Development and validation of two self-reported tools for insulin resistance and hypertension risk assessment in a European cohort : the Feel4Diabetes-study

Early identification of type 2 diabetes mellitus (T2DM) and hypertension (HTN) risk may improve prevention and promote public health. Implementation of self-reported scores for risk assessment provides an alternative cost-effective tool. The study aimed to develop and validate two easy-to-apply screening tools identifying high-risk individuals for insulin resistance (IR) and HTN in a European cohort. Sociodemographic, lifestyle, anthropometric and clinical data obtained from 1581 and 1350 adults (baseline data from the Feel4Diabetes-study) were used for the European IR and the European HTN risk assessment index respectively. Body mass index, waist circumference, sex, age, breakfast consumption, alcohol, legumes and sugary drinks intake, physical activity and sedentary behavior were significantly correlated with Homeostatic Model Assessment of IR (HOMA-IR) and/or HTN and incorporated in the two models. For the IR index, the Area Under the Curve (AUC), sensitivity and specificity for identifying individuals above the 75th and 95th of HOMA-IR percentiles were 0.768 (95%CI: 0.721–0.815), 0.720 and 0.691 and 0.828 (95%CI: 0.766–0.890), 0.696 and 0.778 respectively. For the HTN index, the AUC, sensitivity and specificity were 0.778 (95%CI: 0.680–0.876), 0.667 and 0.797. The developed risk assessment tools are easy-to-apply, valid, and low-cost, identifying European adults at high risk for developing T2DM or having HTN

Blood pressure and hypertension in type 1 diabetes mellitus patients with long duration

Type 1 diabetes mellitus (T1DM) has significantly better prognosis which has led to increased cardio-vascular diseases (CVD) prevalence. The detection of CVD risk factors and their treatment become tasks of paramount importance. Among them, high blood pressure (BP) is a target of primary purpose. Aim: to explore the blood pressure values, the prevalence of hypertension (HTN) and its management in patients with T1DM with long duration and without overt CVD, in comparison to matched controls. Participants and methods: totally, 124 patients with T1DM were matched to 59 controls by sex, age and approximate body mass index (BMI). All participants filled in questionnaires with information on demographics, physical activity, life style, concomitant diseases, treatments, presence of complications, etc. Blood samples were taken for laboratory and biomarkers investigation. Blood pressure was measured by investigators twice and the mean of the two measurements was used. HTN was accepted using standard definitions. BP values were compared using t-test. Multiple linear regression models with dependent variable BP measures and age, sex, BMI, presence of T1DM, glycated hemoglobin levels, creatinine levels as independent variables were created. ANOVA method was used to test the interaction of sex and presence of T1DM. Results: The mean age of the participants was 43.47 ± 10.1 years, 54% were males. The mean duration of T1DM was 25.31 ± 8.2 years and the mean HbA1c was 8.42 ± 1.8% for diabetic patients. The mean blood pressure measures in T1DM groups were higher than in controls, both in males and females. The difference reached significance for SBP and pulse pressure (PP). The presence of T1DM independently affected the BP values, after adjusting for major confounders. The mean adjusted differences between T1DM and controls were 8.37 mm Hg for SBP, 4.92 mm Hg for DBP, and 5.19 mm Hg for PP (p < 0.001). HTN was significantly more frequent in T1DM patients than in controls – 54% vs. 27%, p = 0.0001, mainly due to already known hypertension. BP control was insufficient – in only 36% and 13% of the treated hypertensive participants, respectively, for BP < 140/90 and < 130/80 mm Hg. The majority of the patients with HTN were treated with combination therapy, mostly single-pill fixed dosage but 30% of the hypertensive patients with diabetes did not take antihypertensive medications. Inhibitors of the renin-angiotensin system were the preferred class of medications. Conclusions: SBP and PP were significantly higher in middle-aged patients with T1DM with long duration than their control counterparts. The presence of HTN was significantly more common in T1DM. Although treated according to the current recommendations, the control of BP was far from effective. These results show the need for constant screening of patients with T1DM for HTN and other risk factors and for more aggressive antihypertensive treatment to prevent future CVD events

Evaluation of the Finnish Diabetes Risk Score as a screening tool for undiagnosed type 2 diabetes and dysglycaemia among early middle-aged adults in a large-scale European cohort. The Feel4Diabetes-study

