Gestational Diabetes MellitusNCT05812547
A Novel Device for Gestational Diabetes Control
A study testing Lumen and Glucose monitoring mobile app in people with Gestational Diabetes Mellitus, run by Rambam Health Care Campus.
Trial summary
Rationale of the study: Gestational diabetes mellitus (GDM) is very common and the rate of women suffering from it expected to increase in the next years. It is associated with maternal and fetal morbidity and the risk is correlated to the patient's degree of glucose control which can be achieved through a change in… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Gestational Diabetes Mellitus
- What is being tested?
- Lumen and Glucose monitoring mobile app
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2023to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Gravidas aged 18-45 years
- Singleton pregnancy
- Diagnosed with GDM in current pregnancy
- First visit to high-risk pregnancy clinic is no late than 32 weeks' gestation
- Not treated with diabetes-related medications
Who cannot join
- -
- Medications:
- Insulin and medications for glycemic control
- Antipsychotics
- Diuretics
- Corticosteroids
Show all 16Show fewer
- Oncologic treatment
- Conditions:
- Previous diagnosis of diabetes
- Renal disease
- Hepatic disease
- Personal requirements:
- Inability to read and understand English
- Inability to use a smartphone
- Any issues arise with using the Lumen device and application
- Aerobic exercise > 3 times per week
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Novel Device for Gestational Diabetes Control, a Randomized Control Trial
Rationale of the study: Gestational diabetes mellitus (GDM) is very common and the rate of women suffering from it expected to increase in the next years. It is associated with maternal and fetal morbidity and the risk is correlated to the patient's degree of glucose control which can be achieved through a change in lifestyle or medication. Several studies have demonstrated the effectiveness of mobile apps in improving obstetric outcomes in GDM. In addition, the LUMEN device is a breathing device that produces dietary and exercise recommendations based on CO2 levels and improves metabolic parameters in patients with type 2 diabetes. No work has been done on its effectiveness in treating GDM. Aims of the study: Comparison of metabolic outcomes in women with gestational diabetes, with or without the use of LUMEN app. Design: This will be an open label parallel group 1:1 randomized-controlled trial Methods: the investigators will recruit women diagnosed with GDM. The women will be randomized to the intervention arm that will use the LUMEN device and app or to the control arm that will use a free mobile tracking app. The women will be required to monitor their blood sugar levels daily and to have GDM follow-up in the feto-maternal outpatient clinic, as is customary in GDM. After the birth, the maternal and neonatal outcome will be recorded. Based on past research data, a recruitment of 170 is needed to demonstrate a 16.7% decrease in insulin use to balance diabetes, with α = 0.05 and β = 80.
Read the detailed description
Objective The aim of the study is to examine the effect of using Lumen on metabolic parameters and anthropometric variables in patients with gestational diabetes mellitus. Aims and hypotheses Primary aim: To evaluate the rate of progression from GDM-A1 to GDM-A2 between the groups.
Secondary aim: To evaluate the efficacy of Lumen on metabolic parameters, obstetric outcomes, and neonatal outcomes. Hypothesis: the investigators expect that using Lumen would reduce the rate of progression from GDM-A1 to GDM- A2. Methods Design This will be an open label parallel group 1:1 randomized-controlled trial. Participants The study will include up to 170 women diagnosed with GDM. GDM will be defined according to current ACOG (The American College of Obstetricians and Gynecologists) guidelines. A positive glucose challenge test at 24-28 weeks' gestation followed by at least two pathological values in oral glucose challenge or one pathological value and at least one additional risk factor for GDM (a first family member diagnosed with type 2 DM, obesity, history of GDM).
Women in both groups it will use a glucometer and will be instructed in the use of the device. Use will include puncture of the fingertip to obtain a drop of blood and use of a suitable probe to obtain a sugar measurement.
