Type 1 DiabetesNCT05487534
Do "sugar Swings" Impact the Brain Function and the Eating Behaviors of People with Type 1 Diabetes
An observational study of Type 1 Diabetes, run by Laval University at 2 sites in Canada.
Trial summary
In type 1 diabetes, it is common to choose the food we eat according to the blood sugar level and the insulin dose and vice versa. Beyond the nutritional aspects, the relationship to food and the resulting eating behaviors can be a source of suffering. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Observational
- How many people
- 150 participants
- Where
- 2 sitesCanada
- Study dates
- 26 Apr 2023to Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be recruited through the endocrinology clinics of the CHU de Québec (approximately 1000 patients living with type 1 diabetes) and the Institut de recherches cliniques de Montréal (IRCM) (>800 patients living with type 1 diabetes). We will also recruit through the BETTER registry, overseen by Dr. Rabasa-Lhoret and Dr. Brazeau (collaborators on the project) and co-funded by IRSC and JDRF: over 2000 people with type 1 diabetes are currently enrolled in the registry and 98% of participants have agreed to be contacted for future research studies. In case of recruitment difficulties, an announcement will also be made on social networks (such as Facebook).
Who may be able to join
- Type 1 diabetes (> 12 months)
- Age between 18 and 65 years old
- 6.5 % < A1C < 9% (to avoid potential severe eating disorder)
Who cannot join
- Type 2 diabetes or other form of diabetes; gastroparesis (clinical diagnosis);
- Recent (< 6 months) major cardiovascular event (e.g. myocardial infarction, cerebrovascular accident, major revascularization)
- Recent (< 12 weeks) severe hypoglycemia episodes (<2.8 mmol/L or assistance from a third party)
- Recent (< 12 weeks) changes in insulin type or delivery method
- Automated Insulin Delivery
- History of severe brain trauma, epilepsy, schizophrenia or bipolar disorders
- Inability to use a computer
- Incorrect vision or auditory problems
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
IRCM
Montreal
Maha Lebbar, MD
- Recruiting
CHU de Québec
Québec
Sylvain Iceta, MD, PhD
About this study
Official title: Impact of Glycemic Variability on Cognitive Impairment, Disordered Eating Behavior, and Self-management Skills in Patients Living with Type 1 Diabetes
In type 1 diabetes, it is common to choose the food we eat according to the blood sugar level and the insulin dose and vice versa. Beyond the nutritional aspects, the relationship to food and the resulting eating behaviors can be a source of suffering. Also, it has been reported that one out of two people over 60 years of age living with type 1 diabetes has cognitive impairment. Changes in cognitive functions can have important implications for daily well-being, diet (e.g., the ability to modulate cravings), and treatment decisions to manage diabetes.
One factor that can affect both eating behaviors and cognitive function is variation in blood glucose levels.
Read more
This research aims to better understand the impact of glycemic variability in disordered eating behaviors and cognitive impairment, and its consequences on self-management skills in people with type 1 diabetes.
The hypotheses are that i) higher glycemic variability is associated with higher disordered eating behaviors and poorer cognitive function in people with type 1 diabetes, and that differences exist between sexes, ii) higher disordered eating behaviors and poorer cognitive function are associated with lower self-management skills; and iii) cognitive impairment, interoception awareness and insulin resistance may mediate the relationship between glycemic variability and disordered eating behaviors.
This research study will contribute to highlighting the consequences of blood sugar fluctuations, "sugar swings", in daily life, in particular the way they disrupt eating behaviors and brain function. A better understanding of the mechanisms involved could eventually allow for early detection and management of these problems. Our study will also seek to understand the patients' point of view, which will allow the design of appropriate and meaningful recommendations.
Read the detailed description
All assessments will be done in virtual mode through secure platforms (but also offered in person in Quebec City if needed to limit discrimination).
The study will start with an inclusion visit during which self-reported and medical data will be collected as well as some anthropometric parameters measured. Following the visit, the participant will be asked to wear a continuous glucose sensor provided by the investigator (Dexcom®) to perform a continuous glucose recording for 10 days. During this 10-day period, the participant will be required to complete:
- A food diary during 3 weekdays and 1 weekend day using the Keenoa® app.
