Diabetes type1ChargeUpNCT06405373
Behavioral Approaches to Reduce Diabetes Distress in Adults With Type 1 Diabetes: A Pragmatic SMART
A study testing ReCharge and TakeCharge in people with Diabetes type1 and Diabetes Mellitus, Type 1, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
This study is designed to compare two behavioral approaches to reduce diabetes distress ("the expected burdens, concerns, fears, and threats that arise from the challenges of living with diabetes") in adults with type 1 diabetes. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Diabetes type1, Diabetes Mellitus, Type 1, Diabetes, Autoimmune
- What is being tested?
- ReCharge and TakeCharge
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2024to 15 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 30 years and older
- Type 1 diabetes OR latent autoimmune diabetes in adults (LADA) clinically managed as type 1 diabetes
- Elevated diabetes distress, defined as a score >= 2.0 on the T1-DDAS core scale
- English speaking
Who cannot join
- Does not receive diabetes care at UNC Endocrinology at Eastowne
- Cannot commit to the pre-scheduled weekly, virtual sessions
- Diagnosis of any major medical or psychiatric condition that would preclude participation
- Diagnosis of dementia or other conditions that affect memory or information retention, such as cognitive impairment
- Visual or auditory impairment that would interfere with participation in a group intervention
- Receiving inpatient psychiatric treatment or history of a suicide attempt within the past 12 months at the time of enrollment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Angela Fruik, MPH, RD, 919-962-6348, angela.fruik@unc.edu
Anna Kahkoska, MD, PhD
About this study
Official title: Fusing Rapid-cycle Testing and Adaptive Trial Designs: A Scientific Pipeline to Translate and Individualize Evidence-based Psychosocial and Behavioral Interventions in Routine Type 1 Diabetes Care
This study is designed to compare two behavioral approaches to reduce diabetes distress ("the expected burdens, concerns, fears, and threats that arise from the challenges of living with diabetes") in adults with type 1 diabetes. At the study baseline, participants will be randomized to take part in one of two virtual, group-based interventions (the "Primary" intervention) utilizing either an emotions-focused or a problem-solving approach to reduce diabetes distress. After the initial intervention, participants will complete surveys to assess their response to the material. Participants who are determined to be "non-responders" (i.e., the Primary intervention was not effective) will be re-randomized to one of two "Supplementary" interventions, which will include individualized sessions to learn and/or practice strategies related to either the psychological or problem-solving approach.
Read the detailed description
The study will compare the effectiveness of an emotions-focused approach with a problem-solving based approach to reduce diabetes distress (DD). The investigators will enroll N=200 adults 30 years and older with type 1 diabetes (T1D) and elevated DD from a single clinical site to participate in a 12-week study. All interventions and assessments will be delivered in a pragmatic and entirely virtual format. The investigators will utilize a precision medicine trial design (Sequential Multiple Assignment Randomized Trial; SMART) to compare two evidence-based, virtual group interventions to reduce DD in adults with T1D (primary aim). The secondary aims of the study are to estimate next best steps for participants who do not respond to group-based interventions, and to estimate optimal treatments or sequences of treatments for different individuals based on their individual characteristics, including response to prior treatment.
The study includes an initial randomization to one of two 5-week Primary Interventions: "ReCharge", an Acceptance and Commitment Therapy (ACT)-focused approach that will help to reduce the emotional burden of diabetes management; or "TakeCharge", a problem-solving focused approach that will equip participants with new skills to manage type 1 diabetes. Participants will complete a series of assessments to determine their response to the Primary Intervention. Participants who did not respond to the Primary Intervention will be re-randomized to participate in one of two Supplementary Interventions over a 5-week period, where they will have three virtual, individualized sessions for exposure and practice with either the ReCharge or TakeCharge curriculum.
The investigators will evaluate the Reach, Effectiveness, Adoption, Implementation, and Maintenance of all phases of the study. By collecting both quantitative data and key qualitative feedback from providers and participants, the investigators will be able to assess and improve the pragmatic design of these evidence-based interventions for routine integration into healthcare settings. Completion of primary and secondary aims will inform a future program which saves resources and expands the availability of guidelines-oriented care to all patients with T1D.
