Type 2 Diabetes MellitusNCT02285881
Shared Decision Making Between Patients and GPs in the Treatment of Type 2 Diabetes in Primary Care.
A study testing Shared decision making in people with Type 2 Diabetes Mellitus, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
Background: Less than 20% of type 2 diabetes mellitus (T2DM) patients in different healthcare settings achieve all treatment goals to prevent cardiometabolic disease. A more personalised approach with shared decision making should increase that percentage. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Shared decision making
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2012to Feb 2016
- 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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Two more or less comparable categories of patients are eligible: 1. if diagnosed with T2DM in 2002-2004 by screening, aged between 50-70 years at that time and having participated in the ADDITION-study that ended in 2009; 2. treated for their T2DM in a practice that participated in the ADDITION study, between 60 and 80 years in 2012-2014 and with a T2DM duration between 8 to 15 years.
Who cannot join
- Patients will be excluded if they have a history of alcoholism, drug abuse, psychosis, personality disorder or another emotional, psychological or intellectual problem that is likely to invalidate informed consent, or limit the ability of the individual to comply with the protocol requirements and patients with a limited life expectancy.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Julius Centre for Health Sciences and Primary Care
Utrecht, 3584CG
About this study
Official title: Shared Decision Making in Type 2 Diabetes With a Support Decision Tool That Takes Into Account Patient Preferences, Clinical Factors and the Intensity of Treatment: Design of a Cluster Randomised Trial
Background: Less than 20% of type 2 diabetes mellitus (T2DM) patients in different healthcare settings achieve all treatment goals to prevent cardiometabolic disease. A more personalised approach with shared decision making should increase that percentage. Because the ADDITION-Europe study demonstrated two (almost) equally effective treatments but with slightly different intensities, it may be a good starting point to discuss with the patients their diabetes treatment, taking into account both the intensity of treatment, clinical factors and patients' preferences. The aim of the study was to evaluate whether such an approach increases the proportion of treatment goals that T2DM patients achieve.
Methods: In a cluster-randomised trial in 40 primary care practices that participated until 2009 in the ADDITION Study, 150 T2DM patients 60 - 80 years, known with T2DM for 8-15 years, will be included. Practices are randomised a second time, i.e. intervention practices in the ADDITION study could be control practices in the current study and vice versa. For the GPs from the intervention group a 2-hour training in shared decision making (SDM) was developed as well as a decision support tool to use during the consultation. These GPs plan the first visit with the patients to decide on the intensity of the treatment, personalised targets and the priorities of treatment. The control group will continue with the treatment they were allocated to in the ADDITION study (treatment-as-before). Follow-up: 24 months. The primary outcome is the proportion of patients who achieve all three treatment goals (HbA1c, blood pressure, total cholesterol) at 24 months. Secondary outcomes are the proportion of patients who achieve five treatment goals (HbA1c, blood pressure, total cholesterol , body weight, not smoking), evaluation of the SDM process (SDM-Q9), satisfaction with the treatment (DTSQ), wellbeing and quality of life (W-BQ12, ADD QoL-19), health status (SF-36, EQ-5D) and coping (DCMQ). The proportions of achieved treatment goals will be compared between groups by estimating the relative risk of meeting the treatment targets. For the secondary outcomes mixed models will be used.
Discussion: To achieve optimal diabetes care with a higher proportion of achieved individualised treatment goals, the SDM approach including a multi-faceted decision support tool might be useful. An intervention with such a support decision tool is designed.
Read the detailed description
See brief summary
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Shared decision making
- Keywords
- diabetes treatment, personalized medicine, shared decision making, goal setting
- 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.
