Diabetes Mellitus, Type 1REAL-TNCT04023487
Evaluation of an Intervention for Young Adults With Diabetes: Resilient, Empowered, Active Living-Telehealth (REAL-T)
A study testing Resilient, Empowered, Active Living-Telehealth (REAL-T) in people with Diabetes Mellitus, Type 1, run by University of Southern California at 1 site in United States.
Trial summary
This study will evaluate (1) the efficacy of REAL-T, a lifestyle-based telehealth intervention, in improving glycemic control (HbA1c) and psychosocial outcomes, (2) which effects are retained over a 6-month follow-up period, and (3) the mediating mechanisms responsible for the intervention's effects. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Resilient, Empowered, Active Living-Telehealth (REAL-T)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 209 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2019to 18 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- T1D for ≥12 months
- A1c ≥7.5% at time of study enrollment
- Age 18-30 yrs. at time of study enrollment
- English or Spanish speaking
- Resides in a state where OT clinicians are licensed, in an area where the participant has access to a local healthcare provider in the event of emergency and can complete data collection in person (when permitted) or via mailings (when required during period of social distance or due to distance from study site)
- Participant has access to a laptop or desktop computer, either their own or loaned by the study (if geographically feasible and permitted given COVID-19 social distancing distractions)
- Willing to participate in 6-month intervention
Who cannot join
- Currently pregnant or planning to become pregnant within the next 12 months
- Previously received REAL intervention
- Cognitive impairment or severe disability limiting life expectancy
Trial locations and contacts
1 site in 1 country.
United States1 site
USC Center for Health Professionals
Los Angeles, California, 90033
About this study
Official title: Evaluation of a Complex Intervention for Young Adults With Diabetes: The Resilient, Empowered, Active Living-Telehealth (REAL-T) Study
This study will evaluate (1) the efficacy of REAL-T, a lifestyle-based telehealth intervention, in improving glycemic control (HbA1c) and psychosocial outcomes, (2) which effects are retained over a 6-month follow-up period, and (3) the mediating mechanisms responsible for the intervention's effects. Half of participants will receive REAL-T, while the other half will receive their usual care.
Read the detailed description
Evaluation of a Complex Behavioral Intervention for Young Adults with Diabetes: The Resilient, Empowered, Active Living-Telehealth (REAL-T) Study will address the unmet self-management and psychosocial needs of young adults (YAs) with type 1 diabetes (T1D).
We will conduct a large-scale randomized controlled trial (n=210) to compare the 6-month REAL-T intervention to usual care in improving glycemic control (A1c and continuous glucose monitor-derived measures), psychosocial well-being, and hypothesized intervention mediators. In addition, we will perform health economic analyses to determine the extent to which REAL-T is cost-effective or produces cost savings.
The study's specific aims are as follows:
Aim 1: Evaluate the efficacy of REAL-T in improving glycemic control and psychosocial well-being.
- Hypothesis 1: Over a 6-month intervention period (including 3 and 6 month measures), YAs with T1D who receive REAL-T demonstrate improvements in glycemic control, in comparison to YAs with T1D who receive usual care.
- Hypothesis 2: Over a 6-month period (including 3 and 6 month measures), YAs with T1D who receive REAL-T demonstrate gains in psychosocial well-being in comparison to YAs with T1D who receive usual care.
Aim 2: Assess the post-intervention durability (at 3 and 6 months post-intervention) of REAL-T's effects on glycemic control and psychosocial well-being.
- Hypothesis 1: Among YAs with T1D, improvements in glycemic control that result from REAL-T relative to usual care are maintained at 3 and 6 months post-treatment.
- Hypothesis 2: Among YAs with T1D, improvements in psychosocial well-being that result from REAL-T relative to usual care are maintained at 3 and 6 months post-treatment.
Aim 3: Examine mediating mechanisms of the REAL-T intervention's effects on glycemic control and psychosocial well-being through structural equation modeling (SEM).
- Hypothesis 1: Improvements in diabetes self-care behaviors mediate positive intervention effects on glycemic control and psychosocial well-being.
