Open access Protocol BMJ Open: first published as 10.1136/bmjopen-2019-033725 on 23 June 2020. Downloaded from http://bmjopen.bmj.com/ on October 30, 2023 at Univesity Autonomous of Barcelona. Effectiveness of a comprehensive care protocol in patients with new diagnoses of type 2 diabetes mellitus and associated comorbidities in primary care: study protocol of a quasi-­ experimental trial Carolina Lapena ‍ ‍,1,2 Enriqueta Borràs,3 Clarisa Digon,4 Rosa Aznar,1 Jose Luis del Val Garcia,2,5 Esmeralda Castelblanco ‍ ‍,6,7 Ana Garaikoetxea,1 Vicencia Laguna1 To cite: Lapena C, Borràs E, Abstract Digon C, et al. Effectiveness Introduction Type 2 diabetes mellitus (T2DM) is Strengths and limitations of this study of a comprehensive care a highly prevalent chronic disease in the Spanish protocol in patients with new ►► Separation between with the intervention and stan- population. Typically, T2DM is associated with other diagnoses of type 2 diabetes dard care centres is planned to minimise the risk of chronic conditions. Intensive medication at the time of mellitus and associated contamination. Protected by copyright. comorbidities in primary care: diagnosis has proven effective in reducing cardiovascular ►► The support materials follow the recommendations study protocol of a quasi-­ risk, improving glycaemic control and preventing T2DM of the guidelines, were reviewed by healthcare pro- experimental trial. BMJ Open complications. However, it has not yet been demonstrated fessionals for content accuracy and were evaluated 2020;10:e033725. doi:10.1136/ that a comprehensive and intensive health education by patients for their full understanding. bmjopen-2019-033725 protocol at the time of diagnosis has the benefits ►► The absence of participant randomisation is a described previously. Currently, there is great variability ►► Prepublication history and limitation. additional material for this in the practices of primary care nurses regarding health ►► The questionnaire used to measure health-­related paper are available online. To education at the time of disease diagnosis. quality of life is not specific to people with diabetes. view these files, please visit We aimed to evaluate the effectiveness of a systematic the journal online (http://​dx.​doi.​ protocol with a comprehensive care programme in people org/​10.​1136/​bmjopen-​2019-​ with newly diagnosed T2DM with associated comorbidities. Introduction 033725). Methods and analysis A multicentre quasi-­experimental Type 2 diabetes mellitus (T2DM) comprises design comparing a group of individuals taking part in the Received 19 August 2019 intervention (intervention group (IG)) with a similar group more than 90% of people with diabetes Revised 22 April 2020 worldwide. It was estimated that in 2017, receiving standard diabetes care (comparison group (CG)) Accepted 01 May 2020 there were 451 million (age 18–99 years) is planned. The intervention will take place during the 3 months after study enrolment. Data will be collected people with diabetes worldwide. Projections at baseline and at 3, 6 and 12 months. Ten primary care indicate that this figure will increase over centres in Barcelona city will be selected for participation: the years to approximately 693 million by 5 for the IG and 5 for the CG. The IG will include five 2045.1 In the Spanish population, almost structured individual visits postdiagnosis with the primary 30% of individuals have some type of distur- care nurse, during which aspects of diabetes education bance of glycaemic status (dysglycaemia), will be discussed with the patient and his/her family. and 13.8% have diabetes, of which approxi- The results will be measured in terms of health-­related mately 50% had unknown diabetes.2 3 Addi- quality of life and the change in main outcomes (glycated © Author(s) (or their tionally, chronic diabetes complications have employer(s)) 2020. Re-­use haemoglobin and weight). Ethics and dissemination The study fully met the an important impact on the quality of life of permitted under CC BY-­NC. No commercial re-­use. See rights requirements of the Ethical Committee of Clinical patients and a high human cost, both from and permissions. Published by Investigation of the IDIAP Jordi Gol (approval code: the social and the economic perspectives.1 2 4 BMJ. P13/118). Patients will be informed that their data are The care of people with diabetes in For numbered affiliations see confidential, and they have the right to withdraw at any primary care poses a major challenge due end of article. time without penalty. Dissemination will include publishing to their multiple comorbidities that demand the findings in peer-­reviewed journals and sharing our continuous efforts to make appropriate Correspondence to findings at scientific conferences. recommendations for self-­management and Mrs Carolina Lapena; Trial registration number NCT03990857; Pre-­results. ​clapena@​gencat.