Fitness TrackersNCT04879758
Intervention Study: Genetic Risk Communication and Wearables
A study testing Genetic Risk Estimate and Genetic Risk Estimate + Fitbit Functions in people with Fitness Trackers and Sedentary Behavior, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
This study aims to determine the effects of communicating genetic risk for type 2 diabetes (T2D) alone or in combination with goal setting and prompts from a wearable device on objectively measured physical activity (PA) and sedentary behavior (SB) in East Asians. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Fitness Trackers, Sedentary Behavior, Exercise
- What is being tested?
- Genetic Risk Estimate and Genetic Risk Estimate + Fitbit Functions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteHong Kong
- Study dates
- 7 Jul 2021to May 2024
- 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 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- East Asian ancestry
- Aged 40-60 years
- Able to perform daily-living physical activity
- Able to use English to communicate
- Use a smartphone
Who cannot join
- have been diagnosed with any type of diabetes
- pregnant or lactating
- unable to perform daily-life physical activities (determined through Physical Activity Readiness Questionnaire [PAR-Q])
- participating in another research study or exercise programs
- had experience of genetic testing
- cannot use English
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Exercise Physiology Lab, The University of Hong Kong
Hong Kong
Youngwon Kim, (+852)28315252, youngwon.kim@hku.hk
About this study
Official title: The Effect of Communicating Genetic Risk of Type 2 Diabetes and Wearable Technologies On Objectively Measured Behavioral Outcomes: A Randomized Controlled Study
This study aims to determine the effects of communicating genetic risk for type 2 diabetes (T2D) alone or in combination with goal setting and prompts from a wearable device on objectively measured physical activity (PA) and sedentary behavior (SB) in East Asians. It is hypothesized that this combination will lead to significant favorable changes in objectively measured PA and SB, and that such changes will be more likely to be sustained over 6-month follow-up.
This study aims to recruit 150 healthy East Asian adults in Hong Kong. At baseline, participants will be invited to visit the research laboratory for measurement of a series of variables including height, body weight, blood pressure and grip strength. Participants will also be invited to complete a set of questionnaires to assess their self-reported PA and SB, fruit and vegetable consumption, smoking status and psychological variables. Blood samples will be collected to analyze key diabetes and cardiovascular disease biochemical markers as well as their estimated genetic risk of T2D. Each individual's unique genetic risk for T2D will be estimated on the basis of established genetic variants associated with T2D specifically for East Asians. Each participant will be asked to wear a Fitbit Charge 4 tracker, an objective activity monitoring device, throughout the entire trial.
Read more
Participants will be randomly allocated into 3 groups: 1 control and 2 intervention groups. A control group will receive an e-leaflet containing general lifestyle advice for prevention of T2D. An intervention group will receive an estimated genetic risk of T2D, in addition to the e-leaflet. The other intervention group will have a Fitbit step goal set 10% higher than their baseline step count and use prompt functions of the Fitbit tracker, in addition to the genetic risk estimate and e-leaflet.
Activity data from the Fitbit will be collected at 4-week post-intervention; information about lifestyle and psychological variables will be assessed through the questionnaires at both immediate and 4-week post-intervention. To determine the longer-term effect of the intervention, participants will be asked to visit the research laboratory 6 months after the intervention to repeat the same set of assessments as baseline, except the blood samples collected at 6-month follow-up are used only to analyze cardiometabolic risk profiles (not genetic risk). Activity levels will also be objectively measured using the Fitbit for 4 weeks.
- Conditions
- Fitness Trackers, Sedentary Behavior, Exercise, Genetic Predisposition to Disease, Type 2 Diabetes
- Being tested
- Genetic Risk Estimate, Genetic Risk Estimate + Fitbit Functions
- Keywords
- diabetes, physical activity, genetic risk, wearable technology, randomized controlled trial, movement behavior, nutrition
- Medical subject headings
- Sedentary Behavior, Motor Activity, Genetic Predisposition to Disease, Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetic Risk EstimateGenetic
The genetic risk information includes individual remaining-lifetime and 10-year genetic risk estimates for T2D as well as a dichotomized genetic risk category: 'increased genetic risk' (if their genetic risk is higher than the average population risk) or 'no increased genetic risk' (if their genetic risk is not higher than the average population risk).