- Hypothesis 2: Improvements in self-efficacy mediate positive intervention effects on psychosocial well-being and partially mediate positive effects on diabetes self-care behaviors.
- Hypothesis 3: Improvements in habit strength for diabetes self-care behaviors partially mediate positive intervention effects on the performance of diabetes self-care behaviors.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Resilient, Empowered, Active Living-Telehealth (REAL-T)
- Keywords
- Diabetes Mellitus, Type 1, randomized controlled trial
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resilient, Empowered, Active Living-Telehealth (REAL-T)Behavioural
REAL-T is an individually-tailored occupational therapy intervention that focuses on incorporating diabetes self-care into participants' daily habits and routines. Participants receive approximately 12 hours of intervention, delivered via telehealth over 6 months by a licensed occupational therapist with training in diabetes education, motivational interviewing, and the REAL Diabetes intervention protocol.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle Intervention | Experimental | Resilient, Empowered, Active Living-Telehealth (REAL-T) Receives: Behavioral: Resilient, Empowered, Active Living-Telehealth (REAL-T) |
| Usual Care | No intervention | Participants will continue to have access to routine diabetes care from the provider of their choosing; they will not receive any study-related intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to 6-months in Glycemic Control, Using Glycated Hemoglobin (HbA1C)
HbA1C is a measure of average blood glucose concentration over approximately the previous 12 weeks. HbA1C will be measured using a finger-prick test using the DCA Vantage Analyzer point-of-care system OR AccuBase A1c test with DTI Laboratories. Assessed at Baseline and 6 months; change from baseline to 6 months reported.
Measured: Assessed at Baseline and 6 months; change from baseline to 6 months reported
Secondary outcomes (10)
Change From Baseline to 6-months Post-test in Diabetes-related Quality of Life, Using the "Audit of Diabetes-Dependent Quality of Life-15" (ADD-QoL-15)
15-item questionnaire assessing diabetes-related quality of life (qol). Each item contains two parts. Part A is: "If I did not have diabetes, [the question topic] would be", followed by 5 options ranging from "very much better" (or similar; scored as -3) to "worse" (or similar; scored as 1). The fourth option is always "the same" and scored as 0. Part B is: "[the question topic] is" followed by 4 options ranging from "very important" (scored as 3) to "not at all important" (scored as 0). For each question, scores on parts A and B are multiplied, and the 15 products are summed for a total score. Questions 2, 4, 6, 8, 9, \& 11 have preliminary yes/no questions, and when a "no" response is given, parts A and B are skipped and the score for that question is 0. The minimum score on each question is -9 and the maximum is 3, with total scores ranging from -135 to 45. Higher/more positive scores represent a better outcome; Lower/ more negative scores represent a worse outcome.
Measured: Assessed at Baseline and 6 months; change from baseline to 6 months reported
Change From Baseline to 6-months Post-test in Diabetes-related Emotional Distress, Using the "Diabetes Distress Scale" (DDS)
17-item questionnaire assessing diabetes-related emotional distress. Total scores (mean score on all 17 items) range from 1 to 6, with higher scores indicating a worse outcome. Sub-scale scores (emotional burden, physician-related distress, regimen-related distress, and interpersonal distress) each range from 1 to 6, with higher scores indicating a worse outcome. A total or sub-scale score 2.0 - 2.9 should be considered 'moderate distress,' and a total or sub-scale score > 3.0 should be considered 'high distress.'
Measured: Assessed at Baseline and 6 months; change from baseline to 6 months reported
Change From Baseline to 6-months in Functional Health and Well-being, Using the "SF-12v2® Health Survey"
Short Form 12-item Health Survey Ver. 2 (SF-12v2) is a 12-item questionnaire assessing functional health \& well-being over the last 4 weeks in 8 health domains (physical functioning, role participation with physical health problems, bodily pain, general health, vitality, social functioning, role participation with emotional health problems, mental health), all from the patient's point of view. These 8 domains can be summarized into a physical component summary (PCS) and a mental component summary (MCS). Higher scores indicate a better health state. MCS and PCS scores range from 0-100. Scores are calibrated using general population-derived normative data so that 50 is the avg score or norm. Results can be further summarized into a single preference-based health utility number ranging from 1 (equivalent to perfect health) to 0 (equivalent to being dead), using a complex scoring algorithm (SF-6D) derived from surveying a general U.S. population's preferences for specific health states.
