Type 1 DiabetesNCT05540704
Study Comparing Acceptance and Commitment Therapy to Supportive Diabetes Counseling and a Waitlist Control for Eating Disorders in Type 1 Diabetes
A study testing ACT and Supportive Diabetes Counseling in people with Type 1 Diabetes and Eating Disorders, run by Duke University at 2 sites in United States.
Trial summary
The goal of this clinical trial is to test whether a new intervention works to treat eating disorders in type 1 diabetes. Participants are assigned to one of the following: (1) Acceptance and Commitment Therapy (ACT), (2) Supportive Diabetes Counseling, or (3) a 6-month Waitlist Control. Read more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- Type 1 Diabetes, Eating Disorders, Disordered Eating Behaviors
- What is being tested?
- ACT and Supportive Diabetes Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 235 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Apr 2023to Sep 2027
- Phase
- Interventional
- 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 16 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 16-50 years of age
- Diagnosis of Type 1 diabetes
- Eating disorder characterized by binge eating and/or problematic weight control behaviors, including withholding insulin (Bulimia Nervosa, Binge Eating and Purging Disorder spectrum diagnoses)
- Independently manages diabetes (not reliant on a caregiver)
- Expansion Cohort
- 16-50 years of age
Show all 9Show fewer
- Diagnosis of Type 1 diabetes
- DEPR-R score >=20 but does not meet criteria for the primary cohort
- Primary and Expansion Cohort
Who cannot join
- Active suicidal ideation
- Diagnosis of Avoidant Restrictive Food Intake Disorder or Anorexia Nervosa spectrum diagnoses
- Hypoglycemic unawareness as assessed by the Gold Method and multiple severe episodes of hypoglycemia requiring 3rd party assistance in the last 2 years
- Current substance abuse disorder or current or past psychotic disorder
- NonEnglish speaking
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Duke University
Durham, North Carolina, 27705
Dottie R Mayo, BA, 919-668-1935, dorothy.mayo@duke.edu
Rhonda M Merwin, Ph.D.
- Recruiting
Brown University
Providence, Rhode Island, 02903
Erica F Robichaud, LCSW, (401) 793-8957, eferguson@lifespan.org
Jason Lillis, Ph.D.
About this study
Official title: Changing the T1DE (Type 1 Diabetes Eating Disorders): A Randomized Controlled Trial Comparing Acceptance and Commitment Therapy (ACT) to Supportive Diabetes Counseling and a Waitlist Control
The goal of this clinical trial is to test whether a new intervention works to treat eating disorders in type 1 diabetes. Participants are assigned to one of the following: (1) Acceptance and Commitment Therapy (ACT), (2) Supportive Diabetes Counseling, or (3) a 6-month Waitlist Control. Participants in the ACT and Supportive Diabetes Counseling conditions complete 12 sessions over 12-16 weeks and use their mobile phone between sessions to increase engagement and reinforce learning.
The main questions are:
Read more
Does treatment improve glycemic levels, eating disorder symptoms, diabetes management and diabetes distress?
Does one treatment do better than the other?
How do the treatments work, if they work, and for whom?
Participants complete assessments that include wearing a continuous glucose sensor and activity watch, and get a blood draw to determine HbA1c. They also complete diagnostic interviews, surveys and computer tests of attention and things like heart rate and reaction time. These assessments help us better understand the types of changes that are happening and how they might influence health and well-being.