Shared decision makingBehavioural
In the intervention practices the SDM process is used. In the SDM proces the patient and GP use a decision aid to discuss the pros and cons of two evidence based treatment possibilities, according to the Dutch College of General Practitioners (NHG) versus the ADDITION guideline, and the patients' preferences for either of these treatments. Together they choose one of these treatments, and set the five treatment targets (blood pressure, cholesterol, HbA1c, smoking status and weight) in order of priority. Subsequent treatment will take place according to the priorities of these OPTIMAL treatment targets. The priorities will be evaluated every 12 months.
| Study group | Role | What they receive |
|---|---|---|
| shared decision making | Experimental | In the intervention practices the SDM process is used. In the SDM proces the patient and GP use a decision aid to discuss the pros and cons of two evidence based treatment possibilities, according to the Dutch College of General Practitioners (NHG) versus the ADDITION guideline, and the patients' preferences for either of these treatments. Together they choose one of these treatments, and set the five treatment targets (blood pressure, cholesterol, HbA1c, smoking status and weight) in order of priority. Subsequent treatment will take place according to the priorities of these OPTIMAL treatment targets. The priorities will be evaluated every 12 months. Receives: Behavioral: Shared decision making |
| control group | No intervention | Patients in the control practices will receive treatment-as-before, which means that the patients will not be offered the structured SDM process. So the GP will treat the former ADDITION patients as they were used during the period that followed after the ADDITION study (2009), either according to the national guidelines or to the ADDITION intensive treatment algorithm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The between groups difference in the proportion of patients which achieve the treatment goals for HbA1c, blood pressure, and total cholesterol
The proportions of achieved treatment goals of HbA1c, blood pressure, total cholesterol within each study group will by estimated by calculating relative risk. Intention-to-treat analyses (ITT) will be performed to examine between-group differences.
Measured: after 12 months
Secondary outcomes (7)
The difference between groups in the proportion of patients which achieved the five treatment goals for HbA1c, blood pressure, total cholesterol, body weight, and smoking.
The proportions of achieved treatment goals of HbA1c, blood pressure, total cholesterol, body weight, and smoking, within each study group will by estimated by calculating relative risk.
Measured: after 24 months
Characteristics of success for the SDM process in the patients in the intervention group.
Generalized linear models will be used to correct for clustering at practice level. To identify patients who show better results after the SDM process, the analysis for the primary outcome will be repeated with taking into account interaction of SDM with age, gender, education level, duration of diabetes.
Measured: after 24 months
The difference in health related Quality of Life between both groups at 24 months as measured with the Audit of Diabetes Dependent Quality of Life and the European Quality of Life questionnaire.
The ADDQoL-19 measures the perceived impact of diabetes on the quality of life and includes 19 items. Items range from -3 to 3 on different questions, with 0 as the neutral score. Scores below 0 reflect a negative influence of the item on quality of life, and all above 0 reflect positive influences. The EQ-5D covers 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and a Visual Analogue Scale (VAS) where respondents can rate their health. Item scores range from 1-3, and a 5-digit health profile is formed, placing the 5 numbers behind each other.
Difference in health-related quality of life between baseline and 24 months follow-up within each group will be analysed by using paired t-tests. Mixed models will be used to study the between groups differences after two years. We will add random effects for patient and practice.
Measured: after 24 months
The difference in health status between both groups at 24 months as measured with the Short Form-36.
The Short Form-36 (SF-36) is 36-item instrument for the self-evaluation of health status; it includes eight subscales: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. These scales can be summarised in Physical Health and Mental Health. The 36 items differ in the scoring ranges.
Difference in health status between baseline and 24 months follow-up within each group will be analysed by using paired t-tests. Mixed models will be used to study the between groups differences after two years. We will add random effects for patient and practice.
Measured: after 24 months
The difference in well-being between baseline and 24 months within and between both groups as measured with the Well-Being Questionnaire.
The Well-Being Questionnaire (W-BQ12) consists of 12-items in three 4-item subscales: negative well-being (item 1-4, higher score reflects a greater sense of negative well-being), energy (items 6 and 7 are reversed, and then together with 5 and 8 form the total amount of energy) and positive well-being (items 9-12, the higher the score the greater the sense of positive well-being). The total score ranges from 0 to 36 and is called the general well-being score. Higher scores indicate a higher overall sense of well-being.
Difference in wellbeing between baseline and 24 months follow-up within each group will be analysed by using paired t-tests. Mixed models will be used to study the between groups differences after two years. We will add random effects for patient and practice.
Measured: after 24 months
The difference in wellbeing between baseline and 24 months within and between both groups as measured with the Well-Being Questionnaire.
