Psychometric properties of the Polish version of SF-12v2 in the general population survey.

BACKGROUND: This study aimed to assess the psychometric properties of the SF-12 questionnaire (in comparison to the EQ-5D questionnaire also), based on a survey conducted on a sample representing the general population of Poland. METHODS: The respondents completed Polish versions of health-related quality of life (HRQoL) questionnaires: SF-12, EQ-5D-5L, EQ VAS, and EQ-5D-3L, together with demographic and socioeconomic characteristic items. The following psychometric properties were analyzed: informativity power, ceiling and floor effects, reliability, and construct validity. We also conducted an exploratory factor analysis. RESULTS: A total of 3,896 respondents (mean age 48.3 years, 53.2% female) were included in the analysis. The results showed exceptional informativity power of SF-12 items. We did not observe any ceiling and floor effects for the PCS and MCS components. The high values of the Cronbach's alpha coefficients confirmed the reliability of SF-12. Our hypothesis about lower scores for the summary components among older respondents, females and patients having declared diabetes was confirmed. The results of factor analysis also provided evidence for a positive assessment of construct validity. CONCLUSIONS: Our results confirmed that the Polish version of the SF-12 questionnaire is a valid instrument for use in HRQoL assessment among the general population of Poland.

The beneficial effect of insulin degludec on nocturnal hypoglycaemia and insulin dose in type 1 diabetic patients: a systematic review and meta-analysis of randomised trials.

AIMS: Insulin degludec is a new-generation ultra-long-acting basal insulin which offers a significantly more predictable glucose-lowering effect than other long-acting insulin analogues. The aim of this study was to compare the effect of treatment with insulin degludec and long-acting insulin analogues glargine and detemir in type 1 diabetic (T1D) patients by means of a systematic review and meta-analysis. METHODS: The following electronic databases were searched up to January 2014: MEDLINE, EMBASE and The Cochrane Library. Additional references were obtained from the reviewed articles. There were included randomised controlled trials of at least 12-week duration with basal-bolus regimen therapies in T1D patients. RESULTS: Current analysis included four studies involving 1,846 T1D patients. The combined data from all trials showed a statistically significant reduction in the basal insulin dose (MD -0.042, 95 % CI -0.067 to -0.018, p = 0.001) and the total daily insulin dose (MD -0.072, 95 % CI 0.016 to -0.027, p = 0.002) in the degludec group compared to other long-acting analogues. There was also a significant reduction of nocturnal hypoglycaemia in the degludec group compared to the controls (rate ratio 0.697, 95 % CI 0.617-0.786, p = 0.000). There were no differences between the groups in terms of glycated haemoglobin values, fasting plasma glucose (FPG) and adverse events. CONCLUSIONS: Basal-bolus treatment with insulin degludec was superior to long-acting insulin analogues detemir and glargine in reducing the rate of nocturnal hypoglycaemia. In comparison with other long-acting analogues, treatment with insulin degludec was safe and patients obtained similar metabolic control expressed by HbA1c and FPG levels with the added benefit of a reduced basal and total insulin dose.

The effect of using the insulin pump bolus calculator compared to standard insulin dosage calculations in patients with type 1 diabetes mellitus - systematic review.

Modern insulin pumps use bolus calculators to determine the appropriate insulin dose to facilitate achievement of glycaemic targets.To summarize the data on insulin pump bolus calculators compared to standard insulin dosage calculations and the impact on glycaemic profile.The MEDLINE, EMBASE and Cochrane Library databases were searched until October 2012 for related randomized controlled trials (RCTs) and observational studies performed in type 1 diabetes. A meta-analysis of RCTs was conducted.We included 6 trials comprising 354 subjects. Combined data of 2 RCTs showed significantly smaller number of correction boluses in the experimental group (MD - 2.31; 95% CI: - 3.59 to - 1.03; p=0.0004) and a trend toward fewer hypoglycaemic episodes per week (MD - 0.47; from - 0.95 to 0.02; 95% CI; p=0.06) in the experimental group compared to control subjects. Other authors reported significant reduction in daily post-prandial blood glucose values in the experimental group compared to controls. The authors observed only one adverse event. More frequent self-monitoring of blood glucose in the experimental group was reported in 3 trials. There were no differences in HbA1c within the groups. Patients were satisfied with the treatment with bolus calculator, according to the treatment satisfaction scale.Insulin pump bolus calculators are effective and safe in prandial insulin calculation with a positive impact on glucose profile.

Beneficial effect of real-time continuous glucose monitoring system on glycemic control in type 1 diabetic patients: systematic review and meta-analysis of randomized trials.