Read the detailed description
This is a randomized controlled trial comparing an Acceptance and Commitment Therapy (ACT) protocol to supportive diabetes counseling (SDC) and a Waitlist Control (WLC) for individuals with type 1 diabetes and disordered eating (or T1DE). Both active conditions are tailored to the needs of individuals living with T1D and the unique conditions under which the eating disorder developed and is maintained. Participants will be 161 individuals with T1D, between the ages of 16-50, with binge-purge eating disorders (EDs), including threshold and subthreshold bulimia nervosa, binge eating disorder and purging disorder. Purging includes restriction of insulin for weight loss. An expansion cohort of 74 persons with T1D and elevated Diabetes Eating Problems Survey-Revised scores (DEPS-R=>20) will also be recruited to assess the utility of the treatments for a broader array of eating and weight control problems in T1D. Participants will be randomized to either ACT, SDC, or a WLC and complete assessments at baseline, mid-treatment, end-of-treatment, and at 1 month, 3 months, and 6 months post-treatment. The primary outcome of interest for power and sample size calculation is blood glucose levels (mean and % time in target glycemic range) as assessed by continuous glucose monitoring. Other outcomes include change in hemoglobin A1c (HbA1c), eating disorder symptoms, diabetes self-management and, secondary, diabetes distress. In addition to examining clinical outcomes, this study tests biobehavioral mechanisms of change and predictors of treatment response. Process of change assessments focus on flexible responding to pathology-relevant stimuli and early improvement in glycemic control affecting executive function. The primary site is Duke University Medical Center. The Miriam Hospital is a secondary site.
- Conditions
- Type 1 Diabetes, Eating Disorders, Disordered Eating Behaviors, Purging (Eating Disorders), Binge-Eating Disorder
- Being tested
- ACT, Supportive Diabetes Counseling
- Keywords
- glycemic control, disordered eating behavior, eating disorders, type 1 diabetes, acceptance and commitment therapy, diabetes counseling, mhealth, psychological flexibility
- Medical subject headings
- Diabetes Mellitus, Type 1, Feeding and Eating Disorders, Disordered Eating Behavior, Binge-Eating Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACTBehavioural
Treatment is based on Acceptance and Commitment Therapy (ACT), a contemporary cognitive behavioral therapy (CBT) that improves human functioning and adaptability by increasing psychological flexibility. Individual therapy sessions are paired with mobile phone delivered interventions.
Supportive Diabetes CounselingBehavioural
Counseling with a diabetes educator knowledgeable about disordered eating in type 1 diabetes. Intervention focuses on supportive listening, diabetes-related education, including management problems and goal setting.
| Study group | Role | What they receive |
|---|---|---|
| Acceptance and Commitment Therapy for Type 1 Diabetes - Eating Disorder (ACT-T1DE) | Experimental | ACT-T1DE consists of 12 sessions of flexible ACT protocol tailored to the unique conditions and needs of type 1 diabetes eating disorders. The protocol is based on an initial pilot study (Merwin et al., 2021); however, the current protocol has been modified, based on key stakeholder feedback and to optimize real-world implementation. Modifications include transition from the use of a mobile app to a text messaging platform and a combination of in-person and virtual visits. Receives: Behavioral: ACT |
| Supportive Diabetes Counseling (SDC) | Active comparator | The SDC condition is a flexible protocol of 12 sessions consisting of supportive listening, psychoeducation about diabetes and its management and management problems, and goal setting, informed by the ADA Type 1 Diabetes Self-Care Manual and ADCES7 Self-Care Behaviors framework. Receives: Behavioral: Supportive Diabetes Counseling |
| 6-Month Waitlist Control | No intervention | Participants assigned to the Waitlist Control complete assessments but do not receive intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glycemic control as indexed by continuous glucose monitoring (CGM)
CGM indices of time in target glycemic range, mean blood sugar, frequency of Level 1 and 2 hyperglycemia and blood glucose variability
Measured: baseline, 6 weeks, 12 weeks, 36 weeks
Change in eating disorder symptoms as indexed by the Diabetes Eating Problems Survey-Revised (DEPS-R)
Severity of eating and body image concerns, frequency of engagement in maladaptive eating and weight control behaviors, specifically in the context of diabetes. Scores range from 0-80, with higher scores indicating greater symptom severity (worse outcome).
Measured: baseline, 12 weeks, 16 weeks, 24 weeks, 36 weeks
Change in diabetes self-management as indexed by the Diabetes Self-Management Questionnaire
Engagement in activities necessary to manage diabetes, including checking blood sugar and administering insulin. Scores range from 0-10 with higher scores indicating better self-management.
