Diabetes Mellitus, Type 2EE-CTHNCT02834923
Enhancing Self-Management Support in Diabetes Through Patient Engagement
A study testing Enhanced Engagement Protocol for CTH (EE-CTH) and Connection to Health (CTH) in people with Diabetes Mellitus, Type 2, run by University of California, San Francisco at 1 site in United States.
Trial summary
The Patient Centered Medical Home (PCMH) and the Chronic Care Model (CCM) are complementary clinical intervention frameworks that are commonly invoked to support better type 2 diabetes (T2DM) outcomes in primary care. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Enhanced Engagement Protocol for CTH (EE-CTH) and Connection to Health (CTH)
- 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
- 725 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to 20 Dec 2020
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes;
- Diagnosed and receiving care at participating practices for at least 12 months;
- Able to read in English or Spanish (at least 6th grade level).
Who cannot join
- Not meeting all inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
The Patient Centered Medical Home (PCMH) and the Chronic Care Model (CCM) are complementary clinical intervention frameworks that are commonly invoked to support better type 2 diabetes (T2DM) outcomes in primary care. Self-management Support (SMS) is a core component of both the PCMH and CCM, and focuses on the central role of patients in managing their illness by engaging with and adopting healthy behaviors that promote optimal clinical outcomes. Despite its recognized importance, SMS programs for diabetes continue to demonstrate limited effectiveness in the real-world of primary care.
SMS is comprised of two complementary and interactive components: (1) patient engagement (e.g., the process of eliciting and responding to patients emotions and motivations related to health behaviors), and (2) behavioral change tools (e.g., selecting specific goals, creating action plans). While several sophisticated SMS programs have been developed for T2DM, the vast majority are designed with a narrow focus on behavioral change tools, largely ignoring unique aspects of the patient context that drive and maintain health behavior. Considerable clinical research suggests that the addition of a structured, evidenced-based program of patient engagement can maximize the effectiveness of SMS programs for patients with T2DM in primary care.
To date there has been no systematic study of the degree to which fully integrating enhanced patient engagement as part of SMS will increase the initiation and maintenance of behavior change over time, and for which kinds of patients enhanced patient engagement is essential. To address this gap, the investigators will compare a state-of-the-art, evidence-based SMS behavior change tool program, called Connection to Health (CTH), with an enhanced CTH program that includes a practical, time-efficient patient engagement protocol, to create a program with an integrated and comprehensive approach to SMS, called "Enhanced Engagement CTH" (EE-CTH). The current study will directly test the added benefit of EE-CTH to CTH with regard to self-management behaviors and glycemic control in resource-limited community health centers, where vast numbers of patients with T2DM from ethnically diverse and medically vulnerable populations receive their care. The investigators will use an effectiveness-implementation hybrid design, employing the "Reach Effectiveness Adoption Implementation Maintenance" (RE-AIM) framework to test these two SMS programs for T2DM. This will provide critical information that will support dissemination and implementation of effective SMS programs in resource-limited primary care settings, serving diverse and medically vulnerable populations with much to gain from improved SMS.
Read the detailed description
This is a two-arm, 14 month pragmatic cluster randomized trial to evaluate the added benefit of EE-CTH relative to CTH for patients with T2DM in primary care.
Primary care practices (not patients) will be randomly assigned to receive and deliver CTH or EE-CTH in an innovative effectiveness-implementation hybrid design. Using the RE-AIM framework, the investigators will evaluate program effectiveness in a real world setting, while at the same time gathering information on program reach, adoption, implementation and maintenance. CTH and EE-CTH practice trainings and delivery will each follow separate and standardized protocols, with support provided to practices through staff training, ongoing supervision and case presentations, and a practice improvement team assisted by a practice facilitator to address issues of staffing and patient flow. Practice training and facilitation notes, in conjunction with feedback from patient advisory councils, will be captured and integrated to identify barriers and facilitators to the implementation process and inform dissemination efforts. Beyond the requirements of the study, practices will be permitted to use EE-CTH or CTH with other patients as wished, which will enable the investigators to document the program's reach within the practice. Patients in both study arms will receive the intervention at a minimum of two primary care appointments (baseline and follow-up between 6 and 12 months).
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Enhanced Engagement Protocol for CTH (EE-CTH), Connection to Health (CTH)
- 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.
Enhanced Engagement Protocol for CTH (EE-CTH)Behavioural
EE-CTH integrates CTH with an efficacious, structured, motivational interview (MI)-informed protocol.
