Results of the implementation of the DP-TRANSFERS project in Catalonia: a translational method to improve diabetes screening and prevention in primary care.

INTRODUCTION: DP-TRANSFERS is a translational lifestyle intervention project, which follows a previous protocol described in the DE-PLAN-CAT study. OBJECTIVE: Analyze the feasibility of reproducing the intensive intervention and estimating the effect of translation in real conditions of clinical practice in primary care. METHODOLOGY: Implementation of the face-to-face group intervention adjusted to 2 years. After screening, the intervention consisted of a basic module and a continuity module. Stratifying by clusters (health centers), a representative sample (centers, professionals and participants) was evaluated (FINDRISC > 11 and/or prediabetes) from 2016 to 2020. The effect of the intervention on the incidence of diabetes was analyzed. RESULTS: The intervention, feasible in 95 of 123 centers, involved 343 of 647 professionals. Of 2381 subjects screened, 1713 participated in the basic module, with 1186 participants completing the first year and 776 completing the second. 121 participants (7.06%) were diagnosed with diabetes: 77 (4.49%) during the first year; 44 (2.57%) during the second. The bivariate analysis showed that those subjects in whom diabetes affected differed in: previous glycemic status, A1c, HDL-cholesterol, FINDRISC score and adherence to the Mediterranean diet, and in the differences between the beginning and end of the study of: body weight, BMI and abdominal circumference. CONCLUSIONS: The intensive intervention substantially reduced (23.6%) the incidence of diabetes compared to that previously estimated in standardized intervention. The following acted as protective factors: a better glycemic status, lower baseline risk, elevated HDL-cholesterol, or achieving a reduction in weight or abdominal circumference during the study.

Delaying progression to type 2 diabetes among high-risk Spanish individuals is feasible in real-life primary healthcare settings using intensive lifestyle intervention.

AIMS/HYPOTHESIS: To assess the feasibility and effectiveness of an active real-life primary care lifestyle intervention in preventing type 2 diabetes within a high-risk Mediterranean population. METHODS: A prospective cohort study was performed in the setting of Spanish primary care. White-European individuals without diabetes aged 45-75 years (n = 2,054) were screened using the Finnish Diabetes Risk Score (FINDRISC) and a subsequent 2 h OGTT. Where feasible, high-risk individuals who were identified were allocated sequentially to standard care, a group-based or an individual level intervention (intensive reinforced DE-PLAN [Diabetes in Europe-Prevention using Lifestyle, Physical Activity and Nutritional] intervention). The primary outcome was the development of diabetes according to WHO criteria. Analyses after 4-year follow-up were performed based on the intention-to-treat principle with comparison of standard care and the combined intervention groups. RESULTS: The standard care (n = 219) and intensive intervention (n = 333) groups were comparable in age (62.0/62.2 years), sex (64.4/68.2% women), BMI (31.3/31.2 kg/m(2)), FINDRISC score (16.2/15.8 points), fasting (5.3/5.2 mmol/l), 2 h plasma glucose (7.1/6.9 mmol/l) and self-reported interest to make lifestyle changes at baseline. Diabetes was diagnosed in 124 individuals: 63 (28.8%) in the standard care group and 61 (18.3%) in the intensive intervention group. During a 4.2-year median follow-up, the incidences of diabetes were 7.2 and 4.6 cases per 100 person-years, respectively (36.5% relative risk reduction, p < 0.005). The number of participants needed to be treated by intensive intervention for 4 years to reduce one case of diabetes was 9.5. CONCLUSIONS/INTERPRETATION: Intensive lifestyle intervention is feasible in a primary care setting and substantially reduces diabetes incidence among high-risk individuals. CLINICAL TRIAL REGISTRATION: ClinicalTrial.gov NCT01519505. FUNDING: Commission of the European Communities, Institute of Health Carlos III, Spanish Ministry of Health and Department of Health, Generalitat de Catalunya.

Shifting from glucose diagnostic criteria to the new HbA(1c) criteria would have a profound impact on prevalence of diabetes among a high-risk Spanish population.

AIM: To investigate changes in the prevalence of diabetes and pre-diabetes by shifting from 2-h plasma glucose and/or fasting plasma glucose diagnostic criteria to the proposed new HbA(1c) -based criteria when applied to a Mediterranean population detected to have a high risk of Type 2 diabetes. METHODS: Individuals without diabetes aged 45-75 years (n = 2287) were screened using the Finnish Diabetes Risk Score questionnaire, a 2-h oral glucose tolerance test plus HbA(1c) test. Prevalence and degree of diagnostic overlap between three sets of criteria (2-h plasma glucose, fasting plasma glucose and HbA(1c) ) and three diagnostic categories (normal, pre-diabetes and diabetes) were calculated. RESULTS: Defining diabetes by a single HbA(1c) measurement resulted in a dramatic decrease in prevalence (1.3%), particularly in comparison with diabetes defined by 2-h plasma glucose (8.6%), but was also significant with regard to fasting plasma glucose (2.8%). A total of 201 screened subjects (8.8%) were classified as having diabetes and 1023 (44.7%) as having pre-diabetes based on at least one of these criteria; among these, the presence of all three criteria simultaneously classified only 21 and 110 individuals respectively, about ten percent of each group. The single overlap index between subjects diagnosed as having diabetes by 2-h plasma glucose/fasting plasma glucose vs. HbA(1c) was 13.9/28%. Similarly, the single overlap index regarding pre-diabetes was 19.2/27.1%. CONCLUSIONS: A shift from the glucose-based diagnosis to the HbA(1c) -based diagnosis for diabetes will reduce diabetes prevalence with a low overall or single degree of overlap between diagnostic categories in this high-risk Spanish population.