- Conditions
- Diabetes type1, Diabetes Mellitus, Type 1, Diabetes, Autoimmune, Diabetes Mellitus, Distress, Emotional
- Being tested
- ReCharge, TakeCharge
- Keywords
- Diabetes, Type 1 diabetes, Diabetes distress, T1D, Emotional distress, Telehealth, SMART design
- 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.
ReChargeBehavioural
ReCharge is an emotions-focused intervention that utilizes core components of Acceptance and Commitment Therapy (ACT) to address and minimize diabetes distress. This 5-week, group-based, virtual intervention will include a stepwise process to address diabetes distress and provide opportunities to practice new skills. Weekly assignments between the sessions will reinforce class material and give additional practice opportunities. Participants will be expected to interact in each session and will have opportunities to share their experiences and be engaged in discussion with the group and the facilitator.
TakeChargeBehavioural
TakeCharge is a problem-solving focused intervention that empowers participants to identify and make meaningful changes in their blood glucose management and other diabetes-related behaviors. This 5-week, group-based, virtual intervention will include a stepwise process to analyze data and resolve challenging situations surrounding diabetes management and provide opportunities to practice new skills. Weekly assignments between the sessions will reinforce class material and give additional practice opportunities. Participants will be expected to interact in each session and will have opportunities to share their experiences and be engaged in discussion with the group and the facilitator.
| Study group | Role | What they receive |
|---|---|---|
| ReCharge | Experimental | Participants randomized to ReCharge will participate in an emotions-focused intervention facilitated by a mental health professional. Receives: Behavioral: ReCharge |
| TakeCharge | Experimental | Participants randomized to TakeCharge will participate in a problem-solving focused intervention facilitated by a diabetes care professional. Receives: Behavioral: TakeCharge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Diabetes Distress (T1-DDS Total Score)
Self-reported total diabetes distress will be measured using the 28-item Type 1 Diabetes Distress Scale (T1-DDS Total Score). The scale yields an overall distress score that is the average of all responses rated on a 6-point Likert scale for all 28 items (range 1-6). A score >= 2.0 is considered clinically significant diabetes distress. The primary efficacy outcomes of this study is the change in the T1D-DDS score and the proportion of individuals with a change in the T1D-DDS score at least as large as one minimally clinically important difference (MCID).
Measured: Baseline, Interim (6 weeks), Endpoint (12 weeks)
Secondary outcomes (12)
Change in Core Diabetes Distress (T1-DDAS Core Score)
Self-reported core diabetes distress will be measured using the newer, 8-item Type 1 Diabetes Distress Assessment System (T1-DDAS Core Score). The scale yields a core distress score that is the average of all responses rated on a 5-point Likert scale for all 8 items (range 1-5). A score >= 2.0 is considered clinically significant diabetes distress.
Measured: Baseline, Interim (6 weeks), Endpoint (12 weeks)
Change in Sources of Diabetes Distress (T1-DDS Subscale Scores)
Self-reported sources of diabetes distress will be measured using the 7 subscales of the 28-item Type 1 Diabetes Distress Scale (T1-DDS Subscale Scores). In addition to the Total Score, the T1-DDS scale also yields a score for each of 7 subscales based on the average response on all of the items in that subscale (range = 1-6). The 7 subscale scores measure sources including: Powerlessness, Management Distress, Hypoglycemia Distress, Negative Social Perceptions, Eating Distress, Physician Distress, and Friend/Family Distress. A score >= 2.0 is considered clinically significant diabetes distress for each source.
Measured: Baseline, Interim (6 weeks), Endpoint (12 weeks)
Change in Perceived Stress
The Perceived Stress Scale 4 (PSS-4) is a 4-item questionnaire used to measure the degree to which situations in one's life are appraised as stressful during the last month. Respondents self-report the frequency of four key thoughts and feelings over the past month using a 5-point Likert scale. Total score is determined by adding together the scores of each of the four items (range 0-4).