Measured: baseline, 12 weeks, 16 weeks, 24 weeks, 36 weeks
Change in glycemic control as indexed by hemoglobin A1c (HbA1c)
Glycated hemoglobin (percentage of red blood cells that are glycated providing an estimate of average blood glucose over 3 months)
Measured: baseline, 24 weeks, 36 weeks
Secondary outcomes (12)
Change in diabetes distress as indexed by the Type 1 - Diabetes Distress Scale
Feelings of stress or overwhelm with the burden of living with diabetes and diabetes management. Scores range from 1-6, with higher scores indicating greater distress (worse outcome)
Measured: baseline, 12 weeks, 24 weeks, 36 weeks
CompACT-10
A 10-item measure of general (rather than diabetes-specific) psychological flexibility. This measure includes component processes of open, aware and engaged, allowing for more in-depth assessment of process of change. This is the primary psychological flexibility measure in the current trial.
Measured: Baseline, Mid-Treatment, 12 weeks, 16 weeks, 24 weeks, 36 weeks.
Acceptance and Action Diabetes Questionnaire (AADQ)
Assesses psychological flexibility (process of change) in the context of diabetes specific thoughts and feelings.
Measured: Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks
Valuing Questionnaire (VQ)
Assesses outcomes expected in an ACT intervention. The VQ consists of 2 Subscales: Values Obstruction and Values Progress. Values Obstruction measures the extent to which thoughts/feelings obstructed engagement in values. Values Progress measures the extent to which an individual made progress in areas of life that are important to them.
Measured: Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks
Executive function
Computer-administered Stroop and a GoNoGo paradigm. Outcomes of interest are interference or bias score and errors and reaction time (respectively). These measures are included to test the hypothesis that executive function is improved with the improvement of eating disorder symptoms and glycemic control.
Measured: Baseline, 12 weeks, 36 weeks
High Frequency Heart Rate Variability (HF-HRV)
Assesses physiological flexibility/adaptability in the presence of emotional stimuli as an exploratory process of change measure.
Measured: Baseline, 12 weeks, 36 weeks
Actigraphy
Measures sleep and physical activity as exploratory measures of behavioral mechanisms of change.
Measured: Baseline, 12 weeks, 36 weeks
Ecological Momentary Assessment (EMA)
Participants complete questions at home using their mobile phone assessing psychological flexibility, mood, eating and diabetes management behavior, for additional data with high ecological validity. The assessment also aims to test the hypothesis that negative mood is decoupled from problem behavior over the course of treatment.
Measured: Baseline, 12 weeks, 36 weeks
Change in Eating Disorder Examination - Questionnaire (EDE-Q)
Self-report version of the Eating Disorder Examination (EDE). The EDE includes a total score and 4 subscale scores: Restraint, Eating Concerns, Weight Concerns, Shape Concerns. It is included to capture aspects of ED not assessed by the DEPS, as well as diagnostic outcome or change.
Measured: Baseline, 16 weeks, 24 weeks, 36 weeks
GAD-7
7-Item assessment of anxiety. The primary purpose for inclusion is as a control variable.
Measured: Baseline, 12 weeks, 36 weeks
PHQ-9
9-Item assessment of Depression. The primary purpose for inclusion is as a control variable.
Measured: Baseline, 12 weeks, 36 weeks
T1DE Questionnaire
This is a 20-item questionnaire developed for the purposes of this trial. The questionnaire is an inventory of target behaviors for individuals with T1DE.
Measured: Baseline, End-of-Treatment, 3 Months, 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start4 Apr 2023
- Primary completionJun 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Duke 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 235 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- The Miriam Hospital, Breakthrough T1D
- Responsible party
- Sponsor
- Investigators
- Rhonda Merwin, PhD, Principal investigator, Duke University faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05540704
- Sponsor's protocol ID
- Pro00111401
- Other IDs
- 4-SRA-2022-1226-M-B
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2022
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changing the T1DE (Type 1 Diabetes Eating Disorders): A Randomized Controlled Trial Comparing Acceptance and Commitment Therapy (ACT) to Supportive Diabetes Counseling and a Waitlist Control
- ClinicalTrials.gov ID
- NCT05540704
- Acronym / sponsor ID
- Pro00111401
- Conditions
- Type 1 Diabetes, Eating Disorders, Disordered Eating Behaviors, Purging (Eating Disorders), Binge-Eating Disorder
- Keywords
- glycemic control, disordered eating behavior, eating disorders, type 1 diabetes, acceptance and commitment therapy, diabetes counseling, mhealth, psychological flexibility
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 235 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- The Miriam Hospital, Breakthrough T1D
- Study start
- 4 Apr 2023 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 15 Sep 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.
