DiabetesDIAMANTENCT03490253
Diabetes and Depression Text Messaging Intervention
A study testing DIAMANTE Adaptive and DIAMANTE Static in people with Diabetes and Depression, run by University of California, San Francisco at 1 site in United States.
Trial summary
The main aim of the "Diabetes and Mental Health Adaptive Notification Tracking and Evaluation" trial (DIAMANTE) is to test a smartphone intervention that generates adaptive messaging, learning from daily patient data to personalize the timing and type of text-messages. We will compare the adaptive content to 1. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Depression, Physical Activity
- What is being tested?
- DIAMANTE Adaptive and DIAMANTE Static
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- HbA1c (Hemoglobin A1c) > 7
- PHQ-8 (Patient Health Questionnaire-8) > 5
Who cannot join
- high levels of physical activity (>30 minutes of moderate to vigorous activity per day)
- pregnancy
- inability to exercise due to physical disability
- serious mental illness
- unable to read and write in English or Spanish
- plans to leave the country for extended periods of time during the trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Zuckerberg San Francisco General Hospital/University of California, San Francisco
San Francisco, California, 94110
About this study
Official title: Improving Diabetes and Depression Self-management Via Adaptive Mobile Messaging
The main aim of the "Diabetes and Mental Health Adaptive Notification Tracking and Evaluation" trial (DIAMANTE) is to test a smartphone intervention that generates adaptive messaging, learning from daily patient data to personalize the timing and type of text-messages. We will compare the adaptive content to 1. a static messaging intervention with health management and educational messages and 2. a control condition that receives a weekly mood message. The primary outcomes for this aim will be improvements in physical activity at 6-month follow-up defined by daily step counts.
Read the detailed description
We utilized user-centered design (UCD) methods to iteratively develop the DIAMANTE content and text messaging system through three iterative phases of UCD with ten patients each (total n=30). The first phase consisted of 1.5-hour individual semi-structured interviews. Findings from phase 1 were used to inform content and information delivery decisions of the final intervention, including selecting the thematic message categories and the design. In the second phase, patients tested out an early prototype of the mobile application through usability testing. Patients tested the final DIAMANTE intervention including thematic message content and the application in the third, final UCD phase, in order to address any user-related issues prior to launching the randomized control trial.
In the DIAMANTE Randomized Controlled Trial, we aim to examine the effect of a smartphone app that uses reinforcement learning to predict the most effective messages for increasing physical activity. We will recruit 276 low-income minority patients with depression and diabetes within he San Francisco Health Network. We will compare this intervention to static messages with health management content, and a control group that only receives a weekly mood message.
- Conditions
- Diabetes, Depression, Physical Activity
- Being tested
- DIAMANTE Adaptive, DIAMANTE Static
- Medical subject headings
- Diabetes Mellitus, Depression, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DIAMANTE AdaptiveBehavioural
Also called Adaptive Mobile Messaging
In a three arm randomized controlled trial we will examine the effect of a text-messaging smartphone application to encourage physical activity in low-income ethnic minority patients with comorbid diabetes and depression. The adaptive intervention group receives messages chosen by a reinforcement learning algorithm.
DIAMANTE StaticBehavioural
Also called Static Mobile Messaging
The static intervention group receives health information text-messages, typical of existing text-messaging interventions for diabetes and depression.
| Study group | Role | What they receive |
|---|---|---|
| Static Messaging | Active comparator | We will send patients a total of seven messages per week (one per day) at 10.00 am. For the physical health management messages we use messages from established topics in the Diabetes Prevention Program(23) content with the emphasis on physical activity and stress management. The final message, on the seventh day will ask patients to rate their mood on a scale from 1 to 9. Physical activity (step-count/day) will be passively monitored via the app on their smartphone. Receives: Behavioral: DIAMANTE Static |
| Adaptive Messaging | Experimental | Patients in the adaptive messaging arm will receive the daily messages of the static arm, and additionally receive daily messages within different categories of feedback and motivational messages that are chosen using a reinforcement learning (RL) algorithm. Physical activity (step-count/day) will be actively monitored via the app on their smartphone. Receives: Behavioral: DIAMANTE Adaptive |
| Control Condition | No intervention | Control patients will only install the app on their phone and will not receive any feedback messages. They will receive one message a week, on a fixed day, asking them to assess their mood in the previous week on a scale of 1 to 9. The message will be sent daily at 10:00 am. Non-responders will receive reminders to submit their mood self-assessments in two hour intervals. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity
Our primary outcome, change in daily step counts, will be passively collected by a mobile phone application during the time that patients remain in the intervention.
