Type2DiabetesNCT05370612
AT GOAL: Adopting Technology for Glucose Optimization and Lifestyle in Pregnancy
A study testing Dexcom G6 CGM and Participant Finger Stick Glucose Monitoring in people with Type2Diabetes and Pregnancy in Diabetic, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This study will assess differences in patient preferences and glucose control between continuous glucose monitoring and standard glucose checks in pregnant patients with Type 2 Diabetes. 40 participants will be on study for approximately 182 days (26 weeks). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Type2Diabetes, Pregnancy in Diabetic
- What is being tested?
- Dexcom G6 CGM and Participant Finger Stick Glucose Monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2022to 6 Oct 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age greater than or equal to 18 years of age at enrollment
- Ability to consent in English
- Gestational age less than or equal to 19 weeks 6 days at enrollment
- Appropriate dating by certain LMP or ultrasound performed less than or equal to 19 weeks 6 day
- Diagnosis of Type 2 Diabetes less than or equal to 19 weeks 6 days
- Singleton gestation
Who cannot join
- Age less than 18 years of age at enrollment
- Lack of appropriate dating
- Multiple gestations
- Use of concentrated insulin at enrollment (ie U500)
- Preexisting CGM in place
- Chronic use of medications known to cause hyperglycemia, such as HIV antiretrovirals and inhaled, injectable and oral corticosteroids
- Be unwilling or unable to present to Center for Perinatal Care for visits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Continuous Glucose Monitoring in Pregnant Patients With Type 2 Diabetes, a Mixed Methods Approach
This study will assess differences in patient preferences and glucose control between continuous glucose monitoring and standard glucose checks in pregnant patients with Type 2 Diabetes. 40 participants will be on study for approximately 182 days (26 weeks).
Read the detailed description
This pilot single site randomized control trial will compare the blood glucose control and participant satisfaction scores of continuous glucose monitoring vs standard glucose checks in pregnant women with a prior diagnosis of Type 2 diabetes.
The study population will consist of 40 women who are less than 20 weeks pregnant at time of enrollment who have a pre-pregnancy diagnosis of Type 2 diabetes. Participants will be randomized to one of two treatment arms.
- Arm 1: Placement of Dexcom G6 continuous glucose monitor for glucose monitoring for duration of pregnancy
- Arm 2: Continuation of standard glucose finger sticks with placement of a blinded Dexcom Pro G6 continuous glucose sensor for two ten day periods (at enrollment and again at 28-32 weeks gestation)
Participant accrual will occur over 18 months at 1 site. Participants will complete 3 study visits, all of which will be in conjunction with previously scheduled prenatal or diabetes visits: at the time of consent (less than 20 weeks gestation), 28-32 weeks gestation, and 2-6 weeks postpartum.. Surveys will be administered at each time point. At the final visit, patients will be asked for participate in a 2-5 minute directed interview as well.
- Primary Objective
- To examine the feasibility of completing a study to assess for differences in patient preferences and glucose control between continuous glucose monitoring and standard glucose checks in pregnant patients with Type 2 Diabetes.
- Secondary Objectives
- To estimate the effect of continuous glucose monitoring devices placed prior to 20 weeks in pregnancy in patients with Type 2 diabetes on time in range, as measured between 28-32 weeks of pregnancy.
- To assess patient satisfaction to continuous glucose monitoring during pregnancy
- To estimate the effect of continuous glucose monitoring on the incidence of neonatal morbidity and mortality.
- Conditions
- Type2Diabetes, Pregnancy in Diabetic
- Being tested
- Dexcom G6 CGM, Participant Finger Stick Glucose Monitoring
- Medical subject headings
- Pregnancy in Diabetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexcom G6 CGMDevice
Dexcom 6 CGM, an FDA approved device. Sensors will be placed on the abdomen per package instruction to collect continuous glucose data.
Experimental Group will wear CGM for the duration of their pregnancy.
Control Group will have CGM data collected for 10 days at enrollment and at 28-32 weeks into their pregnancy.
Participant Finger Stick Glucose MonitoringOther
Also called Glucose Monitor
Standard of care for individual participant
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Continuous Glucose Monitor (CGM) | Experimental | CGM for duration of pregnancy. Receives: Device: Dexcom G6 CGM |
| Arm 2: Point of Care Glucose Testing (POCT) | Active comparator | Point of care finger sticks for glucose monitoring.