The goal of this clinical trial is to test whether a new intervention works to treat eating disorders in type 1 diabetes. Participants are assigned to one of the following: (1) Acceptance and Commitment Therapy (ACT), (2) Supportive Diabetes Counseling, or (3) a 6-month Waitlist Control. Participants in the ACT and Supportive Diabetes Counseling conditions complete 12 sessions over 12-16 weeks and use their mobile phone between sessions to increase engagement and reinforce learning.
The main questions are:
Does treatment improve glycemic levels, eating disorder symptoms, diabetes management and diabetes distress?
Does one treatment do better than the other?
How do the treatments work, if they work, and for whom?
Participants complete assessments that include wearing a continuous glucose sensor and activity watch, and get a blood draw to determine HbA1c. They also complete diagnostic interviews, surveys and computer tests of attention and things like heart rate and reaction time. These assessments help us better understand the types of changes that are happening and how they might influence health and well-being.
Detailed description
This is a randomized controlled trial comparing an Acceptance and Commitment Therapy (ACT) protocol to supportive diabetes counseling (SDC) and a Waitlist Control (WLC) for individuals with type 1 diabetes and disordered eating (or T1DE). Both active conditions are tailored to the needs of individuals living with T1D and the unique conditions under which the eating disorder developed and is maintained. Participants will be 161 individuals with T1D, between the ages of 16-50, with binge-purge eating disorders (EDs), including threshold and subthreshold bulimia nervosa, binge eating disorder and purging disorder. Purging includes restriction of insulin for weight loss. An expansion cohort of 74 persons with T1D and elevated Diabetes Eating Problems Survey-Revised scores (DEPS-R=>20) will also be recruited to assess the utility of the treatments for a broader array of eating and weight control problems in T1D. Participants will be randomized to either ACT, SDC, or a WLC and complete assessments at baseline, mid-treatment, end-of-treatment, and at 1 month, 3 months, and 6 months post-treatment. The primary outcome of interest for power and sample size calculation is blood glucose levels (mean and % time in target glycemic range) as assessed by continuous glucose monitoring. Other outcomes include change in hemoglobin A1c (HbA1c), eating disorder symptoms, diabetes self-management and, secondary, diabetes distress. In addition to examining clinical outcomes, this study tests biobehavioral mechanisms of change and predictors of treatment response. Process of change assessments focus on flexible responding to pathology-relevant stimuli and early improvement in glycemic control affecting executive function. The primary site is Duke University Medical Center. The Miriam Hospital is a secondary site.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acceptance and Commitment Therapy for Type 1 Diabetes - Eating Disorder (ACT-T1DE) | Experimental | Behavioral: ACTACT-T1DE consists of 12 sessions of flexible ACT protocol tailored to the unique conditions and needs of type 1 diabetes eating disorders. The protocol is based on an initial pilot study (Merwin et al., 2021); however, the current protocol has been modified, based on key stakeholder feedback and to optimize real-world implementation. Modifications include transition from the use of a mobile app to a text messaging platform and a combination of in-person and virtual visits. |
| Supportive Diabetes Counseling (SDC) | Active comparator | Behavioral: Supportive Diabetes CounselingThe SDC condition is a flexible protocol of 12 sessions consisting of supportive listening, psychoeducation about diabetes and its management and management problems, and goal setting, informed by the ADA Type 1 Diabetes Self-Care Manual and ADCES7 Self-Care Behaviors framework. |
| 6-Month Waitlist Control | No intervention | –Participants assigned to the Waitlist Control complete assessments but do not receive intervention. |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 16-50 years of age
- Diagnosis of Type 1 diabetes
- Eating disorder characterized by binge eating and/or problematic weight control behaviors, including withholding insulin (Bulimia Nervosa, Binge Eating and Purging Disorder spectrum diagnoses)
