Type 2 DiabetesFREE CGMNCT06089070
Continuous Glucose Monitoring System Feasibility in Youth With T2D
A study testing FreeStyle Libre Continuous Glucose Monitor System in people with Type 2 Diabetes, run by University of California, San Francisco at 1 site in United States.
Trial summary
The primary scientific question of this proposal is to investigate whether youth with T2D will wear and interact with a continuous glucose monitor (CGM) system and whether this will influence behavior and management decisions. There will be 30 participants enrolled in the study. Read more about this study
- Who is it for?
- Ages 8 to 20 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- FreeStyle Libre Continuous Glucose Monitor System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2024to 1 Dec 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 8 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 8- 20 years at the time of consent.
- Clinical diagnosis of type 2 diabetes.
- Duration of type 2 diabetes at least 4 weeks.
- HbA1C ≥ 6.5% .
- Stable medication regimen (No medication changes and no change in basal insulin dose by more than 20% in the 2 weeks prior to enrollment).
- No use of CGM 90 days before screening visit.
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- English or Spanish speakers.
- Willing to abide by recommendations and study procedures.
- Willing and able to sign the Informed Consent Form (ICF) and/or has a parent or guardian willing and able to sign the ICF.
- Participant and parent(s)/guardian(s) willingness to participate in all training sessions as directed by study staff. Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
Who cannot join
- Pancreatic autoantibody positivity (GAD-65, insulin, IA-2, ICA 512, Zn-T8).
- Plan for undergoing bariatric surgery during the study period.
- Known history of significant mental illness or developmental delay impacting the ability to complete study activities independently.
- Known history of adrenal insufficiency, or ongoing renal or hepatic disease.
- Pregnancy or lactation.
- Currently undergoing cancer treatment or systemic treatment with steroids.
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco (UCSF)
San Francisco, California, 94158
About this study
Official title: Feasibility of the FreeStyle Libre Continuous Glucose Monitoring System in Youth With Type 2 Diabetes (FREE CGM)
The primary scientific question of this proposal is to investigate whether youth with T2D will wear and interact with a continuous glucose monitor (CGM) system and whether this will influence behavior and management decisions. There will be 30 participants enrolled in the study. 20 in the treatment arm and 10 in the control. The length of study participation will be 6 months for each participant.
Read the detailed description
At the beginning of the study, participants will be asked to complete surveys where demographic, clinical and behavioral data will be collected. We will ask participants to wear a glucose sensor that is "blinded" for 14-days so that we can gather baseline data about blood sugar levels.
Participants must wear the CGM sensor for at least 10 days out of the 14 days of the blinding period to move on to the next part of the study. After wearing the blinded sensor, the study team will place participants in one of two groups:
One group (intervention group) will be shown how to use the sensors along with the FreeStyle Libre App, and the other group (control group) will continue with their standard diabetes care without using the CGM system. Participants will be "randomized" into one of the study groups described below. Participants will have a 2 in 3 chance of being placed in the group who receives the glucose sensor and will have access to the data.
Group 1 participants will receive the FreeStyle Libre 3 sensor and have access to the data on their smartphone during the study.
Group 2 participants will be asked to continue standard blood glucose monitoring with a glucometer. Participants will be asked to perform 2 checks a day, fasting and 2 hours post dinner as is standard practice.
If randomized to group 1, participants will receive the FreeStyle Libre 3 system with education from the study coordinator on how to insert sensors and view data on the connected mobile app.
Standardized study education materials with suggestions on how to react to the data such as avoidance of sugary beverages or increased physical activity will also be provided.
Participants will be asked to wear the sensor for the rest of the 6-month participation in the study.
If randomized to group 2, participants will be asked to continue standard blood glucose monitoring with a glucometer. Participants will also receive standardized study education materials about reacting to glucose values. Participants will be asked to perform 2 glucose checks a day, fasting and 2 hours after a meal as is standard practice.
As a part of usual care, participants will come to clinic 3 months after starting the study to meet with their usual diabetes provider and a diabetes educator. We will also have a phone check-in visit with participants at 1 month, 2 months, 4 months, and 5 months after starting the study.