Measured: 6 months
Secondary outcomes (2)
Hemoglobin A1c
We will derive HbA1c, the average plasma glucose over the previous eight to 12 weeks, recommended as a means to diagnose diabetes (20), from patients' electronic health records (EHR). We will use the most recent, available measurement from a maximum of 12 months before participating in the study. After 6 months, we will again assess the most recent HbA1c (pulling from patients EHR), ensuring that at least 3 months elapsed between baseline and follow-up HbA1c levels.
Measured: 6 months
Patient Health Questionnaire-8 (PHQ-8)
We will compare the self-reported PHQ-8 from medical records at baseline, intervention completion, and at the 6 month follow-up.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2018
- Study start5 Feb 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a randomized, controlled, one-center superiority trial with three-arm groups and a primary endpoint of increase in daily steps during a 6 month intervention by a smartphone app. Randomization will be performed as block randomization with a 1:1:1 allocation. Patients will be automatically randomized into groups trough our secure server during on-boarding of the app. Patients need to be informed of the nature and frequency of the messages they will be receiving and discuss this with investigators during the course of the study. Therefore, investigators and patients will not be blinded. We used the SPIRIT checklist when writing our report.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Berkeley, Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Courtney Lyles, PhD, Principal investigator, University of California, San FranciscoAdrian Aguilera, PhD, Principal investigator, UC Berkeley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03490253
- Sponsor's protocol ID
- R01HS025429-02
- Other IDs
- R01HS025429-02
- Acronym
- DIAMANTE
- Status last verified
- Mar 2023
- First submitted
- 27 Mar 2018
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will submit study-results for publication in peer reviewed journals and presentation at (inter)national meetings, taking into account relevant reporting guidelines (e.g. CONSORT(32)). We will attempt to publish all findings in open-access journals when possible, or in other journals with a concurrent uploading of the manuscript content into PubMed Central for public access. Curated technical appendices, statistical code, and anonymized data will become freely available from the corresponding authors upon request.
Publications
Aguilera A, Schueller SM, Leykin Y. Daily mood ratings via text message as a proxy for clinic based depression assessment. J Affect Disord. 2015 Apr 1;175:471-4. doi: 10.1016/j.jad.2015.01.033. Epub 2015 Jan 29.
PubMed 25679202Lyles CR, Ratanawongsa N, Bolen SD, Samal L. mHealth and Health Information Technology Tools for Diverse Patients with Diabetes. J Diabetes Res. 2017;2017:1704917. doi: 10.1155/2017/1704917. Epub 2017 Feb 23. No abstract available.
PubMed 28326330Nouri SS, Avila-Garcia P, Cemballi AG, Sarkar U, Aguilera A, Lyles CR. Assessing Mobile Phone Digital Literacy and Engagement in User-Centered Design in a Diverse, Safety-Net Population: Mixed Methods Study. JMIR Mhealth Uhealth. 2019 Aug 29;7(8):e14250. doi: 10.2196/14250.
PubMed 31469083Avila-Garcia P, Hernandez-Ramos R, Nouri SS, Cemballi A, Sarkar U, Lyles CR, Aguilera A. Engaging users in the design of an mHealth, text message-based intervention to increase physical activity at a safety-net health care system. JAMIA Open. 2019 Oct 11;2(4):489-497. doi: 10.1093/jamiaopen/ooz049. eCollection 2019 Dec.
PubMed 32025646Hernandez-Ramos R, Aguilera A, Garcia F, Miramontes-Gomez J, Pathak LE, Figueroa CA, Lyles CR. Conducting Internet-Based Visits for Onboarding Populations With Limited Digital Literacy to an mHealth Intervention: Development of a Patient-Centered Approach. JMIR Form Res. 2021 Apr 29;5(4):e25299. doi: 10.2196/25299.