Connection to Health (CTH)Behavioural
CTH is a comprehensive SMS program that focuses on behavior change.
| Study group | Role | What they receive |
|---|---|---|
| Connection to Health (CTH) | Active comparator | CTH is a comprehensive SMS program that focuses on behavior change. CTH utilizes web-based interactive behavior change technology, based on a logic model of behavior and maintenance that is informed by social-cognitive and social ecological theories. Prior to diabetes visits with a clinician, health educator, or care manager, patients complete a pre-visit CTH assessment at their practice through a tablet computer or computer kiosk. CTH assesses multiple diabetes management behaviors (diet, physical activity, medication adherence, alcohol and tobacco use, stress, mood) using brief assessment measures, each with cut-points highlighting areas of deficit. Action planning plays a central role, through a web-based platform that allows the patient and health care team to select and set goals collaboratively. Receives: Behavioral: Connection to Health (CTH) |
| Enhanced Engagement Protocol for CTH (EE-CTH) | Experimental | EE-CTH seamlessly integrates CTH with an efficacious, structured, motivational interview (MI)-informed protocol specifically designed to enhance patient engagement in SMS activities. Key components of MI have been incorporated into a practical and systematic engagement protocol that includes: (1) acknowledging the patient's point of view; (2) identifying and labeling the patient's ambivalence (both the good reasons for making the change and the good reasons for not making the change); (3) evaluating whether change is really worth the effort; (4) identifying, reflecting and labeling accompanying feelings and concerns about change; and (5) establishing a small and meaningful goal by the end of the encounter. Receives: Behavioral: Enhanced Engagement Protocol for CTH (EE-CTH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c (glycated haemoglobin)
Percentage HbA1c
Measured: Change from baseline to follow-up (6 to 12 months)
High fat food
Amount of high fat food consumed weekly adapted from the Summary of Diabetes Self-Care Activities
Measured: Change from baseline to follow-up (6 to 12 months)
Physical activity
Number of minutes of participation in physical activity from the International Physical Activity Questionnaire
Measured: Change from baseline to follow-up (6 to 12 months)
Number of days missed medications
Number of days missed missing one or more medications in the past 14 days
Measured: Change from baseline to follow-up (6 to 12 months)
Medication adherence
Frequency of reasons for missing medications.
Measured: Change from baseline to follow-up (6 to 12 months)
Fruit and vegetable intake
Number of daily fruit and vegetable servings adapted from the Summary of Diabetes Self-Care Activities
Measured: Change from baseline to follow-up (6 to 12 months)
Sugar-sweetened beverages
Number of daily sugar-sweetened beverages from the Starting the Conversation Measure
Measured: Change from baseline to follow-up (6 to 12 months)
Secondary outcomes (3)
Health-related distress
Modified from the Diabetes Distress Scale
Measured: Change from baseline to follow-up (6 to 12 months)
Depression symptoms
Patient Health Questionnaire (PHQ8) Score
Measured: Change from baseline to follow-up (6 to 12 months)
Weight
Weight (pounds)
Measured: Change from baseline to follow-up (6 to 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2016 (estimated)
- Study startOct 2016
- Primary completion20 Dec 2020
- Study completion20 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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 University of California, San FranciscoThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 725 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Denver, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
- Investigators
- Danielle M Hessler, Ph.D., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02834923
- Sponsor's protocol ID
- 15-17033
- Other IDs
- R18DK108039-05
- Acronym
- EE-CTH
- Status last verified
- Feb 2021
- First submitted
- 6 Jul 2016
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kroenke K, Strine TW, Spitzer RL, Williams JB, Berry JT, Mokdad AH. The PHQ-8 as a measure of current depression in the general population. J Affect Disord. 2009 Apr;114(1-3):163-73. doi: 10.1016/j.jad.2008.06.026. Epub 2008 Aug 27.
PubMed 18752852Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care. 1986 Jan;24(1):67-74. doi: 10.1097/00005650-198601000-00007.
PubMed 3945130Fisher L, Glasgow RE, Mullan JT, Skaff MM, Polonsky WH. Development of a brief diabetes distress screening instrument. Ann Fam Med. 2008 May-Jun;6(3):246-52. doi: 10.1370/afm.842.
PubMed 18474888Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
PubMed 12900694Toobert DJ, Hampson SE, Glasgow RE. The summary of diabetes self-care activities measure: results from 7 studies and a revised scale. Diabetes Care. 2000 Jul;23(7):943-50. doi: 10.2337/diacare.23.7.943.
PubMed 10895844Paxton AE, Strycker LA, Toobert DJ, Ammerman AS, Glasgow RE. Starting the conversation performance of a brief dietary assessment and intervention tool for health professionals. Am J Prev Med. 2011 Jan;40(1):67-71. doi: 10.1016/j.amepre.2010.10.009.
PubMed 21146770Hessler D, Fisher L, Dickinson M, Dickinson P, Parra J, Potter MB. The impact of enhancing self-management support for diabetes in Community Health Centers through patient engagement and relationship building: a primary care pragmatic cluster-randomized trial. Transl Behav Med. 2022 Oct 7;12(9):909-918. doi: 10.1093/tbm/ibac046.