OBJECTIVE: Real-time continuous glucose monitoring (RT-CGM) provides detailed information on glucose patterns and trends, thus allowing the patients to manage their diabetes more effectively. DESIGN: The aim of this study was to explore the potential beneficial effects of the use of RT-CGM on diabetes management compared with self blood glucose measurement (SBGM) in patients with type 1 diabetes mellitus (T1DM), by means of a systematic review and meta-analysis of randomized controlled trials (RCTs). METHODS: MEDLINE, EMBASE, and the Cochrane Library were searched through by two independent investigators for RCTs concerning the use of RT-CGM in patients with T1DM. Only studies with a similar insulin regimen in the experimental and control groups were included in the analysis. RESULTS: Seven RCTs (n=948) met the inclusion criteria. Combined data from all studies showed better HbA1c reduction in subjects using RT-CGM compared with those using SBGM (mean difference (MD) -0.25; 95% confidence interval (95% CI): from -0.34 to -0.17; P<0.001). Patients treated with insulin pump and RT-CGM had a lower HbA1c level compared with subjects managed with insulin pump and SBGM (four RCTs, n=497; MD -0.26; 95% CI: from -0.43 to -0.10; P=0.002). The benefits of applying RT-CGM were not associated with an increasing rate of major hypoglycemic episodes. The use of RT-CGM for over 60-70% of time was associated with a significant lowering of HbA1c. CONCLUSIONS: RT-CGM is more beneficial than SBGM in reducing HbA1c in patients with type 1 diabetes. Further studies are needed to evaluate the efficacy of this system in the pediatric population, especially in very young children.

Meta-analysis: zinc supplementation for acute gastroenteritis in children.

BACKGROUND: Uncertainty exists regarding the use of zinc in the treatment of acute gastroenteritis in children living in Europe, where zinc deficiency is rare. AIM: To review evidence for the effectiveness of zinc in treating acute gastroenteritis in children, with special emphasis on data from developed countries. METHODS: MEDLINE, EMBASE, and the Cochrane Library were searched through November 2007 for randomized controlled trials (RCTs) relevant to acute gastroenteritis in children younger than 5 years of age and zinc; additional references were obtained from the reviewed articles. RESULTS: Eighteen RCTs (11,180 participants, mainly from developing countries) met the inclusion criteria. Use of zinc was associated with a significant reduction in diarrhoea duration (13 RCTs, 5643 infants, weighted mean difference -0.69 day, 95% CI -0.97 to -0.40) and the risk of diarrhoea lasting longer than 7 days [eight RCTs, n = 5769, relative risk (RR) 0.71, 95% CI 0.53-0.96]. No significant reduction in stool volume was observed for those receiving zinc compared with placebo (three RCTs, n = 606, standardized mean difference, -0.38, 95% CI -1.04 to 0.27). Combined data from five RCTs (n = 3156) showed that zinc significantly increased the chance of vomiting compared to the control agent (RR 1.2, 95% CI 1.05-1.4). CONCLUSIONS: These data confirm that zinc supplementation can be useful for treating acute gastroenteritis in children, particularly those from developing countries. However, the role of zinc supplements in treating children with acute gastroenteritis in developed countries needs further evaluation.

Continuous Glucose Monitoring System in children with type 1 diabetes mellitus: a systematic review and meta-analysis.

AIMS/HYPOTHESIS: We investigated the potential effects of the Continuous Glucose Monitoring System (CGMS), as compared with self-monitoring of blood glucose, on glycaemic control in children with type 1 diabetes. METHODS: The following electronic databases were searched throughout June 2007: MEDLINE, EMBASE and The Cochrane Library. Additional references were obtained from reviewed articles. Only randomised controlled trials were included. RESULTS: We included five trials involving 131 type 1 diabetic patients in the study. Combined data from all trials showed that the CGMS did not significantly reduce HbA1c levels compared with control groups. The pooled weighted mean difference was -0.02% (95% CI -0.29 to 0.25) with a fixed model and remained insignificant in the random effect model. Sensitivity analysis determined that the findings were stable. There was a trend towards a longer time under the CGMS curve for glucose <3.89 mmol/l in the CGMS group compared with the control group (mean difference 49.00 min, 95% CI -18.00 to 116.00). The CGMS significantly increased the number of insulin dose changes per patient per month for those managed with CGMS compared with the control groups (mean difference 6.3 changes, 95% CI 2.88-9.72). CONCLUSIONS/INTERPRETATION: The Continuous Glucose Monitoring System is not better than self-monitoring of blood glucose with regard to improvement of metabolic control among type 1 diabetic children. However, due to the small number of participants and methodological limitations of the studies included, findings of this meta-analysis should be interpreted with caution.