Type 2 Diabetes MellitusNCT03159299
Yo Puedo! Diabetes Self-Management Education + mHealth in Mexico City
A study testing Yo Puedo + mHealth in people with Type 2 Diabetes Mellitus, run by Yale University at 1 site in United States.
Trial summary
The aims of this study are: 1. To translate an evidence-based diabetes self-management education (DSME) program, Yo Puedo!, to the cultural norms, expertise of providers, and systems of care in Seguro Popular clinics in Mexico. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Yo Puedo + mHealth
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2017to 30 Jun 2019
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Phase 1:
- For provider interviews/focus groups: administrator or health care provider at Seguro Popular clinic with at least 3 months experience.
- For adult interviews/focus groups: 21-65 years of age and have had T2D for at least one year
- Phase 2:
- Age 21-65 years; receiving care for T2D at a Seguro Popular clinic; diagnosed with T2D with A1C >8.0% and duration ≤ 5 years; medically stable and safe to exercise; and have a cell phone (MMS text-messaging will be provided).
Who cannot join
- Phase 2:
- Cognitive impairment, severe untreated clinical depression in the past 6 months, major cardiac event in past 12 months, uncontrolled blood pressure, resting tachycardia, renal failure, severe peripheral neuropathy, treatment of T2D with insulin, and participation in focus groups or interviews.
Trial locations and contacts
1 site in 1 country.
About this study
The aims of this study are:
- To translate an evidence-based diabetes self-management education (DSME) program, Yo Puedo!, to the cultural norms, expertise of providers, and systems of care in Seguro Popular clinics in Mexico. The program will be adapted through a collaborative team of diabetes experts in the US and Mexico, Seguro Popular clinic administrators, physicians, nurses and adults with type 2 diabetes (T2D) in Mexico City, Mexico. This will include development and testing of a theory-based mHealth (pictorial text-messaging) component.
- To evaluate the feasibility (process of implementation, fidelity of sessions, attendance, attrition), acceptability (interviews with nurse, CHW, participants) and preliminary efficacy of Yo Puedo!+mHealth in adults with T2D in Mexico City. A randomized, controlled pilot study design will be used in which 40 adults with T2D are randomized to the Yo Puedo! + mHealth or a wait-list control condition with the hypothesis that clinical [A1C, body mass index (BMI), blood pressure (BP)], T2D self-management, and self-efficacy outcomes will be greater in You Puedo!+mHealth participants compared to the wait-list control condition at 3 and 6 month follow-up. A secondary hypothesis that the Yo Puedo! + mHealth program is feasible and acceptable to adults with T2D and providers and that fidelity of the program will be maintained.
Read the detailed description
This mixed-method design study will be accomplished in two phases with an interdisciplinary, bi-national collaboration between the Yale School of Nursing, the Yale School of Public Health, the Iberoamericana University in Mexico City, and up to 10 Seguro Popular clinics to evaluate the adapted DSME program for adults with T2D in Mexico City.
Phase 1: While the Yo Puedo! program addresses some of the needs of Mexican adults with type 2 diabetes - interactive health education for low health literacy, Spanish language materials and video novellas, and activities to enhance self-efficacy, the program was developed to address the needs of Latino immigrants in the U.S, who are from different Latin countries. The program needs to be adapted to Mexican adults with respect to personal beliefs about disease causation, cultural health practices, self-care practices of type 2 diabetes, and issues regarding access to care. This aim will be accomplished by using an interpretive and participatory method with a collaborative team of diabetes experts in the US and Mexico, Seguro Popular clinic administrators, physicians, and nurses, and adults with T2D in Mexico City, Mexico. In focus groups and interviews, the study team will explore how the cultural context, family, and health system shape beliefs and practices related to T2D. Access and familiarity with texting technology to identify potential barriers to using a text-messaging mHealth program will also be explored. These results will inform any modifications to the Yo Puedo! curriculum that may need to be made before Phase 2 can begin.
