PreDiabetesPhase 2NCT04742751
An Open-Label Pilot Intervention Trial to Prevent Diabetes in Prediabetic Adult Survivors of Childhood Cancer
A Phase 2 study testing Metformin and Digital Intervention in people with PreDiabetes and Adult Children, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
This is a first-in survivor, single-arm pilot study with the goal of establishing evidence of feasibility and safety of a combined pharmacologic (metformin) and lifestyle intervention (using an existing digital platform) to prevent diabetes in prediabetic adult survivors of childhood cancer. Read more about this study
- Who is it for?
- Ages 18 to 44 years
- Conditions the study is for
- PreDiabetes, Adult Children
- What is being tested?
- Metformin and Digital Intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2022to Mar 2027
- Phase
- Phase 2
- 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 18 to 44 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Investigators will recruit to enroll 55 survivors who are at least 18 but <45 years of age who participate in the St. Jude Lifetime Cohort Study (SJLIFE) and have been identified to have prediabetes defined as hemoglobin A1c (HbA1c)
- Participant in SJLIFE
- ≥18 and <45 years of age
- Prediabetic: fasting plasma glucose 105-125 mg/dL, hemoglobin A1c 5.7- 6.4% (either or both criteria may be present) According to institutional and NIH policy, the study will accession research participants regardless of sex and ethnic background. Institutional experience confirms broad representation in this regard.
Who cannot join
- Absence of treatment related diabetes risk. Survivors will be excluded if their cancer treatment required observation only, surgery alone not involving the abdomen or brain, radiation alone not involving the chest (pancreatic risk), abdomen or brain (e.g. retinoblastoma treated with enucleation alone, melanoma of an extremity treated with excision alone, neuroblastoma in an infant requiring observation only)
- Diabetes at baseline assessment: FPG ≥126 mg/dL, HbA1c ≥6.5% or previous diagnosis by a physician (except gestational diabetes that resolved post-partum)
- BMI <19 kg/m2
- Current metformin use (including for any period ≥30 days in the past 1yr)
- Known allergy to metformin
- Current use of other oral glucose lowering medications, non-insulin injectable diabetes medications or insulin (Appendix)
Show all 22Show fewer
- Current participation in a lifestyle change program
- Chronic kidney disease ≥ stage IIIb (eGFR < 45 mL/min)
- Severe cardiovascular disease or recent intervention (NYHA class ≥2 or heart failure hospitalization in the past 6mo, Aortic stenosis, Heart block including LBBB or 3rd degree AV block, SBP >180 or DBP >105 mmHg, myocardial infarction or coronary revascularization in the past 1 month)
- Severe hepatic dysfunction: cirrhosis or AST/ALT >3 times upper limit of normal
- Pulmonary disease with dependence on oxygen or daily use of bronchodilators
- Weight loss >10% in the past 6 months
- Bariatric surgery in the past 2 years
- Pregnant, within 3 months post-partum, nursing, or planning to become pregnant
- Anemia: hematocrit <36% in males or <33% in females
- Ongoing alcohol or substance abuse using criteria from the AUDIT and DAST questionnaires (Appendix)
- Diagnosis of schizophrenia or other psychotic disorder
- Vision impairment limiting ability to interface with the digital program
- Unable to swallow medication
- Non-English speaking
- Cognitive impairment defined by IQ <80
- Current active cancer or undergoing treatment for active cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
This is a first-in survivor, single-arm pilot study with the goal of establishing evidence of feasibility and safety of a combined pharmacologic (metformin) and lifestyle intervention (using an existing digital platform) to prevent diabetes in prediabetic adult survivors of childhood cancer.
Primary Objective
Read more
The primary aim of this proposal is to establish the feasibility and safety of a 24-week combined metformin + intensive lifestyle intervention among adult survivors with prediabetes (including a 12-week lifestyle alone run-in followed by 12-week combined intervention among survivors remaining prediabetic).
Primary endpoints of this trial will be adherence to 1) daily metformin administration and 2) completion of required core-curriculum of the lifestyle change intervention. Safety will be assessed using the Global Rating of Side Effects Burden
Secondary Objectives
The secondary aim is to assess preliminary evidence for efficacy of the combined metformin + intensive lifestyle intervention on glycemic control and insulin resistance. Glycemic control will be measured by fasting plasma glucose (FPG) and hemoglobin A1c (HbA1c) and insulin resistance measured by the homeostatic model assessment (HOMA-IR) and IGF- binding protein 1 (IGF-BP1; a measure of insulin sensitivity strongly correlated with euglycemic insulin clamp testing).
Exploratory Objectives
To assess preliminary evidence for efficacy of the combined metformin + intensive lifestyle intervention on weight, other anthropometric measures, blood pressure and lipid profile, physical activity (self-reported and as measured by accelerometer), frailty measures, and health-related quality of life (HRQOL). We will also assess diabetes development at future SJLIFE visits.
