Diabetes Mellitus, Type 2NCT04035395
Salud y Vida 2.0: Enhancing Integrated Behavioral Health for Diabetics in the Rio Grande Valley
A study testing Peer-led Support Group, Behavioral Health Consult and Medication Therapy Management Consult in people with Diabetes Mellitus, Type 2 and Behavior, Health, run by The University of Texas Health Science Center, Houston.
Trial summary
The purpose of this study is to implement a system of integrated health care that provides a continuum of care for those with diabetes. This study will use a randomized behavioral intervention trial experimental design to compare participants receiving the enhanced delivery of integrated behavioral care with… Read more about this study
- Who is it for?
- Ages 18 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Behavior, Health
- What is being tested?
- Peer-led Support Group, Behavioral Health Consult and Medication Therapy Management Consult
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 353 participants
- Where
- No sites listed yet
- Study dates
- 29 Sep 2016to 13 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants of the Salud y Vida (SyV) program who are patients at two specific clinics
- Reside in the lower Rio Grande Valley of Texas
- A diagnosis of poorly controlled diabetes (HbA1c greater than or equal to 9.0%)
- Enrollment in the SyV 1.0 services for a minimum of 6 months
- At 6 months still have uncontrolled diabetes (HbA1c greater than or equal to 9.0%)
Who cannot join
- Enrollment in another research study
- Does not speak either English or Spanish
- Immediate family member of current SyV 2.0 participant
- Not a registered patient at 1 of the 2 specified clinics
About this study
Official title: Salud y Vida 2.0: Enhancing Integrated Behavioral Health for Individuals With Diabetes in the Rio Grande Valley
The purpose of this study is to implement a system of integrated health care that provides a continuum of care for those with diabetes. This study will use a randomized behavioral intervention trial experimental design to compare participants receiving the enhanced delivery of integrated behavioral care with nonparticipants receiving the usual care until after the study period, at which time they will be offered access to expansion services.
Read the detailed description
The Rio Grande Valley (RGV), located on the northern bank of the Rio Grande River that separates the United States from Mexico, is home to more than 1.2 million residents, representing about 5% of Texas' general population. The SyV 2.0 program focuses on the system of health care in the lower RGV, comprised of a predominantly Mexican American, low-income, underserved community with chronic disease rates and related mortality that exceed those in most other regions of the state and the nation. Based on a cohort study of 2,000 Mexican American adults from this region between 2003 to 2008 called the Cameron County Hispanic Cohort (CCHC), researchers estimated diabetes prevalence to be 31% and 81% of the population were either obese (49%) or overweight (32%). Residents in this region suffer from disproportionate health disparities that stem from extreme poverty (40% of families live below federal poverty line), lower levels of educational attainment (9.9 average years of education), and inadequate access to basic health care needs, income, and education.
The SyV 2.0 program is an expansion of SyV 1.0, a program for individuals with uncontrolled diabetes. Enhancement includes two major initiatives: clinical-based services and community-based services. Clinical based services will include medication therapy management for participants with low levels of medication adherence and care coordination which includes behavioral health services for participants who do not qualify for services with the mental health authority, but need behavioral health support. Community-based services will include peer led support groups and access to community-based lifestyle programs (capacity building cooking classes and an obesity awareness program). Clinical-based and community-based services will be directed by a multidisciplinary care team and will be customized to meet each participant's individualized needs.
The proposed study does not pose any major risks or dangers beyond what a normal physician visit would present. Benefits include improved control of chronic disease (diabetes, hypertension, and obesity), a reduction in depression, increased access to behavioral healthcare services, and improved adult functioning and quality of life for current SyV 1.0 participants.
This study will contribute to the investigator's understanding of how to increase access to health care services and treatment among those individuals with diabetes, namely, low-income, Hispanic communities.
- This study was not funded by the National Institutes of Health (NIH). It was funded by two Texas foundations, Methodist Healthcare Ministries and Valley Baptist Legacy Foundation.
- Conditions
- Diabetes Mellitus, Type 2, Behavior, Health
- Being tested
- Peer-led Support Group, Behavioral Health Consult, Medication Therapy Management Consult, La Cocina Alegre/ The Happy Kitchen, Mind, Exercise, Nutrition, Do it!
