectomy (patients who previously participated in APPEL 5+ are allowed to be included)
  • At least three months after total pancreatectomy
  • Patients using flash or continuous glucose sensor (Free Style Libre, Guardian or Medtronic) ,willing to scan this sensor at least three times per day during the control period and to remove this sensor during BIHAP treatment
  • Undergoing treatment with CSII or subcutaneous insulin injections.

Exclusion Criteria:

  • Known or suspected allergy to trial product(s) or related products;
  • Suboptimal clinical condition, for instance due to active postoperative surgical complications, including skin condition prohibiting needle insertion;
  • Actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or device in the last 2 weeks before enrolment into this study, as per investigator judgment;
  • Donation of blood or plasma in the past month, or in excess of 500 mL within 12 weeks prior to screening for other clinical trial related purposes;
  • Current treatment with chemotherapy or when used less than 3 months prior to screening;
  • BMI > 35 kg/m2;
  • HbA1c > 97 mmol/ml (=11.0 %);
  • Use of oral glucose-lowering medication;
  • Limited ability to see, and to hear or feel alarms signals of the BIHAP;
  • Use of acetaminophen (paracetamol) during the use of the BIHAP, as this may influence the sensor glucose measurements.
  • Current pregnancy, breast feeding or planning to become pregnant during the trial or using ineffective birth control methods;
  • Patients with a concomitant disease affecting metabolic control;
  • Presence of a medical or psychiatric condition, longstanding serious adherence problems, anticipated problems in handing over diabetes control to a device or use of a medication that, in the judgment of the investigator, clinical protocol chair, or medical monitor, could compromise the results of the study or the safety of the participant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Open loop
The control arm (open loop) consists of standard treatment for diabetes with continuous subcutaneous insulin infusion or insulin injections for 3 months.
Device: Bihormonal artificial pancreas (BIHAP) / closed loop

The investigational device is a dual-hormonal fully closed loop system (BIHAP; industrial name AP® 5, Inreda Diabetic B.V.) which aims at optimally controlling plasma glucose levels. This BIHAP contains of two pumps for subcutaneous infusion of either insulin (Humalog, 3 ml pre-fill cartridge, Eli Lilly) or glucagon (GlucaGen, Novo Nordisk; 3.15 ml cartridge Accu-Chek Spirit, Roche) via an infusion set (Accu-Chek Insight Flex or AccuChek Flex Link, Roche), two subcutaneously placed glucose-sensors (Guardian, Medtronic) and an algorithm driving pump infusion rates based on the sensor input. Daily self-measurements of blood glucose (SMBGs; Accu-Chek Instant, Roche) are needed for calibration of the glucose sensors.

The BIHAP-system has to be worn continuously, except while showering.

Other Names:
  • Current regular diabetes treatment / open loop
Experimental: Closed loop
The intervention arm is 3 months closed loop control of blood glucose with the BIHAP. The BIHAP contains a self-learning algorithm which automatically maintains the glucose levels within target limits via subcutaneous administration of insulin (Humalog®) and glucagon. Patients complete a training period before the intervention period will start.
Device: Bihormonal artificial pancreas (BIHAP) / closed loop

The investigational device is a dual-hormonal fully closed loop system (BIHAP; industrial name AP® 5, Inreda Diabetic B.V.) which aims at optimally controlling plasma glucose levels. This BIHAP contains of two pumps for subcutaneous infusion of either insulin (Humalog, 3 ml pre-fill cartridge, Eli Lilly) or glucagon (GlucaGen, Novo Nordisk; 3.15 ml cartridge Accu-Chek Spirit, Roche) via an infusion set (Accu-Chek Insight Flex or AccuChek Flex Link, Roche), two subcutaneously placed glucose-sensors (Guardian, Medtronic) and an algorithm driving pump infusion rates based on the sensor input. Daily self-measurements of blood glucose (SMBGs; Accu-Chek Instant, Roche) are needed for calibration of the glucose sensors.

The BIHAP-system has to be worn continuously, except while showering.

Other Names:
  • Current regular diabetes treatment / open loop

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time in range
Time Frame: During open and closed loop treatment (both 3 months)
Time spent in euglycemia (glucose value 3.9-10.0 mmol/l or 70-180mg/dL) during BIHAP treatment
During open and closed loop treatment (both 3 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Efficacy of open and closed loop system
Time Frame: During open and closed loop treatment (both 3 months)

Additional metrics relating to glucose control will be compared between intervention and control period to provide more information about the efficacy of the BIHAP. This includes the following;

  • Day, night, and overall time spent in the following hypo-, and hyperglycemic ranges (percentage of time)

  • Percentage of time spent in the following categories:

    • Hypoglycemia level 1: <3.9 mmol/l;
    • Hypoglycemia level 2: <3.0 mmol/l;
    • Hyperglycemia level 1: >10mmol/l;
    • Hyperglycemia level 2: >13.9mmol/l.
During open and closed loop treatment (both 3 months)
Efficacy of open and closed loop system
Time Frame: During open and closed loop treatment (both 3 months)