To assess measures of participation in the lifestyle change program as well as barriers to participation and medication adherence.
Read the detailed description
Eligible subjects who meet inclusion criteria will be enrolled in a 12 week run-in period of the digital lifestyle intervention program. At the 12 week study visit, those who remain prediabetic will received metformin extended release daily, first at lower dose (500 mg/day) to minimize gastrointestinal side effects (diarrhea, nausea, flatulence, bloating), then escalated to a maximum dose of 1000 mg/day at week 14. The digitally delivered lifestyle change program will include a core curriculum focused on diet quality, food types, exercise and behavioral strategies for goal setting, and self- monitoring.
- Conditions
- PreDiabetes, Adult Children
- Being tested
- Metformin, Digital Intervention
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called D-Care DM2, Fortamet, Glucophage, Glucophage XR
To begin week 12 for participants who remain prediabetic after 12 week lifestyle run-in. Dosage and Route of Administration: 500 mg dose/ day to be taken orally, increased to 1000 mg dose/ day at week 14 through week 24. The dose should be taken immediately following the evening meal and at approximately the same time daily
Digital InterventionBehavioural
Also called Lifestyle Change Digital Intervention
Lifestyle Change Digital Intervention - This is a digital platform that will include a core curriculum focused on diet, exercise, and behavioral strategies for goal setting and self-monitoring to improve diet including a weight loss On Day 1, participants will begin their digital lifestyle intervention using their smart-phone application with their lifestyle coach and peer group.
On day 14, participants will be contacted by phone (+/- 4 days, day 10 to 18) and adherence assessed using virtual pill counts via phone calls.
At weeks 4, 8, 16 and 20 a phone-based pill count for adherence and adverse event symptom log will be completed and study medication dispensed.
At week 12 (interim assessment) and 24 (study-end), the participant will return to St. Jude Children's Research Hospital (SJCRH) for an in-person assessment.
The digital lifestyle change program will complete at week 24.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Metformin is an antihyperglycemic agent which improves glucose tolerance in patients with type 2 diabetes mellitus, lowering both basal and postprandial plasma glucose. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization. With Metformin therapy, insulin secretion remains unchanged while fasting insulin levels and day-long plasma insulin response may decrease. Receives: Drug: Metformin; Behavioral: Digital Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence for feasibility
Adherence to the intervention with 80% adherence to prescribed metformin and completion of 60% of the digitally-delivered core education curriculum through the lifestyle change platform.
Measured: 2 years
Digitally-delivered core education curriculum through the lifestyle change platform
Adherence will be monitored by completion logs of lessons
Measured: At end of Week 24
Safety and Adverse Events (Symptom Log including monitoring for AEs)
An Adverse Event Monitoring Log with Global Rating of Side Effects Burden
Measured: Week 4
Safety and Adverse Events (Symptom Log including monitoring for AEs)
An Adverse Event Monitoring Log with Global Rating of Side Effects Burden
Measured: Week 8
Safety and Adverse Events (Symptom Log including monitoring for AEs)
An Adverse Event Monitoring Log with Global Rating of Side Effects Burden
Measured: Week 12
Safety and Adverse Events (Symptom Log including monitoring for AEs)
An Adverse Event Monitoring Log with Global Rating of Side Effects Burden
Measured: Week 14
Safety and Adverse Events (Symptom Log including monitoring for AEs)
An Adverse Event Monitoring Log with Global Rating of Side Effects Burden
Measured: Week 16
Safety and Adverse Events (Symptom Log including monitoring for AEs)
An Adverse Event Monitoring Log with Global Rating of Side Effects Burden
Measured: Week 20
Safety and Adverse Events (Symptom Log including monitoring for AEs)
An Adverse Event Monitoring Log with Global Rating of Side Effects Burden
Measured: Week 24
Drug adherence/Pill Counts
Adherence will be monitored by pill counts showing participant taking study drug, metformin ER, 80% of the time.
Measured: Week 2
Drug adherence/Pill Counts
Adherence will be monitored by pill counts showing participant taking study drug, metformin ER, 80% of the time.
Measured: Week 4
Drug adherence/Pill Counts
Adherence will be monitored by pill counts showing participant taking study drug, metformin ER, 80% of the time.
Measured: Week 8
Drug adherence/Pill Counts
Adherence will be monitored by pill counts showing participant taking study drug, metformin ER, 80% of the time.
Measured: Week 12
Drug adherence/Pill Counts
Adherence will be monitored by pill counts showing participant taking study drug, metformin ER, 80% of the time.
Measured: Week 16
Drug adherence/Pill Counts
Adherence will be monitored by pill counts showing participant taking study drug, metformin ER, 80% of the time.
Measured: Week 20
Drug adherence/Pill Counts
Adherence will be monitored by pill counts showing participant taking study drug, metformin ER, 80% of the time.