- Keywords
- Integrated Behavioral Health, Community Health Workers
- Medical subject headings
- Diabetes Mellitus, Type 2, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer-led Support GroupOther
Also called Viviendo Saludable platicas
The Viviendo Saludable pláticas (or talks) connected Salud y Vida participants living with diabetes together. These talks served as a forum for Salud y Vida participants to share their knowledge and experiences, including some that many health workers, friends, or family do not have. Viviendo Saludable helped participants develop better strategies for managing their diabetes in their daily life. The Viviendo Saludable pláticas complement and enhance the other services by helping participants create a network of emotional, social, and practical support needed to manage diabetes and stay healthy over the long term. Classes met once a week for one hour at locations central to participants' homes.
Behavioral Health ConsultOther
In a Behavioral Health consult, a participant meets with a counselor for one or more thorough meetings to talk about things that influence their health and well-being. A participant receiving a Behavioral Health consult receives support and is empowered with health coping skills that will allow for improved medication adherence and motivation to control their diabetes.
Medication Therapy Management ConsultOther
Medication Therapy Management helps participants and their doctors make sure that their medications are working to improve their health. In a Medication Therapy Management (MTM) consult, a pharmacist gives participants a comprehensive review of all their medications and speaks with them about 1) how well their medications are working, 2) whether their medications have side effects, 3) if there might be interactions between the drugs their taking, 4) whether costs can be lowered and 5) other problems participants are having. The participant will get a written summary of this discussion, including an action plan that recommends what can be done to make the best use of their medications.
La Cocina Alegre/ The Happy KitchenOther
The Happy Kitchen is a program where people come together to learn skills and self-sufficiency in preparing healthy, economical meals, laugh, cook, and enjoy food together. The cooking and nutrition program is an interactive 6-week series of classes, where the essential skills for healthy eating is taught and emphasis is placed on the selection and preparation of fresh, seasonal foods that are nutritious, economical, and delicious. Classes meet once a week for 1 ½ hours to cook, discuss, and learn together. All participants leave each class with recipes and groceries to practice new cooking skills.
Mind, Exercise, Nutrition, Do it!Other
MEND is a diet and exercise education program that helps families support their kids, ages 6-13, to reach a healthy weight. The program teaches adults and their children how to maintain energy and confidence throughout the day while learning how to cook healthy meals. Each program lasts 10 weeks and classes are 2 times per week. An adult must attend with the child.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants randomized to the intervention group will receive the SyV 2.0 program, which in addition to standard diabetes management services of SyV 1.0 services, could include MTM services, care coordination by a team of behavioral health care providers, and/or referrals to community-based lifestyle programs, as determined by their tailored care plan. The participant will be seen by evaluation staff to complete baseline assessment for the study. Then, an individualized care plan will be developed by SyV 1.0 interdisciplinary staff and reviewed by the chronic care case management team. The care plan will include information on additional services provided by UTHealth such as, but not limited to, behavioral health services, or pharmacy services. Each participant will receive an individualized care plan and when applicable, referrals to community-based programs. Evaluation staff and CHWs will make follow-up appointments for the participant depending on their care plan. Receives: Other: Peer-led Support Group; Other: Behavioral Health Consult; Other: Medication Therapy Management Consult; Other: La Cocina Alegre/ The Happy Kitchen; Other: Mind, Exercise, Nutrition, Do it! |
| Control | No intervention | Participants randomized to the usual care group will receive the SyV 1.0 program which includes community based program referrals (excluding intervention programs) and home-based visits from CHWs. These participants will also receive the standard follow-up from UTHealth staff such as a phone call, an information session as per their treatment plan, and /or a onetime mailing of information about the importance of following their treatment plan. Before implementation begins, additional details about standard care will be ascertained from partner organizations to better understand how these differ from the treatment conditions of the intervention group. Once the participant completes 12 months in the study, 2.0 services will be initiated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Change in Hemoglobin A1c
Participants who receive SyV 2.0 will experience a change in HbA1c after 12 months compared to participants who receive SyV 1.0 (the standard of care).
Measured: 12 month period
Secondary outcomes (6)
Rate of Change in Blood Pressure
Participants who receive SyV 2.0 will experience a change in their blood pressure after 12 months compared to participants who receive SyV 1.0. Both systolic and diastolic pressures will be assessed during the study period.
Measured: 12 month period
Rate of Change in BMI
Participants who receive SyV 2.0 will experience a change in their BMI after 12 months compared to overweight or obese participants who receive SyV 1.0.