Measured: Baseline, Interim (6 weeks), Endpoint (12 weeks)
Change in Diabetes Quality of Life
The Diabetes Quality of Life (DQOL) - Brief Clinical Inventory is a 15-item questionnaire used to provide a total health-related quality of life score that predicts self-reported diabetes care behaviors and satisfaction with diabetes control. Items are scored on 5-point Likert scale under two general formats. One format asks about the frequency of negative impact of diabetes itself or of the diabetes treatment and provides response options from 1 ("Never") to 5 ("All the time"). The second format asks about satisfaction with treatment and quality of life and is scored from 1 ("Very satisfied") to 5 ("Very dissatisfied").
Measured: Baseline, Interim (6 weeks), Endpoint (12 weeks)
Change in Perceived Confidence in Diabetes
The Perceived Competence in Diabetes Scale (PCDS) is a 4-item questionnaire used to assess the degree to which persons with diabetes feel they can manage the everyday aspects of diabetes care. Items are scored on a 1-7 Likert scale from 1 ("not at all true") to 7 ("very true"); items are averaged to form a perceived competence score (range 1-7).
Measured: Baseline, Interim (6 weeks), Endpoint (12 weeks)
Change in Diabetes Specific Self-Compassion
The Diabetes Specific Self-Compassion (SCS-D) is a 19-item questionnaire used to assess diabetes specific self-compassion and self-buffering against negative emotions in adults with T1D. Items are scored on a 1-5 Likert scale; average scores determined by calculating the mean of subscale item responses.
Measured: Baseline, Interim (6 weeks), Endpoint (12 weeks)
Change in Hypoglycemic Attitudes and Behaviors
The Hypoglycemic Attitudes and Behavior Scale (HABS) is a 14-item self-report scale highlighting two critical dimensions of hypoglycemia-related concerns (anxiety and avoidance) and one positive dimension (confidence). Items are scored on a 1-5 Likert scale from 1 ("Strongly Disagree") to 5 ("Strongly Agree"); Mean item scores are assessed for each hypoglycemia related dimension.
Measured: Baseline, Interim (6 weeks), Endpoint (12 weeks)
Change in Hemoglobin A1c (HbA1c)
HbA1c (%) reflects average glucose over the past 2-3 months. Value will be assessed by standardized laboratory assay for trial baseline and endpoint. 3- and 6-mo post-Endpoint data will be extracted from the electronic medical record.
Measured: Baseline, Endpoint (12 weeks)
Change in Percent of Time in Range (TIR)
For participants using personal continuous glucose monitors (CGM), the percentage of sensor values between 70-180 mg/dL will be measured using 7-14 days of retrospective data at each time-point. Change in TIR will be calculated across time-points.
Measured: Baseline, Endpoint (12 weeks)
Change in Percent of Time Below Range (TBR)
For participants using personal continuous glucose monitors (CGM), the percentage of sensor values in the hypoglycemic range (<70 mg/dL) will be measured using 7-14 days of retrospective data at each time-point. Change in TBR will be calculated across time-points.
Measured: Baseline, Endpoint (12 weeks)
Change in Percent of Time Above Range (TAR)
For participants using personal continuous glucose monitors (CGM), the percentage of sensor values in the hyperglycemia range (>180 mg/dL) will be measured using 7-14 days of retrospective data at each time-point. Change in TAR will be calculated across time-points.
Measured: Baseline, Endpoint (12 weeks)
Glycemic Variability
For participants using personal continuous glucose monitors (CGM), glycemic variability will be assessed using the coefficient of variation (%CV). Change in %CV will be calculated across time-points.