​cat medication in a stepwise manner to achieve Lapena C, et al. BMJ Open 2020;10:e033725. doi:10.1136/bmjopen-2019-033725 1 Open access BMJ Open: first published as 10.1136/bmjopen-2019-033725 on 23 June 2020. Downloaded from http://bmjopen.bmj.com/ on October 30, 2023 at Univesity Autonomous of Barcelona. evidence-­based targets. The three core pillars of T2DM pilot study, reported that the intervention was effective in management and prevention of its complications are terms of clinical results, educational results and patient drug treatment, changes in lifestyle and education. In this satisfaction.25 Although there is favourable evidence, in sense, an intensive approach to the disease, especially at the Spanish primary care setting, there are few specific the time of diagnosis, can contribute to the prevention of sustainable programmes of structured education for both microangiopathic complications and cardiovascular people with a new diagnosis of T2DM, and they do not events, regardless of the degree of glycaemic control in incorporate other prevalent diseases. Thus, it is evident more advanced stages.5 It is uncertain, however, whether that an ample room of improvement in the protocols used intensive control of the disease in more advanced stages, in the care of patients with a recent diabetes diagnosis particularly in older patients with coexisting chronic exists, especially those with multiple comorbidities that complications or significant comorbidity, has benefits can be easily adaptable to daily practice in the Spanish in terms of macrovascular complications and global primary care setting. mortality.6 7 The benefits of controlling T2DM and its accompa- Aims and objectives nying cardiovascular risk factors are well established in The primary aim of this study was to determine the clinical practice guidelines.8–11 Current guidelines for effectiveness of a systematic application of a compre- the prevention and management of T2DM point to the hensive care protocol for people with a recent (less than need to implement changes in lifestyle, such as diet and 5 months) diagnosis of T2DM with associated comorbid- exercise, as crucial elements of treatment12 13; however, ities, on health-­related quality of life (HRQoL), weight a major focus of drug treatment (including multiple loss and HbA1c in primary healthcare centres when combinations) is to reduce blood glucose and the associ- compared with usual care. ated elevated risks of cardiovascular disease.14 15 Evidence The secondary objective was to evaluate the effective- from cross-­ sectional studies indicates that there are ness of the comprehensive care protocol compared with barriers and difficulties in achieving these treatment usual care on parameters as blood pressure, lipid profile, objectives.16 17 However, some studies have also shown the waist circumference, medication consumption, adher- positive changes in main outcomes.18–20 Previous studies ence to dietary recommendations, measures of physical Protected by copyright. have also shown the benefits of glycaemic control on activity, frequency of visits to the primary care centre and microvascular risk if drug intensification occurs at the participant satisfaction. onset of T2DM.21 Furthermore, lifestyle interventions, that is, increasing physical activity, reducing caloric intake and education regarding treatment adherence, have also Methods and analysis demonstrated a reduction of new T2DM diagnoses, a Study design reduction of glycaemic control (HbA1c) by training exer- A multicentre quantitative quasi-­ experimental design cise, improvements in cardiovascular disease in patients with a 1-­year follow-­up of patients with a recent diag- with T2DM and a reduction in urgent care visits and nostic of T2DM (less than 5 months) with comorbidities hospitalisations for preventable diabetes-­ related condi- (hypertension, dyslipidaemia and obesity) will be used tions.22–29 Additional studies involving weight loss of at to compare the effectiveness of a comprehensive care least 10–15 kg have