Measured: 12 month period
Rate of Change in Depressive Symptoms
Participants who receive SyV 2.0 will experience a change in their depressive symptoms, as measured by the Patient Health Questionnaire-9 (PHQ-9), after 12 months compared to participants who receive SyV 1.0. The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. The PHQ-9 total possible score is 27. The PHQ-9 scoring criteria is categorized as minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19) and severe (20-27) depression. Higher values represent worse outcome.
Measured: 12 month period
Rate of Change in Quality of Life: Duke Health Profile
Participants who receive SyV 2.0 will experience a change in their quality of life, as measured by the Duke Health Profile, after 12 months compared to participants who receive SyV 1.0. The Duke Health Profile is a 17-item generic questionnaire instrument designed to measure adult self-reported functional health status quantitatively during a one-week time window. The Duke Health profile has 11 scales, six of which measure function and five of which measure dysfunction. Scores range from 0 to 100. For scales measuring function, the higher the score, the more functional the person being evaluated. For scales measuring dysfunction, the higher the score, the more dysfunctional the person being evaluated. The general health domain score, a composite of the physical health, mental health and social health domain scores, was utilized as the primary quality of life indicator in our analyses.
Measured: 12 month period
Rate of Change in Total Cholesterol
Participants who receive SyV 2.0 will experience a change in their total cholesterol after 12 months compared to participants who receive SyV 1.0.
Measured: 12 month period
Rate of Change in Self-efficacy: Diabetes Self-Efficacy Scale
Participants who receive SyV 2.0 will experience a change in self-efficacy, as measured by the Diabetes Self-Efficacy Scale, after 12 months compared to participants who receive SyV 1.0. The Diabetes Self-Efficacy Scale is an 8-item generic questionnaire instrument that is self-reported and designed to measure adult patient perception in regard to performing self-care tasks related to diabetes. The Diabetes Self-Efficacy Scale has 8 items. Scores range from 0 to 10. The lower the score, the lower the self-efficacy of the person being evaluated.
Measured: 12 month period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start29 Sep 2016
- Primary completion13 Jun 2018
- Study completion13 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 353 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Health Resources in Action, Inc.
- Responsible party
- Principal investigator, Belinda Reininger, The University of Texas Health Science Center, Houston
- Investigators
- Belinda M. Reininger, DrPH, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04035395
- Sponsor's protocol ID
- HSC-SPH-16-0044
- Status last verified
- Jul 2019
- First submitted
- 24 Jul 2019
- Last updated
- 2 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fisher-Hoch SP, Vatcheva KP, Laing ST, Hossain MM, Rahbar MH, Hanis CL, Brown HS 3rd, Rentfro AR, Reininger BM, McCormick JB. Missed opportunities for diagnosis and treatment of diabetes, hypertension, and hypercholesterolemia in a Mexican American population, Cameron County Hispanic Cohort, 2003-2008. Prev Chronic Dis. 2012;9:110298. doi: 10.5888/pcd9.110298.
PubMed 22863308Reininger BM, Lee M, Hessabi M, Mitchell-Bennett LA, Sifuentes MR, Guerra JA, Ayala CD, Xu T, Polletta V, Flynn A, Rahbar MH. Improved diabetes control among low-income Mexican Americans through community-clinical interventions: results of an RCT. BMJ Open Diabetes Res Care. 2020 May;8(1):e000867. doi: 10.1136/bmjdrc-2019-000867.
PubMed 32475836
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salud y Vida 2.0: Enhancing Integrated Behavioral Health for Individuals With Diabetes in the Rio Grande Valley
- ClinicalTrials.gov ID
- NCT04035395
- Acronym / sponsor ID
- HSC-SPH-16-0044
- Conditions
- Diabetes Mellitus, Type 2, Behavior, Health
- Keywords
- Integrated Behavioral Health, Community Health Workers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 353 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Health Resources in Action, Inc.
- Study start
- 29 Sep 2016 (actual)
- Primary completion
- 13 Jun 2018 (actual)
- Study completion
- 13 Jun 2018 (actual)
- First posted
- 29 Jul 2019 (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 purpose of this study is to implement a system of integrated health care that provides a continuum of care for those with diabetes. This study will use a randomized behavioral intervention trial experimental design to compare participants receiving the enhanced delivery of integrated behavioral care with nonparticipants receiving the usual care until after the study period, at which time they will be offered access to expansion services.