For month 3 and month 6 of the study, participants will already be in clinic to see their regular diabetes provider and we can combine their clinic and research visit. At the end of the study, participants will be invited to come to an optional online focus group to talk about the technology that you used with the study researchers.
Participants will be able to share the things that they liked or did not like about the technology. The researchers will speak with approximately 5-7 participants at a time in a group. The conversation will be recorded via a secure videoconference so that the researchers can remember everything that was said. The audio files will be stored in secure locations and participants' full names will not be used in the sessions.
Additional notes:
- If participants do not have the appropriate device to download the app, a reader will be provided by the study team.
- Diagnoses, medication history, medical history, and lab results will be collected from the medical record for research purposes.
- A Random number generator will be used for randomization.
- The study coordinators and/or the investigators will distribute the participant surveys.
- The study coordinators and the investigators will conduct the focus groups.
- There are no in patient procedures.
- For younger participants who may not be able to complete surveys by themselves, parents or guardians may assist younger participants to complete the surveys.
Parents will be requested to complete the parent reports.
- Conditions
- Type 2 Diabetes
- Being tested
- FreeStyle Libre Continuous Glucose Monitor System
- Keywords
- freestyle libre, continuous glucose monitor, type 2 diabetes, T2D, pediatric
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FreeStyle Libre Continuous Glucose Monitor SystemDevice
Continuous Glucose Monitor System for people with Type 2 Diabetes
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants will not have access to view the data from the CGM sensor during the screening period, nor during the main part of the study. |
| Intervention | Experimental | Participants will wear the CGM sensor and have access to the data during the main part of the study. Receives: Device: FreeStyle Libre Continuous Glucose Monitor System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to use CGM
Use of CGM measured by number of hours participants in the intervention arm wear the CGM device and view data on the mobile application.
Measured: Measured at 6 months
Acceptability of CGM use measured with Acceptability of Intervention Measure (AIM)
The perception that CGM use is agreeable or satisfactory measured with the 4-item Acceptability of Intervention Measure (AIM). Greater the score, higher the acceptability
Measured: Measured at 6 months
Appropriateness of CGM use measured with Intervention Appropriateness Measure
The perceived fit of the CGM to improve diabetes related metrics measured with the 4-item Intervention Appropriateness Measure (IAM). Greater the score, higher the appropriateness of CGM use
Measured: Measured at 6 months
Feasibility of CGM use measured with Feasibility of Intervention Measure.
The extent to which a CGM study can be successfully carried out measured with 4-item Feasibility of Intervention Measure (FIM). The higher the score, the greater the feasibility of CGM use
Measured: Measured at 6 months
Secondary outcomes (16)
Glycemic change
Change in HbA1C at 6 months adjusted for the baseline value youth with T2D.
Measured: Baseline (0) to 6 months
Time in target glucose range
Time spent in target glucose range of 70 to 180 mg/dL
Measured: Baseline (0) to 6 months
Time above high glucose range
percent of readings and time >250 mg/dL
Measured: Baseline (0) to 6 months
Time above glucose range
percent of readings and time 181-250 mg/dL
Measured: Baseline (0) to 6 months
Time below glucose range
percent of readings and time 54-69 mg/dL
Measured: Baseline (0) to 6 months
Time below low glucose range
percent of readings and time <54 mg/dl
Measured: Baseline (0) to 6 months
Glucose management indicator
CGM metric that indicates average blood glucose
Measured: Baseline (0) to 6 months
Co-efficient of variation of glucose
CGM metric that measures variability in CGM values
Measured: Baseline (0) to 6 months
Change in BMI
Change in BMI SDS over the course of the study
Measured: Baseline (0) to 6 months
Frequency of taking diabetes medications
Self-reported medication adherence in the past week before visit
Measured: Baseline (0) to 6 months
Starting or stopping medications
Percentage of subjects with addition or removal of diabetes medications
Measured: Baseline (0) to 6 months
Titration of insulin dosing by provider
Percentage of subjects who receive insulin dose titration
Measured: Baseline (0) to 6 months
Dietary measures
Change in score on SEARCH for Diabetes in Youth food frequency questionnaire. This is a 85 question survey ( Mayer-Davis EJ, Nichols M, Liese AD et al. (2006) Dietary intake among youth with diabetes: the SEARCH for Diabetes in Youth Study. J Am Diet Assoc.2006)
Measured: Baseline (0) to 6 months
Physical activity measures
Number of minutes of physical activity in the past week before visit. The greater the value the better the score.