- 3 online sessions combining questionnaires (using the Redcap platform) and computerized tests (Inquisit® platform). Each session will last approximately 45 minutes (can vary between 30 and 60 minutes).
Participants who wish to participate in the qualitative phase of this study will also be offered the opportunity to do so. Participants will be recruited consecutively until a total of 50 are reached. For this part of the study, an individual interview will be conducted by a professional specifically trained in this method of analysis. This meeting will last on average 1.5 hours, but may last up to 2.5 hours depending on the length of the discussion. There will be an audio and video recording of this meeting. The discussions will then be transcribed into text and analyzed.
- Conditions
- Type 1 Diabetes
- Being tested
- Observational
- Keywords
- Diabetes, Cognition, Eating behaviors, Glycemic variation, Blood glucose
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
The same self-reported questionnaires and cognitive tests will be completed by both groups. There is no intervention.
| Study group | Role | What they receive |
|---|---|---|
| Sugar Swing + | Patients with type 1 diabetes with a high glucose variability (i.e., a coefficient of variation > 36% over a 10-day continuous glucose monitoring) Receives: Other: Observational | |
| Sugar Swing - | Patients with type 1 diabetes with low glucose variability (i.e., a coefficient of variation < 36% over a 10-day continuous glucose monitoring) Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eating Disorder examination (EDE-Q)
To assess eating behaviors according to their glycemic variability.
Measured: Day 1 (+/- 2 days)
Glucose variability and insulin resistance (CGMS - 10 days)
CGMS will be performed over a 10-day period using a DEXCOM G6 to separate participants into groups based on glycemic variation (i.e., a coefficient of variation [CV] >36% over a 10-day CGMS) versus those with a low glucose variability (i.e., CV <36%).
Measured: Start at inclusion (Day 1 to Day 10)
Secondary outcomes (33)
Distress Diabetes Scale (T1-DDS)
To assess self-management's skills.
Measured: Inclusion
Diabetes Behavior Ratting Scale (DBRS)
To assess self-management's skills.
Measured: Inclusion
Generalized Anxiety Disorder (GAD-7)
To assess anxiety disorders.
Measured: Inclusion
Patient Health Questionnaire (PHQ-9)
To assess depression disorder.
Measured: Inclusion
Diabetes Numeracy Test (DNT-15)
To assess diabetes literacy and numeracy skills.
Measured: Inclusion
Physical and psychological comorbidities
Including eating disorders.
Measured: Inclusion (medical data)
Diabetes Information : Duration
Number of years since the diagnosis of diabetes.
Measured: Inclusion (medical data)
Diabetes Information : Modality of insulin delivery
Pumps or injections of insulin.
Measured: Inclusion (medical data)
Diabetes Information : Total daily insulin dose
The dose of insulin taken per day.
Measured: Inclusion (medical data)
Diabetes Information : Duration of diabetes self-monitoring
Number of years or months of its use, either self-monitoring with capillary glucose tests or CGMS.
Measured: Inclusion (medical data)
Diabetes Information : Severe hypoglycemic episodes
Number of severe hypoglycemic episodes over the last year.
Measured: Inclusion (medical data)
Diabetes Information : Medication
Past year and current medications (included use of psychotropic drugs to be considered as a potential confounding factor).
Measured: Inclusion (medical data)
Diabetes Information : Diabetes complications
Number and type of diabetes complications.
Measured: Inclusion (medical data)
Diabetes Information : Coefficient of variation
Measured coefficient of variation based on previous CGMS and last available HbA1c (max 6 months).
Measured: Inclusion (medical data)
Anthropometric markers : BMI
Weight and height will be combined to report BMI in kg/m^2.
Measured: Inclusion (medical data)
Anthropometric markers : Waist, hips and neck circumferences
Waist, hips and neck circumferences will be self measured in cm with a measuring tape.
Measured: Inclusion (medical data)
Biological information : Cholesterol and triglycerides
Measurement of cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides in mg/dL.
Measured: Inclusion (biological data)
Biological information : Fasting blood glucose
Measurement of fasting blood glucose in mg/dL.