Eligibility criteria
Inclusion criteria:
- Gravidas aged 18-45 years
- Singleton pregnancy
- Diagnosed with GDM in current pregnancy
- First visit to high-risk pregnancy clinic is no late than 32 weeks' gestation
- Not treated with diabetes-related medications
Exclusion criteria:
Medications:
- Insulin and medications for glycemic control
- Antipsychotics
- Diuretics
- Corticosteroids
- Oncologic treatment
Version 4.0 , 24/05/2022 0572-21-RMB
5
Conditions:
- Previous diagnosis of diabetes
- Renal disease
- Hepatic disease
Personal requirements:
- Inability to read and understand English
- Inability to use a smartphone
- Any issues arise with using the Lumen device and application
- Aerobic exercise \> 3 times per week Recruitment Women with GDM will be recruited via clinical referrals from the feto-maternal outpatient clinic or the feto-maternal unit in Rambam medical center (RMC) Intervention All the participants will be under regular follow-up of the treating obstetrician in the feto-maternal outpatient clinic. After the diagnosis of GDM the patients (of both groups) will be instructed regarding recommended diet and glucose monitoring as accustomed in our department. After randomization to the lumen group, subjects will use the Lumen device and mobile phone application, which will guide them once a day after the night fast regarding their daily diet, sleep, and routines according to their Lumen measurements. Subjects will need Google Fit (Android) or Apple Health Kit (iOS) and will be encouraged to communicate with a study investigator via the app during the entirety of the study to resolve technical questions about the device and data collection. The control group will use the glucose buddy app and will be managed in accordance with the common guidelines for GDM management. Participants of both group will measure their fating blood glucose levels and their postprandial blood glucose levels and record it in their mobile app.
- Conditions
- Gestational Diabetes Mellitus
- Being tested
- Lumen, Glucose monitoring mobile app
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LumenDevice
subjects will use the Lumen device and mobile phone application, which will guide them once a day after the night fast regarding their daily diet, sleep, and routines according to their Lumen measurements. Subjects will need Google Fit (Android) or Apple Health Kit (iOS) and will be encouraged to communicate with a study investigator via the app during the entirety of the study to resolve technical questions about the device and data collection.
Glucose monitoring mobile appOther
The control group will use a designated glucose monitoring mobile app to record their glucose levels
| Study group | Role | What they receive |
|---|---|---|
| The Lumen group | Experimental | subjects will use the Lumen device and mobile phone application, which will guide them once a day after the night fast regarding their daily diet, sleep, and routines according to their Lumen measurements. Subjects will need Google Fit (Android) or Apple Health Kit (iOS) and will be encouraged to communicate with a study investigator via the app during the entirety of the study to resolve technical questions about the device and data collection Receives: Device: Lumen |
| The control group | Active comparator | The control group will use a mobile app to keep track of their glucose levels and will be managed in accordance with the common guidelines for GDM management. Participants of both groups will measure their fasting blood glucose levels and their postprandial blood glucose levels and record it in their mobile app Receives: Other: Glucose monitoring mobile app |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the average change in blood glucose levels with the use the Lumen device
The blood glucose levels will be recorded and the average levels will be compared between the groups
Measured: From date of randomization until the date delivery, assessed up to 4 months
Secondary outcomes (27)
to compare the maternal age
maternal age in years
Measured: From date of randomization until the date delivery, assessed up to 4 months
to compare the gestational age at delivery
gestational age at delivery in weeks
Measured: From date of randomization until the date delivery, assessed up to 4 months
to compare the parity between the groups
parity
Measured: From date of randomization until the date delivery, assessed up to 4 months
to compare the rate of family history of DM
family history of DM
Measured: From date of randomization until the date delivery, assessed up to 4 months
to compare the rate of chronic hypertension
reported chronic hypertension
Measured: From date of randomization until the date delivery, assessed up to 4 months
to compare smoking status
smoking status in medical records
Measured: From date of randomization until the date delivery, assessed up to 4 months
to compare baseline fertility characteristics
Need for assisted reproductive technology
Measured: From date of randomization until the date delivery, assessed up to 4 months
to compare baseline metabolic parameters
fasting glucose obtained at first trimester, values of glucose challenge test (GCT) and oral glucose tolerance test (OGTT), hemoglobin A1C (HbA1C) upon diagnosis