also achieved normalisation of blood protocol. Selection of the centres with intervention group glucose in people with short-­duration T2DM.30 (IG) and comparison group (CG) will be randomised. A Therapeutic education is an ongoing process that aims computerised random integer programme will be used to to provide knowledge, skills and abilities necessary for the refer worksites to condition. Cluster randomisation of the self-­care of people with chronic diseases. According to the centres will be adopted to increase the feasibility of roll-­out latest recommendations of the American Diabetes Associ- in the organisational setting and minimise contamination ation, everyone with diabetes should be part of education across conditions. The IG will receive intensive education programmes from the moment of diagnosis.13 In coun- and support, and the CG will receive standard care. In the tries such as the UK, there are educational programmes calculation of the sample, the cluster effect attributable to focused on the onset of T2DM (DESMOND Newly Diag- this design has been considered. The CG will know that nosed Programme).31 32 Some clinical trials, both at the they are not providing the intervention, although they do primary level and in managed care, have shown signif- not know what it is. The outcome variables will be eval- icant improvements in the goals of better control of uated in both groups at baseline and after 3, 6 and 12 T2DM, especially when nurses have a higher degree of months of inclusion in the study (figure 1). autonomy.15 22 23 In Spain, there are prevention strategies33 and training Scope of the study initiatives among peers.34 Furthermore, the RedGEDAPS The study will be developed in 10 primary care health quality of care programme showed an improvement in centres of the same urban district in the city of Barce- the quality care indicators of T2DM.35 A study on T2DM lona: Passeig Sant Joan, Carles I, Joanic, Vila de Gràcia, onset, such as the Health Care and Therapeutic Educa- Sanllehy (coordinating centre), La Sagrera, Congrès, tion Programme for Newly Diagnosed Type 2 Diabetes Encants, Camp de’lArpa and Guinardó. These 10 centres 2 Lapena C, et al. BMJ Open 2020;10:e033725. doi:10.1136/bmjopen-2019-033725 Open access BMJ Open: first published as 10.1136/bmjopen-2019-033725 on 23 June 2020. Downloaded from http://bmjopen.bmj.com/ on October 30, 2023 at Univesity Autonomous of Barcelona. Protected by copyright. Figure 1 Flowchart of the intervention study. DLP, dyslipidaemia; HT, hypertension; T2DM, type 2 diabetes mellitus. were selected because they belong to the reference area of​​ two chronic conditions, and the remaining 30% have the Hospital de la Santa Creu i Sant Pau and are managed three or more. Moreover, 41% are overweight and 42% by the Institut Català de la Salut. Centres run by indepen- are obese. The inclusion criteria are listed in table 1. All dent healthcare providers were not included in the study. procedures and interventions for patient care are allowed Five centres will be assigned to the IG, and the other five except for participation in a similar protocol during the centres will be assigned to the CG by the research team. study. Subjects of the study Recruitment process The 10 participating primary care centres serve a popula- Eligible patient participants will be identified through tion of 225 857, from which newly diagnosed T2DM cases the general practitioners and nurses of the primary care (less than 5 months) that fulfil the inclusion criteria will health centres. These professionals will be asked to refer be invited to participate; patients will be enrolled on their patients who meet the inclusion criteria. Furthermore, consent to participate. Electronic medical records from the list of new diagnoses of T2DM with comorbidities the Barcelona urban area report a T2DM prevalence of provided by the information systems and healthcare 7.02% in subjects over 18 years old, with up to 71.8% quality unit (Unitat d'Avaluació, Sistemes d'Informació i in clinical risk groups six or seven of low or medium Qualitat Assistencial, BASIQ) will be reviewed monthly. severity, that is, significant chronic diseases in multiple Patients who fulfil the inclusion criteria will be invited organ systems with at least one (group 6) or two (group to participate in the study. Then, baseline data will be 7) dominant chronic diseases.36 The target population of collected after obtaining written informed consent. patients