Genetic Risk Estimate + Fitbit FunctionsOther
The genetic risk information includes individual remaining-lifetime and 10-year genetic risk estimates for T2D as well as a dichotomized genetic risk category: 'increased genetic risk' (if their genetic risk is higher than the average population risk) or 'no increased genetic risk' (if their genetic risk is not higher than the average population risk).
The two unique Fitbit functions are step goal setting and prompts. Individualized daily step goals will be set to be 10% higher than participants' own baseline Fitbit step counts. The 'Reminder To Move' function of Fitbit will be used as a prompt to remind participants to reduce sedentary time and walk at least 250 steps/hour within a specified timeframe (i.e., from 9am to 10pm in the proposed research). If the user has not accumulated at least 250 steps/hour, a reminder (for example, 150 steps to go) will appear on the Fitbit screen at 10 minutes before the hour (for example, at 10:50 a.m.) and cause the device to vibrate.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | The control group will receive a Fitbit device and general lifestyle advice e-leaflet, which includes information about T2D, health impacts of T2D and lifestyle advice on 4 major risk markers of T2D (e.g., PA, diet, smoking, weight management) as recommended by the World Health Organization. |
| Intervention Group - Genetic Risk Estimate | Experimental | This intervention group will receive an estimated genetic risk of T2D in addition to the Fitbit and e-leaflet. Receives: Genetic: Genetic Risk Estimate |
| Intervention Group - Genetic Risk Estimate + Fitbit Functions | Experimental | This intervention group will receive a Fitbit device, but have a Fitbit step goal set 10% higher than their baseline step count, and use its prompt functions, in addition to the genetic risk estimate and e-leaflet. Receives: Other: Genetic Risk Estimate + Fitbit Functions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Steps between baseline and 4-week post-intervention, and between baseline and 6-month follow-up
Step count (per day) will be objectively measured by the Fitbit tracker.
Measured: Baseline, 4-week post-intervention, 6-month follow-up
Changes in Sedentary Minutes between baseline and 4-week post-intervention, and between baseline and 6-month follow-up
Sedentary Minutes (per day) will be objectively measured by the Fitbit tracker.
Measured: Baseline, 4-week post-intervention, 6-month follow-up
Changes in Lightly Active Minutes between baseline and 4-week post-intervention, and between baseline and 6-month follow-up
Lightly Active Minutes (per day) will be objectively measured by the Fitbit tracker.
Measured: Baseline, 4-week post-intervention, 6-month follow-up
Changes in Fairly Active Minutes between baseline and 4-week post-intervention, and between baseline and 6-month follow-up
Fairly Active Minutes (per day) will be objectively measured by the Fitbit tracker.
Measured: Baseline, 4-week post-intervention, 6-month follow-up
Changes in Very Active Minutes between baseline and 4-week post-intervention, and between baseline and 6-month follow-up
Very Active Minutes (per day) will be objectively measured by the Fitbit tracker.
Measured: Baseline, 4-week post-intervention, 6-month follow-up
Changes in Calories Burn between baseline and 4-week post-intervention, and between baseline and 6-month follow-up
Calories Burn (kcal per day) will be objectively measured by the Fitbit tracker.
Measured: Baseline, 4-week post-intervention, 6-month follow-up
Secondary outcomes (13)
Changes in body mass index (BMI) between baseline and 6-month follow-up
Measured height (in meters) and body weight (in kilograms) will be used to calculate BMI (in kg/m²).
Measured: Baseline and 6-month follow-up
Changes in systolic blood pressure between baseline and 6-month follow-up
Systolic blood pressure (mm Hg) will be measured using the OMRON HEM-907 Digital Automatic Blood Pressure Monitor.
Measured: Baseline and 6-month follow-up
Changes in diastolic blood pressure between baseline and 6-month follow-up
Diastolic blood pressure (mm Hg) will be measured using the OMRON HEM-907 Digital Automatic Blood Pressure Monitor.