PubMed 36205473
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Self-Management Support in Diabetes Through Patient Engagement
- ClinicalTrials.gov ID
- NCT02834923
- Acronym / sponsor ID
- EE-CTH / 15-17033
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 725 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- University of Colorado, Denver, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Oct 2016 (actual)
- Primary completion
- 20 Dec 2020 (actual)
- Study completion
- 20 Dec 2020 (actual)
- First posted
- 15 Jul 2016 (estimated)
- 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 Patient Centered Medical Home (PCMH) and the Chronic Care Model (CCM) are complementary clinical intervention frameworks that are commonly invoked to support better type 2 diabetes (T2DM) outcomes in primary care. Self-management Support (SMS) is a core component of both the PCMH and CCM, and focuses on the central role of patients in managing their illness by engaging with and adopting healthy behaviors that promote optimal clinical outcomes. Despite its recognized importance, SMS programs for diabetes continue to demonstrate limited effectiveness in the real-world of primary care.
SMS is comprised of two complementary and interactive components: (1) patient engagement (e.g., the process of eliciting and responding to patients emotions and motivations related to health behaviors), and (2) behavioral change tools (e.g., selecting specific goals, creating action plans). While several sophisticated SMS programs have been developed for T2DM, the vast majority are designed with a narrow focus on behavioral change tools, largely ignoring unique aspects of the patient context that drive and maintain health behavior. Considerable clinical research suggests that the addition of a structured, evidenced-based program of patient engagement can maximize the effectiveness of SMS programs for patients with T2DM in primary care.
To date there has been no systematic study of the degree to which fully integrating enhanced patient engagement as part of SMS will increase the initiation and maintenance of behavior change over time, and for which kinds of patients enhanced patient engagement is essential. To address this gap, the investigators will compare a state-of-the-art, evidence-based SMS behavior change tool program, called Connection to Health (CTH), with an enhanced CTH program that includes a practical, time-efficient patient engagement protocol, to create a program with an integrated and comprehensive approach to SMS, called "Enhanced Engagement CTH" (EE-CTH). The current study will directly test the added benefit of EE-CTH to CTH with regard to self-management behaviors and glycemic control in resource-limited community health centers, where vast numbers of patients with T2DM from ethnically diverse and medically vulnerable populations receive their care. The investigators will use an effectiveness-implementation hybrid design, employing the "Reach Effectiveness Adoption Implementation Maintenance" (RE-AIM) framework to test these two SMS programs for T2DM. This will provide critical information that will support dissemination and implementation of effective SMS programs in resource-limited primary care settings, serving diverse and medically vulnerable populations with much to gain from improved SMS.
Detailed description
This is a two-arm, 14 month pragmatic cluster randomized trial to evaluate the added benefit of EE-CTH relative to CTH for patients with T2DM in primary care.
Primary care practices (not patients) will be randomly assigned to receive and deliver CTH or EE-CTH in an innovative effectiveness-implementation hybrid design. Using the RE-AIM framework, the investigators will evaluate program effectiveness in a real world setting, while at the same time gathering information on program reach, adoption, implementation and maintenance. CTH and EE-CTH practice trainings and delivery will each follow separate and standardized protocols, with support provided to practices through staff training, ongoing supervision and case presentations, and a practice improvement team assisted by a practice facilitator to address issues of staffing and patient flow. Practice training and facilitation notes, in conjunction with feedback from patient advisory councils, will be captured and integrated to identify barriers and facilitators to the implementation process and inform dissemination efforts. Beyond the requirements of the study, practices will be permitted to use EE-CTH or CTH with other patients as wished, which will enable the investigators to document the program's reach within the practice. Patients in both study arms will receive the intervention at a minimum of two primary care appointments (baseline and follow-up between 6 and 12 months).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Connection to Health (CTH) | Active comparator | Behavioral: Connection to Health (CTH)CTH is a comprehensive SMS program that focuses on behavior change. CTH utilizes web-based interactive behavior change technology, based on a logic model of behavior and maintenance that is informed by social-cognitive and social ecological theories. Prior to diabetes visits with a clinician, health educator, or care manager, patients complete a pre-visit CTH assessment at their practice through a tablet computer or computer kiosk. CTH assesses multiple diabetes management behaviors (diet, physical activity, medication adherence, alcohol and tobacco use, stress, mood) using brief assessment measures, each with cut-points highlighting areas of deficit. Action planning plays a central role, through a web-based platform that allows the patient and health care team to select and set goals collaboratively. |
| Enhanced Engagement Protocol for CTH (EE-CTH) | Experimental | Behavioral: Enhanced Engagement Protocol for CTH (EE-CTH)EE-CTH seamlessly integrates CTH with an efficacious, structured, motivational interview (MI)-informed protocol specifically designed to enhance patient engagement in SMS activities. Key components of MI have been incorporated into a practical and systematic engagement protocol that includes: (1) acknowledging the patient's point of view; (2) identifying and labeling the patient's ambivalence (both the good reasons for making the change and the good reasons for not making the change); (3) evaluating whether change is really worth the effort; (4) identifying, reflecting and labeling accompanying feelings and concerns about change; and (5) establishing a small and meaningful goal by the end of the encounter. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 2 diabetes;
- Diagnosed and receiving care at participating practices for at least 12 months;
- Able to read in English or Spanish (at least 6th grade level).