Phase 2: A randomized, controlled pilot study design will be used in which 40 adults with T2D are randomized to the Yo Puedo + mHealth or wait-list control condition with the hypothesis that clinical (A1C, BMI, BP), T2D self-management, and self-efficacy outcomes will be greater in Yo Puedo + mHealth participants compared to the wait-list control condition at 3 and 6 month follow-up. It is also hypothesized that the Yo Puedo + mHealth program is feasible and acceptable to adults with T2D and providers, and that fidelity of the program will be maintained. Those in the control group will be invited to participate in the program after completion of the 6-month data collection. Interviews will be conducted with the nurse, community health worker (CHW), participants, and select clinic personnel to identify barriers, facilitators, and acceptability of the program from multiple perspectives, recognizing the complexity of the health care system. Detailed notes on the process of implementation will be carefully recorded with the purpose of identifying successful and unsuccessful components of the program (positive and negative feedback loops in a complex system).
Setting. The study will be conducted in up to 10 Seguro Popular clinics. These clinics are part of the Social Protection System in Health in Mexico. Individuals who obtain health care at these clinics are covered by public health insurance (Seguro Popular), and the services offered for T2D care include medical visits, referrals to specialists and nutritionist when needed, laboratory testing, and free medicines. The medical visits include medication prescription, blood pressure management, lipid monitoring, and eye/foot care. Laboratory analyses vary from patient to patient but generally includes 3 annual tests of A1C, although other glucose, urine, and lipids tests are also available. Patients with complications are referred to specialized health centers. Evidence suggests that the impact of the Seguro Popular in adults with T2D has been positive.
Interventions. All participants will receive standard T2D care at a Seguro Popular clinic as described above. The wait-list control condition group will receive a handout on T2D self-management and the opportunity to participate in the Yo Puedo! + mHealth program at the completion of 6-month data collection. The Yo Puedo! + mHealth DSME program includes: a) an initial consultation with the nurse to collaboratively determine goals; b) five interactive group-based sessions led by the CHW on T2D self-management that is culturally relevant and at a low health literacy level (Yo Puedo! protocol adapted for Mexican context; c) behavioral support to collaboratively problem-solve barriers to change; and d) empowerment-based strategies to facilitate provider-patient communication. The Yo Puedo! program will be supplemented by 2-way text-messaging capability provided by a web-based platform with privacy and security rules, which allows for automated and personalized messages and a database to store all messages. Automated daily text messages will include messages to promote understanding of T2D self-management, self-efficacy, and adherence to self-management goals. The in-person component will be 6 weeks; daily text messaging will be for 6 months.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Yo Puedo + mHealth
- Keywords
- mHealth, Hispanic/Latinos, Diabetes Self-Management Education
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yo Puedo + mHealthBehavioural
This intervention is an adapted diabetes self-management education program. Study participants will attend group classes weekly for 6 weeks, and receive daily text messages over 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Yo Puedo | Experimental | This group will receive the modified Yo Puedo + mHealth program. Receives: Behavioral: Yo Puedo + mHealth |
| Wait-list Control | No intervention | This group will not receive the Yo Puedo + mHealth program during the 6 month data collection period, but will be invited to participate in it after data collection has finished. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin A1C From Baseline
The change in A1C from baseline to 6 months is the result of the Generalized Linear Mixed Models (GLMM) with an intent-to-treat analysis that was used. HbA1c was measured from finger stick blood sample.
Measured: Baseline, 3, 6 months
Secondary outcomes (18)
Baseline Systolic and Diastolic Blood Pressure
Systolic and diastolic BP will be measured according to practice standards. Two readings separated by 1 minute will be averaged
Measured: Baseline
Change in Baseline Systolic and Diastolic Blood Pressure From Baseline
Systolic and diastolic BP will be measured according to practice standards. Two readings separated by 1 minute will be averaged
Measured: 3 months
Change in Baseline Systolic and Diastolic Blood Pressure From Baseline
Systolic and diastolic BP will be measured according to practice standards. Two readings separated by 1 minute will be averaged
Measured: 6 months
Body Mass Index (BMI)
A calibrated electronic scale will be used to record weight and a wall-based stadiometer will be used to record height. Weight and height will be combined to report BMI in kg/m^2.
Measured: Baseline
Change in Body Mass Index (BMI) From Baseline
A calibrated electronic scale will be used to record weight and a wall-based stadiometer will be used to record height. Weight and height will be combined to report BMI in kg/m^2.