with T2DM with comorbidities of low or medium severity presents 80% arterial hypertension, 13.5% isch- Sample size aemic cardiovascular problems, 9.3% chronic obstructive The change in HRQoL score at 6 months from enrolment pulmonary disease, 8.8% stroke, 8.1% renal insufficiency is the primary effectiveness endpoint. We will recruit and and 4.8% heart failure. Up to 70% of these subjects have follow 123 participants per group for 2 years to detect a Lapena C, et al. BMJ Open 2020;10:e033725. doi:10.1136/bmjopen-2019-033725 3 Open access BMJ Open: first published as 10.1136/bmjopen-2019-033725 on 23 June 2020. Downloaded from http://bmjopen.bmj.com/ on October 30, 2023 at Univesity Autonomous of Barcelona. Table 1 Inclusion criteria for patients in the study Inclusion Exclusion ►► Age between 18 and 80 years old. ►► Participation in another clinical trial or a similar ►► A recent (less than 5 months) diagnosis of type 2 diabetes. project. ►► Two of the following comorbidities: previous diagnosed ►► Serious health problems: psychiatric or terminal hypertension (≥140/≥90),* dyslipidaemia (cholesterol>200 mg/dL diseases. or ≥250 mg/dL depending of CVRF)† and/or obesity (BMI ≥30) ►► Difficulties in maintaining participation for 1 year. ►► Adequate Catalan or Spanish literacy to complete the assessments. *Clinical practice guidelines on arterial hypertension.45 †Clinical practice guidelines on cholesterol and coronary risk.46 BMI, body mass index; CVRF, cardiovascular risk factor. difference of 20% in HRQoL, accepting an alfa risk of and anxiety/depression. Each dimension has three 0.05 and a beta risk of 0.2, and assuming a design effect levels (no problems, some problems and extreme of 1.2. Additionally, we took into account an estimated problems). This scale can be converted to a unique 10% participant loss and differences between the groups. index. The utility index of quality of life was also The sample size was calculated based on the expected created based on previous studies.38 39 As a result of improvement of the HRQoL of the participants. It was an intervention aimed at improving the control of assumed that 70% of participants who receive the inter- chronic diseases and minimising their complica- vention will improve his/her HRQoL and that only 50% tions, the quality of life of the people served is a main of participants who receive standard care will improve. outcome. According to the diabetes incidence of 5.3/1000 patients/ ►► Prevention with Mediterranean Diet (PREDIMED) year reported in primary healthcare centres in Barcelona questionnaire.40 This is a tool consisting of 14 items city in 2018, a sufficiently large number of patients with Protected by copyright. aimed at measuring adherence to the Mediterranean a new diagnosis of T2DM will be available to fulfil the diet. This indicator will allow us to assess how knowl- sample size.25 edge has been incorporated by modifying life habits related to diet. Data collection and follow-up ►► International Physical Activity Questionnaire The primary endpoints are the change in HRQoL, (IPAQ).41 42 IPAQ is an instrument for monitoring glycaemic control (HbA1c) and weight loss at 6 and 12 physical activity and inactivity. Data from the short months from baseline. The data collection will be carried IPAQ form will be summarised according to the out simultaneously through self-­administered question- physical activities recorded (walking, moderate and naires (quality of life, diet and physical activity) and the measurement of biological variables in both groups, vigorous activities) and the estimated time spent intervention and comparison, before initiating the inter- sitting per week. Data will be used to estimate the vention, after the intervention (3 months), and 6 and 12 total weekly physical activity by weighting the reported months after the intervention. A specific evaluation of the minutes per week within each activity category by a knowledge acquired will not be carried out, but its incor- the metabolic equivalent energy expenditure esti- poration into the patients' lives will be reflected in the mate assigned to each category of activity. This indi- improvement of diabetes control and their quality of life. cator will allow us to assess the modification of lifestyle Original study questionnaires will be entered and kept on habits related to exercise. file at the participating centre or the coordinating centre. ►► Satisfaction Questionnaire adapted from the ques- All