PubMed 33872184Figueroa CA, Aguilera A, Chakraborty B, Modiri A, Aggarwal J, Deliu N, Sarkar U, Jay Williams J, Lyles CR. Adaptive learning algorithms to optimize mobile applications for behavioral health: guidelines for design decisions. J Am Med Inform Assoc. 2021 Jun 12;28(6):1225-1234. doi: 10.1093/jamia/ocab001.
PubMed 33657217Aguilera A, Figueroa CA, Hernandez-Ramos R, Sarkar U, Cemballi A, Gomez-Pathak L, Miramontes J, Yom-Tov E, Chakraborty B, Yan X, Xu J, Modiri A, Aggarwal J, Jay Williams J, Lyles CR. mHealth app using machine learning to increase physical activity in diabetes and depression: clinical trial protocol for the DIAMANTE Study. BMJ Open. 2020 Aug 20;10(8):e034723. doi: 10.1136/bmjopen-2019-034723.
PubMed 32819981Figueroa CA, Deliu N, Chakraborty B, Modiri A, Xu J, Aggarwal J, Jay Williams J, Lyles C, Aguilera A. Daily Motivational Text Messages to Promote Physical Activity in University Students: Results From a Microrandomized Trial. Ann Behav Med. 2022 Feb 11;56(2):212-218. doi: 10.1093/abm/kaab028.
PubMed 33871015Leng L, Arevalo Avalos MR, Aguilera A, Lyles CR. The Impact of an Adaptive mHealth Intervention on Improving Patient-Provider Health Care Communication: Secondary Analysis of the DIAMANTE Trial. JMIR Mhealth Uhealth. 2025 Jul 17;13:e64296. doi: 10.2196/64296.
PubMed 40674692Aguilera A, Arevalo Avalos M, Xu J, Chakraborty B, Figueroa C, Garcia F, Rosales K, Hernandez-Ramos R, Karr C, Williams J, Ochoa-Frongia L, Sarkar U, Yom-Tov E, Lyles C. Effectiveness of a Digital Health Intervention Leveraging Reinforcement Learning: Results From the Diabetes and Mental Health Adaptive Notification Tracking and Evaluation (DIAMANTE) Randomized Clinical Trial. J Med Internet Res. 2024 Oct 8;26:e60834. doi: 10.2196/60834.
PubMed 39378080
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Diabetes and Depression Self-management Via Adaptive Mobile Messaging
- ClinicalTrials.gov ID
- NCT03490253
- Acronym / sponsor ID
- DIAMANTE / R01HS025429-02
- Conditions
- Diabetes, Depression, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- University of California, Berkeley, Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 5 Feb 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 6 Apr 2018 (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 main aim of the "Diabetes and Mental Health Adaptive Notification Tracking and Evaluation" trial (DIAMANTE) is to test a smartphone intervention that generates adaptive messaging, learning from daily patient data to personalize the timing and type of text-messages. We will compare the adaptive content to 1. a static messaging intervention with health management and educational messages and 2. a control condition that receives a weekly mood message. The primary outcomes for this aim will be improvements in physical activity at 6-month follow-up defined by daily step counts.
Detailed description
We utilized user-centered design (UCD) methods to iteratively develop the DIAMANTE content and text messaging system through three iterative phases of UCD with ten patients each (total n=30). The first phase consisted of 1.5-hour individual semi-structured interviews. Findings from phase 1 were used to inform content and information delivery decisions of the final intervention, including selecting the thematic message categories and the design. In the second phase, patients tested out an early prototype of the mobile application through usability testing. Patients tested the final DIAMANTE intervention including thematic message content and the application in the third, final UCD phase, in order to address any user-related issues prior to launching the randomized control trial.