Measured: Inclusion (biological data)
Biological information : C-peptide
Measurement of c-peptide in nmol/L.
Measured: Inclusion (biological data)
Biological information : Triglycerides
otal cholesterol, triglycerides, HDL-cholesterol, LDL-cholesterol, fasting blood glucose, c-peptide, ghrelin fasting and CRP
Measured: Inclusion (biological data)
Biological information : Ghrelin fasting and C-Reactive protein (CRP)
Measurement of ghrelin fasting and CRP in mg/L.
Measured: Inclusion (biological data)
Detail and Flexibility Questionnaire (DFQ)
To assess cognitive flexibility.
Measured: Day 1 (+/- 2 days)
Adult ADHD Self-Report Scale (ASRS)
To screen for Attention Deficit Hyperactive Disorder (ADHD).
Measured: Day 1 (+/- 2 days)
Category Switch Task
To assess attention.
Measured: Day 1 (+/- 2 days)
Multidimensional Assessment of Interoceptive Awareness Version 2 (MAIA)
To assess the level of interoception.
Measured: Day 4 (+/- 2 days)
Binge Eating Scale (BES)
To assess eating behaviors.
Measured: Day 4 (+/- 2 days)
Tower of London Task
To assess executive functioning.
Measured: Day 4 (+/- 2 days)
Stop Signal Task
To assess impulsivity and inhibition.
Measured: Day 4 (+/- 2 days)
5-Trial Adjusting Delay Discounting
To assess temporal discounting.
Measured: Day 4 (+/- 2 days)
Short UPPS-P Impulsive Behavior Scale
To assess behavior impulsivity.
Measured: Day 8 (+/- 2 days)
Modified Yale Food Addiction Scale 2.0 (mYFAS 2.0)
To estimate susceptibility to food reward.
Measured: Day 8 (+/- 2 days)
Emotional Go/No-Go Task
To assess inhibition leverages by emotion recognition and regulation.
Measured: Day 8 (+/- 2 days)
Attentional Cueing Procedure
To assess the effects of threat stimuli on capturing and holding attention.
Measured: Day 8 (+/- 2 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start26 Apr 2023
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- CHU de Quebec-Universite Laval, Institut de Recherches Cliniques de Montreal, Centre d'expertise Poids, Image et Alimentation (CEPIA), Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
- Responsible party
- Principal investigator, Sylvain Iceta, Laval University
- Investigators
- Sylvain Iceta, MD, PhD, Principal investigator, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05487534
- Sponsor's protocol ID
- MP-20-2023-6466
- Status last verified
- Oct 2024
- First submitted
- 8 Jul 2022
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Iceta S, Sohier L, Begin C, Brazeau AS, Rabasa-Lhoret R, Gagnon C. Impact of glycemic variability on cognitive impairment, disordered eating behaviors and self-management skills in patients with type 1 diabetes: study protocol for a cross-sectional online study, the Sugar Swing study. BMC Endocr Disord. 2022 Nov 18;22(1):283. doi: 10.1186/s12902-022-01191-4.
PubMed 36401237
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Glycemic Variability on Cognitive Impairment, Disordered Eating Behavior, and Self-management Skills in Patients Living with Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT05487534
- Acronym / sponsor ID
- MP-20-2023-6466
- Conditions
- Type 1 Diabetes
- Keywords
- Diabetes, Cognition, Eating behaviors, Glycemic variation, Blood glucose
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- CHU de Quebec-Universite Laval, Institut de Recherches Cliniques de Montreal, Centre d'expertise Poids, Image et Alimentation (CEPIA), Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
- Study start
- 26 Apr 2023 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 4 Aug 2022 (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.
In type 1 diabetes, it is common to choose the food we eat according to the blood sugar level and the insulin dose and vice versa. Beyond the nutritional aspects, the relationship to food and the resulting eating behaviors can be a source of suffering. Also, it has been reported that one out of two people over 60 years of age living with type 1 diabetes has cognitive impairment. Changes in cognitive functions can have important implications for daily well-being, diet (e.g., the ability to modulate cravings), and treatment decisions to manage diabetes.