Measured: Baseline, Endpoint (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start1 Oct 2024
- Primary completion15 Sep 2027 (estimated)
- Study completion15 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes type1Studies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Sequential
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association
- Responsible party
- Sponsor
- Investigators
- Anna Kahkoska, MD, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06405373
- Sponsor's protocol ID
- 23-2228b
- Other IDs
- 12-22-ACE-18
- Acronym
- ChargeUp
- Status last verified
- Oct 2025
- First submitted
- 6 May 2024
- Last updated
- 29 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 6 to 18 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fusing Rapid-cycle Testing and Adaptive Trial Designs: A Scientific Pipeline to Translate and Individualize Evidence-based Psychosocial and Behavioral Interventions in Routine Type 1 Diabetes Care
- ClinicalTrials.gov ID
- NCT06405373
- Acronym / sponsor ID
- ChargeUp / 23-2228b
- Conditions
- Diabetes type1, Diabetes Mellitus, Type 1, Diabetes, Autoimmune, Diabetes Mellitus, Distress, Emotional
- Keywords
- Diabetes, Type 1 diabetes, Diabetes distress, T1D, Emotional distress, Telehealth, SMART design
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- American Diabetes Association
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 15 Sep 2027 (estimated)
- Study completion
- 15 Sep 2027 (estimated)
- First posted
- 8 May 2024 (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.
This study is designed to compare two behavioral approaches to reduce diabetes distress ("the expected burdens, concerns, fears, and threats that arise from the challenges of living with diabetes") in adults with type 1 diabetes. At the study baseline, participants will be randomized to take part in one of two virtual, group-based interventions (the "Primary" intervention) utilizing either an emotions-focused or a problem-solving approach to reduce diabetes distress. After the initial intervention, participants will complete surveys to assess their response to the material. Participants who are determined to be "non-responders" (i.e., the Primary intervention was not effective) will be re-randomized to one of two "Supplementary" interventions, which will include individualized sessions to learn and/or practice strategies related to either the psychological or problem-solving approach.
Detailed description
The study will compare the effectiveness of an emotions-focused approach with a problem-solving based approach to reduce diabetes distress (DD). The investigators will enroll N=200 adults 30 years and older with type 1 diabetes (T1D) and elevated DD from a single clinical site to participate in a 12-week study. All interventions and assessments will be delivered in a pragmatic and entirely virtual format. The investigators will utilize a precision medicine trial design (Sequential Multiple Assignment Randomized Trial; SMART) to compare two evidence-based, virtual group interventions to reduce DD in adults with T1D (primary aim). The secondary aims of the study are to estimate next best steps for participants who do not respond to group-based interventions, and to estimate optimal treatments or sequences of treatments for different individuals based on their individual characteristics, including response to prior treatment.
The study includes an initial randomization to one of two 5-week Primary Interventions: "ReCharge", an Acceptance and Commitment Therapy (ACT)-focused approach that will help to reduce the emotional burden of diabetes management; or "TakeCharge", a problem-solving focused approach that will equip participants with new skills to manage type 1 diabetes. Participants will complete a series of assessments to determine their response to the Primary Intervention. Participants who did not respond to the Primary Intervention will be re-randomized to participate in one of two Supplementary Interventions over a 5-week period, where they will have three virtual, individualized sessions for exposure and practice with either the ReCharge or TakeCharge curriculum.