Measured: 3 months
Change in Body Mass Index (BMI) From Baseline
A calibrated electronic scale will be used to record weight and a wall-based stadiometer will be used to record height. Weight and height will be combined to report BMI in kg/m^2.
Measured: 6 months
Diabetes Self-management
Measured by the Summary of Diabetes Self-Care Activities questionnaire, a multi-dimensional12-item scale with items on general diet, specific diet, monitoring blood glucose, foot care, and smoking
Measured: Baseline
Change in Diabetes Self-management From Baseline
Measured by the Summary of Diabetes Self-Care Activities questionnaire, a multi-dimensional12-item scale with items on general diet, specific diet, monitoring blood glucose, foot care, and smoking
Measured: 3 months
Change in Diabetes Self-management From Baseline
Measured by the Summary of Diabetes Self-Care Activities questionnaire, a multi-dimensional12-item scale with items on general diet, specific diet, monitoring blood glucose, foot care, and smoking
Measured: 6 months
Dietary Intake
Dietary intake will be evaluated by a two-day diet history
Measured: Baseline
Change in Dietary Intake From Baseline
Dietary intake will be evaluated by a two-day diet history
Measured: 3 months
Change in Dietary Intake From Baseline
Dietary intake will be evaluated by a two-day diet history
Measured: 6 months
Physical Activity
Physical activity will be measured by accelerometer, using the Actigraph Actigraphy, a 3-axial accelerometer.
Measured: Baseline
Change in Physical Activity From Baseline
Physical activity will be measured by accelerometer, using the Actigraph Actigraphy, a 3-axial accelerometer.
Measured: 3 months
Change in Physical Activity From Baseline
Physical activity will be measured by accelerometer, using the Actigraph Actigraphy, a 3-axial accelerometer.
Measured: 6 months
Diabetes Self-Efficacy
Self-efficacy will be measured by the Stanford Diabetes Self-Efficacy Scale, an 8-item scale specific to T2D self-management self-efficacy.
Measured: Baseline
Change in Diabetes Self-Efficacy From Baseline
Self-efficacy will be measured by the Stanford Diabetes Self-Efficacy Scale, an 8-item scale specific to T2D self-management self-efficacy.
Measured: 3 months
Change in Diabetes Self-Efficacy From Baseline
Self-efficacy will be measured by the Stanford Diabetes Self-Efficacy Scale, an 8-item scale specific to T2D self-management self-efficacy.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2017
- Study start8 May 2017
- Primary completion28 Apr 2019
- Study completion30 Jun 2019
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Iberoamericana
- Responsible party
- Sponsor
- Investigators
- Robin Whittemore, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03159299
- Sponsor's protocol ID
- 1511016854
- Status last verified
- Apr 2020
- First submitted
- 4 May 2017
- Last updated
- 27 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Whittemore R, Vilar-Compte M, De La Cerda S, Delvy R, Jeon S, Burrola-Mendez S, Pardo-Carrillo M, Lozano-Marrufo A, Perez-Escamilla R. inverted exclamation markSi, Yo Puedo Vivir Sano con Diabetes! A Self-Management Randomized Controlled Pilot Trial for Low-Income Adults with Type 2 Diabetes in Mexico City. Curr Dev Nutr. 2020 Apr 14;4(5):nzaa074. doi: 10.1093/cdn/nzaa074. eCollection 2020 May.
PubMed 32368713
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yo Puedo! Diabetes Self-Management Education + mHealth in Mexico City
- ClinicalTrials.gov ID
- NCT03159299
- Acronym / sponsor ID
- 1511016854
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- mHealth, Hispanic/Latinos, Diabetes Self-Management Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Universidad Iberoamericana
- Study start
- 8 May 2017 (actual)
- Primary completion
- 28 Apr 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 18 May 2017 (actual)
- Results
- Posted 27 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aims of this study are:
- To translate an evidence-based diabetes self-management education (DSME) program, Yo Puedo!, to the cultural norms, expertise of providers, and systems of care in Seguro Popular clinics in Mexico. The program will be adapted through a collaborative team of diabetes experts in the US and Mexico, Seguro Popular clinic administrators, physicians, nurses and adults with type 2 diabetes (T2D) in Mexico City, Mexico. This will include development and testing of a theory-based mHealth (pictorial text-messaging) component.