The Well-Being Questionnaire (W-BQ12) consists of 12-items in three 4-item subscales: negative well-being (item 1-4, higher score reflects a greater sense of negative well-being), energy (items 6 and 7 are reversed, and then together with 5 and 8 form the total amount of energy) and positive well-being (items 9-12, the higher the score the greater the sense of positive well-being). The total score ranges from 0 to 36 and is called the general well-being score. Higher scores indicate a higher overall sense of well-being.
Difference in wellbeing between baseline and 24 months follow-up within each group will be analysed by using paired t-tests. Mixed models will be used to study the between groups differences after two years. We will add random effects for patient and practice.
Measured: after 24 months
The difference in coping style between baseline and 24 months within and between both groups as measured with the Diabetes Coping Measurement Questionnaire.
The Diabetes Coping Measurement Questionnaire (DCMQ) consists of 21 items. Overall scores range from 7 to 35. The items are measures on a 5-point Likert scale, ranging from 1 ("disagree") to 5 ("agree strongly") or from 1 ('I strongly agree') to 5 (I 'disagree'). It includes 4 subscales: spirit coping, avoidance coping, passive resignation coping and diabetes integration coping. Higher scores on tackling spirit and diabetes integration indicate more adaptive coping. Higher scores on passive resignation and avoidance indicate poor coping.
Difference in coping style between baseline and 24 months follow-up within each group will be analysed by using paired t-tests. Mixed models will be used to study the between groups differences after two years. We will add random effects for patient and practice.
Measured: after 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2014 (estimated)
- Study startMar 2012
- Primary completionMar 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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 UMC UtrechtThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rimke Vos, UMC Utrecht
- Investigators
- Guy EH Rutten, MD PhD, Principal investigator, Julius Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02285881
- Sponsor's protocol ID
- NL39039.041.11
- Status last verified
- May 2016
- First submitted
- 5 Sep 2014
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: no plan yet, but for data request the authors can be contacted
Publications
Griffin SJ, Borch-Johnsen K, Davies MJ, Khunti K, Rutten GE, Sandbaek A, Sharp SJ, Simmons RK, van den Donk M, Wareham NJ, Lauritzen T. Effect of early intensive multifactorial therapy on 5-year cardiovascular outcomes in individuals with type 2 diabetes detected by screening (ADDITION-Europe): a cluster-randomised trial. Lancet. 2011 Jul 9;378(9786):156-67. doi: 10.1016/S0140-6736(11)60698-3. Epub 2011 Jun 24.
PubMed 21705063Inzucchi SE, Bergenstal RM, Buse JB, Diamant M, Ferrannini E, Nauck M, Peters AL, Tsapas A, Wender R, Matthews DR; American Diabetes Association (ADA); European Association for the Study of Diabetes (EASD). Management of hyperglycemia in type 2 diabetes: a patient-centered approach: position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2012 Jun;35(6):1364-79. doi: 10.2337/dc12-0413. Epub 2012 Apr 19. No abstract available.
PubMed 22517736Stiggelbout AM, Van der Weijden T, De Wit MP, Frosch D, Legare F, Montori VM, Trevena L, Elwyn G. Shared decision making: really putting patients at the centre of healthcare. BMJ. 2012 Jan 27;344:e256. doi: 10.1136/bmj.e256.
PubMed 22286508Wilkinson MJ, Nathan AG, Huang ES. Personalized decision support in type 2 diabetes mellitus: current evidence and future directions. Curr Diab Rep. 2013 Apr;13(2):205-12. doi: 10.1007/s11892-012-0348-6.
PubMed 23160795den Ouden H, Vos RC, Reidsma C, Rutten GE. Shared decision making in type 2 diabetes with a support decision tool that takes into account clinical factors, the intensity of treatment and patient preferences: design of a cluster randomised (OPTIMAL) trial. BMC Fam Pract. 2015 Feb 27;16:27. doi: 10.1186/s12875-015-0230-0.
PubMed 25887759
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shared Decision Making in Type 2 Diabetes With a Support Decision Tool That Takes Into Account Patient Preferences, Clinical Factors and the Intensity of Treatment: Design of a Cluster Randomised Trial
- ClinicalTrials.gov ID
- NCT02285881
- Acronym / sponsor ID
- NL39039.041.11
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- diabetes treatment, personalized medicine, shared decision making, goal setting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 7 Nov 2014 (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.