data will be recorded by a nurse in every centre, and tionnaire of the Catalan Health Service. This is a monthly data with any identifying participant informa- generic tool used as a measure of satisfaction level of tion removed will be sent to the coordinating centre. All participants regarding the attention, instruction and investigators will be given access to the cleaned datasets. material received during the intervention. Partici- Recruitment and follow-­up began in September 2019, pants will be asked to complete this questionnaire and we expect to end in September 2021. to measure their satisfaction level with the provided The following data will be collected from participants, attention in the primary healthcare centres after their when appropriate, using validated tools at baseline, after T2DM diagnosis. the intervention period (3 months), and at 6 and 12 Patient demographics such as age, gender, marital status months: (single/married/divorced/widowed), cohabitation status 37 ►► EuroQol-­5D (EQ-­5D-­3L) questionnaire. This is (living alone/living with someone else), educational level a generic tool used as a measure of HRQoL. This (illiterate/primary/secondary/university) and employ- tool obtains information through five dimensions: ment (currently working/unemployed/retired) will be mobility, self-­ care, usual activities, pain/discomfort collected. The patients’ medical records will be reviewed 4 Lapena C, et al. BMJ Open 2020;10:e033725. doi:10.1136/bmjopen-2019-033725 Open access BMJ Open: first published as 10.1136/bmjopen-2019-033725 on 23 June 2020. Downloaded from http://bmjopen.bmj.com/ on October 30, 2023 at Univesity Autonomous of Barcelona. Figure 2 Structured intensive intervention and data collection. to obtain clinical and medication histories. Further, 1. What is diabetes? General concepts and cardiovascular chronic pathologies and their diagnosis dates, tobacco risk factors. and alcohol consumption, and use of healthcare services 2. Physical exercise and healthy diet. Protected by copyright. in the last year will be collected at baseline and at the 3. Pharmacological treatment. end of the study. We will also collect specific biological 4. Toxic habits, stress and foot care. variables related to T2DM and associated comorbidities: 5. Myths of diabetes: tracking tests and alarm signals. HbA1c, weight, BMI, abdominal perimeter, blood pres- The research team developed the support materials sure and cholesterol. All these variables will allow us to that contain the minimum contents that every patient determine the clinical impact of this project. newly diagnosed with T2DM and other chronic pathol- ogies should know, based on a previous review of the Intervention recommendations of the clinical practice guidelines of The intervention consists of an intensive health educa- reference. These support materials were approved by tion protocol offered after the diagnosis of T2DM (less the hospital diabetes educators and family doctors in the than 5 months) (see figure 2). It provides a triple action area. A graphic designer was hired to give the materials to address all the aspects that influence the good manage- an attractive and enticing design. The materials were vali- ment of T2DM and a commitment to self-­care: ►► Knowledge: about the T2DM and associated comor- dated with a group of patients who verified their utility bidities (offering the minimum needed but allowing and intelligibility. The support materials integrate all the providers to tailor it for each person), the warnings agreed on minimum knowledge in a structured way and signs and the necessary monitoring tests. allow for the incorporation of cultural and emotional ►► Abilities: how to perform self-­care. aspects. It is delivered to and discussed with the patient ►► Act/motivation: how to engage in self-­care. during the intervention. Once the five sessions finish, the This comprehensive approach is developed sequen- patient will have consultation and reinforcement material tially in the primary care nurse office. Five individual that can be reconsulted when deemed appropriate. intensive visits will be carried out with a weekly or In the IG group, once this first stage of higher intensity biweekly frequency (according to the learning process) care has been completed, during which each patient must to obtain all the necessary information for compre- integrate the knowledge and skills necessary to assume hensive care and to transfer the knowledge