Measured: Baseline (0) to 6 months
Quality of Life score on survey
Pediatric Quality of Life Inventory Diabetes Module score. 33 item score. The greater the value the better the score.
Measured: Baseline (0) to 6 months
Problem Areas in Diabetes
Problem Areas In Diabetes (PAID) Scale. 20 question survey. Higher the score, the worse the outcome
Measured: Baseline (0) to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start3 Jan 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Type 2 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Feasibility study of the FreeStyle Libre Continuous Glucose Monitoring System in Youth with Type 2 Diabetes
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shylaja Srinivasan, MD, MAS, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06089070
- Sponsor's protocol ID
- 22-38272
- Acronym
- FREE CGM
- Status last verified
- Sep 2025
- First submitted
- 12 Oct 2023
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Wagenknecht LE, Lawrence JM, Isom S, Jensen ET, Dabelea D, Liese AD, Dolan LM, Shah AS, Bellatorre A, Sauder K, Marcovina S, Reynolds K, Pihoker C, Imperatore G, Divers J; SEARCH for Diabetes in Youth study. Trends in incidence of youth-onset type 1 and type 2 diabetes in the USA, 2002-18: results from the population-based SEARCH for Diabetes in Youth study. Lancet Diabetes Endocrinol. 2023 Apr;11(4):242-250. doi: 10.1016/S2213-8587(23)00025-6. Epub 2023 Feb 28.
PubMed 36868256TODAY Study Group; Bjornstad P, Drews KL, Caprio S, Gubitosi-Klug R, Nathan DM, Tesfaldet B, Tryggestad J, White NH, Zeitler P. Long-Term Complications in Youth-Onset Type 2 Diabetes. N Engl J Med. 2021 Jul 29;385(5):416-426. doi: 10.1056/NEJMoa2100165.
PubMed 34320286TODAY Study Group; Zeitler P, Hirst K, Pyle L, Linder B, Copeland K, Arslanian S, Cuttler L, Nathan DM, Tollefsen S, Wilfley D, Kaufman F. A clinical trial to maintain glycemic control in youth with type 2 diabetes. N Engl J Med. 2012 Jun 14;366(24):2247-56. doi: 10.1056/NEJMoa1109333. Epub 2012 Apr 29.
PubMed 22540912U.K. prospective diabetes study 16. Overview of 6 years' therapy of type II diabetes: a progressive disease. U.K. Prospective Diabetes Study Group. Diabetes. 1995 Nov;44(11):1249-58.
PubMed 7589820
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of the FreeStyle Libre Continuous Glucose Monitoring System in Youth With Type 2 Diabetes (FREE CGM)
- ClinicalTrials.gov ID
- NCT06089070
- Acronym / sponsor ID
- FREE CGM / 22-38272
- Conditions
- Type 2 Diabetes
- Keywords
- freestyle libre, continuous glucose monitor, type 2 diabetes, T2D, pediatric
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 3 Jan 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 18 Oct 2023 (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 primary scientific question of this proposal is to investigate whether youth with T2D will wear and interact with a continuous glucose monitor (CGM) system and whether this will influence behavior and management decisions. There will be 30 participants enrolled in the study. 20 in the treatment arm and 10 in the control. The length of study participation will be 6 months for each participant.
Detailed description
At the beginning of the study, participants will be asked to complete surveys where demographic, clinical and behavioral data will be collected. We will ask participants to wear a glucose sensor that is "blinded" for 14-days so that we can gather baseline data about blood sugar levels.