Background: Less than 20% of type 2 diabetes mellitus (T2DM) patients in different healthcare settings achieve all treatment goals to prevent cardiometabolic disease. A more personalised approach with shared decision making should increase that percentage. Because the ADDITION-Europe study demonstrated two (almost) equally effective treatments but with slightly different intensities, it may be a good starting point to discuss with the patients their diabetes treatment, taking into account both the intensity of treatment, clinical factors and patients' preferences. The aim of the study was to evaluate whether such an approach increases the proportion of treatment goals that T2DM patients achieve.
Methods: In a cluster-randomised trial in 40 primary care practices that participated until 2009 in the ADDITION Study, 150 T2DM patients 60 - 80 years, known with T2DM for 8-15 years, will be included. Practices are randomised a second time, i.e. intervention practices in the ADDITION study could be control practices in the current study and vice versa. For the GPs from the intervention group a 2-hour training in shared decision making (SDM) was developed as well as a decision support tool to use during the consultation. These GPs plan the first visit with the patients to decide on the intensity of the treatment, personalised targets and the priorities of treatment. The control group will continue with the treatment they were allocated to in the ADDITION study (treatment-as-before). Follow-up: 24 months. The primary outcome is the proportion of patients who achieve all three treatment goals (HbA1c, blood pressure, total cholesterol) at 24 months. Secondary outcomes are the proportion of patients who achieve five treatment goals (HbA1c, blood pressure, total cholesterol , body weight, not smoking), evaluation of the SDM process (SDM-Q9), satisfaction with the treatment (DTSQ), wellbeing and quality of life (W-BQ12, ADD QoL-19), health status (SF-36, EQ-5D) and coping (DCMQ). The proportions of achieved treatment goals will be compared between groups by estimating the relative risk of meeting the treatment targets. For the secondary outcomes mixed models will be used.
Discussion: To achieve optimal diabetes care with a higher proportion of achieved individualised treatment goals, the SDM approach including a multi-faceted decision support tool might be useful. An intervention with such a support decision tool is designed.
Detailed description
See brief summary
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| shared decision making | Experimental | Behavioral: Shared decision makingIn the intervention practices the SDM process is used. In the SDM proces the patient and GP use a decision aid to discuss the pros and cons of two evidence based treatment possibilities, according to the Dutch College of General Practitioners (NHG) versus the ADDITION guideline, and the patients' preferences for either of these treatments. Together they choose one of these treatments, and set the five treatment targets (blood pressure, cholesterol, HbA1c, smoking status and weight) in order of priority. Subsequent treatment will take place according to the priorities of these OPTIMAL treatment targets. The priorities will be evaluated every 12 months. |
| control group | No intervention | –Patients in the control practices will receive treatment-as-before, which means that the patients will not be offered the structured SDM process. So the GP will treat the former ADDITION patients as they were used during the period that followed after the ADDITION study (2009), either according to the national guidelines or to the ADDITION intensive treatment algorithm. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Two more or less comparable categories of patients are eligible: 1. if diagnosed with T2DM in 2002-2004 by screening, aged between 50-70 years at that time and having participated in the ADDITION-study that ended in 2009; 2. treated for their T2DM in a practice that participated in the ADDITION study, between 60 and 80 years in 2012-2014 and with a T2DM duration between 8 to 15 years.
Key exclusion criteria (1 listed)
- Patients will be excluded if they have a history of alcoholism, drug abuse, psychosis, personality disorder or another emotional, psychological or intellectual problem that is likely to invalidate informed consent, or limit the ability of the individual to comply with the protocol requirements and patients with a limited life expectancy.