Additional metrics relating to glucose control will be compared between intervention and control period to provide more information about the efficacy of the BIHAP. This includes the following;

- Glycemic, variability assessed by SD and CV (Coefficient of Variation)
During open and closed loop treatment (both 3 months)
Efficacy of open and closed loop system
Time Frame: During open and closed loop treatment (both 3 months)

Additional metrics relating to glucose control will be compared between intervention and control period to provide more information about the efficacy of the BIHAP. This includes the following;

- Daily insulin and glucagon use (in IE)
During open and closed loop treatment (both 3 months)
Efficacy of open and closed loop system
Time Frame: During open and closed loop treatment (both 3 months)

Additional metrics relating to glucose control will be compared between intervention and control period to provide more information about the efficacy of the BIHAP. This includes the following;

  • Day, night and overall median sensor glucose concentration (mmol/l)
  • Median sensor glucose concentrations (mmol/l)
  • Mean HbA1c (mmol/ml)
During open and closed loop treatment (both 3 months)
Efficacy of open and closed loop system
Time Frame: During open and closed loop treatment (both 3 months)

Additional metrics relating to glucose control will be compared between intervention and control period to provide more information about the efficacy of the BIHAP. This includes the following;

- Percentage of patients achieving HbA1c ≤ 53 mmol/mol at baseline and after each treatment period
During open and closed loop treatment (both 3 months)
Adverse events and device issues associated with closed loop system with BIHAP
Time Frame: During open and closed loop treatment (both 3 months)
Safety of glucose control with BIHAP treatment will be evaluated by assessing the incidence of (severe) adverse events and the incidence of device issues.
During open and closed loop treatment (both 3 months)
Patient reported outcomes on quality of life - WHO-5
Time Frame: During open and closed loop treatment (both 3 months)

To assess the impact of novel treatment with BIHAP on quality of life. The following questionnaires will be used to assess and compare quality of life during BIHAP treatment and regular treatment. All questionnaires will be filled at baseline, the start and end of both treatment arms;

- World Health Organization-Five Well-Being Index (WHO-5) score; The total raw score, ranging from 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being.
During open and closed loop treatment (both 3 months)
Patient reported outcomes on quality of life - EQ-5D-5L
Time Frame: During open and closed loop treatment (both 3 months)

To assess the impact of novel treatment with BIHAP on quality of life. The following questionnaires will be used to assess and compare quality of life during BIHAP treatment and regular treatment. All questionnaires will be filled at baseline, the start and end of both treatment arms;

- Health-related quality of life scores (EQ-5D-5L); Overall current health is scored on a scale from 0-100, whereby 100 is labelled as 'The best health you can imagine' and 0 as 'The worst health you can imagine.
During open and closed loop treatment (both 3 months)
Patient reported outcomes on quality of life - DTSQc andDTSQs
Time Frame: During open and closed loop treatment (both 3 months)

To assess the impact of novel treatment with BIHAP on quality of life. The following questionnaires will be used to assess and compare quality of life during BIHAP treatment and regular treatment. All questionnaires will be filled at baseline, the start and end of both treatment arms;

- Diabetes Treatment and Satisfaction Questionnaire status and change (DTSQ-s and DTSQ-c) scores; The DTSQ status (DTSQs) items are scored on a scale from 6 to 0 and DTSQ change (DTSQc) items are on a scale from 3 to -3. The scale total is computed by adding the six items 1, 4, 5, 6, 7 and 8 to produce the Treatment Satisfaction scale total, which has a minimum of zero and a maximum of 36 on the DTSQs and a minimum of -18 and a maximum of 18 on the DTSQc.
During open and closed loop treatment (both 3 months)
Patient reported outcomes on quality of life - PAID-20
Time Frame: During open and closed loop treatment (both 3 months)

To assess the impact of novel treatment with BIHAP on quality of life. The following questionnaires will be used to assess and compare quality of life during BIHAP treatment and regular treatment. All questionnaires will be filled at baseline, the start and end of both treatment arms;

- Problem Areas In Diabetes (PAID-20) score; PAID is a self-administered 20-item scale. Each item is scored from 0 (not a problem) to 4 (serious problem). The sum of all item scores multiplied by 1.25 gives the total PAID score, which ranges from 0 to 100, higher scores reflecting greater emotional distress. A score of 40 or above is indicative of severe emotional distress.
During open and closed loop treatment (both 3 months)
Patient reported outcomes on quality of life - HFS-II
Time Frame: During open and closed loop treatment (both 3 months)

To assess the impact of novel treatment with BIHAP on quality of life. The following questionnaires will be used to assess and compare quality of life during BIHAP treatment and regular treatment. All questionnaires will be filled at baseline, the start and end of both treatment arms;