Measured: Week 24
Secondary outcomes (2)
Glycemic Control
Glycemic Control will be measured by Change in Hemoglobin A1c
Measured: Baseline to Week 24 (on campus labs at Baseline, Week 12 and 24)
Glycemic Control
Glycemic Control will be measure by Change in Fasting Plasma Glucose
Measured: Baseline to Week 24 (on campus labs at Baseline, Week 12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start2 Mar 2022
- Primary completion16 Jan 2026
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- St. Baldrick's Foundation, Conquer Cancer Foundation, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Stephanie Dixon, MD, MPH, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04742751
- Sponsor's protocol ID
- PREDM
- Other IDs
- R21CA261713
- Status last verified
- Apr 2026
- First submitted
- 6 Jan 2021
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Pilot Intervention Trial to Prevent Diabetes in Prediabetic Adult Survivors of Childhood Cancer
- ClinicalTrials.gov ID
- NCT04742751
- Acronym / sponsor ID
- PREDM
- Conditions
- PreDiabetes, Adult Children
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 96 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Collaborators
- St. Baldrick's Foundation, Conquer Cancer Foundation, National Cancer Institute (NCI)
- Study start
- 2 Mar 2022 (actual)
- Primary completion
- 16 Jan 2026 (actual)
- Study completion
- Mar 2027 (estimated)
- First posted
- 8 Feb 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 is a first-in survivor, single-arm pilot study with the goal of establishing evidence of feasibility and safety of a combined pharmacologic (metformin) and lifestyle intervention (using an existing digital platform) to prevent diabetes in prediabetic adult survivors of childhood cancer.
Primary Objective
The primary aim of this proposal is to establish the feasibility and safety of a 24-week combined metformin + intensive lifestyle intervention among adult survivors with prediabetes (including a 12-week lifestyle alone run-in followed by 12-week combined intervention among survivors remaining prediabetic).
Primary endpoints of this trial will be adherence to 1) daily metformin administration and 2) completion of required core-curriculum of the lifestyle change intervention. Safety will be assessed using the Global Rating of Side Effects Burden
Secondary Objectives
The secondary aim is to assess preliminary evidence for efficacy of the combined metformin + intensive lifestyle intervention on glycemic control and insulin resistance. Glycemic control will be measured by fasting plasma glucose (FPG) and hemoglobin A1c (HbA1c) and insulin resistance measured by the homeostatic model assessment (HOMA-IR) and IGF- binding protein 1 (IGF-BP1; a measure of insulin sensitivity strongly correlated with euglycemic insulin clamp testing).
Exploratory Objectives
To assess preliminary evidence for efficacy of the combined metformin + intensive lifestyle intervention on weight, other anthropometric measures, blood pressure and lipid profile, physical activity (self-reported and as measured by accelerometer), frailty measures, and health-related quality of life (HRQOL). We will also assess diabetes development at future SJLIFE visits.
To assess measures of participation in the lifestyle change program as well as barriers to participation and medication adherence.
Detailed description
Eligible subjects who meet inclusion criteria will be enrolled in a 12 week run-in period of the digital lifestyle intervention program. At the 12 week study visit, those who remain prediabetic will received metformin extended release daily, first at lower dose (500 mg/day) to minimize gastrointestinal side effects (diarrhea, nausea, flatulence, bloating), then escalated to a maximum dose of 1000 mg/day at week 14. The digitally delivered lifestyle change program will include a core curriculum focused on diet quality, food types, exercise and behavioral strategies for goal setting, and self- monitoring.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Metformin, Behavioral: Digital InterventionMetformin is an antihyperglycemic agent which improves glucose tolerance in patients with type 2 diabetes mellitus, lowering both basal and postprandial plasma glucose. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization. With Metformin therapy, insulin secretion remains unchanged while fasting insulin levels and day-long plasma insulin response may decrease. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Investigators will recruit to enroll 55 survivors who are at least 18 but <45 years of age who participate in the St. Jude Lifetime Cohort Study (SJLIFE) and have been identified to have prediabetes defined as hemoglobin A1c (HbA1c)
- Participant in SJLIFE
- ≥18 and <45 years of age
- Prediabetic: fasting plasma glucose 105-125 mg/dL, hemoglobin A1c 5.7- 6.4% (either or both criteria may be present) According to institutional and NIH policy, the study will accession research participants regardless of sex and ethnic background. Institutional experience confirms broad representation in this regard.