The investigators will evaluate the Reach, Effectiveness, Adoption, Implementation, and Maintenance of all phases of the study. By collecting both quantitative data and key qualitative feedback from providers and participants, the investigators will be able to assess and improve the pragmatic design of these evidence-based interventions for routine integration into healthcare settings. Completion of primary and secondary aims will inform a future program which saves resources and expands the availability of guidelines-oriented care to all patients with T1D.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ReCharge | Experimental | Behavioral: ReChargeParticipants randomized to ReCharge will participate in an emotions-focused intervention facilitated by a mental health professional. |
| TakeCharge | Experimental | Behavioral: TakeChargeParticipants randomized to TakeCharge will participate in a problem-solving focused intervention facilitated by a diabetes care professional. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults 30 years and older
- Type 1 diabetes OR latent autoimmune diabetes in adults (LADA) clinically managed as type 1 diabetes
- Elevated diabetes distress, defined as a score >= 2.0 on the T1-DDAS core scale
- English speaking
Key exclusion criteria (6 listed)
- Does not receive diabetes care at UNC Endocrinology at Eastowne
- Cannot commit to the pre-scheduled weekly, virtual sessions
- Diagnosis of any major medical or psychiatric condition that would preclude participation
- Diagnosis of dementia or other conditions that affect memory or information retention, such as cognitive impairment
- Visual or auditory impairment that would interfere with participation in a group intervention
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 |
|---|---|---|
| ReChargeReCharge is an emotions-focused intervention that utilizes core components of Acceptance and Commitment Therapy (ACT) to address and minimize diabetes distress. This 5-week, group-based, virtual intervention will include a stepwise process to address diabetes distress and provide opportunities to practice new skills. Weekly assignments between the sessions will reinforce class material and give additional practice opportunities. Participants will be expected to interact in each session and will have opportunities to share their experiences and be engaged in discussion with the group and the facilitator. | Behavioural | ReCharge |
| TakeChargeTakeCharge is a problem-solving focused intervention that empowers participants to identify and make meaningful changes in their blood glucose management and other diabetes-related behaviors. This 5-week, group-based, virtual intervention will include a stepwise process to analyze data and resolve challenging situations surrounding diabetes management and provide opportunities to practice new skills. Weekly assignments between the sessions will reinforce class material and give additional practice opportunities. Participants will be expected to interact in each session and will have opportunities to share their experiences and be engaged in discussion with the group and the facilitator. | Behavioural | TakeCharge |
Primary outcome
Change in Total Diabetes Distress (T1-DDS Total Score)
Time frame: Baseline, Interim (6 weeks), Endpoint (12 weeks)
Self-reported total diabetes distress will be measured using the 28-item Type 1 Diabetes Distress Scale (T1-DDS Total Score). The scale yields an overall distress score that is the average of all responses rated on a 6-point Likert scale for all 28 items (range 1-6). A score >= 2.0 is considered clinically significant diabetes distress. The primary efficacy outcomes of this study is the change in the T1D-DDS score and the proportion of individuals with a change in the T1D-DDS score at least as large as one minimally clinically important difference (MCID).
12 secondary outcomes
Change in Core Diabetes Distress (T1-DDAS Core Score)
Time frame: Baseline, Interim (6 weeks), Endpoint (12 weeks)
Change in Sources of Diabetes Distress (T1-DDS Subscale Scores)
Time frame: Baseline, Interim (6 weeks), Endpoint (12 weeks)
Change in Perceived Stress
Time frame: Baseline, Interim (6 weeks), Endpoint (12 weeks)
Change in Diabetes Quality of Life
Time frame: Baseline, Interim (6 weeks), Endpoint (12 weeks)
Change in Perceived Confidence in Diabetes
Time frame: Baseline, Interim (6 weeks), Endpoint (12 weeks)
Change in Diabetes Specific Self-Compassion
Time frame: Baseline, Interim (6 weeks), Endpoint (12 weeks)
Change in Hypoglycemic Attitudes and Behaviors
Time frame: Baseline, Interim (6 weeks), Endpoint (12 weeks)
Change in Hemoglobin A1c (HbA1c)
Time frame: Baseline, Endpoint (12 weeks)
Change in Percent of Time in Range (TIR)
Time frame: Baseline, Endpoint (12 weeks)
Change in Percent of Time Below Range (TBR)
Time frame: Baseline, Endpoint (12 weeks)
Change in Percent of Time Above Range (TAR)
Time frame: Baseline, Endpoint (12 weeks)
Glycemic Variability
Time frame: Baseline, Endpoint (12 weeks)
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 29 Oct 2025.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 6 to 18 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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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.
Anna Kahkoska, MD, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ReCharge and TakeCharge in people with Diabetes type1 and Diabetes Mellitus, Type 1, run by University of North Carolina, Chapel Hill 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 4 inclusion and 6 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 29 Oct 2025. 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?
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 Angela Fruik, MPH, RD (919-962-6348, angela.fruik@unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Total Diabetes Distress (T1-DDS Total Score) (time frame: Baseline, Interim (6 weeks), Endpoint (12 weeks)). 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 29 Oct 2025.