Aim: To assess the diagnostic accuracy of the FINDRISC for undiagnosed type 2 diabetes mellitus (T2DM) and dysglycaemia (i.e. the presence of prediabetes or T2DM) among early middle-aged adults from vulnerable groups in a large-scale European cohort. Methods: Participants were recruited from low-socioeconomic areas in high-income countries (HICs) (Belgium-Finland) and in HICs under austerity measures (Greece-Spain) and from the overall population in low/middle-income countries (LMICs) (Bulgaria-Hungary). Study population comprised of 2116 parents of primary-school children from families identified at increased risk of T2DM, based on parental self-reported FINDRISC. Sensitivity (Se), specificity (Sp), area under the receiver operating characteristic curves (AUC-ROC) and the optimal cut-offs of FINDRISC that indicate an increased probability for undiagnosed T2DM or dysglycaemia were calculated. Results: The AUC-ROC for undiagnosed T2DM was 0.824 with optimal cut-off =14 (Se = 68%, Sp = 81.7%) for the total sample, 0.839 with optimal cut-off =15 (Se = 83.3%, Sp = 86.9%) for HICs, 0.794 with optimal cut-off =12 (Se = 83.3%, Sp = 61.1%) for HICs under austerity measures and 0.882 with optimal cut-off =14 (Se = 71.4%, Sp = 87.8%) for LMICs. The AUC-ROC for dysglycaemia was 0.663 with optimal cut-off =12 (Se = 58.3%, Sp = 65.7%) for the total sample, 0.656 with optimal cut-off =12 (Se = 54.5%, Sp = 64.8%) for HICs, 0.631 with optimal cut-off =12 (Se = 59.7%, Sp = 62.0%) for HICs under austerity measures and 0.735 with optimal cut-off =11 (Se = 72.7%, Sp = 70.2%) for LMICs. Conclusion: FINDRISC can be applied for screening primarily undiagnosed T2DM but also dysglycaemia among vulnerable groups across Europe, considering the use of different cut-offs for each subpopulation

Lipidemic profile changes over a two-year intervention period : who benefited most from the Feel4Diabetes program?

Identification of participants' characteristics who benefited most from large community-based intervention studies may guide future prevention initiatives in order to maximize their effectiveness. The current study aimed to examine the socio-demographic, anthropometric, and behavioral characteristics, as well as the health and eating perceptions of those who improved their lipidemic profile, in the Feel4Diabetes early screening and prevention program. In the present analyses, 1773 adults from families at high risk for developing type 2 diabetes mellitus (T2DM) were enrolled, receiving either the standard care or the more intensive intervention, and 33.3-55.2% of them improved one or more of their lipidemic indices by >5%. Women, people living in Southeastern Europe, coming from two-parent families, having higher financial security, educational level and better diet quality were associated with a 27-64% higher likelihood for benefiting from the program regarding one or more of their lipidemic profile indices. Participants who were overweight or obese (especially with central obesity), employed, with prolonged sedentary behavior, prone to emotional eating and perceiving their weight status as lower than their actual weight were 24-43% less likely to have benefited. These findings should guide future interventions, prioritizing regions in greater need, and being tailor-made to specific population characteristics in order to further improve their effectiveness

Methodology of the health economic evaluation of the Feel4Diabetes-study

Background: The clinical and economic burden of type 2 diabetes mellitus on society is rising. Effective and efficient preventive measures may stop the increasing prevalence, given that type 2 diabetes mellitus is mainly a lifestyle-driven disease. The Feel4Diabetes-study aimed to tackle unhealthy lifestyle (unhealthy diet, lack of physical activity, sedentary behaviour, and excess weight) of families with a child in the first grades of elementary school. These schools were located in regions with a relatively low socio-economic status in Belgium, Bulgaria, Finland, Greece, Hungary and Spain. Special attention was paid to families with a high risk of developing type 2 diabetes mellitus. Methods: The aim of this paper is to describe the detailed methodology of the intervention’s cost-effectiveness analysis. Based on the health economic evaluation of the Toybox-study, both a decision analytic part and a Markov model have been designed to assess the long-term (time horizon of 70 year with one-year cycles) intervention’s value for money. Data sources used for the calculation of health state incidences, transition probabilities between health states, health state costs, and health state utilities are listed. Intervention-related costs were collected by questionnaires and diaries, and attributed to either all families or high risk families only. Conclusions: The optimal use of limited resources is pivotal. The future results of the health economic evaluation of the Feel4Diabetes-study will contribute to the efficient use of those resources.Publication of this supplement was funded by the European Union’s Horizon 2020 research and innovation programme under grant agreement n° 643708

Feel4Diabetes healthy diet score: Development and evaluation of clinical validity