Measured: From date of randomization until the date delivery, assessed up to 4 months
to compare baseline educational status
years of education
Measured: From date of randomization until the date delivery, assessed up to 4 months
to compare the level of physical activity
level of physical activity as reported by the patients
Measured: at the date of randomization
to compare baseline body mass index between the groups
patient's body mass index (BMI)
Measured: at the date of randomization
To compare the Gestational age at delivery
Gestational age at delivery in weeks
Measured: at the date if delivery
to compare the mode of onset of labor
mode of onset of labor (medical or surgical)
Measured: at the date if delivery
to compare the rate of of preeclampsia or gestational hypertension
the presence of preeclampsia or gestational hypertension
Measured: From date of randomization until the date delivery, assessed up to 4 months
to compare the rate of polyhydramnios
polyhydramnios (amniotic fluid index > 95th percentile for gestational age)
Measured: From date of randomization until the date delivery, assessed up to 4 months
To compare the rate of antenatal corticosteroids administration
Antenatal corticosteroids administration
Measured: From date of randomization until the date delivery, assessed up to 4 months
To evaluate the efficacy of Lumen on mode of delivery
mode of delivery
Measured: At the date of delivery
To evaluate the efficacy of Lumen on shoulder dystocia rate
shoulder dystocia as reported in medical records
Measured: At the date of delivery
To compare the rate of episiotomy
the use of episiotomy
Measured: At the date of delivery
To evaluate the change it the rate of obstetric anal sphincter injuries
Rate of obstetric anal sphincter injuries
Measured: At the date of delivery
To evaluate the change in birthweight
Birth weight in grams
Measured: At the date of delivery
To evaluate the change in neonatal death rate
neonatal death rate
Measured: from the date of delivery and up to 1 month from delivery
To evaluate the change in neonatal length of stay
neonatal length of stay in days
Measured: from the date of delivery and up to 1 month from delivery
To evaluate the change in hypoglycemia of the newborn
hypoglycemia of the newborn is defined as blood glucose levels below 40
Measured: from the date of delivery and up to 1 month from delivery
To evaluate the change in respiratory morbidity
respiratory morbidity
Measured: from the date of delivery and up to 1 month from delivery
To evaluate the change in need for phototherapy
Need for phototherapy
Measured: from the date of delivery and up to 1 month from delivery
To evaluate the change in need for neonatal intensive care unit (NICU) admission
neonatal intensive care unit (NICU) admission
Measured: from the date of delivery and up to 1 month from delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start1 Aug 2023 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be an open label parallel group 1:1 randomized-controlled trial.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05812547
- Sponsor's protocol ID
- 0572-21-RMB CTIL
- Status last verified
- Jun 2023
- First submitted
- 22 Nov 2022
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Device for Gestational Diabetes Control, a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05812547
- Acronym / sponsor ID
- 0572-21-RMB CTIL
- Conditions
- Gestational Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 13 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rationale of the study: Gestational diabetes mellitus (GDM) is very common and the rate of women suffering from it expected to increase in the next years. It is associated with maternal and fetal morbidity and the risk is correlated to the patient's degree of glucose control which can be achieved through a change in lifestyle or medication. Several studies have demonstrated the effectiveness of mobile apps in improving obstetric outcomes in GDM. In addition, the LUMEN device is a breathing device that produces dietary and exercise recommendations based on CO2 levels and improves metabolic parameters in patients with type 2 diabetes. No work has been done on its effectiveness in treating GDM. Aims of the study: Comparison of metabolic outcomes in women with gestational diabetes, with or without the use of LUMEN app. Design: This will be an open label parallel group 1:1 randomized-controlled trial Methods: the investigators will recruit women diagnosed with GDM. The women will be randomized to the intervention arm that will use the LUMEN device and app or to the control arm that will use a free mobile tracking app. The women will be required to monitor their blood sugar levels daily and to have GDM follow-up in the feto-maternal outpatient clinic, as is customary in GDM. After the birth, the maternal and neonatal outcome will be recorded. Based on past research data, a recruitment of 170 is needed to demonstrate a 16.7% decrease in insulin use to balance diabetes, with α = 0.05 and β = 80.
Detailed description
Objective The aim of the study is to examine the effect of using Lumen on metabolic parameters and anthropometric variables in patients with gestational diabetes mellitus. Aims and hypotheses Primary aim: To evaluate the rate of progression from GDM-A1 to GDM-A2 between the groups.