Detailed description
The Rio Grande Valley (RGV), located on the northern bank of the Rio Grande River that separates the United States from Mexico, is home to more than 1.2 million residents, representing about 5% of Texas' general population. The SyV 2.0 program focuses on the system of health care in the lower RGV, comprised of a predominantly Mexican American, low-income, underserved community with chronic disease rates and related mortality that exceed those in most other regions of the state and the nation. Based on a cohort study of 2,000 Mexican American adults from this region between 2003 to 2008 called the Cameron County Hispanic Cohort (CCHC), researchers estimated diabetes prevalence to be 31% and 81% of the population were either obese (49%) or overweight (32%). Residents in this region suffer from disproportionate health disparities that stem from extreme poverty (40% of families live below federal poverty line), lower levels of educational attainment (9.9 average years of education), and inadequate access to basic health care needs, income, and education.
The SyV 2.0 program is an expansion of SyV 1.0, a program for individuals with uncontrolled diabetes. Enhancement includes two major initiatives: clinical-based services and community-based services. Clinical based services will include medication therapy management for participants with low levels of medication adherence and care coordination which includes behavioral health services for participants who do not qualify for services with the mental health authority, but need behavioral health support. Community-based services will include peer led support groups and access to community-based lifestyle programs (capacity building cooking classes and an obesity awareness program). Clinical-based and community-based services will be directed by a multidisciplinary care team and will be customized to meet each participant's individualized needs.
The proposed study does not pose any major risks or dangers beyond what a normal physician visit would present. Benefits include improved control of chronic disease (diabetes, hypertension, and obesity), a reduction in depression, increased access to behavioral healthcare services, and improved adult functioning and quality of life for current SyV 1.0 participants.
This study will contribute to the investigator's understanding of how to increase access to health care services and treatment among those individuals with diabetes, namely, low-income, Hispanic communities.
- This study was not funded by the National Institutes of Health (NIH). It was funded by two Texas foundations, Methodist Healthcare Ministries and Valley Baptist Legacy Foundation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Peer-led Support Group, Other: Behavioral Health Consult, Other: Medication Therapy Management Consult, Other: La Cocina Alegre/ The Happy Kitchen, Other: Mind, Exercise, Nutrition, Do it!Participants randomized to the intervention group will receive the SyV 2.0 program, which in addition to standard diabetes management services of SyV 1.0 services, could include MTM services, care coordination by a team of behavioral health care providers, and/or referrals to community-based lifestyle programs, as determined by their tailored care plan. The participant will be seen by evaluation staff to complete baseline assessment for the study. Then, an individualized care plan will be developed by SyV 1.0 interdisciplinary staff and reviewed by the chronic care case management team. The care plan will include information on additional services provided by UTHealth such as, but not limited to, behavioral health services, or pharmacy services. Each participant will receive an individualized care plan and when applicable, referrals to community-based programs. Evaluation staff and CHWs will make follow-up appointments for the participant depending on their care plan. |
| Control | No intervention | –Participants randomized to the usual care group will receive the SyV 1.0 program which includes community based program referrals (excluding intervention programs) and home-based visits from CHWs. These participants will also receive the standard follow-up from UTHealth staff such as a phone call, an information session as per their treatment plan, and /or a onetime mailing of information about the importance of following their treatment plan. Before implementation begins, additional details about standard care will be ascertained from partner organizations to better understand how these differ from the treatment conditions of the intervention group. Once the participant completes 12 months in the study, 2.0 services will be initiated. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants of the Salud y Vida (SyV) program who are patients at two specific clinics
- Reside in the lower Rio Grande Valley of Texas
- A diagnosis of poorly controlled diabetes (HbA1c greater than or equal to 9.0%)
- Enrollment in the SyV 1.0 services for a minimum of 6 months
- At 6 months still have uncontrolled diabetes (HbA1c greater than or equal to 9.0%)
Key exclusion criteria (4 listed)
- Enrollment in another research study
- Does not speak either English or Spanish
- Immediate family member of current SyV 2.0 participant
- Not a registered patient at 1 of the 2 specified clinics
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 |
|---|---|---|