In the DIAMANTE Randomized Controlled Trial, we aim to examine the effect of a smartphone app that uses reinforcement learning to predict the most effective messages for increasing physical activity. We will recruit 276 low-income minority patients with depression and diabetes within he San Francisco Health Network. We will compare this intervention to static messages with health management content, and a control group that only receives a weekly mood message.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- This study is a randomized, controlled, one-center superiority trial with three-arm groups and a primary endpoint of increase in daily steps during a 6 month intervention by a smartphone app. Randomization will be performed as block randomization with a 1:1:1 allocation. Patients will be automatically randomized into groups trough our secure server during on-boarding of the app. Patients need to be informed of the nature and frequency of the messages they will be receiving and discuss this with investigators during the course of the study. Therefore, investigators and patients will not be blinded. We used the SPIRIT checklist when writing our report.
| Arm | Type | Receives |
|---|---|---|
| Static Messaging | Active comparator | Behavioral: DIAMANTE StaticWe will send patients a total of seven messages per week (one per day) at 10.00 am. For the physical health management messages we use messages from established topics in the Diabetes Prevention Program(23) content with the emphasis on physical activity and stress management. The final message, on the seventh day will ask patients to rate their mood on a scale from 1 to 9. Physical activity (step-count/day) will be passively monitored via the app on their smartphone. |
| Adaptive Messaging | Experimental | Behavioral: DIAMANTE AdaptivePatients in the adaptive messaging arm will receive the daily messages of the static arm, and additionally receive daily messages within different categories of feedback and motivational messages that are chosen using a reinforcement learning (RL) algorithm. Physical activity (step-count/day) will be actively monitored via the app on their smartphone. |
| Control Condition | No intervention | –Control patients will only install the app on their phone and will not receive any feedback messages. They will receive one message a week, on a fixed day, asking them to assess their mood in the previous week on a scale of 1 to 9. The message will be sent daily at 10:00 am. Non-responders will receive reminders to submit their mood self-assessments in two hour intervals. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- HbA1c (Hemoglobin A1c) > 7
- PHQ-8 (Patient Health Questionnaire-8) > 5
Key exclusion criteria (6 listed)
- high levels of physical activity (>30 minutes of moderate to vigorous activity per day)
- pregnancy
- inability to exercise due to physical disability
- serious mental illness
- unable to read and write in English or Spanish
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 |
|---|---|---|
| DIAMANTE AdaptiveAlso: Adaptive Mobile MessagingIn a three arm randomized controlled trial we will examine the effect of a text-messaging smartphone application to encourage physical activity in low-income ethnic minority patients with comorbid diabetes and depression. The adaptive intervention group receives messages chosen by a reinforcement learning algorithm. | Behavioural | Adaptive Messaging |
| DIAMANTE StaticAlso: Static Mobile MessagingThe static intervention group receives health information text-messages, typical of existing text-messaging interventions for diabetes and depression. | Behavioural | Static Messaging |
Primary outcome
Physical Activity
Time frame: 6 months
Our primary outcome, change in daily step counts, will be passively collected by a mobile phone application during the time that patients remain in the intervention.
2 secondary outcomes
Hemoglobin A1c
Time frame: 6 months
Patient Health Questionnaire-8 (PHQ-8)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2023.
- Background: PubMed 25679202Aguilera A, Schueller SM, Leykin Y. Daily mood ratings via text message as a proxy for clinic based depression assessment. J Affect Disord. 2015 Apr 1;175:471-4. doi: 10.1016/j.jad.2015.01.033. Epub 2015 Jan 29.
- Background: PubMed 28326330Lyles CR, Ratanawongsa N, Bolen SD, Samal L. mHealth and Health Information Technology Tools for Diverse Patients with Diabetes. J Diabetes Res. 2017;2017:1704917. doi: 10.1155/2017/1704917. Epub 2017 Feb 23. No abstract available.
- Results publication: PubMed 31469083Nouri SS, Avila-Garcia P, Cemballi AG, Sarkar U, Aguilera A, Lyles CR. Assessing Mobile Phone Digital Literacy and Engagement in User-Centered Design in a Diverse, Safety-Net Population: Mixed Methods Study. JMIR Mhealth Uhealth. 2019 Aug 29;7(8):e14250. doi: 10.2196/14250.