Measured: Assessed at Baseline, 6 months, and 12 months; change from baseline to 6 months reported
Change From Baseline to 6-months in Global Diabetes Self-management, Using the "Diabetes Self-Management Questionnaire-Revised" (DSMQ-R).
27-item questionnaire assessing self-care activities associated with glycemic control. Higher values indicate more effective self-management. Transformed scores = Actual sum of items / maximum possible sum of items x 10. Total transformed scores range from 0 to 10. Transformed scores on six sub-scales (Dietary control, Glucose management, Glucose monitoring, Medication adherence, Physical activity, and Physician contact) also range from 0 to 10.
Measured: Assessed at Baseline, 3 months, 6 months, 9 months, and 12 months; change from baseline to 6 months reported
Change From Baseline to 6-months in Medication Adherence, Using the "3-item Adherence Self-report Scale" Questionnaire
3-item questionnaire (Wilson,Lee, Fowler, \& Rogers, 2016) assessing adherence to diabetes medication regimen. Item responses for the three adherence items are linearly transformed to a 0-100 scale with zero being the worst adherence, and 100 the best. A total summary score is calculated as the mean of the three individual items, with a range of 0 to 100.
Measured: Assessed at Baseline, 3 months, 6 months, 9 months, and 12 months; change from baseline to 6 months reported
Change From Baseline to 6-months in Self-efficacy for Performing Diabetes Self-management, Using the "Diabetes Empowerment Scale - Short Form" (DES-SF)
8-item questionnaire assessing self-efficacy for performing diabetes self-management, using 5-point likert scales. The scale is scored by averaging the scores of all completed items. Scores range from 8 to 40, with higher scores indicating higher self-efficacy.
Measured: Assessed at Baseline, 3 months, 6 months, 9 months, and 12 months; change from baseline to 6 months reported
Change From Baseline to 6-months in Autonomy of Taking Insulin and/or Checking Blood Sugar, Using the "Treatment Self-Regulation Questionnaire" (TSRQ)
19-item questionnaire, adapted for type 1 diabetes, assessing the degree to which a person's motivation for a particular behavior or a set of behaviors is relatively autonomous or self-determined. Each item can receive a value ranging from 1 - 7 as selected by the participant. The scale has 2 sub-scales: the autonomous regulatory style and the controlled regulatory style. Calculating the scores for the sub-scales consists of averaging the items on that sub-scale. A Relative Autonomous Motivation Index can be formed by subtracting the average for the controlled reasons from the average for the autonomous reasons. Scores range from 1 to 7, with 7 indicating a strong identification with the given autonomy style. The autonomous regulatory style represents the most self-determined form of motivation.
Measured: Assessed at Baseline, 3 months, 6 months, 9 months, and 12 months; change from baseline to 6 months reported
Change From Baseline to 6-months Post-test in Glycemia, Using Percent Time-in-Range
The percentage of time when blood glucose was between 70 and 180 mg/dl, as measured by a continuous glucose monitor worn for 14 days.
Measured: Assessed at Baseline and 6 months; change from baseline to 6 months reported
Change From Baseline to 6-months Post-test in Glycemia, Using Percent Time in Hyperglycemia
The percentage of time when blood glucose was above 180 mg/dl, as measured by a continuous glucose monitor worn for 14 days.
Measured: Assessed at Baseline and 6 months; change from baseline to 6 months reported
Change From Baseline to 6-months Post-test in Glycemia, Using Percent Time in Hypoglycemia
The percentage of time when blood glucose was below 70 mg/dl, as measured by a continuous glucose monitor worn for 14 days.