- Independently manages diabetes (not reliant on a caregiver)
- Expansion Cohort
Key exclusion criteria (5 listed)
- Active suicidal ideation
- Diagnosis of Avoidant Restrictive Food Intake Disorder or Anorexia Nervosa spectrum diagnoses
- Hypoglycemic unawareness as assessed by the Gold Method and multiple severe episodes of hypoglycemia requiring 3rd party assistance in the last 2 years
- Current substance abuse disorder or current or past psychotic disorder
- NonEnglish speaking
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 |
|---|---|---|
| ACTTreatment is based on Acceptance and Commitment Therapy (ACT), a contemporary cognitive behavioral therapy (CBT) that improves human functioning and adaptability by increasing psychological flexibility. Individual therapy sessions are paired with mobile phone delivered interventions. | Behavioural | Acceptance and Commitment Therapy for Type 1 Diabetes - Eating Disorder (ACT-T1DE) |
| Supportive Diabetes CounselingCounseling with a diabetes educator knowledgeable about disordered eating in type 1 diabetes. Intervention focuses on supportive listening, diabetes-related education, including management problems and goal setting. | Behavioural | Supportive Diabetes Counseling (SDC) |
Primary outcome
Change in glycemic control as indexed by continuous glucose monitoring (CGM)
Time frame: baseline, 6 weeks, 12 weeks, 36 weeks
CGM indices of time in target glycemic range, mean blood sugar, frequency of Level 1 and 2 hyperglycemia and blood glucose variability
Change in eating disorder symptoms as indexed by the Diabetes Eating Problems Survey-Revised (DEPS-R)
Time frame: baseline, 12 weeks, 16 weeks, 24 weeks, 36 weeks
Severity of eating and body image concerns, frequency of engagement in maladaptive eating and weight control behaviors, specifically in the context of diabetes. Scores range from 0-80, with higher scores indicating greater symptom severity (worse outcome).
Change in diabetes self-management as indexed by the Diabetes Self-Management Questionnaire
Time frame: baseline, 12 weeks, 16 weeks, 24 weeks, 36 weeks
Engagement in activities necessary to manage diabetes, including checking blood sugar and administering insulin. Scores range from 0-10 with higher scores indicating better self-management.
Change in glycemic control as indexed by hemoglobin A1c (HbA1c)
Time frame: baseline, 24 weeks, 36 weeks
Glycated hemoglobin (percentage of red blood cells that are glycated providing an estimate of average blood glucose over 3 months)
12 secondary outcomes
Change in diabetes distress as indexed by the Type 1 - Diabetes Distress Scale
Time frame: baseline, 12 weeks, 24 weeks, 36 weeks
CompACT-10
Time frame: Baseline, Mid-Treatment, 12 weeks, 16 weeks, 24 weeks, 36 weeks.
Acceptance and Action Diabetes Questionnaire (AADQ)
Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks
Valuing Questionnaire (VQ)
Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks
Executive function
Time frame: Baseline, 12 weeks, 36 weeks
High Frequency Heart Rate Variability (HF-HRV)
Time frame: Baseline, 12 weeks, 36 weeks
Actigraphy
Time frame: Baseline, 12 weeks, 36 weeks
Ecological Momentary Assessment (EMA)
Time frame: Baseline, 12 weeks, 36 weeks
Change in Eating Disorder Examination - Questionnaire (EDE-Q)
Time frame: Baseline, 16 weeks, 24 weeks, 36 weeks
GAD-7
Time frame: Baseline, 12 weeks, 36 weeks
PHQ-9
Time frame: Baseline, 12 weeks, 36 weeks
T1DE Questionnaire
Time frame: Baseline, End-of-Treatment, 3 Months, 6 Months
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 8 Sep 2026.
- 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.
Rhonda Merwin, PhD principal investigator
Duke University faculty
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT and Supportive Diabetes Counseling in people with Type 1 Diabetes and Eating Disorders, run by Duke University at 2 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 9 inclusion and 5 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 8 Sep 2026. 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 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?
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 Dottie R Mayo, BA ((919) 668-1935, drm72@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in glycemic control as indexed by continuous glucose monitoring (CGM) (time frame: baseline, 6 weeks, 12 weeks, 36 weeks). The study lists 4 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 8 Sep 2026.