Key exclusion criteria (22 listed)
- Absence of treatment related diabetes risk. Survivors will be excluded if their cancer treatment required observation only, surgery alone not involving the abdomen or brain, radiation alone not involving the chest (pancreatic risk), abdomen or brain (e.g. retinoblastoma treated with enucleation alone, melanoma of an extremity treated with excision alone, neuroblastoma in an infant requiring observation only)
- Diabetes at baseline assessment: FPG ≥126 mg/dL, HbA1c ≥6.5% or previous diagnosis by a physician (except gestational diabetes that resolved post-partum)
- BMI <19 kg/m2
- Current metformin use (including for any period ≥30 days in the past 1yr)
- Known allergy to metformin
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 |
|---|---|---|
| MetforminAlso: D-Care DM2, Fortamet, Glucophage, Glucophage XRTo begin week 12 for participants who remain prediabetic after 12 week lifestyle run-in. Dosage and Route of Administration: 500 mg dose/ day to be taken orally, increased to 1000 mg dose/ day at week 14 through week 24. The dose should be taken immediately following the evening meal and at approximately the same time daily | Drug | Treatment |
| Digital InterventionAlso: Lifestyle Change Digital InterventionLifestyle Change Digital Intervention - This is a digital platform that will include a core curriculum focused on diet, exercise, and behavioral strategies for goal setting and self-monitoring to improve diet including a weight loss On Day 1, participants will begin their digital lifestyle intervention using their smart-phone application with their lifestyle coach and peer group. On day 14, participants will be contacted by phone (+/- 4 days, day 10 to 18) and adherence assessed using virtual pill counts via phone calls. At weeks 4, 8, 16 and 20 a phone-based pill count for adherence and adverse event symptom log will be completed and study medication dispensed. At week 12 (interim assessment) and 24 (study-end), the participant will return to St. Jude Children's Research Hospital (SJCRH) for an in-person assessment. The digital lifestyle change program will complete at week 24. | Behavioural | Treatment |
Primary outcome
Adherence for feasibility
Time frame: 2 years
Adherence to the intervention with 80% adherence to prescribed metformin and completion of 60% of the digitally-delivered core education curriculum through the lifestyle change platform.
Digitally-delivered core education curriculum through the lifestyle change platform
Time frame: At end of Week 24
Adherence will be monitored by completion logs of lessons
Safety and Adverse Events (Symptom Log including monitoring for AEs)
Time frame: Week 4
An Adverse Event Monitoring Log with Global Rating of Side Effects Burden
Safety and Adverse Events (Symptom Log including monitoring for AEs)
Time frame: Week 8
An Adverse Event Monitoring Log with Global Rating of Side Effects Burden
Safety and Adverse Events (Symptom Log including monitoring for AEs)
Time frame: Week 12
An Adverse Event Monitoring Log with Global Rating of Side Effects Burden
Safety and Adverse Events (Symptom Log including monitoring for AEs)
Time frame: Week 14
An Adverse Event Monitoring Log with Global Rating of Side Effects Burden
Safety and Adverse Events (Symptom Log including monitoring for AEs)
Time frame: Week 16
An Adverse Event Monitoring Log with Global Rating of Side Effects Burden
Safety and Adverse Events (Symptom Log including monitoring for AEs)
Time frame: Week 20
An Adverse Event Monitoring Log with Global Rating of Side Effects Burden
Safety and Adverse Events (Symptom Log including monitoring for AEs)
Time frame: Week 24
An Adverse Event Monitoring Log with Global Rating of Side Effects Burden
Drug adherence/Pill Counts
Time frame: Week 2
Adherence will be monitored by pill counts showing participant taking study drug, metformin ER, 80% of the time.
Drug adherence/Pill Counts
Time frame: Week 4
Adherence will be monitored by pill counts showing participant taking study drug, metformin ER, 80% of the time.
Drug adherence/Pill Counts
Time frame: Week 8
Adherence will be monitored by pill counts showing participant taking study drug, metformin ER, 80% of the time.
Drug adherence/Pill Counts
Time frame: Week 12
Adherence will be monitored by pill counts showing participant taking study drug, metformin ER, 80% of the time.
Drug adherence/Pill Counts
Time frame: Week 16
Adherence will be monitored by pill counts showing participant taking study drug, metformin ER, 80% of the time.
Drug adherence/Pill Counts
Time frame: Week 20
Adherence will be monitored by pill counts showing participant taking study drug, metformin ER, 80% of the time.
Drug adherence/Pill Counts
Time frame: Week 24
Adherence will be monitored by pill counts showing participant taking study drug, metformin ER, 80% of the time.
2 secondary outcomes
Glycemic Control
Time frame: Baseline to Week 24 (on campus labs at Baseline, Week 12 and 24)
Glycemic Control
Time frame: Baseline to Week 24 (on campus labs at Baseline, Week 12 and 24
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 30 Apr 2026.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data 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.
Stephanie Dixon, MD, MPH principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metformin and Digital Intervention in people with PreDiabetes and Adult Children, run by St. Jude Children's Research Hospital 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 22 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 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Adherence for feasibility (time frame: 2 years). The study lists 16 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 30 Apr 2026.