At two time points during the study - at time of enrollment and at 28-32 weeks gestation, CGM sensor will be placed and remain in place for 10 days. Participant and Physician will be blinded to CGM data. Receives: Device: Dexcom G6 CGM; Other: Participant Finger Stick Glucose Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Number of Participants Who Complete the Study Within 24 Month Time Period
Completion of the study within the 24-month timeframe, including recruitment, randomization, retention, and completion of 36 out of 40 subjects will be a measure of how feasible the intervention is.
Measured: up to 24 months
Change in Qualitative Survey Answers to Assess Participant Thoughts and Experiences With Diabetes Management
Individualized postpartum interviews and qualitative surveys administered at each time point will be used to gather information about participants thoughts and experiences in both arms of the trial about their ability to manage diabetes in pregnancy. Interviews will be analyzed for theme and content. Higher numbers indicate higher satisfaction with diabetes management.
Measured: baseline, 12 weeks on study, and postpartum (up to 26 weeks on study)
Percentage of Time Where Blood Glucose is Between 70-140 Milligrams Per Deciliter (mg/dL) - Time in Range
The primary endpoint is the total time within range (blood glucose level 70-140 mg/dL). All CGM data will be extracted from the Dexcom server for analysis. This measure is used to determine if time in range (TIR) is a suitable clinical endpoint for a larger trial. TIR for both arms will be determined and 95% confidence intervals around the difference in means calculated. TIR will be considered suitable if the upper 95% confidence interval for the difference in means is greater than 5 units in favor of CGM.
Measured: Baseline, 26 weeks
Secondary outcomes (19)
Number of Participants With Cesarean Delivery
Measured: approximately 20 weeks on study (at time of delivery)
Change in Hemoglobin A1c (Percentage) From Initiation to Third Trimester
Measured: baseline (approximately 20 weeks gestation), up to 12 weeks on study (up to 32 weeks gestation)
Percentage of Time Spent in Hyperglycemic Range
Hyperglycemic range is considered greater than 140 mg/dL. A very high hyperglycemic range is >250mg/dL.
Measured: up to 26 weeks
Percentage of Time Spent in Hypoglycemic Range
Hypoglycemic range is considered less than 70 mg/dL. Low is 55-70, very low is <54.
Measured: 26 weeks
Rates of Gestational Hypertension
Gestational hypertension is defined as systolic blood pressure 140 mm Hg or diastolic blood pressure 90 mg Hg on two occasions at least 4 hours apart.
Measured: up to approximately 20 weeks on study
Rates of Preeclampsia
Gestational hypertension plus either new-onset proteinuria [300 mg/24 hours, protein:creatinine 0.3 mg/dL], thrombocytopenia [platelet count<100,000/uL], elevated Aspartate transaminase or alanine transaminase [>2 upper limit of normal], renal insufficiency [serum creatinine>1.1 mg/dL or an unexplained doubling of creatinine], pulmonary edema, or cerebral or visual symptoms.
Measured: up to approximately 20 weeks on study
Rates of Polyhydramnios
Measured: up to approximately 20 weeks on study
Incidence of Neonatal Hypoglycemia
Measured: up to 26 weeks
Rates of Fetal Macrosomia
Actual birthweight greater than 95 percent by Fenton growth curve for newborns
Measured: up to 26 weeks
Rates of NICU Admission
Measured: up to 26 weeks
Rates of Spontaneous Preterm Delivery
Preterm delivery is considered less than 37 weeks.
Measured: up to approximately 17 weeks on study (less than 37 weeks gestation)
Satisfaction and Quality of Life Survey Scores (5-point Likert Scale)
Satisfaction and Quality of Life survey will be administered and answers will be compared between groups. Survey questions include answers on a 5-point Likert scale. Scores range from 15-75, where higher scores indicate lower satisfaction and quality of life, and lower scores indicate higher satisfaction and quality of life.
Measured: at enrollment, 28-32 weeks gestation (10 to 14 weeks on study), 2-4 weeks postpartum (up to 26 weeks on study)
Qualitative Outcome: Semi-Structured Interviews to Explore How Glucose Monitoring Affects Participants Thoughts and Feelings
The interviews will be recorded and transcribed by the Survey Center and analyzed for theme and content by two reviewers for validity.