and skills his/her self-­care and proper management of diabetes, that are required for the proper management of the the patients will continue their individual follow-­up with disease. The maximum time expected to complete their general practitioners, with the frequency established these five visits is 3 months. During at least one of the according to the associated comorbidities in each case visits, preferably the one that deals with dietary aspects, as in the usual care group. The nurses of all centres will the patient will be asked to attend with her/his partner, participate in two to four sessions to explain the study and child or cohabitants. the variables to be collected. Furthermore, the nurses of The five modules address the following: the centres in which the intervention will be carried out Lapena C, et al. BMJ Open 2020;10:e033725. doi:10.1136/bmjopen-2019-033725 5 Open access BMJ Open: first published as 10.1136/bmjopen-2019-033725 on 23 June 2020. Downloaded from http://bmjopen.bmj.com/ on October 30, 2023 at Univesity Autonomous of Barcelona. will undergo specific training. This training will consist analysis, unadjusted estimates will also be presented of a detailed explanation of the intervention, the partic- in different scenarios to assess the robustness of the ipant support materials will be reviewed and delivered, results. Additionally, two subgroups will be evaluated and a written guide specifically developed to unify the to give robustness to the results: the intention-­to-­treat criteria when carrying out the therapeutic education will subgroup, which will consider all participants assigned to also be given to the nurses. The time calculated to recruit each group independently of whether they complete the the individuals needed for the study and follow them is entire protocol or not, and the ‘per protocol’ subgroup. 2 years. Since the nurses in the study will be the patient's The criterion for per protocol subgroup assignment will usual primary care nurse, we anticipate that the nurse's be completion of the entire protocol. The analysis will relationship with each participant will help promote be carried out according to the statistical analysis plan. patient permanence in the study. Participants who have The 95% CIs and p values will be computed with robust missed a visit will be contacted by phone by the nurse to SEs to account for the cluster design sample, and statis- invite them to a new visit. tical significance will be established as a p value of <0.05. Statistical analysis will be performed using SPSS software Monitoring V.22. The monitoring committee will consist of four nurses from the research team. These nurses will remind Ethics and dissemination monthly the nurse in charge of each primary care health Ethics approval for this study, including all sites, has been centre to present reports of the data already collected, obtained from the Ethical Committee of Clinical Investiga- send the lists of newly diagnosed and pending data, and tion of the IDIAP Jordi Gol (approval code: P13/118). All remind information regarding the intervention and data recruited patients will be informed by the nurses, verbally collection (figure 2). Preliminary extractions will be and in writing, about the objectives, methodology, tests made to assess the evolution of the study and the quality and interventions they may receive if they participate in of the information collected. The end of the trial will the study. They will be included if they grant their permis- be when the required study sample is reached; we esti- sion and sign the informed consent form (online supple- mate that this will take 2 years. The centre nurses will be Protected by copyright. mentary file) in writing. This document will be written in blinded for the results of the interim analyses at 3 and a language (Spanish and Catalan) that the patients can 6 months. Nurses from participating centres will send the understand. All participant information will be stored possible adverse events to the research team, and partic- in locked file cabinets in areas with limited access. Local ipants can express any discomfort in the Satisfaction databases will be secured with password-­protected access Questionnaire. Meetings with researchers will be held in systems. Any modifications to the protocol will require a the participating centres to promote knowledge, unify formal amendment to the protocol and acceptance by criteria and exchange information before