Background: The aim of this paper is to present the development of the Feel4Diabetes Healthy Diet Score and to evaluate its clinical validity. Methods: Study population consisted of 3268 adults (63% women) from high diabetes risk families living in 6 European countries. Participants filled in questionnaires at baseline and after 1 year, reflecting the dietary goals of the Feel4Diabetes intervention. Based on these questions the Healthy Diet Score was constructed, consisting of the following components: breakfast, vegetables, fruit and berries, sugary drinks, whole-grain cereals, nuts and seeds, low-fat dairy products, oils and fats, red meat, sweet snacks, salty snacks, and family meals. Maximum score for each component was set based on its estimated relative importance regarding T2DM risk, higher score indicating better quality of diet. Clinical measurements included height, weight, waist circumference, heart rate, blood pressure, and fasting blood sampling, with analyses of glucose, total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglycerides. Analysis of (co) variance was used to compare the Healthy Diet Score and its components between countries and sexes using baseline data, and to test differences in clinical characteristics between score categories, adjusted for age, sex and country. Pearson''s correlations were used to study the association between changes from baseline to year 1 in the Healthy Diet Score and clinical markers. To estimate reproducibility, Pearson''s correlations were studied between baseline and 1 year score, within the control group only. Results: The mean total score was 52.8 ± 12.8 among women and 46.6 ± 12.8 among men (p < 0.001). The total score and its components differed between countries. The change in the Healthy Diet Score was significantly correlated with changes in BMI, waist circumference, and total and LDL cholesterol. The Healthy Diet Score as well as its components at baseline were significantly correlated with the values at year 1, in the control group participants. Conclusion: The Feel4Diabetes Healthy Diet Score is a reproducible method to capture the dietary information collected with the Feel4Diabetes questionnaire and measure the level of and changes in the adherence to the dietary goals of the intervention. It gives a simple parameter that associates with clinical risk factors in a meaningful manner

Sociodemographic, anthropometric, and lifestyle correlates of prediabetes and type 2 diabetes in europe: The Feel4Diabetes study

Background and aims: The current work aimed to identify the predominant correlates of prediabetes and T2DM among a variety of socio-demographic, anthropometric and lifestyle indices, in a large sample of adults from families at high risk for T2DM. Methods and results: In this cross-sectional study, 2816 adults were recruited from low-socioeconomic areas in high-income countries (HICs) (Belgium-Finland), HICs under austerity measures (Greece-Spain), and low/middle-income countries (LMICs) (Bulgaria-Hungary). A positive association between the male sex (OR, 95% C.I.2.77 (1.69–4.54)) and prediabetes was revealed compared to females, while there was a negative association between younger age (&lt;45 years) (OR, 95% C.I. 0.58 (0.37–0.92)), and low/medium levels of waist circumference (OR, 95% C.I. 0.44 (0.22–0.89)) with prediabetes compared to older age and high levels of waist circumference, respectively. Concerning T2DM, 0–0.5 cups/day of fruits and berries (OR, 95% C.I.2. 13 (1.16–3.91)) and 150–300 g fish/week (OR, 95% C.I. 2.55 (1.01–6.41)) have a positive association compared to higher consumptions, respectively. Conversely, &lt;1 cup/week legumes (OR, 95% C.I. 0.55 (0.31–0.99) as well as 0–0.5 servings (OR, 95% C.I. 0.34 (0.12–0.95) and 0.5–1 servings (OR, 95% C.I. 0.37 (0.19–0.71) of full-fat dairy/day have a negative association compared to higher consumptions, respectively. Conclusion: These findings indicate the need for diabetes prevention measures targeting young adults and especially men, above 45 years of age, with central obesity and poor dietary habits and prioritize vulnerable groups and populations living in LMICs. National Clinical Trial number: NCT 02393872 © 2022 The Italian Diabetes Society, the Italian Society for the Study of Atherosclerosis, the Italian Society of Human Nutrition and the Department of Clinical Medicine and Surgery, Federico II Universit

Evaluation of the Finnish Diabetes Risk Score as a screening tool for undiagnosed type 2 diabetes and dysglycaemia among early middle-aged adults in a large-scale European cohort. The Feel4Diabetes-study