- To evaluate the feasibility (process of implementation, fidelity of sessions, attendance, attrition), acceptability (interviews with nurse, CHW, participants) and preliminary efficacy of Yo Puedo!+mHealth in adults with T2D in Mexico City. A randomized, controlled pilot study design will be used in which 40 adults with T2D are randomized to the Yo Puedo! + mHealth or a wait-list control condition with the hypothesis that clinical [A1C, body mass index (BMI), blood pressure (BP)], T2D self-management, and self-efficacy outcomes will be greater in You Puedo!+mHealth participants compared to the wait-list control condition at 3 and 6 month follow-up. A secondary hypothesis that the Yo Puedo! + mHealth program is feasible and acceptable to adults with T2D and providers and that fidelity of the program will be maintained.
Detailed description
This mixed-method design study will be accomplished in two phases with an interdisciplinary, bi-national collaboration between the Yale School of Nursing, the Yale School of Public Health, the Iberoamericana University in Mexico City, and up to 10 Seguro Popular clinics to evaluate the adapted DSME program for adults with T2D in Mexico City.
Phase 1: While the Yo Puedo! program addresses some of the needs of Mexican adults with type 2 diabetes - interactive health education for low health literacy, Spanish language materials and video novellas, and activities to enhance self-efficacy, the program was developed to address the needs of Latino immigrants in the U.S, who are from different Latin countries. The program needs to be adapted to Mexican adults with respect to personal beliefs about disease causation, cultural health practices, self-care practices of type 2 diabetes, and issues regarding access to care. This aim will be accomplished by using an interpretive and participatory method with a collaborative team of diabetes experts in the US and Mexico, Seguro Popular clinic administrators, physicians, and nurses, and adults with T2D in Mexico City, Mexico. In focus groups and interviews, the study team will explore how the cultural context, family, and health system shape beliefs and practices related to T2D. Access and familiarity with texting technology to identify potential barriers to using a text-messaging mHealth program will also be explored. These results will inform any modifications to the Yo Puedo! curriculum that may need to be made before Phase 2 can begin.
Phase 2: A randomized, controlled pilot study design will be used in which 40 adults with T2D are randomized to the Yo Puedo + mHealth or wait-list control condition with the hypothesis that clinical (A1C, BMI, BP), T2D self-management, and self-efficacy outcomes will be greater in Yo Puedo + mHealth participants compared to the wait-list control condition at 3 and 6 month follow-up. It is also hypothesized that the Yo Puedo + mHealth program is feasible and acceptable to adults with T2D and providers, and that fidelity of the program will be maintained. Those in the control group will be invited to participate in the program after completion of the 6-month data collection. Interviews will be conducted with the nurse, community health worker (CHW), participants, and select clinic personnel to identify barriers, facilitators, and acceptability of the program from multiple perspectives, recognizing the complexity of the health care system. Detailed notes on the process of implementation will be carefully recorded with the purpose of identifying successful and unsuccessful components of the program (positive and negative feedback loops in a complex system).
Setting. The study will be conducted in up to 10 Seguro Popular clinics. These clinics are part of the Social Protection System in Health in Mexico. Individuals who obtain health care at these clinics are covered by public health insurance (Seguro Popular), and the services offered for T2D care include medical visits, referrals to specialists and nutritionist when needed, laboratory testing, and free medicines. The medical visits include medication prescription, blood pressure management, lipid monitoring, and eye/foot care. Laboratory analyses vary from patient to patient but generally includes 3 annual tests of A1C, although other glucose, urine, and lipids tests are also available. Patients with complications are referred to specialized health centers. Evidence suggests that the impact of the Seguro Popular in adults with T2D has been positive.