Measured: 2-4 weeks postpartum (up to 26 weeks on study)
Qualitative Outcome: Interviews to Understand Participant Sense of Control Around Glucose Monitoring
Explore if traditional management versus continuous glucose management has higher feelings of control over diabetes management. The interviews will be recorded and transcribed by the Survey Center and analyzed for theme and content by two reviewers for validity.
Measured: 2-4 weeks postpartum (up to 26 weeks on study)
Satisfaction and Quality of Life Survey - How Satisfied Are You Currently With the Amount of Time it Takes to Manage Your Diabetes?
A custom survey for Satisfaction and Quality of Life will be administered and answers will be compared between groups. Questions include answers on a 7-point Likert scale, where 1 = very dissatisfied and 7 = very satisfied
Measured: at enrollment, 28-32 weeks gestation (10 to 14 weeks on study), 2-4 weeks postpartum (up to 26 weeks on study)
Satisfaction and Quality of Life Survey - How Satisfied Are You With the Time it Takes to Determine Your Sugar Level?
A custom survey for Satisfaction and Quality of Life will be administered and answers will be compared between groups. Questions include answers on a 7-point Likert scale, where 1 = very dissatisfied and 7 = very satisfied
Measured: at enrollment, 28-32 weeks gestation (10 to 14 weeks on study), 2-4 weeks postpartum (up to 26 weeks on study)
Satisfaction and Quality of Life Survey - How Satisfied Are You With the Total Time it Has Taken to Manage Your Diabetes Over the Last 2 Weeks?
A custom survey for Satisfaction and Quality of Life will be administered and answers will be compared between groups. Questions include answers on a 7-point Likert scale, where 1 = very dissatisfied and 7 = very satisfied
Measured: at enrollment, 28-32 weeks gestation (10 to 14 weeks on study), 2-4 weeks postpartum (up to 26 weeks on study)
Satisfaction and Quality of Life Survey - How Satisfied Are You With Your Current Diabetes Treatment?
A custom survey for Satisfaction and Quality of Life will be administered and answers will be compared between groups. Questions include answers on a 7-point Likert scale, where 1 = very dissatisfied and 7 = very satisfied
Measured: at enrollment, 28-32 weeks gestation (10 to 14 weeks on study), 2-4 weeks postpartum (up to 26 weeks on study)
Satisfaction and Quality of Life Survey - How Satisfied Are You With Time Spent Getting Checkups for Your Diabetes?
A custom survey for Satisfaction and Quality of Life will be administered and answers will be compared between groups. Questions include answers on a 7-point Likert scale, where 1 = very dissatisfied and 7 = very satisfied
Measured: at enrollment, 28-32 weeks gestation (10 to 14 weeks on study), 2-4 weeks postpartum (up to 26 weeks on study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start8 Aug 2022
- Primary completion6 Oct 2024
- Study completion6 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type2DiabetesStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- pilot, prospective, randomized trial
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- DexCom, Inc.
- Responsible party
- Sponsor
- Investigators
- Jacquelyn H Adams, MD, Principal investigator, UW School of Medicine and Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05370612
- Sponsor's protocol ID
- 2025-1028
- Other IDs
- Protocol Version 3/18/2024, A532860, 2022-0459, 2022-028
- Status last verified
- Mar 2026
- First submitted
- 6 May 2022
- Last updated
- 31 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Glucose Monitoring in Pregnant Patients With Type 2 Diabetes, a Mixed Methods Approach
- ClinicalTrials.gov ID
- NCT05370612
- Acronym / sponsor ID
- 2025-1028
- Conditions
- Type2Diabetes, Pregnancy in Diabetic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- DexCom, Inc.
- Study start
- 8 Aug 2022 (actual)
- Primary completion
- 6 Oct 2024 (actual)
- Study completion
- 6 Oct 2024 (actual)
- First posted
- 11 May 2022 (actual)
- Results
- Posted 31 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess differences in patient preferences and glucose control between continuous glucose monitoring and standard glucose checks in pregnant patients with Type 2 Diabetes. 40 participants will be on study for approximately 182 days (26 weeks).