Lifestyle interventions for diabetes mellitus type 2 prevention.

BACKGROUND AND AIMS: Transferring the results from clinical trials on type 2 diabetes prevention is the objective of the Diabetes in Europe-Prevention using Lifestyle, Physical Activity and Nutritional intervention (DE-PLAN) project in Catalonia, whose cost-effectiveness analysis is now presented. PATIENTS AND METHODS: A prospective cohort study was performed in primary care involving individuals without diagnosed diabetes aged 45-75 years (n=2054) screened using the questionnaire Finnish Diabetes Risk Score (FINDRISC) and a subsequent oral glucose tolerance test. Where feasible, high-risk individuals who were identified (n=552) were allocated sequentially to standard care (n=219), a group-based (n=230) or an individual-level (n=103) intensive (structured programme of six hours using specific teaching techniques) lifestyle intervention (n=333). The primary outcome was the development of diabetes (WHO). We evaluated the cost of resources used with comparison of standard care and the intervention groups in terms of effectiveness and quality of life (15D questionnaire). RESULTS: After 4.2-year median follow-up, the cumulative incidences were 18.3% (14.3-22.9%) in the intensive intervention group and 28.8% (22.9-35.3%) in the standard care group (36.5% relative-risk-reduction). The corresponding 4-year HR was 0.64 (0.47-0.87; P<.004). The incremental cost induced by intensive intervention compared with the standard was 106€ per participant in the individual level and 10€ in the group-based intervention representing 746€ and 108€ per averted case of diabetes, respectively. The estimated incremental cost-utility ratio was 3243€ per quality-adjusted life-years gained. CONCLUSION: The intensive lifestyle intervention delayed the development of diabetes and was efficient in economic analysis.

[The Framingham function overestimates stroke risk for diabetes and metabolic syndrome among Spanish population]. / La escala de Framingham sobrevalora el riesgo cerebrovascular de la diabetes y el síndrome metabólico en la población española.

OBJECTIVE: To estimate stroke risk for diabetes, isolated or associated to metabolic syndrome (MS) according WHO and National Cholesterol Education Program (NCEP) criteria. DESIGN: Multicentre and prospective cohort study. SETTING: Primary health care. PARTICIPANTS: Subjects between 55-85 years-old without any evidence of stroke, included from 1998 in a random population sample for MS follow-up during routine practice in Reus (Tarragona, Spain). MAIN MEASUREMENTS: Stroke risk was achieved using Framingham function by means of a computerized algorithm using a diagnostic factorial design (diabetes and/or MS). Theoretical stroke risk and cumulated incidence of stroke events (1998-2003) were compared. RESULTS: Among 728 subjects (412 women, mean age =66 years old, body mass index =29 kg/m2), 457 (62.8%) did not have diabetes, nor MS, 93 (12.8%) had MS without diabetes, 72 (9.9%) diabetes without MS, and 106 (14.5%) presented both conditions (WHO rules). According NCEP criteria were 60.7%, 14.8%, 7.8%, and 16.7%, respectively. Ten-year estimated stroke risk accounted for (WHO/NCEP) 8.4/9.1%, 10.8/10.5%, 18/17.3%, and 18.8/19.1%. Cumulated incidence for stroke events were: 2.8%, 1.4%, 5.4%, and 3.8% (WHO), and 2.5%, 2.8%, 3.5%, and 5.8%, respectively (NCEP). CONCLUSIONS: Stroke risk scores were extremely increased among diabetic subjects irrespective to MS diagnose. The Framingham function probably overestimates stroke risk among Spanish individuals.

[The RECORD project. continuous blood glucose monitoring among high risk subjects for developing diabetes in Spanish primary health care]. / El proyecto RECORD (Registro Continuo de la Glucemia en Sujetos de Alto Riesgo para la Diabetes Tipo 2). Diseño y aplicación en atención primaria de salud.

OBJECTIVE: To evaluate the accuracy of continuous blood glucose monitoring (CBGM) in order to asses diagnostic procedures and predict glycaemic status in type 2 prediabetes. DESIGN: Observational, multicenter, cross-sectional (phase 1) plus longitudinal, cohort follow-up study (phase 2). SETTING: Five primary health-care centers. INTERVENTIONS: A total of 84 high-risk subjects will be included after a non-diabetic oral glucose tolerance test (OGTT). A first CBGM using a subcutaneous microdialysis glucose sensor technique in order to obtain a continuous profile will be carried out. Two different cohorts, subjects with normal OGTT (n = 42) and individuals with prediabetic hyperglycemia (n = 42) will be established. Diagnoses will be revised at 12 and 24 month follow-up by means of an OGTT together with a new monitoring. MAIN MEASUREMENT: Demographical, clinical (including metabolic syndrome items), basic, and advanced analyses (inflammation emergent markers, insulinemia, C-peptide). CBGM computerized analysis comparing fasting, preprandial, postprandial, nocturnal period, and area under the curve of continuous profile with regular diagnoses, taking into account temporary concordance. Relationship of CBGM parameters with normal glucose tolerance or diabetes incidence. Evaluation of day-to-day quality of life of CBGM users by means of an standardized Likert questionnaire. DISCUSSION: This study seeks to demonstrate the effectiveness and feasibility of CBGM, more physiological than OGTT and based on an underestimated random blood glucose diagnostic criterion. This innovative system may provide interesting scientific data in the field of type 2 prediabetes.

Síndrome metabólico, resistencia a la insulina y diabetes. ¿Qué se oculta bajo la punta del iceberg? / Metabolic syndrome, resistance to insulin and diabetes. What is hidden beneath the tip of the iceberg?

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