Measured: Assessed at Baseline and 6 months; change from baseline to 6 months reported
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start22 Oct 2019
- Primary completion5 Jun 2023
- Study completion18 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beth Pyatak, University of Southern California
- Investigators
- Elizabeth Pyatak, PhD, OTR/L, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04023487
- Sponsor's protocol ID
- 1R01DK116719
- Other IDs
- 1R01DK116719
- Acronym
- REAL-T
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2019
- Last updated
- 21 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Complex Intervention for Young Adults With Diabetes: The Resilient, Empowered, Active Living-Telehealth (REAL-T) Study
- ClinicalTrials.gov ID
- NCT04023487
- Acronym / sponsor ID
- REAL-T / 1R01DK116719
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Diabetes Mellitus, Type 1, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 22 Oct 2019 (actual)
- Primary completion
- 5 Jun 2023 (actual)
- Study completion
- 18 Nov 2023 (actual)
- First posted
- 17 Jul 2019 (actual)
- Results
- Posted 21 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate (1) the efficacy of REAL-T, a lifestyle-based telehealth intervention, in improving glycemic control (HbA1c) and psychosocial outcomes, (2) which effects are retained over a 6-month follow-up period, and (3) the mediating mechanisms responsible for the intervention's effects. Half of participants will receive REAL-T, while the other half will receive their usual care.
Detailed description
Evaluation of a Complex Behavioral Intervention for Young Adults with Diabetes: The Resilient, Empowered, Active Living-Telehealth (REAL-T) Study will address the unmet self-management and psychosocial needs of young adults (YAs) with type 1 diabetes (T1D).
We will conduct a large-scale randomized controlled trial (n=210) to compare the 6-month REAL-T intervention to usual care in improving glycemic control (A1c and continuous glucose monitor-derived measures), psychosocial well-being, and hypothesized intervention mediators. In addition, we will perform health economic analyses to determine the extent to which REAL-T is cost-effective or produces cost savings.
The study's specific aims are as follows:
Aim 1: Evaluate the efficacy of REAL-T in improving glycemic control and psychosocial well-being.
- Hypothesis 1: Over a 6-month intervention period (including 3 and 6 month measures), YAs with T1D who receive REAL-T demonstrate improvements in glycemic control, in comparison to YAs with T1D who receive usual care.
- Hypothesis 2: Over a 6-month period (including 3 and 6 month measures), YAs with T1D who receive REAL-T demonstrate gains in psychosocial well-being in comparison to YAs with T1D who receive usual care.
Aim 2: Assess the post-intervention durability (at 3 and 6 months post-intervention) of REAL-T's effects on glycemic control and psychosocial well-being.
- Hypothesis 1: Among YAs with T1D, improvements in glycemic control that result from REAL-T relative to usual care are maintained at 3 and 6 months post-treatment.
- Hypothesis 2: Among YAs with T1D, improvements in psychosocial well-being that result from REAL-T relative to usual care are maintained at 3 and 6 months post-treatment.
Aim 3: Examine mediating mechanisms of the REAL-T intervention's effects on glycemic control and psychosocial well-being through structural equation modeling (SEM).
- Hypothesis 1: Improvements in diabetes self-care behaviors mediate positive intervention effects on glycemic control and psychosocial well-being.
- Hypothesis 2: Improvements in self-efficacy mediate positive intervention effects on psychosocial well-being and partially mediate positive effects on diabetes self-care behaviors.