Measured: Baseline and 6-month follow-up
Changes in hand grip strength between baseline and 6-month follow-up
Hand grip strength (in kilograms) will be measured using the Jamar Hydraulic Hand Dynamometer, which has good reliability and reproducibility.
Measured: Baseline and 6-month follow-up
Changes in Hemoglobin A1c (HbA1c) between baseline and 6-month follow-up
Blood samples will be collected to test the five key biochemical markers of T2D and cardiovascular disease, including HbA1c (%).
Measured: Baseline and 6-month follow-up
Changes in Total cholesterol between baseline and 6-month follow-up
Blood samples will be collected to test the five key biochemical markers of T2D and cardiovascular disease, including Total cholesterol (mmol/L).
Measured: Baseline and 6-month follow-up
Changes in High-density lipoproteins (HDL) between baseline and 6-month follow-up
Blood samples will be collected to test the five key biochemical markers of T2D and cardiovascular disease, including HDL (mmol/L).
Measured: Baseline and 6-month follow-up
Changes in Low-density lipoproteins (LDL) between baseline and 6-month follow-up
Blood samples will be collected to test the five key biochemical markers of T2D and cardiovascular disease, including LDL (mmol/L).
Measured: Baseline and 6-month follow-up
Changes in Triglycerides between baseline and 6-month follow-up
Blood samples will be collected to test the five key biochemical markers of T2D and cardiovascular disease, including Triglycerides (mmol/L).
Measured: Baseline and 6-month follow-up
Changes in Self-reported Physical Activity between baseline and Immediate post-intervention, between baseline and 4-week post-intervention, and between baseline and 6-month follow-up
This outcome will be assessed using an assessment questionnaire.
Measured: Baseline, Immediate post-intervention, 4-week post-intervention, 6-month follow-up
Changes in Self-reported Fruit and Vegetable Consumption between baseline and Immediate post-intervention, between baseline and 4-week post-intervention, and between baseline and 6-month follow-up
This outcome will be assessed using an assessment questionnaire.
Measured: Baseline, Immediate post-intervention, 4-week post-intervention, 6-month follow-up
Changes in Self-reported Smoking Status between baseline and Immediate post-intervention, between baseline and 4-week post-intervention, and between baseline and 6-month follow-up
This outcome will be assessed using an assessment questionnaire.
Measured: Baseline, Immediate post-intervention, 4-week post-intervention, 6-month follow-up
Changes in Self-reported Psychological Status between baseline and Immediate post-intervention, between baseline and 4-week post-intervention, and between baseline and 6-month follow-up
This outcome will be assessed using an assessment questionnaire.
Measured: Baseline, Immediate post-intervention, 4-week post-intervention, 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start7 Jul 2021
- Primary completionDec 2023 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fitness TrackersStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- parallel-group, open randomized controlled trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Kim, Youngwon, The University of Hong Kong
- Investigators
- Youngwon Kim, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04879758
- Sponsor's protocol ID
- geneticriskwearabletrial
- Status last verified
- Jul 2021
- First submitted
- 27 Apr 2021
- Last updated
- 23 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Communicating Genetic Risk of Type 2 Diabetes and Wearable Technologies On Objectively Measured Behavioral Outcomes: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04879758
- Acronym / sponsor ID
- geneticriskwearabletrial
- Conditions
- Fitness Trackers, Sedentary Behavior, Exercise, Genetic Predisposition to Disease, Type 2 Diabetes
- Keywords
- diabetes, physical activity, genetic risk, wearable technology, randomized controlled trial, movement behavior, nutrition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 10 May 2021 (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 aims to determine the effects of communicating genetic risk for type 2 diabetes (T2D) alone or in combination with goal setting and prompts from a wearable device on objectively measured physical activity (PA) and sedentary behavior (SB) in East Asians. It is hypothesized that this combination will lead to significant favorable changes in objectively measured PA and SB, and that such changes will be more likely to be sustained over 6-month follow-up.