Secondary aim: To evaluate the efficacy of Lumen on metabolic parameters, obstetric outcomes, and neonatal outcomes. Hypothesis: the investigators expect that using Lumen would reduce the rate of progression from GDM-A1 to GDM- A2. Methods Design This will be an open label parallel group 1:1 randomized-controlled trial. Participants The study will include up to 170 women diagnosed with GDM. GDM will be defined according to current ACOG (The American College of Obstetricians and Gynecologists) guidelines. A positive glucose challenge test at 24-28 weeks' gestation followed by at least two pathological values in oral glucose challenge or one pathological value and at least one additional risk factor for GDM (a first family member diagnosed with type 2 DM, obesity, history of GDM).
Women in both groups it will use a glucometer and will be instructed in the use of the device. Use will include puncture of the fingertip to obtain a drop of blood and use of a suitable probe to obtain a sugar measurement.
Eligibility criteria
Inclusion criteria:
- Gravidas aged 18-45 years
- Singleton pregnancy
- Diagnosed with GDM in current pregnancy
- First visit to high-risk pregnancy clinic is no late than 32 weeks' gestation
- Not treated with diabetes-related medications
Exclusion criteria:
Medications:
- Insulin and medications for glycemic control
- Antipsychotics
- Diuretics
- Corticosteroids
- Oncologic treatment
Version 4.0 , 24/05/2022 0572-21-RMB
5
Conditions:
- Previous diagnosis of diabetes
- Renal disease
- Hepatic disease
Personal requirements:
- Inability to read and understand English
- Inability to use a smartphone
- Any issues arise with using the Lumen device and application
- Aerobic exercise \> 3 times per week Recruitment Women with GDM will be recruited via clinical referrals from the feto-maternal outpatient clinic or the feto-maternal unit in Rambam medical center (RMC) Intervention All the participants will be under regular follow-up of the treating obstetrician in the feto-maternal outpatient clinic. After the diagnosis of GDM the patients (of both groups) will be instructed regarding recommended diet and glucose monitoring as accustomed in our department. After randomization to the lumen group, subjects will use the Lumen device and mobile phone application, which will guide them once a day after the night fast regarding their daily diet, sleep, and routines according to their Lumen measurements. Subjects will need Google Fit (Android) or Apple Health Kit (iOS) and will be encouraged to communicate with a study investigator via the app during the entirety of the study to resolve technical questions about the device and data collection. The control group will use the glucose buddy app and will be managed in accordance with the common guidelines for GDM management. Participants of both group will measure their fating blood glucose levels and their postprandial blood glucose levels and record it in their mobile app.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This will be an open label parallel group 1:1 randomized-controlled trial.
| Arm | Type | Receives |
|---|---|---|
| The Lumen group | Experimental | Device: Lumensubjects will use the Lumen device and mobile phone application, which will guide them once a day after the night fast regarding their daily diet, sleep, and routines according to their Lumen measurements. Subjects will need Google Fit (Android) or Apple Health Kit (iOS) and will be encouraged to communicate with a study investigator via the app during the entirety of the study to resolve technical questions about the device and data collection |
| The control group | Active comparator | Other: Glucose monitoring mobile appThe control group will use a mobile app to keep track of their glucose levels and will be managed in accordance with the common guidelines for GDM management. Participants of both groups will measure their fasting blood glucose levels and their postprandial blood glucose levels and record it in their mobile app |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Gravidas aged 18-45 years
- Singleton pregnancy
- Diagnosed with GDM in current pregnancy
- First visit to high-risk pregnancy clinic is no late than 32 weeks' gestation
- Not treated with diabetes-related medications
Key exclusion criteria (16 listed)
- -
- Insulin and medications for glycemic control
- Antipsychotics
- Diuretics
- Corticosteroids
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 |
|---|---|---|
| Lumensubjects will use the Lumen device and mobile phone application, which will guide them once a day after the night fast regarding their daily diet, sleep, and routines according to their Lumen measurements. Subjects will need Google Fit (Android) or Apple Health Kit (iOS) and will be encouraged to communicate with a study investigator via the app during the entirety of the study to resolve technical questions about the device and data collection. | Device | The Lumen group |