Participants must wear the CGM sensor for at least 10 days out of the 14 days of the blinding period to move on to the next part of the study. After wearing the blinded sensor, the study team will place participants in one of two groups:
One group (intervention group) will be shown how to use the sensors along with the FreeStyle Libre App, and the other group (control group) will continue with their standard diabetes care without using the CGM system. Participants will be "randomized" into one of the study groups described below. Participants will have a 2 in 3 chance of being placed in the group who receives the glucose sensor and will have access to the data.
Group 1 participants will receive the FreeStyle Libre 3 sensor and have access to the data on their smartphone during the study.
Group 2 participants will be asked to continue standard blood glucose monitoring with a glucometer. Participants will be asked to perform 2 checks a day, fasting and 2 hours post dinner as is standard practice.
If randomized to group 1, participants will receive the FreeStyle Libre 3 system with education from the study coordinator on how to insert sensors and view data on the connected mobile app.
Standardized study education materials with suggestions on how to react to the data such as avoidance of sugary beverages or increased physical activity will also be provided.
Participants will be asked to wear the sensor for the rest of the 6-month participation in the study.
If randomized to group 2, participants will be asked to continue standard blood glucose monitoring with a glucometer. Participants will also receive standardized study education materials about reacting to glucose values. Participants will be asked to perform 2 glucose checks a day, fasting and 2 hours after a meal as is standard practice.
As a part of usual care, participants will come to clinic 3 months after starting the study to meet with their usual diabetes provider and a diabetes educator. We will also have a phone check-in visit with participants at 1 month, 2 months, 4 months, and 5 months after starting the study.
For month 3 and month 6 of the study, participants will already be in clinic to see their regular diabetes provider and we can combine their clinic and research visit. At the end of the study, participants will be invited to come to an optional online focus group to talk about the technology that you used with the study researchers.
Participants will be able to share the things that they liked or did not like about the technology. The researchers will speak with approximately 5-7 participants at a time in a group. The conversation will be recorded via a secure videoconference so that the researchers can remember everything that was said. The audio files will be stored in secure locations and participants' full names will not be used in the sessions.
Additional notes:
- If participants do not have the appropriate device to download the app, a reader will be provided by the study team.
- Diagnoses, medication history, medical history, and lab results will be collected from the medical record for research purposes.
- A Random number generator will be used for randomization.
- The study coordinators and/or the investigators will distribute the participant surveys.
- The study coordinators and the investigators will conduct the focus groups.
- There are no in patient procedures.
- For younger participants who may not be able to complete surveys by themselves, parents or guardians may assist younger participants to complete the surveys.
Parents will be requested to complete the parent reports.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Feasibility study of the FreeStyle Libre Continuous Glucose Monitoring System in Youth with Type 2 Diabetes
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants will not have access to view the data from the CGM sensor during the screening period, nor during the main part of the study. |
| Intervention | Experimental | Device: FreeStyle Libre Continuous Glucose Monitor SystemParticipants will wear the CGM sensor and have access to the data during the main part of the study. |
Who may qualify
- Ages
- 8 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Age 8- 20 years at the time of consent.
- Clinical diagnosis of type 2 diabetes.
- Duration of type 2 diabetes at least 4 weeks.
- HbA1C ≥ 6.5% .
- Stable medication regimen (No medication changes and no change in basal insulin dose by more than 20% in the 2 weeks prior to enrollment).
Key exclusion criteria (7 listed)
- Pancreatic autoantibody positivity (GAD-65, insulin, IA-2, ICA 512, Zn-T8).
- Plan for undergoing bariatric surgery during the study period.
- Known history of significant mental illness or developmental delay impacting the ability to complete study activities independently.
- Known history of adrenal insufficiency, or ongoing renal or hepatic disease.
- Pregnancy or lactation.
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 |
|---|---|---|
| FreeStyle Libre Continuous Glucose Monitor SystemContinuous Glucose Monitor System for people with Type 2 Diabetes | Device | Intervention |
Primary outcome
Ability to use CGM
Time frame: Measured at 6 months
Use of CGM measured by number of hours participants in the intervention arm wear the CGM device and view data on the mobile application.