This study aims to recruit 150 healthy East Asian adults in Hong Kong. At baseline, participants will be invited to visit the research laboratory for measurement of a series of variables including height, body weight, blood pressure and grip strength. Participants will also be invited to complete a set of questionnaires to assess their self-reported PA and SB, fruit and vegetable consumption, smoking status and psychological variables. Blood samples will be collected to analyze key diabetes and cardiovascular disease biochemical markers as well as their estimated genetic risk of T2D. Each individual's unique genetic risk for T2D will be estimated on the basis of established genetic variants associated with T2D specifically for East Asians. Each participant will be asked to wear a Fitbit Charge 4 tracker, an objective activity monitoring device, throughout the entire trial.
Participants will be randomly allocated into 3 groups: 1 control and 2 intervention groups. A control group will receive an e-leaflet containing general lifestyle advice for prevention of T2D. An intervention group will receive an estimated genetic risk of T2D, in addition to the e-leaflet. The other intervention group will have a Fitbit step goal set 10% higher than their baseline step count and use prompt functions of the Fitbit tracker, in addition to the genetic risk estimate and e-leaflet.
Activity data from the Fitbit will be collected at 4-week post-intervention; information about lifestyle and psychological variables will be assessed through the questionnaires at both immediate and 4-week post-intervention. To determine the longer-term effect of the intervention, participants will be asked to visit the research laboratory 6 months after the intervention to repeat the same set of assessments as baseline, except the blood samples collected at 6-month follow-up are used only to analyze cardiometabolic risk profiles (not genetic risk). Activity levels will also be objectively measured using the Fitbit for 4 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- parallel-group, open randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –The control group will receive a Fitbit device and general lifestyle advice e-leaflet, which includes information about T2D, health impacts of T2D and lifestyle advice on 4 major risk markers of T2D (e.g., PA, diet, smoking, weight management) as recommended by the World Health Organization. |
| Intervention Group - Genetic Risk Estimate | Experimental | Genetic: Genetic Risk EstimateThis intervention group will receive an estimated genetic risk of T2D in addition to the Fitbit and e-leaflet. |
| Intervention Group - Genetic Risk Estimate + Fitbit Functions | Experimental | Other: Genetic Risk Estimate + Fitbit FunctionsThis intervention group will receive a Fitbit device, but have a Fitbit step goal set 10% higher than their baseline step count, and use its prompt functions, in addition to the genetic risk estimate and e-leaflet. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- East Asian ancestry
- Aged 40-60 years
- Able to perform daily-living physical activity
- Able to use English to communicate
- Use a smartphone
Key exclusion criteria (6 listed)
- have been diagnosed with any type of diabetes
- pregnant or lactating
- unable to perform daily-life physical activities (determined through Physical Activity Readiness Questionnaire [PAR-Q])
- participating in another research study or exercise programs
- had experience of genetic testing
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 |
|---|---|---|
| Genetic Risk EstimateThe genetic risk information includes individual remaining-lifetime and 10-year genetic risk estimates for T2D as well as a dichotomized genetic risk category: 'increased genetic risk' (if their genetic risk is higher than the average population risk) or 'no increased genetic risk' (if their genetic risk is not higher than the average population risk). | Genetic | Intervention Group - Genetic Risk Estimate |
| Genetic Risk Estimate + Fitbit FunctionsThe genetic risk information includes individual remaining-lifetime and 10-year genetic risk estimates for T2D as well as a dichotomized genetic risk category: 'increased genetic risk' (if their genetic risk is higher than the average population risk) or 'no increased genetic risk' (if their genetic risk is not higher than the average population risk). The two unique Fitbit functions are step goal setting and prompts. Individualized daily step goals will be set to be 10% higher than participants' own baseline Fitbit step counts. The 'Reminder To Move' function of Fitbit will be used as a prompt to remind participants to reduce sedentary time and walk at least 250 steps/hour within a specified timeframe (i.e., from 9am to 10pm in the proposed research). If the user has not accumulated at least 250 steps/hour, a reminder (for example, 150 steps to go) will appear on the Fitbit screen at 10 minutes before the hour (for example, at 10:50 a.m.) and cause the device to vibrate. | Other | Intervention Group - Genetic Risk Estimate + Fitbit Functions |
Primary outcome
Changes in Steps between baseline and 4-week post-intervention, and between baseline and 6-month follow-up
Time frame: Baseline, 4-week post-intervention, 6-month follow-up
Step count (per day) will be objectively measured by the Fitbit tracker.