- Hypoglycaemia Fear Survey-II (HFS-II) Worry subscale score; The HFS-II subscale scores and total score are sum scores of all or relevant subset of items ranging 0-60, 0-72, and 0-132 for the HFS-B, HFS-W, and HFS-II, respectively. Higher scores indicate higher fear of hypoglycemia.
During open and closed loop treatment (both 3 months)
Patient reported outcomes on quality of life - PSQI
Time Frame: During open and closed loop treatment (both 3 months)

To assess the impact of novel treatment with BIHAP on quality of life. The following questionnaires will be used to assess and compare quality of life during BIHAP treatment and regular treatment. All questionnaires will be filled at baseline, the start and end of both treatment arms;

- Pittsburg Sleep Quality Index score (PSQI); In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
During open and closed loop treatment (both 3 months)
Patient reported outcomes on quality of life - INSPIRE
Time Frame: During open and closed loop treatment (both 3 months)

To assess the impact of novel treatment with BIHAP on quality of life. The following questionnaires will be used to assess and compare quality of life during BIHAP treatment and regular treatment. All questionnaires will be filled at baseline, the start and end of both treatment arms;

- Insulin delivery systems: perceptions, ideas, reflections and expectations (INSPIRE) scores; The five response options are scored as 4 = Strongly Agree, 3 = Agree, 2 = Neither Agree or Disagree, 1 = Disagree, and 0 = Strongly Disagree. All items are responded to on this same scale and there are no reverse-scored items. Multiply the mean score calculated in step two by 25. This score represents a scaled score from 0 to 100 and was done in order to provide similar scaling as other commonly used quality of life scales. This final score will range from 0 to 100. Higher scores indicate more positive appraisal of automated insulin dosing
During open and closed loop treatment (both 3 months)
Patient reported outcomes on quality of life - Hypoglycaemia unawareness
Time Frame: During open and closed loop treatment (both 3 months)

To assess the impact of novel treatment with BIHAP on quality of life. The following questionnaires will be used to assess and compare quality of life during BIHAP treatment and regular treatment. All questionnaires will be filled at baseline, the start and end of both treatment arms;

- Hypoglycaemia unawareness (Gold-Clarke); Each question's response corresponds to "aware" (value 0) or "unaware" (value 1); scores are then summed. Scores of 0-2 are categorized as "aware", 4-7 as "unaware", and 3 as "indeterminant". The Gold questionnaire has only 1 question: "Do you know when your hypoglycemic episodes are commencing?" and is scored on a 7-point Likert scale. Scores of 1-2 are categorized as "Aware", 4-7 as "unaware", and 3 as "indeterminant".
During open and closed loop treatment (both 3 months)
Patient reported outcomes on quality of life - benefits and disadvantages of BIHAP treatment
Time Frame: During open and closed loop treatment (both 3 months)

To assess the impact of novel treatment with BIHAP on quality of life. The following questionnaires will be used to assess and compare quality of life during BIHAP treatment and regular treatment. All questionnaires will be filled at baseline, the start and end of both treatment arms;

- Patient reported benefits and disadvantages of BIHAP treatment, including continuation of BIHAP treatment if this was possible
During open and closed loop treatment (both 3 months)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Other treatment endpoints - daily insulin and glucagon use
Time Frame: During open and closed loop treatment (both 3 months)
- Insulin and glucagon use during the study at baseline and during each month for both treatment arms;
During open and closed loop treatment (both 3 months)
Other treatment endpoints - activity of BIHAP algorithm
Time Frame: During open and closed loop treatment (both 3 months)
- The time that the control algorithm of the BIHAP is active. This will be given as mean with standard deviation or as median with IQR;
During open and closed loop treatment (both 3 months)
Other treatment endpoints - daily insulin use
Time Frame: During open and closed loop treatment (both 3 months)
- Patient reported daily insulin use in the control group at 1, 2 and 3 months.
During open and closed loop treatment (both 3 months)
Other treatment endpoints - treatment related actions
Time Frame: During open and closed loop treatment (both 3 months)

- Number of treatment related actions:

  • During BIHAP: number of hypoglycemic events, number of inserting new glucagon and/or insulin infusion sets and sensors, BIHAP alarm frequency, minor hazard frequency;
  • During the control period: number of hypoglycemic events, number of daily injections.
During open and closed loop treatment (both 3 months)
Other treatment endpoints - demographics
Time Frame: During open and closed loop treatment (both 3 months)
  • Demographic variables at baseline;
  • Concomitant medication use at baseline, an during each month for both treatment arms.
During open and closed loop treatment (both 3 months)
Other treatment endpoints - demographics
Time Frame: During open and closed loop treatment (both 3 months)
- Demographic variables at baseline;
During open and closed loop treatment (both 3 months)
Other treatment endpoints - concomitant medication
Time Frame: During open and closed loop treatment (both 3 months)
- Concomitant medication use at baseline, an during each month for both treatment arms.
During open and closed loop treatment (both 3 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 25, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 4, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NL.82557.018.22

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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