- Hypothesis 3: Improvements in habit strength for diabetes self-care behaviors partially mediate positive intervention effects on the performance of diabetes self-care behaviors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle Intervention | Experimental | Behavioral: Resilient, Empowered, Active Living-Telehealth (REAL-T)Resilient, Empowered, Active Living-Telehealth (REAL-T) |
| Usual Care | No intervention | –Participants will continue to have access to routine diabetes care from the provider of their choosing; they will not receive any study-related intervention. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- T1D for ≥12 months
- A1c ≥7.5% at time of study enrollment
- Age 18-30 yrs. at time of study enrollment
- English or Spanish speaking
- Resides in a state where OT clinicians are licensed, in an area where the participant has access to a local healthcare provider in the event of emergency and can complete data collection in person (when permitted) or via mailings (when required during period of social distance or due to distance from study site)
Key exclusion criteria (3 listed)
- Currently pregnant or planning to become pregnant within the next 12 months
- Previously received REAL intervention
- Cognitive impairment or severe disability limiting life expectancy
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 |
|---|---|---|
| Resilient, Empowered, Active Living-Telehealth (REAL-T)REAL-T is an individually-tailored occupational therapy intervention that focuses on incorporating diabetes self-care into participants' daily habits and routines. Participants receive approximately 12 hours of intervention, delivered via telehealth over 6 months by a licensed occupational therapist with training in diabetes education, motivational interviewing, and the REAL Diabetes intervention protocol. | Behavioural | Lifestyle Intervention |
Primary outcome
Change From Baseline to 6-months in Glycemic Control, Using Glycated Hemoglobin (HbA1C)
Time frame: Assessed at Baseline and 6 months; change from baseline to 6 months reported
HbA1C is a measure of average blood glucose concentration over approximately the previous 12 weeks. HbA1C will be measured using a finger-prick test using the DCA Vantage Analyzer point-of-care system OR AccuBase A1c test with DTI Laboratories. Assessed at Baseline and 6 months; change from baseline to 6 months reported.
10 secondary outcomes
Change From Baseline to 6-months Post-test in Diabetes-related Quality of Life, Using the "Audit of Diabetes-Dependent Quality of Life-15" (ADD-QoL-15)
Time frame: Assessed at Baseline and 6 months; change from baseline to 6 months reported
Change From Baseline to 6-months Post-test in Diabetes-related Emotional Distress, Using the "Diabetes Distress Scale" (DDS)
Time frame: Assessed at Baseline and 6 months; change from baseline to 6 months reported
Change From Baseline to 6-months in Functional Health and Well-being, Using the "SF-12v2® Health Survey"
Time frame: Assessed at Baseline, 6 months, and 12 months; change from baseline to 6 months reported
Change From Baseline to 6-months in Global Diabetes Self-management, Using the "Diabetes Self-Management Questionnaire-Revised" (DSMQ-R).
Time frame: Assessed at Baseline, 3 months, 6 months, 9 months, and 12 months; change from baseline to 6 months reported
Change From Baseline to 6-months in Medication Adherence, Using the "3-item Adherence Self-report Scale" Questionnaire
Time frame: Assessed at Baseline, 3 months, 6 months, 9 months, and 12 months; change from baseline to 6 months reported
Change From Baseline to 6-months in Self-efficacy for Performing Diabetes Self-management, Using the "Diabetes Empowerment Scale - Short Form" (DES-SF)
Time frame: Assessed at Baseline, 3 months, 6 months, 9 months, and 12 months; change from baseline to 6 months reported
Change From Baseline to 6-months in Autonomy of Taking Insulin and/or Checking Blood Sugar, Using the "Treatment Self-Regulation Questionnaire" (TSRQ)
Time frame: Assessed at Baseline, 3 months, 6 months, 9 months, and 12 months; change from baseline to 6 months reported
Change From Baseline to 6-months Post-test in Glycemia, Using Percent Time-in-Range
Time frame: Assessed at Baseline and 6 months; change from baseline to 6 months reported
Change From Baseline to 6-months Post-test in Glycemia, Using Percent Time in Hyperglycemia
Time frame: Assessed at Baseline and 6 months; change from baseline to 6 months reported
Change From Baseline to 6-months Post-test in Glycemia, Using Percent Time in Hypoglycemia
Time frame: Assessed at Baseline and 6 months; change from baseline to 6 months reported
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Pyatak, PhD, OTR/L principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resilient, Empowered, Active Living-Telehealth (REAL-T) in people with Diabetes Mellitus, Type 1, run by University of Southern California at 1 site 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 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline to 6-months in Glycemic Control, Using Glycated Hemoglobin (HbA1C) (time frame: Assessed at Baseline and 6 months; change from baseline to 6 months reported). 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 21 Aug 2026.