Detailed description
This pilot single site randomized control trial will compare the blood glucose control and participant satisfaction scores of continuous glucose monitoring vs standard glucose checks in pregnant women with a prior diagnosis of Type 2 diabetes.
The study population will consist of 40 women who are less than 20 weeks pregnant at time of enrollment who have a pre-pregnancy diagnosis of Type 2 diabetes. Participants will be randomized to one of two treatment arms.
- Arm 1: Placement of Dexcom G6 continuous glucose monitor for glucose monitoring for duration of pregnancy
- Arm 2: Continuation of standard glucose finger sticks with placement of a blinded Dexcom Pro G6 continuous glucose sensor for two ten day periods (at enrollment and again at 28-32 weeks gestation)
Participant accrual will occur over 18 months at 1 site. Participants will complete 3 study visits, all of which will be in conjunction with previously scheduled prenatal or diabetes visits: at the time of consent (less than 20 weeks gestation), 28-32 weeks gestation, and 2-6 weeks postpartum.. Surveys will be administered at each time point. At the final visit, patients will be asked for participate in a 2-5 minute directed interview as well.
- Primary Objective
- To examine the feasibility of completing a study to assess for differences in patient preferences and glucose control between continuous glucose monitoring and standard glucose checks in pregnant patients with Type 2 Diabetes.
- Secondary Objectives
- To estimate the effect of continuous glucose monitoring devices placed prior to 20 weeks in pregnancy in patients with Type 2 diabetes on time in range, as measured between 28-32 weeks of pregnancy.
- To assess patient satisfaction to continuous glucose monitoring during pregnancy
- To estimate the effect of continuous glucose monitoring on the incidence of neonatal morbidity and mortality.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- pilot, prospective, randomized trial
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Continuous Glucose Monitor (CGM) | Experimental | Device: Dexcom G6 CGMCGM for duration of pregnancy. |
| Arm 2: Point of Care Glucose Testing (POCT) | Active comparator | Device: Dexcom G6 CGM, Other: Participant Finger Stick Glucose MonitoringPoint of care finger sticks for glucose monitoring. At two time points during the study - at time of enrollment and at 28-32 weeks gestation, CGM sensor will be placed and remain in place for 10 days. Participant and Physician will be blinded to CGM data. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age greater than or equal to 18 years of age at enrollment
- Ability to consent in English
- Gestational age less than or equal to 19 weeks 6 days at enrollment
- Appropriate dating by certain LMP or ultrasound performed less than or equal to 19 weeks 6 day
- Diagnosis of Type 2 Diabetes less than or equal to 19 weeks 6 days
Key exclusion criteria (7 listed)
- Age less than 18 years of age at enrollment
- Lack of appropriate dating
- Multiple gestations
- Use of concentrated insulin at enrollment (ie U500)
- Preexisting CGM in place
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 |
|---|---|---|
| Dexcom G6 CGMDexcom 6 CGM, an FDA approved device. Sensors will be placed on the abdomen per package instruction to collect continuous glucose data. Experimental Group will wear CGM for the duration of their pregnancy. Control Group will have CGM data collected for 10 days at enrollment and at 28-32 weeks into their pregnancy. | Device | Arm 1: Continuous Glucose Monitor (CGM), Arm 2: Point of Care Glucose Testing (POCT) |
| Participant Finger Stick Glucose MonitoringAlso: Glucose MonitorStandard of care for individual participant | Other | Arm 2: Point of Care Glucose Testing (POCT) |
Primary outcome
Feasibility: Number of Participants Who Complete the Study Within 24 Month Time Period
Time frame: up to 24 months
Completion of the study within the 24-month timeframe, including recruitment, randomization, retention, and completion of 36 out of 40 subjects will be a measure of how feasible the intervention is.
Change in Qualitative Survey Answers to Assess Participant Thoughts and Experiences With Diabetes Management
Time frame: baseline, 12 weeks on study, and postpartum (up to 26 weeks on study)
Individualized postpartum interviews and qualitative surveys administered at each time point will be used to gather information about participants thoughts and experiences in both arms of the trial about their ability to manage diabetes in pregnancy. Interviews will be analyzed for theme and content. Higher numbers indicate higher satisfaction with diabetes management.