the start of the the ethical committee. We plan to publish the findings in study and every 6 months. The nurses of the participating peer-­reviewed journals and share our findings at scientific centres will have at their disposal the telephone number conferences. The investigators will consider authorship and email of two researchers to answer any question that following widely accepted criteria. may arise during the recruitment and follow-­up process. At least, monthly contacts and information exchange will be made between the nurses of each centre. Limitations of the study This protocol has some weaknesses. First, the allocation Patient and public involvement of the participants in the study will not be randomised. No patients were involved in this study. To avoid possible contamination of the staff who perform the intervention and those who provide standard care, Data analysis plan every centre will have only one group of participants. Initial data analysis will be performed to debug and Second, the grouping of the participants may be biassed if validate the data entered into the dataset. Initially, base- the homogeneity conditions are not met. These possible line characteristics of both groups will be evaluated to differences between groups have been taken into account assess homogeneity in age, comorbidities and expo- for the calculation of the sample size. Third, the ques- sure. To assess the comparability of baseline character- tionnaire that will be used to measure the HRQoL is istics between the study groups, we will use a χ2 test or not specific to people with diabetes. However, this ques- Fisher’s exact test for nominal variables and Student’s tionnaire is extensively used in interventional studies t-­test or the Mann-­Whitney test for continuous variables. involving patients with different diseases.43 44 Fourth, The changes in main outcomes will also be assessed, we do not assess the behaviour change of health profes- by group, for the different periods, using a multilevel sionals who are responsible for delivering the interven- model, such as a linear mixed model, at baseline, 3, 6 tion. Finally, acquired knowledge has not been evaluated and 12 months adjusted by the centre. Estimations will as an outcome in this study; instead, we will evaluate the be adjusted by significant variables in univariate anal- changes in lifestyles, which are an expression of the newly yses and other clinically relevant factors. As a sensitivity acquired knowledge during the intervention. 6 Lapena C, et al. BMJ Open 2020;10:e033725. doi:10.1136/bmjopen-2019-033725 Open access BMJ Open: first published as 10.1136/bmjopen-2019-033725 on 23 June 2020. Downloaded from http://bmjopen.bmj.com/ on October 30, 2023 at Univesity Autonomous of Barcelona. Author affiliations 5 Patel A, MacMahon S, et al, ADVANCE Collaborative Group, 1 Centre d’Atenció Primària Sanllehy, Gerència d’Àmbit d’Atenció Primària Barcelona ADVANCE Collaborative Group. Intensive blood glucose control and Ciutat, Institut Català de la Salut, Barcelona, Spain vascular outcomes in patients with type 2 diabetes. N Engl J Med 2 2008;358:2560–72. Unitat de Suport a la Recerca Barcelona Ciutat, Fundació Institut Universitari 6 Gerstein HC, Miller ME, Byington RP, et al. Action to control per a la recerca en Atenció Primària de Salut Jordi Gol i Gurina (IDIAP Jordi Gol), cardiovascular risk in diabetes Study Group. Effects of intensive Barcelona, Spain glucose lowering in type 2 diabetes. N Engl J Med2008;358:2545–59. 3 Gerència Territorial de Barcelona Ciutat, Institut Català de la Salut, Barcelona, 7 Lipska KJ, Krumholz H, Soones T, et al. Polypharmacy in the aging Spain patient: a review of glycemic control in older adults with type 2 4 Centre d’Atenció Primària Sagrera, Gerència d’Àmbit d’Atenció Primària Barcelona diabetes. JAMA 2016;315:1034–45. 