| Peer-led Support GroupAlso: Viviendo Saludable platicasThe Viviendo Saludable pláticas (or talks) connected Salud y Vida participants living with diabetes together. These talks served as a forum for Salud y Vida participants to share their knowledge and experiences, including some that many health workers, friends, or family do not have. Viviendo Saludable helped participants develop better strategies for managing their diabetes in their daily life. The Viviendo Saludable pláticas complement and enhance the other services by helping participants create a network of emotional, social, and practical support needed to manage diabetes and stay healthy over the long term. Classes met once a week for one hour at locations central to participants' homes. | Other | Intervention |
| Behavioral Health ConsultIn a Behavioral Health consult, a participant meets with a counselor for one or more thorough meetings to talk about things that influence their health and well-being. A participant receiving a Behavioral Health consult receives support and is empowered with health coping skills that will allow for improved medication adherence and motivation to control their diabetes. | Other | Intervention |
| Medication Therapy Management ConsultMedication Therapy Management helps participants and their doctors make sure that their medications are working to improve their health. In a Medication Therapy Management (MTM) consult, a pharmacist gives participants a comprehensive review of all their medications and speaks with them about 1) how well their medications are working, 2) whether their medications have side effects, 3) if there might be interactions between the drugs their taking, 4) whether costs can be lowered and 5) other problems participants are having. The participant will get a written summary of this discussion, including an action plan that recommends what can be done to make the best use of their medications. | Other | Intervention |
| La Cocina Alegre/ The Happy KitchenThe Happy Kitchen is a program where people come together to learn skills and self-sufficiency in preparing healthy, economical meals, laugh, cook, and enjoy food together. The cooking and nutrition program is an interactive 6-week series of classes, where the essential skills for healthy eating is taught and emphasis is placed on the selection and preparation of fresh, seasonal foods that are nutritious, economical, and delicious. Classes meet once a week for 1 ½ hours to cook, discuss, and learn together. All participants leave each class with recipes and groceries to practice new cooking skills. | Other | Intervention |
| Mind, Exercise, Nutrition, Do it!MEND is a diet and exercise education program that helps families support their kids, ages 6-13, to reach a healthy weight. The program teaches adults and their children how to maintain energy and confidence throughout the day while learning how to cook healthy meals. Each program lasts 10 weeks and classes are 2 times per week. An adult must attend with the child. | Other | Intervention |
Primary outcome
Rate of Change in Hemoglobin A1c
Time frame: 12 month period
Participants who receive SyV 2.0 will experience a change in HbA1c after 12 months compared to participants who receive SyV 1.0 (the standard of care).
6 secondary outcomes
Rate of Change in Blood Pressure
Time frame: 12 month period
Rate of Change in BMI
Time frame: 12 month period
Rate of Change in Depressive Symptoms
Time frame: 12 month period
Rate of Change in Quality of Life: Duke Health Profile
Time frame: 12 month period
Rate of Change in Total Cholesterol
Time frame: 12 month period
Rate of Change in Self-efficacy: Diabetes Self-Efficacy Scale
Time frame: 12 month period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2019.
- Background: PubMed 22863308Fisher-Hoch SP, Vatcheva KP, Laing ST, Hossain MM, Rahbar MH, Hanis CL, Brown HS 3rd, Rentfro AR, Reininger BM, McCormick JB. Missed opportunities for diagnosis and treatment of diabetes, hypertension, and hypercholesterolemia in a Mexican American population, Cameron County Hispanic Cohort, 2003-2008. Prev Chronic Dis. 2012;9:110298. doi: 10.5888/pcd9.110298.
- Derived from this study: PubMed 32475836Reininger BM, Lee M, Hessabi M, Mitchell-Bennett LA, Sifuentes MR, Guerra JA, Ayala CD, Xu T, Polletta V, Flynn A, Rahbar MH. Improved diabetes control among low-income Mexican Americans through community-clinical interventions: results of an RCT. BMJ Open Diabetes Res Care. 2020 May;8(1):e000867. doi: 10.1136/bmjdrc-2019-000867.
- U.S. Census Bureau. (2013). 2013 American Community Survey 5-Year Estimates.Link provided by the sponsor.
- 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.
Belinda M. Reininger, DrPH principal investigator
The University of Texas Health Science Center, Houston
Questions about this trial
What is this clinical trial studying?
A study testing Peer-led Support Group, Behavioral Health Consult and Medication Therapy Management Consult in people with Diabetes Mellitus, Type 2 and Behavior, Health, run by The University of Texas Health Science Center, Houston.
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 4 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 2 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Change in Hemoglobin A1c (time frame: 12 month period). 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 NCT04035395, which also lists 2 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 2 Aug 2019.