| Glucose monitoring mobile appThe control group will use a designated glucose monitoring mobile app to record their glucose levels | Other | The control group |
Primary outcome
To evaluate the average change in blood glucose levels with the use the Lumen device
Time frame: From date of randomization until the date delivery, assessed up to 4 months
The blood glucose levels will be recorded and the average levels will be compared between the groups
27 secondary outcomes
to compare the maternal age
Time frame: From date of randomization until the date delivery, assessed up to 4 months
to compare the gestational age at delivery
Time frame: From date of randomization until the date delivery, assessed up to 4 months
to compare the parity between the groups
Time frame: From date of randomization until the date delivery, assessed up to 4 months
to compare the rate of family history of DM
Time frame: From date of randomization until the date delivery, assessed up to 4 months
to compare the rate of chronic hypertension
Time frame: From date of randomization until the date delivery, assessed up to 4 months
to compare smoking status
Time frame: From date of randomization until the date delivery, assessed up to 4 months
to compare baseline fertility characteristics
Time frame: From date of randomization until the date delivery, assessed up to 4 months
to compare baseline metabolic parameters
Time frame: From date of randomization until the date delivery, assessed up to 4 months
to compare baseline educational status
Time frame: From date of randomization until the date delivery, assessed up to 4 months
to compare the level of physical activity
Time frame: at the date of randomization
to compare baseline body mass index between the groups
Time frame: at the date of randomization
To compare the Gestational age at delivery
Time frame: at the date if delivery
to compare the mode of onset of labor
Time frame: at the date if delivery
to compare the rate of of preeclampsia or gestational hypertension
Time frame: From date of randomization until the date delivery, assessed up to 4 months
to compare the rate of polyhydramnios
Time frame: From date of randomization until the date delivery, assessed up to 4 months
To compare the rate of antenatal corticosteroids administration
Time frame: From date of randomization until the date delivery, assessed up to 4 months
To evaluate the efficacy of Lumen on mode of delivery
Time frame: At the date of delivery
To evaluate the efficacy of Lumen on shoulder dystocia rate
Time frame: At the date of delivery
To compare the rate of episiotomy
Time frame: At the date of delivery
To evaluate the change it the rate of obstetric anal sphincter injuries
Time frame: At the date of delivery
To evaluate the change in birthweight
Time frame: At the date of delivery
To evaluate the change in neonatal death rate
Time frame: from the date of delivery and up to 1 month from delivery
To evaluate the change in neonatal length of stay
Time frame: from the date of delivery and up to 1 month from delivery
To evaluate the change in hypoglycemia of the newborn
Time frame: from the date of delivery and up to 1 month from delivery
To evaluate the change in respiratory morbidity
Time frame: from the date of delivery and up to 1 month from delivery
To evaluate the change in need for phototherapy
Time frame: from the date of delivery and up to 1 month from delivery
To evaluate the change in need for neonatal intensive care unit (NICU) admission
Time frame: from the date of delivery and up to 1 month from delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Gestational Diabetes Mellitus
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
Recruiting
RIGHTEST iFree 2 CGM in Pregnant Women With Diabetes Study
Diabetes Mellitus, Type 1 Diabetes, Diabetes Mellitus, Type 2
RecruitingEarly Phase 1
Role of ET-1, Physical Activity, and Sedentary Behavior in Microvascular Dysfunction Following GDM
Gestational Diabetes, Endothelial Dysfunction
RecruitingEarly Phase 1
Metformin for the Treatment of Microvascular Dysfunction After Gestational Diabetes
Gestational Diabetes
Recruiting
Fueling Labor: Protein Supplementation for Intrapartum Glucose Control
Diabetes During Pregnancy
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.
Questions about this trial
What is this clinical trial studying?
A study testing Lumen and Glucose monitoring mobile app in people with Gestational Diabetes Mellitus, run by Rambam Health Care Campus.
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 5 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Naphtali Justman, MD (0546836644, njustman88@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the average change in blood glucose levels with the use the Lumen device (time frame: From date of randomization until the date delivery, assessed up to 4 months). 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 22 Jun 2023.