Percentage of Time Where Blood Glucose is Between 70-140 Milligrams Per Deciliter (mg/dL) - Time in Range
Time frame: Baseline, 26 weeks
The primary endpoint is the total time within range (blood glucose level 70-140 mg/dL). All CGM data will be extracted from the Dexcom server for analysis. This measure is used to determine if time in range (TIR) is a suitable clinical endpoint for a larger trial. TIR for both arms will be determined and 95% confidence intervals around the difference in means calculated. TIR will be considered suitable if the upper 95% confidence interval for the difference in means is greater than 5 units in favor of CGM.
19 secondary outcomes
Number of Participants With Cesarean Delivery
Time frame: approximately 20 weeks on study (at time of delivery)
Change in Hemoglobin A1c (Percentage) From Initiation to Third Trimester
Time frame: baseline (approximately 20 weeks gestation), up to 12 weeks on study (up to 32 weeks gestation)
Percentage of Time Spent in Hyperglycemic Range
Time frame: up to 26 weeks
Percentage of Time Spent in Hypoglycemic Range
Time frame: 26 weeks
Rates of Gestational Hypertension
Time frame: up to approximately 20 weeks on study
Rates of Preeclampsia
Time frame: up to approximately 20 weeks on study
Rates of Polyhydramnios
Time frame: up to approximately 20 weeks on study
Incidence of Neonatal Hypoglycemia
Time frame: up to 26 weeks
Rates of Fetal Macrosomia
Time frame: up to 26 weeks
Rates of NICU Admission
Time frame: up to 26 weeks
Rates of Spontaneous Preterm Delivery
Time frame: up to approximately 17 weeks on study (less than 37 weeks gestation)
Satisfaction and Quality of Life Survey Scores (5-point Likert Scale)
Time frame: at enrollment, 28-32 weeks gestation (10 to 14 weeks on study), 2-4 weeks postpartum (up to 26 weeks on study)
Qualitative Outcome: Semi-Structured Interviews to Explore How Glucose Monitoring Affects Participants Thoughts and Feelings
Time frame: 2-4 weeks postpartum (up to 26 weeks on study)
Qualitative Outcome: Interviews to Understand Participant Sense of Control Around Glucose Monitoring
Time frame: 2-4 weeks postpartum (up to 26 weeks on study)
Satisfaction and Quality of Life Survey - How Satisfied Are You Currently With the Amount of Time it Takes to Manage Your Diabetes?
Time frame: at enrollment, 28-32 weeks gestation (10 to 14 weeks on study), 2-4 weeks postpartum (up to 26 weeks on study)
Satisfaction and Quality of Life Survey - How Satisfied Are You With the Time it Takes to Determine Your Sugar Level?
Time frame: at enrollment, 28-32 weeks gestation (10 to 14 weeks on study), 2-4 weeks postpartum (up to 26 weeks on study)
Satisfaction and Quality of Life Survey - How Satisfied Are You With the Total Time it Has Taken to Manage Your Diabetes Over the Last 2 Weeks?
Time frame: at enrollment, 28-32 weeks gestation (10 to 14 weeks on study), 2-4 weeks postpartum (up to 26 weeks on study)
Satisfaction and Quality of Life Survey - How Satisfied Are You With Your Current Diabetes Treatment?
Time frame: at enrollment, 28-32 weeks gestation (10 to 14 weeks on study), 2-4 weeks postpartum (up to 26 weeks on study)
Satisfaction and Quality of Life Survey - How Satisfied Are You With Time Spent Getting Checkups for Your Diabetes?
Time frame: at enrollment, 28-32 weeks gestation (10 to 14 weeks on study), 2-4 weeks postpartum (up to 26 weeks on study)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Jacquelyn H Adams, MD principal investigator
UW School of Medicine and Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexcom G6 CGM and Participant Finger Stick Glucose Monitoring in people with Type2Diabetes and Pregnancy in Diabetic, run by University of Wisconsin, Madison 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 6 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: finished, as of the sponsor's last update on 31 Mar 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Feasibility: Number of Participants Who Complete the Study Within 24 Month Time Period (time frame: up to 24 months). The study lists 3 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 31 Mar 2026.