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.

Intra- and 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- and 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 https://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.

Assessment of glucose variability in subjects with prediabetes.

The aim of the study was to assess glucose variability in subjects with prediabetes by means of CGM. MATERIAL AND METHODS: 32 subjects with prediabetes - mean age 56.6 ±â€¯9.6 years, mean BMI 30.3 ±â€¯5.3 kg/m2 and 18 subjects with normal glucose tolerance (NGT) - mean age 54.4 ±â€¯9.9 years, mean BMI 24.8 ±â€¯6.9 kg/m2, were enrolled. Glucose tolerance was studied during OGTT. HbA1c was measured by NGSP certified method. CGM was performed with FreeStyle Libre Pro sensor. RESULTS: The following indices of glucose variability were significantly higher in the prediabetes group - CV (p < 0.041), J-index (p < 0.014), CONGA (p < 0.047) and GRADE (p < 0.036). A significant increase in HbA1c (p < 0.036), mean interstitial glucose (p < 0.025), time above range (p < 0.018) and a significant decrease in time in range (p < 0.014) was found in prediabetes compared to NGT. Significant correlations between HbA1c and LBGI (r = -0.33, p = 0.02), HBGI (r = 0.31, p = 0.03), CONGA (r = 0.36, p = 0.01), J-index (r = 0.37, p = 0.01) and M-value (r = -0.34, p = 0.02) were established. CONCLUSION: Glucose variability is significantly increased in prediabetes and is an additional parameter in the assessment of glucose homeostasis even at these early stages of glucose dysregulation.

Barriers from Multiple Perspectives Towards Physical Activity, Sedentary Behaviour, Physical Activity and Dietary Habits When Living in Low Socio-Economic Areas in Europe. The Feel4Diabetes Study.

This study investigated barriers towards health behaviours (physical activity, limiting sedentary behaviour and healthy dietary habits) experienced by young European families living in vulnerable areas, from multiple perspectives (parents, teachers, local community workers). Focus groups were conducted in six European countries (Belgium, Bulgaria, Finland, Hungary, Greece and Spain). In each country, three focus groups were conducted with parents, one with teachers and one with local community workers. Data were analysed using a deductive framework approach with a manifest content analysis using the software NVivo. The present study identified barriers on four levels (individual, interpersonal, organisational and macro level) of a socio-ecological model of health behaviour. From parents' perspectives, both general barriers (e.g., financial limitations and lack of time) and country-specific barriers (e.g., organisational difficulties and inappropriate work environment) were identified. Additional barriers (e.g., lack of parental knowledge and lack of parental skills) were provided by other stakeholders (i.e., teachers and local community workers). The results of this study demonstrate the additional value of including multiple perspectives when developing a lifestyle intervention aiming to prevent type 2 diabetes in vulnerable groups. Future lifestyle interventions are recommended to include multiple components (family, school, and community) and could be implemented across European countries if country-specific adaptations are allowed.

Assessment of HbA1c as a diagnostic tool in diabetes and prediabetes.

To evaluate HbA1c as a diagnostic tool in prediabetes-impaired fasting glucose (IFG) and impaired glucose tolerance (IGT), and newly detected diabetes (NDD), defined by plasma glucose and OGTT. 2,231 subjects, of mean age 50.3 ± 13.9 years and mean BMI 29.5 ± 6.2 kg/m(2), underwent an OGTT. HbA1c performance was assessed using the area under the receiver operating characteristics curve (AUC-ROC). HbA1c was significantly higher in all groups with altered glucose tolerance-5.72 ± 0.61% in IFG, 5.84 ± 0.63% in IGT, and 7.5 ± 1.69% in NDD when compared to normal glucose tolerance-5.23 ± 0.65% (P < 0.0001). HbA1c of both prediabetic groups was significantly lower in comparison with NDD (P < 0.0001); in IGT being significantly higher than in IFG (P = 0.02). ROC analysis demonstrated good performance of HbA1c for diagnosing diabetes-AUC-ROC 0.958 (95% CI: 0.946-0.970), as well as prediabetes-AUC-ROC 0.729 (95% CI: 0.702-0.755). The optimal cut-off level of HbA1c for diagnosing diabetes was 6.1% (sensitivity 86%, specificity 92%) and for undiagnosed prediabetes-5.5% (sensitivity 71%, specificity 64%). HbA(1c) appears to be a useful, convenient, and reliable tool for identifying subjects with prediabetes and diabetes and should be considered in the development of diagnostic strategies.