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 |
|---|---|---|
| Shared decision makingIn the intervention practices the SDM process is used. In the SDM proces the patient and GP use a decision aid to discuss the pros and cons of two evidence based treatment possibilities, according to the Dutch College of General Practitioners (NHG) versus the ADDITION guideline, and the patients' preferences for either of these treatments. Together they choose one of these treatments, and set the five treatment targets (blood pressure, cholesterol, HbA1c, smoking status and weight) in order of priority. Subsequent treatment will take place according to the priorities of these OPTIMAL treatment targets. The priorities will be evaluated every 12 months. | Behavioural | shared decision making |
Primary outcome
The between groups difference in the proportion of patients which achieve the treatment goals for HbA1c, blood pressure, and total cholesterol
Time frame: after 12 months
The proportions of achieved treatment goals of HbA1c, blood pressure, total cholesterol within each study group will by estimated by calculating relative risk. Intention-to-treat analyses (ITT) will be performed to examine between-group differences.
7 secondary outcomes
The difference between groups in the proportion of patients which achieved the five treatment goals for HbA1c, blood pressure, total cholesterol, body weight, and smoking.
Time frame: after 24 months
Characteristics of success for the SDM process in the patients in the intervention group.
Time frame: after 24 months
The difference in health related Quality of Life between both groups at 24 months as measured with the Audit of Diabetes Dependent Quality of Life and the European Quality of Life questionnaire.
Time frame: after 24 months
The difference in health status between both groups at 24 months as measured with the Short Form-36.
Time frame: after 24 months
The difference in well-being between baseline and 24 months within and between both groups as measured with the Well-Being Questionnaire.
Time frame: after 24 months
The difference in wellbeing between baseline and 24 months within and between both groups as measured with the Well-Being Questionnaire.
Time frame: after 24 months
The difference in coping style between baseline and 24 months within and between both groups as measured with the Diabetes Coping Measurement Questionnaire.
Time frame: after 24 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 13 May 2016.
- Background: PubMed 21705063Griffin SJ, Borch-Johnsen K, Davies MJ, Khunti K, Rutten GE, Sandbaek A, Sharp SJ, Simmons RK, van den Donk M, Wareham NJ, Lauritzen T. Effect of early intensive multifactorial therapy on 5-year cardiovascular outcomes in individuals with type 2 diabetes detected by screening (ADDITION-Europe): a cluster-randomised trial. Lancet. 2011 Jul 9;378(9786):156-67. doi: 10.1016/S0140-6736(11)60698-3. Epub 2011 Jun 24.
- Background: PubMed 22517736Inzucchi SE, Bergenstal RM, Buse JB, Diamant M, Ferrannini E, Nauck M, Peters AL, Tsapas A, Wender R, Matthews DR; American Diabetes Association (ADA); European Association for the Study of Diabetes (EASD). Management of hyperglycemia in type 2 diabetes: a patient-centered approach: position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2012 Jun;35(6):1364-79. doi: 10.2337/dc12-0413. Epub 2012 Apr 19. No abstract available.
- Background: PubMed 22286508Stiggelbout AM, Van der Weijden T, De Wit MP, Frosch D, Legare F, Montori VM, Trevena L, Elwyn G. Shared decision making: really putting patients at the centre of healthcare. BMJ. 2012 Jan 27;344:e256. doi: 10.1136/bmj.e256.
- Background: PubMed 23160795Wilkinson MJ, Nathan AG, Huang ES. Personalized decision support in type 2 diabetes mellitus: current evidence and future directions. Curr Diab Rep. 2013 Apr;13(2):205-12. doi: 10.1007/s11892-012-0348-6.
- Derived from this study: PubMed 25887759den Ouden H, Vos RC, Reidsma C, Rutten GE. Shared decision making in type 2 diabetes with a support decision tool that takes into account clinical factors, the intensity of treatment and patient preferences: design of a cluster randomised (OPTIMAL) trial. BMC Fam Pract. 2015 Feb 27;16:27. doi: 10.1186/s12875-015-0230-0.
- Individual participant dataSharing planned: Undecided. no plan yet, but for data request the authors can be contacted
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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.
Guy EH Rutten, MD PhD principal investigator
Julius Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shared decision making in people with Type 2 Diabetes Mellitus, run by UMC Utrecht at 1 site in Netherlands.
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 1 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 13 May 2016. 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 Netherlands. 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?
The between groups difference in the proportion of patients which achieve the treatment goals for HbA1c, blood pressure, and total cholesterol (time frame: after 12 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 NCT02285881, which also lists 5 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 13 May 2016.