Key exclusion criteria (1 listed)
- Not meeting all inclusion criteria
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 |
|---|---|---|
| Enhanced Engagement Protocol for CTH (EE-CTH)EE-CTH integrates CTH with an efficacious, structured, motivational interview (MI)-informed protocol. | Behavioural | Enhanced Engagement Protocol for CTH (EE-CTH) |
| Connection to Health (CTH)CTH is a comprehensive SMS program that focuses on behavior change. | Behavioural | Connection to Health (CTH) |
Primary outcome
HbA1c (glycated haemoglobin)
Time frame: Change from baseline to follow-up (6 to 12 months)
Percentage HbA1c
High fat food
Time frame: Change from baseline to follow-up (6 to 12 months)
Amount of high fat food consumed weekly adapted from the Summary of Diabetes Self-Care Activities
Physical activity
Time frame: Change from baseline to follow-up (6 to 12 months)
Number of minutes of participation in physical activity from the International Physical Activity Questionnaire
Number of days missed medications
Time frame: Change from baseline to follow-up (6 to 12 months)
Number of days missed missing one or more medications in the past 14 days
Medication adherence
Time frame: Change from baseline to follow-up (6 to 12 months)
Frequency of reasons for missing medications.
Fruit and vegetable intake
Time frame: Change from baseline to follow-up (6 to 12 months)
Number of daily fruit and vegetable servings adapted from the Summary of Diabetes Self-Care Activities
Sugar-sweetened beverages
Time frame: Change from baseline to follow-up (6 to 12 months)
Number of daily sugar-sweetened beverages from the Starting the Conversation Measure
3 secondary outcomes
Health-related distress
Time frame: Change from baseline to follow-up (6 to 12 months)
Depression symptoms
Time frame: Change from baseline to follow-up (6 to 12 months)
Weight
Time frame: Change from baseline to follow-up (6 to 12 months)
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 23 Feb 2021.
- Background: PubMed 18752852Kroenke K, Strine TW, Spitzer RL, Williams JB, Berry JT, Mokdad AH. The PHQ-8 as a measure of current depression in the general population. J Affect Disord. 2009 Apr;114(1-3):163-73. doi: 10.1016/j.jad.2008.06.026. Epub 2008 Aug 27.
- Background: PubMed 3945130Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care. 1986 Jan;24(1):67-74. doi: 10.1097/00005650-198601000-00007.
- Background: PubMed 18474888Fisher L, Glasgow RE, Mullan JT, Skaff MM, Polonsky WH. Development of a brief diabetes distress screening instrument. Ann Fam Med. 2008 May-Jun;6(3):246-52. doi: 10.1370/afm.842.
- Background: PubMed 12900694Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
- Background: PubMed 10895844Toobert DJ, Hampson SE, Glasgow RE. The summary of diabetes self-care activities measure: results from 7 studies and a revised scale. Diabetes Care. 2000 Jul;23(7):943-50. doi: 10.2337/diacare.23.7.943.
- Background: PubMed 21146770Paxton AE, Strycker LA, Toobert DJ, Ammerman AS, Glasgow RE. Starting the conversation performance of a brief dietary assessment and intervention tool for health professionals. Am J Prev Med. 2011 Jan;40(1):67-71. doi: 10.1016/j.amepre.2010.10.009.
- Derived from this study: PubMed 36205473Hessler D, Fisher L, Dickinson M, Dickinson P, Parra J, Potter MB. The impact of enhancing self-management support for diabetes in Community Health Centers through patient engagement and relationship building: a primary care pragmatic cluster-randomized trial. Transl Behav Med. 2022 Oct 7;12(9):909-918. doi: 10.1093/tbm/ibac046.
- Individual participant dataSharing planned: No
Related trials for Diabetes Mellitus, Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
Danielle M Hessler, Ph.D. principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Engagement Protocol for CTH (EE-CTH) and Connection to Health (CTH) in people with Diabetes Mellitus, Type 2, run by University of California, San Francisco 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 3 inclusion and 1 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 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
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?
HbA1c (glycated haemoglobin) (time frame: Change from baseline to follow-up (6 to 12 months)). The study lists 7 primary outcomes in all. 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 NCT02834923, which also lists 7 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 23 Feb 2021.