One factor that can affect both eating behaviors and cognitive function is variation in blood glucose levels.
This research aims to better understand the impact of glycemic variability in disordered eating behaviors and cognitive impairment, and its consequences on self-management skills in people with type 1 diabetes.
The hypotheses are that i) higher glycemic variability is associated with higher disordered eating behaviors and poorer cognitive function in people with type 1 diabetes, and that differences exist between sexes, ii) higher disordered eating behaviors and poorer cognitive function are associated with lower self-management skills; and iii) cognitive impairment, interoception awareness and insulin resistance may mediate the relationship between glycemic variability and disordered eating behaviors.
This research study will contribute to highlighting the consequences of blood sugar fluctuations, "sugar swings", in daily life, in particular the way they disrupt eating behaviors and brain function. A better understanding of the mechanisms involved could eventually allow for early detection and management of these problems. Our study will also seek to understand the patients' point of view, which will allow the design of appropriate and meaningful recommendations.
Detailed description
All assessments will be done in virtual mode through secure platforms (but also offered in person in Quebec City if needed to limit discrimination).
The study will start with an inclusion visit during which self-reported and medical data will be collected as well as some anthropometric parameters measured. Following the visit, the participant will be asked to wear a continuous glucose sensor provided by the investigator (Dexcom®) to perform a continuous glucose recording for 10 days. During this 10-day period, the participant will be required to complete:
- A food diary during 3 weekdays and 1 weekend day using the Keenoa® app.
- 3 online sessions combining questionnaires (using the Redcap platform) and computerized tests (Inquisit® platform). Each session will last approximately 45 minutes (can vary between 30 and 60 minutes).
Participants who wish to participate in the qualitative phase of this study will also be offered the opportunity to do so. Participants will be recruited consecutively until a total of 50 are reached. For this part of the study, an individual interview will be conducted by a professional specifically trained in this method of analysis. This meeting will last on average 1.5 hours, but may last up to 2.5 hours depending on the length of the discussion. There will be an audio and video recording of this meeting. The discussions will then be transcribed into text and analyzed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugar Swing + | – | Other: ObservationalPatients with type 1 diabetes with a high glucose variability (i.e., a coefficient of variation > 36% over a 10-day continuous glucose monitoring) |
| Sugar Swing - | – | Other: ObservationalPatients with type 1 diabetes with low glucose variability (i.e., a coefficient of variation < 36% over a 10-day continuous glucose monitoring) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited through the endocrinology clinics of the CHU de Québec (approximately 1000 patients living with type 1 diabetes) and the Institut de recherches cliniques de Montréal (IRCM) (>800 patients living with type 1 diabetes). We will also recruit through the BETTER registry, overseen by Dr. Rabasa-Lhoret and Dr. Brazeau (collaborators on the project) and co-funded by IRSC and JDRF: over 2000 people with type 1 diabetes are currently enrolled in the registry and 98% of participants have agreed to be contacted for future research studies. In case of recruitment difficulties, an announcement will also be made on social networks (such as Facebook).
Key inclusion criteria (3 listed)
- Type 1 diabetes (> 12 months)
- Age between 18 and 65 years old
- 6.5 % < A1C < 9% (to avoid potential severe eating disorder)
Key exclusion criteria (8 listed)
- Type 2 diabetes or other form of diabetes; gastroparesis (clinical diagnosis);
- Recent (< 6 months) major cardiovascular event (e.g. myocardial infarction, cerebrovascular accident, major revascularization)
- Recent (< 12 weeks) severe hypoglycemia episodes (<2.8 mmol/L or assistance from a third party)
- Recent (< 12 weeks) changes in insulin type or delivery method
- Automated Insulin Delivery
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 |
|---|---|---|
| ObservationalThe same self-reported questionnaires and cognitive tests will be completed by both groups. There is no intervention. | Other | Sugar Swing +, Sugar Swing - |
Primary outcome
Eating Disorder examination (EDE-Q)
Time frame: Day 1 (+/- 2 days)
To assess eating behaviors according to their glycemic variability.