- Results publication: PubMed 32025646Avila-Garcia P, Hernandez-Ramos R, Nouri SS, Cemballi A, Sarkar U, Lyles CR, Aguilera A. Engaging users in the design of an mHealth, text message-based intervention to increase physical activity at a safety-net health care system. JAMIA Open. 2019 Oct 11;2(4):489-497. doi: 10.1093/jamiaopen/ooz049. eCollection 2019 Dec.
- Results publication: PubMed 33872184Hernandez-Ramos R, Aguilera A, Garcia F, Miramontes-Gomez J, Pathak LE, Figueroa CA, Lyles CR. Conducting Internet-Based Visits for Onboarding Populations With Limited Digital Literacy to an mHealth Intervention: Development of a Patient-Centered Approach. JMIR Form Res. 2021 Apr 29;5(4):e25299. doi: 10.2196/25299.
- Results publication: PubMed 33657217Figueroa CA, Aguilera A, Chakraborty B, Modiri A, Aggarwal J, Deliu N, Sarkar U, Jay Williams J, Lyles CR. Adaptive learning algorithms to optimize mobile applications for behavioral health: guidelines for design decisions. J Am Med Inform Assoc. 2021 Jun 12;28(6):1225-1234. doi: 10.1093/jamia/ocab001.
- Results publication: PubMed 32819981Aguilera A, Figueroa CA, Hernandez-Ramos R, Sarkar U, Cemballi A, Gomez-Pathak L, Miramontes J, Yom-Tov E, Chakraborty B, Yan X, Xu J, Modiri A, Aggarwal J, Jay Williams J, Lyles CR. mHealth app using machine learning to increase physical activity in diabetes and depression: clinical trial protocol for the DIAMANTE Study. BMJ Open. 2020 Aug 20;10(8):e034723. doi: 10.1136/bmjopen-2019-034723.
- Results publication: PubMed 33871015Figueroa CA, Deliu N, Chakraborty B, Modiri A, Xu J, Aggarwal J, Jay Williams J, Lyles C, Aguilera A. Daily Motivational Text Messages to Promote Physical Activity in University Students: Results From a Microrandomized Trial. Ann Behav Med. 2022 Feb 11;56(2):212-218. doi: 10.1093/abm/kaab028.
- Derived from this study: PubMed 40674692Leng L, Arevalo Avalos MR, Aguilera A, Lyles CR. The Impact of an Adaptive mHealth Intervention on Improving Patient-Provider Health Care Communication: Secondary Analysis of the DIAMANTE Trial. JMIR Mhealth Uhealth. 2025 Jul 17;13:e64296. doi: 10.2196/64296.
- Derived from this study: PubMed 39378080Aguilera A, Arevalo Avalos M, Xu J, Chakraborty B, Figueroa C, Garcia F, Rosales K, Hernandez-Ramos R, Karr C, Williams J, Ochoa-Frongia L, Sarkar U, Yom-Tov E, Lyles C. Effectiveness of a Digital Health Intervention Leveraging Reinforcement Learning: Results From the Diabetes and Mental Health Adaptive Notification Tracking and Evaluation (DIAMANTE) Randomized Clinical Trial. J Med Internet Res. 2024 Oct 8;26:e60834. doi: 10.2196/60834.
- Individual participant dataSharing planned: Yes. We will submit study-results for publication in peer reviewed journals and presentation at (inter)national meetings, taking into account relevant reporting guidelines (e.g. CONSORT(32)). We will attempt to publish all findings in open-access journals when possible, or in other journals with a concurrent uploading of the manuscript content into PubMed Central for public access. Curated technical appendices, statistical code, and anonymized data will become freely available from the corresponding authors upon request.
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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.
Courtney Lyles, PhD principal investigator
University of California, San Francisco
Adrian Aguilera, PhD principal investigator
UC Berkeley
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DIAMANTE Adaptive and DIAMANTE Static in people with Diabetes and Depression, run by University of California, San Francisco 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 2 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: finished, as of the sponsor's last update on 3 Apr 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Physical Activity (time frame: 6 months). 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 NCT03490253, which also lists 10 linked publications.
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 3 Apr 2023.