Aim: To assess the diagnostic accuracy of the FINDRISC for undiagnosed type 2 diabetes mellitus (T2DM) and dysglycaemia (i.e. the presence of prediabetes or T2DM) among early middle-aged adults from vulnerable groups in a large-scale European cohort. Methods: Participants were recruited from low-socioeconomic areas in high-income countries (HICs) (Belgium-Finland) and in HICs under austerity measures (Greece-Spain) and from the overall population in low/middle-income countries (LMICs) (Bulgaria-Hungary). Study population comprised of 2116 parents of primary-school children from families identified at increased risk of T2DM, based on parental self-reported FINDRISC. Sensitivity (Se), specificity (Sp), area under the receiver operating characteristic curves (AUC-ROC) and the optimal cut-offs of FINDRISC that indicate an increased probability for undiagnosed T2DM or dysglycaemia were calculated. Results: The AUC-ROC for undiagnosed T2DM was 0.824 with optimal cut-off ≥14 (Se = 68%, Sp = 81.7%) for the total sample, 0.839 with optimal cut-off ≥15 (Se = 83.3%, Sp = 86.9%) for HICs, 0.794 with optimal cut-off ≥12 (Se = 83.3%, Sp = 61.1%) for HICs under austerity measures and 0.882 with optimal cut-off ≥14 (Se = 71.4%, Sp = 87.8%) for LMICs. The AUC-ROC for dysglycaemia was 0.663 with optimal cut-off ≥12 (Se = 58.3%, Sp = 65.7%) for the total sample, 0.656 with optimal cut-off ≥12 (Se = 54.5%, Sp = 64.8%) for HICs, 0.631 with optimal cut-off ≥12 (Se = 59.7%, Sp = 62.0%) for HICs under austerity measures and 0.735 with optimal cut-off ≥11 (Se = 72.7%, Sp = 70.2%) for LMICs. Conclusion: FINDRISC can be applied for screening primarily undiagnosed T2DM but also dysglycaemia among vulnerable groups across Europe, considering the use of different cut-offs for each subpopulation. © 2019 Elsevier B.V

Development and validation of two self-reported tools for insulin resistance and hypertension risk assessment in a european cohort: The feel4diabetes-study

Early identification of type 2 diabetes mellitus (T2DM) and hypertension (HTN) risk may improve prevention and promote public health. Implementation of self-reported scores for risk assessment provides an alternative cost-effective tool. The study aimed to develop and validate two easy-to-apply screening tools identifying high-risk individuals for insulin resistance (IR) and HTN in a European cohort. Sociodemographic, lifestyle, anthropometric and clinical data obtained from 1581 and 1350 adults (baseline data from the Feel4Diabetes-study) were used for the European IR and the European HTN risk assessment index respectively. Body mass index, waist circumference, sex, age, breakfast consumption, alcohol, legumes and sugary drinks intake, physical activity and sedentary behavior were significantly correlated with Homeostatic Model Assessment of IR (HOMA-IR) and/or HTN and incorporated in the two models. For the IR index, the Area Under the Curve (AUC), sensitivity and specificity for identifying individuals above the 75th and 95th of HOMA-IR percentiles were 0.768 (95%CI: 0.721–0.815), 0.720 and 0.691 and 0.828 (95%CI: 0.766–0.890), 0.696 and 0.778 respectively. For the HTN index, the AUC, sensitivity and specificity were 0.778 (95%CI: 0.680–0.876), 0.667 and 0.797. The developed risk assessment tools are easy-to-apply, valid, and low-cost, identifying European adults at high risk for developing T2DM or having HTN. © 2020 by the authors. Licensee MDPI, Basel, Switzerland

Intra- A nd inter-observer reliability of anthropometric measurements and blood pressure in primary schoolchildren and adults: The Feel4Diabetes-study

Background: Feel4Diabetes was a large-scale, multicenter lifestyle intervention aiming to prevent type 2 diabetes among families from vulnerable population groups in six European countries (Belgium, Bulgaria, Finland, Greece, Hungary and Spain). The current study aimed to describe the process that was followed to harmonize and standardize the measurement of anthropometric (weight, height and waist circumference) and blood pressure (systolic and diastolic) indices, as well as to assess the intra- A nd inter-observer reliability of these measurements. Methods: A central training workshop was conducted prior to the baseline measurements of the Feel4Diabetes-intervention. One researcher from each intervention country, as well as 12 adults and 12 children (for the anthropometric measurements) and 21 adults (for the blood pressure measurements) participated in this workshop. Technical Error of Measurement (TEM) and reliability (%R) were calculated to assess the reliability of the indices which were assessed to evaluate the outcome of the Feel4Diabetes-intervention. The Feel4Diabetes-intervention is registered at http://clinicaltrials.gov/(NCT02393872). Results: Intra-observer reliability was found to be higher than 99.5% for all anthropometric measurements in both children and adults. Inter-observer reliability was found to be higher than 98% regarding the anthropometric measurements, while for blood pressure measurements %R was 76.62 and 91.38% for systolic and diastolic blood pressure measurements, respectively. Conclusion: The central training of the Fee4Diabetes-intervention ensured that the data collected for the outcome evaluation of the Feel4Diabetes-intervention in the six European countries at three different time points (baseline, follow-up 1 and follow-up 2) were valid and comparable. © 2020 The Author(s)