Interventions. All participants will receive standard T2D care at a Seguro Popular clinic as described above. The wait-list control condition group will receive a handout on T2D self-management and the opportunity to participate in the Yo Puedo! + mHealth program at the completion of 6-month data collection. The Yo Puedo! + mHealth DSME program includes: a) an initial consultation with the nurse to collaboratively determine goals; b) five interactive group-based sessions led by the CHW on T2D self-management that is culturally relevant and at a low health literacy level (Yo Puedo! protocol adapted for Mexican context; c) behavioral support to collaboratively problem-solve barriers to change; and d) empowerment-based strategies to facilitate provider-patient communication. The Yo Puedo! program will be supplemented by 2-way text-messaging capability provided by a web-based platform with privacy and security rules, which allows for automated and personalized messages and a database to store all messages. Automated daily text messages will include messages to promote understanding of T2D self-management, self-efficacy, and adherence to self-management goals. The in-person component will be 6 weeks; daily text messaging will be for 6 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yo Puedo | Experimental | Behavioral: Yo Puedo + mHealthThis group will receive the modified Yo Puedo + mHealth program. |
| Wait-list Control | No intervention | –This group will not receive the Yo Puedo + mHealth program during the 6 month data collection period, but will be invited to participate in it after data collection has finished. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- For provider interviews/focus groups: administrator or health care provider at Seguro Popular clinic with at least 3 months experience.
- For adult interviews/focus groups: 21-65 years of age and have had T2D for at least one year
- Age 21-65 years; receiving care for T2D at a Seguro Popular clinic; diagnosed with T2D with A1C >8.0% and duration ≤ 5 years; medically stable and safe to exercise; and have a cell phone (MMS text-messaging will be provided).
Key exclusion criteria (2 listed)
- Cognitive impairment, severe untreated clinical depression in the past 6 months, major cardiac event in past 12 months, uncontrolled blood pressure, resting tachycardia, renal failure, severe peripheral neuropathy, treatment of T2D with insulin, and participation in focus groups or interviews.
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 |
|---|---|---|
| Yo Puedo + mHealthThis intervention is an adapted diabetes self-management education program. Study participants will attend group classes weekly for 6 weeks, and receive daily text messages over 6 months. | Behavioural | Yo Puedo |
Primary outcome
Change in Hemoglobin A1C From Baseline
Time frame: Baseline, 3, 6 months
The change in A1C from baseline to 6 months is the result of the Generalized Linear Mixed Models (GLMM) with an intent-to-treat analysis that was used. HbA1c was measured from finger stick blood sample.
18 secondary outcomes
Baseline Systolic and Diastolic Blood Pressure
Time frame: Baseline
Change in Baseline Systolic and Diastolic Blood Pressure From Baseline
Time frame: 3 months
Change in Baseline Systolic and Diastolic Blood Pressure From Baseline
Time frame: 6 months
Body Mass Index (BMI)
Time frame: Baseline
Change in Body Mass Index (BMI) From Baseline
Time frame: 3 months
Change in Body Mass Index (BMI) From Baseline
Time frame: 6 months
Diabetes Self-management
Time frame: Baseline
Change in Diabetes Self-management From Baseline
Time frame: 3 months
Change in Diabetes Self-management From Baseline
Time frame: 6 months
Dietary Intake
Time frame: Baseline
Change in Dietary Intake From Baseline
Time frame: 3 months
Change in Dietary Intake From Baseline
Time frame: 6 months
Physical Activity
Time frame: Baseline
Change in Physical Activity From Baseline
Time frame: 3 months
Change in Physical Activity From Baseline
Time frame: 6 months
Diabetes Self-Efficacy
Time frame: Baseline
Change in Diabetes Self-Efficacy From Baseline
Time frame: 3 months
Change in Diabetes Self-Efficacy From Baseline
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32368713Whittemore R, Vilar-Compte M, De La Cerda S, Delvy R, Jeon S, Burrola-Mendez S, Pardo-Carrillo M, Lozano-Marrufo A, Perez-Escamilla R. inverted exclamation markSi, Yo Puedo Vivir Sano con Diabetes! A Self-Management Randomized Controlled Pilot Trial for Low-Income Adults with Type 2 Diabetes in Mexico City. Curr Dev Nutr. 2020 Apr 14;4(5):nzaa074. doi: 10.1093/cdn/nzaa074. eCollection 2020 May.
- Individual participant dataSharing planned: Yes
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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.
Robin Whittemore, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yo Puedo + mHealth in people with Type 2 Diabetes Mellitus, run by Yale University 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 5 inclusion and 2 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 27 Apr 2020. 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 27 Apr 2020). 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?
Change in Hemoglobin A1C From Baseline (time frame: Baseline, 3, 6 months). 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 NCT03159299, which also lists 1 linked publication.
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 27 Apr 2020.