8 Krans HMJ, Porta M, Keen H. Diabetes care and research in Europe. Ciutat, Institut Català de la Salut, Barcelona, Spain The Saint Vincent Declaration action programme. Ginebra: WHO 5 Unidad de Evaluación, Sistemas de Información y Calidad, Institut Català de la Regional Office for Europe, 1992. Salut, Barcelona, Spain 9 Cano JF, Franch J, Mata M, et al. Guide for the treatment of type 2 6 DAP-­Cat Group, Unitat de Suport a la Recerca Barcelona, Fundació Institut diabetes in primary care. 4ª edición. Madrid: Harcourt Ed, 2004. Universitari per a la Recerca a l'Atenció Primària de Salut Jordi Gol i Gurina 10 IDF Clinical Guidelines Task Force. Global guideline for type 2 (IDIAPJGol), Barcelona, Spain diabetes: recommendations for standard, comprehensive, and 7 minimal care. Diabet Med 2006;23:579–93. Department of Endocrinology and Nutrition, Hospital de la Santa Creu i Sant Pau 11 Rydén L, Grant P, Anker SD, et al. Guidelines on diabetes, pre-­ & Institut d’Investigació Biomédica Sant Pau (IIB Sant Pau) & Centre for Biomedical diabetes and cardiovascular diseases developed in collaboration Research on Diabetes and Associated Metabolic Diseases (CIBERDEM), Barcelona, with the EASD. Eur Heart J 2013;39:3035–87. Spain 12 American Diabetes Association. Standards of medical care in diabetes--2013. Diabetes Care 2013;36 Suppl 1:S11–66. 13 Association AD. Standars of medical care in diabetes 2017. Diabetes Acknowledgements CIBER of Diabetes and Associated Metabolic Diseases is Care 2017;40:533–43. an initiative from Instituto de Salud Carlos III (Plan Nacional de I+D+I and Fondo 14 Lean ME, Leslie WS, Barnes AC, et al. Primary care-­led weight Europeo de Desarrollo Regional). The research team thanks the participant and management for remission of type 2 diabetes (direct): an open-­label, professional advisers who generously shared their time, experience and knowledge cluster-­randomised trial. Lancet 2018;391:541–51. for the purposes of this project. 15 Holman RR, Paul SK, Bethel MA, et al. 10-­Year follow-­up of intensive glucose control in type 2 diabetes. N Engl J Med Overseas Ed Contributors CL conceived of the study. CL and VL initiated the study design, and 2008;359:1577–89. EB, CD, RA, AG and EC helped with implementation. CL, VL, JLdVG, CD and RA are 16 Liebl A, Mata M, Eschwège E. Evaluation of risk factors for grant holders. JLdVG provided statistical expertise in clinical trial design and will be development of complications in type II diabetes in Europe. conducting the primary statistical analysis. All authors contributed to refinement of Diabetologia 2002;45:S23–8. the study protocol and approved the final manuscript. 17 de la Calle H, Costa A, Díez-­Espino J, et al. [Evaluation on the compliance of the metabolic control aims in outpatients with Protected by copyright. Funding This study has been funded in part by the Nursing and Society Foundation type 2 diabetes mellitus in Spain. The TranSTAR study]. Med Clin as part of the Nurse Research Projects Grants PR-042/16. This funding source had 2003;120:446–50. no role in the design of this study and will not have any role during its execution, 18 López B, García-­Mayor R, Puig-­Domingo M, et al. Pathological analyses and data interpretation, or in making the decision to submit its results for characteristics of patients with diabetes mellitus TipE 2, in Spanish publication. primary care. Rev Clin Esp 2004;1:18–24. 19 Alvarez-­Sala LA, Suárez C, Mantilla T, et al. [PREVENCAT Competing interests None declared. study: control of cardiovascular risk in primary care]. Med Clin Patient and public involvement Patients and/or the public were not involved in 2005;124:406–10. 20 Orozco-­Beltrán D, Gil-­Guillen VF, Quirce F, et al. Control of diabetes the design, or conduct, or reporting, or dissemination plans of this research. and cardiovascular risk factors in patients with type 2 diabetes in Patient consent for publication Not required. primary care. the gap between guidelines and reality in Spain. Int J Clin Pract 2007;61:909–15. Ethics approval The Ethical Committee of Clinical Investigation of the IDIAP Jordi 21 Mengual L, Roura P, Serra M, et al. Multifactorial control and Gol has approved of this protocol (approval code: P13/118). treatment intensity of type-2 diabetes in primary care settings in Catalonia. Cardiovasc Diabetol 2010;9:14. Provenance and peer review Not commissioned; externally peer reviewed. 22 Glechner A, Keuchel L, Affengruber L, et al. Effects of lifestyle Open access This is an open access article distributed in accordance with the changes on adults with prediabetes: a systematic review and meta-­ Creative Commons Attribution Non Commercial (CC BY-­NC 4.0) license, which analysis. Prim Care Diabetes 2018;12:393–408. permits others to distribute, remix, adapt, build upon this work non-­commercially, 23 Taylor CB, Miller NH, Reilly KR, et al. Evaluation of a nurse-­ and license their derivative works on different terms, provided the original work is care management system to improve outcomes in patients with complicated diabetes. 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