Changes in Sedentary Minutes between baseline and 4-week post-intervention, and between baseline and 6-month follow-up
Time frame: Baseline, 4-week post-intervention, 6-month follow-up
Sedentary Minutes (per day) will be objectively measured by the Fitbit tracker.
Changes in Lightly Active Minutes between baseline and 4-week post-intervention, and between baseline and 6-month follow-up
Time frame: Baseline, 4-week post-intervention, 6-month follow-up
Lightly Active Minutes (per day) will be objectively measured by the Fitbit tracker.
Changes in Fairly Active Minutes between baseline and 4-week post-intervention, and between baseline and 6-month follow-up
Time frame: Baseline, 4-week post-intervention, 6-month follow-up
Fairly Active Minutes (per day) will be objectively measured by the Fitbit tracker.
Changes in Very Active Minutes between baseline and 4-week post-intervention, and between baseline and 6-month follow-up
Time frame: Baseline, 4-week post-intervention, 6-month follow-up
Very Active Minutes (per day) will be objectively measured by the Fitbit tracker.
Changes in Calories Burn between baseline and 4-week post-intervention, and between baseline and 6-month follow-up
Time frame: Baseline, 4-week post-intervention, 6-month follow-up
Calories Burn (kcal per day) will be objectively measured by the Fitbit tracker.
13 secondary outcomes
Changes in body mass index (BMI) between baseline and 6-month follow-up
Time frame: Baseline and 6-month follow-up
Changes in systolic blood pressure between baseline and 6-month follow-up
Time frame: Baseline and 6-month follow-up
Changes in diastolic blood pressure between baseline and 6-month follow-up
Time frame: Baseline and 6-month follow-up
Changes in hand grip strength between baseline and 6-month follow-up
Time frame: Baseline and 6-month follow-up
Changes in Hemoglobin A1c (HbA1c) between baseline and 6-month follow-up
Time frame: Baseline and 6-month follow-up
Changes in Total cholesterol between baseline and 6-month follow-up
Time frame: Baseline and 6-month follow-up
Changes in High-density lipoproteins (HDL) between baseline and 6-month follow-up
Time frame: Baseline and 6-month follow-up
Changes in Low-density lipoproteins (LDL) between baseline and 6-month follow-up
Time frame: Baseline and 6-month follow-up
Changes in Triglycerides between baseline and 6-month follow-up
Time frame: Baseline and 6-month follow-up
Changes in Self-reported Physical Activity between baseline and Immediate post-intervention, between baseline and 4-week post-intervention, and between baseline and 6-month follow-up
Time frame: Baseline, Immediate post-intervention, 4-week post-intervention, 6-month follow-up
Changes in Self-reported Fruit and Vegetable Consumption between baseline and Immediate post-intervention, between baseline and 4-week post-intervention, and between baseline and 6-month follow-up
Time frame: Baseline, Immediate post-intervention, 4-week post-intervention, 6-month follow-up
Changes in Self-reported Smoking Status between baseline and Immediate post-intervention, between baseline and 4-week post-intervention, and between baseline and 6-month follow-up
Time frame: Baseline, Immediate post-intervention, 4-week post-intervention, 6-month follow-up
Changes in Self-reported Psychological Status between baseline and Immediate post-intervention, between baseline and 4-week post-intervention, and between baseline and 6-month follow-up
Time frame: Baseline, Immediate post-intervention, 4-week post-intervention, 6-month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
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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.
Youngwon Kim principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Genetic Risk Estimate and Genetic Risk Estimate + Fitbit Functions in people with Fitness Trackers and Sedentary Behavior, run by The University of Hong Kong at 1 site in Hong Kong.
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 5 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: status not confirmed, as of the sponsor's last update on 23 Jul 2021. 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 Hong Kong. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Youngwon Kim ((+852)28315252, youngwon.kim@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Steps between baseline and 4-week post-intervention, and between baseline and 6-month follow-up (time frame: Baseline, 4-week post-intervention, 6-month follow-up). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2021.