Glucose variability and insulin resistance (CGMS - 10 days)
Time frame: Start at inclusion (Day 1 to Day 10)
CGMS will be performed over a 10-day period using a DEXCOM G6 to separate participants into groups based on glycemic variation (i.e., a coefficient of variation [CV] >36% over a 10-day CGMS) versus those with a low glucose variability (i.e., CV <36%).
33 secondary outcomes
Distress Diabetes Scale (T1-DDS)
Time frame: Inclusion
Diabetes Behavior Ratting Scale (DBRS)
Time frame: Inclusion
Generalized Anxiety Disorder (GAD-7)
Time frame: Inclusion
Patient Health Questionnaire (PHQ-9)
Time frame: Inclusion
Diabetes Numeracy Test (DNT-15)
Time frame: Inclusion
Physical and psychological comorbidities
Time frame: Inclusion (medical data)
Diabetes Information : Duration
Time frame: Inclusion (medical data)
Diabetes Information : Modality of insulin delivery
Time frame: Inclusion (medical data)
Diabetes Information : Total daily insulin dose
Time frame: Inclusion (medical data)
Diabetes Information : Duration of diabetes self-monitoring
Time frame: Inclusion (medical data)
Diabetes Information : Severe hypoglycemic episodes
Time frame: Inclusion (medical data)
Diabetes Information : Medication
Time frame: Inclusion (medical data)
Diabetes Information : Diabetes complications
Time frame: Inclusion (medical data)
Diabetes Information : Coefficient of variation
Time frame: Inclusion (medical data)
Anthropometric markers : BMI
Time frame: Inclusion (medical data)
Anthropometric markers : Waist, hips and neck circumferences
Time frame: Inclusion (medical data)
Biological information : Cholesterol and triglycerides
Time frame: Inclusion (biological data)
Biological information : Fasting blood glucose
Time frame: Inclusion (biological data)
Biological information : C-peptide
Time frame: Inclusion (biological data)
Biological information : Triglycerides
Time frame: Inclusion (biological data)
Biological information : Ghrelin fasting and C-Reactive protein (CRP)
Time frame: Inclusion (biological data)
Detail and Flexibility Questionnaire (DFQ)
Time frame: Day 1 (+/- 2 days)
Adult ADHD Self-Report Scale (ASRS)
Time frame: Day 1 (+/- 2 days)
Category Switch Task
Time frame: Day 1 (+/- 2 days)
Multidimensional Assessment of Interoceptive Awareness Version 2 (MAIA)
Time frame: Day 4 (+/- 2 days)
Binge Eating Scale (BES)
Time frame: Day 4 (+/- 2 days)
Tower of London Task
Time frame: Day 4 (+/- 2 days)
Stop Signal Task
Time frame: Day 4 (+/- 2 days)
5-Trial Adjusting Delay Discounting
Time frame: Day 4 (+/- 2 days)
Short UPPS-P Impulsive Behavior Scale
Time frame: Day 8 (+/- 2 days)
Modified Yale Food Addiction Scale 2.0 (mYFAS 2.0)
Time frame: Day 8 (+/- 2 days)
Emotional Go/No-Go Task
Time frame: Day 8 (+/- 2 days)
Attentional Cueing Procedure
Time frame: Day 8 (+/- 2 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Derived from this study: PubMed 36401237Iceta S, Sohier L, Begin C, Brazeau AS, Rabasa-Lhoret R, Gagnon C. Impact of glycemic variability on cognitive impairment, disordered eating behaviors and self-management skills in patients with type 1 diabetes: study protocol for a cross-sectional online study, the Sugar Swing study. BMC Endocr Disord. 2022 Nov 18;22(1):283. doi: 10.1186/s12902-022-01191-4.
- Individual participant dataSharing planned: Undecided
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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.
Sylvain Iceta, MD, PhD principal investigator
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes, run by Laval University at 2 sites in Canada.
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 3 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sylvain Iceta, MD, PhD (+1 (418) 656-8711 ext. 4565, equipe.iceta@criucpq.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eating Disorder examination (EDE-Q) (time frame: Day 1 (+/- 2 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?
On the ClinicalTrials.gov record for NCT05487534, which also lists 1 linked publication.
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 9 Oct 2024.