Acceptability of CGM use measured with Acceptability of Intervention Measure (AIM)
Time frame: Measured at 6 months
The perception that CGM use is agreeable or satisfactory measured with the 4-item Acceptability of Intervention Measure (AIM). Greater the score, higher the acceptability
Appropriateness of CGM use measured with Intervention Appropriateness Measure
Time frame: Measured at 6 months
The perceived fit of the CGM to improve diabetes related metrics measured with the 4-item Intervention Appropriateness Measure (IAM). Greater the score, higher the appropriateness of CGM use
Feasibility of CGM use measured with Feasibility of Intervention Measure.
Time frame: Measured at 6 months
The extent to which a CGM study can be successfully carried out measured with 4-item Feasibility of Intervention Measure (FIM). The higher the score, the greater the feasibility of CGM use
16 secondary outcomes
Glycemic change
Time frame: Baseline (0) to 6 months
Time in target glucose range
Time frame: Baseline (0) to 6 months
Time above high glucose range
Time frame: Baseline (0) to 6 months
Time above glucose range
Time frame: Baseline (0) to 6 months
Time below glucose range
Time frame: Baseline (0) to 6 months
Time below low glucose range
Time frame: Baseline (0) to 6 months
Glucose management indicator
Time frame: Baseline (0) to 6 months
Co-efficient of variation of glucose
Time frame: Baseline (0) to 6 months
Change in BMI
Time frame: Baseline (0) to 6 months
Frequency of taking diabetes medications
Time frame: Baseline (0) to 6 months
Starting or stopping medications
Time frame: Baseline (0) to 6 months
Titration of insulin dosing by provider
Time frame: Baseline (0) to 6 months
Dietary measures
Time frame: Baseline (0) to 6 months
Physical activity measures
Time frame: Baseline (0) to 6 months
Quality of Life score on survey
Time frame: Baseline (0) to 6 months
Problem Areas in Diabetes
Time frame: Baseline (0) to 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 2025.
- Results publication: PubMed 36868256Wagenknecht LE, Lawrence JM, Isom S, Jensen ET, Dabelea D, Liese AD, Dolan LM, Shah AS, Bellatorre A, Sauder K, Marcovina S, Reynolds K, Pihoker C, Imperatore G, Divers J; SEARCH for Diabetes in Youth study. Trends in incidence of youth-onset type 1 and type 2 diabetes in the USA, 2002-18: results from the population-based SEARCH for Diabetes in Youth study. Lancet Diabetes Endocrinol. 2023 Apr;11(4):242-250. doi: 10.1016/S2213-8587(23)00025-6. Epub 2023 Feb 28.
- Results publication: PubMed 34320286TODAY Study Group; Bjornstad P, Drews KL, Caprio S, Gubitosi-Klug R, Nathan DM, Tesfaldet B, Tryggestad J, White NH, Zeitler P. Long-Term Complications in Youth-Onset Type 2 Diabetes. N Engl J Med. 2021 Jul 29;385(5):416-426. doi: 10.1056/NEJMoa2100165.
- Results publication: PubMed 22540912TODAY Study Group; Zeitler P, Hirst K, Pyle L, Linder B, Copeland K, Arslanian S, Cuttler L, Nathan DM, Tollefsen S, Wilfley D, Kaufman F. A clinical trial to maintain glycemic control in youth with type 2 diabetes. N Engl J Med. 2012 Jun 14;366(24):2247-56. doi: 10.1056/NEJMoa1109333. Epub 2012 Apr 29.
- Results publication: PubMed 7589820U.K. prospective diabetes study 16. Overview of 6 years' therapy of type II diabetes: a progressive disease. U.K. Prospective Diabetes Study Group. Diabetes. 1995 Nov;44(11):1249-58.
- 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.
Shylaja Srinivasan, MD, MAS principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FreeStyle Libre Continuous Glucose Monitor System in people with Type 2 Diabetes, 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 10 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 8 Sep 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?
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?
Ability to use CGM (time frame: Measured at 6 months). 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?
On the ClinicalTrials.gov record for NCT06089070, which also lists 4 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 8 Sep 2025.