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IntroductionRadiotherapy (RT) in combination with chemotherapy is a standard of care for patients with head and neck squamous cell carcinoma (HNSCC). The RT is associated with side effects, which impact on quality of life (QoL). Thus, the aim of this prospective longitudinal study was to investigate the impact of RT on the QoL of patients with HNSCC during RT.Material and methodsFrom September 2008 to February 2010, 205 patients with locally advanced HNSCC were enrolled. The data pertaining to their QoL were collected using the EORTC QLQ-C30 and the EORTC Head and Neck Module (QLQ-H&N35) and then all items were transformed to a 0-100 scale according to the guidelines of the EORTC. The following clinical factors were chosen to study their potential influence on the QoL; site of primary, clinical stage, and methods of therapy: RT vs. chemoradiotherapy (CRT). Additionally, the sociodemographic factors (age, gender, education, habit of smoking) were studied.ResultsDeterioration of almost all scales and items in the QLQ-C30 and QLQ-H&N35 questionnaire were noted at the end of RT. The following factors negatively influenced the QoL: age < 60 years (p < 0.05), female gender (p < 0.05), habit of smoking (p < 0.01), advanced clinical stage (III and IV) (p < 0.05), site of primary (larynx, hypopharynx) (p < 0.01), and CRT (p < 0.01).ConclusionsOur study showed that RT significantly negatively influenced QoL at the end of the RT course. Additionally, this study demonstrated that age, gender, smoking habit, tumor site, and clinical stage of disease showed a significant effect on the QoL of HNSCC patients during RT.

INTRODUCTION Gastrointestinal symptoms may occur in 50% to 70% of patients with diabetes. OBJECTIVES The aim of this study was to evaluate the prevalence of small intestinal bacterial overgrowth (SIBO) in patients with diabetes, as well as the relationship between SIBO and metabolic control of diabetes and the presence of chronic complications of the disease. PATIENTS AND METHODSThe study group included 148 patients with type 1 diabetes, treated in the years 2013-2015. The control group consisted of 41 healthy volunteers. The presence of SIBO was assessed with a noninvasive breath test using 20 g of lactulose suspended in 200 ml of water, with the assessment of exhaled hydrogen concentrations. The measurements were performed at 15-minute intervals in the first hour and at 30-minute intervals in the second hour of the test. A positive result was considered as the output value of exhaled hydrogen of 20 parts per million (ppm) or higher or an increase in the output value of the exhaled hydrogen of 12 ppm during the first 60 minutes of the test. RESULTSWe observed a lower prevalence of SIBO in the study group in comparison with controls (56 patients [37.8%] vs 30 healthy volunteers [73%]; P = 0.006). In the logistic regression model, this association was independent of age, sex, body mass index, cigarette smoking, serum C-reactive protein concentrations, and estimated glomerular filtration rate (odds ratio, 0.26; 95% confidence interval, 0.10-0.68; P = 0.006).CONCLUSIONS The prevalence of SIBO in patients with type 1 diabetes is lower than that in healthy subjects. One of the possible causes might be the beneficial effect of nutritional therapy in patients with diabetes.

Background The aim of the study was to assess the safety and glycemic outcomes with the use of a Do-It-Yourself (DIY) Hybrid Closed-Loop (HCL) system based on the AndroidAPS application in type 1 diabetes (T1D). Methods Single-center clinical trial, with 3-week run-in and 12-week study period. DIY HCL system consisted of the Dana Diabecare RS insulin pump, Dexcom G5 continuous glucose monitoring system and AndroidAPS application. Primary outcome was safety: incidences of severe hypoglycemia, diabetic ketoacidosis, time spent in glycemia <54 mg/dl. Secondary endpoints included percentage of time in range (TIR) 70–180 mg/dl, time below 70 mg/dl, HbA1c, insulin requirements, and body weight. Results In total 12 subjects (5 men, 7 women) were enrolled, mean age 31.3±6.7, 95%CI(27.7–34.9) years, mean diabetes duration 16.1±5.7, 95%CI(13.0–19.2) years. No episodes of severe hypoglycemia or ketoacidosis were observed. Percentage of time spent in glycemia below 54mg/dl was not increased. Average sensor glycemia was lower in the study period than baseline (141.1 ± 8.4, 95%CI(136.3–145.9) vs. 153.3 ± 17.9, 95%CI(143.2–163.4), mg/dl p<0.001). TIR 70–180 mg/dl was improved by 11.3%, 95%CI(2.8%-19.8%) (from 68.0 ± 12.7 to 79.3 ± 6.4%, p<0.001), without increasing hypoglycemia time. The HbA1c level decreased by -0.5%, 95%CI(-0.9%–-0.1%) (from 6.8 ± 0.5 to 6.3 ± 0.4%, p<0.001). Additionally, in the last 4 weeks of the study period participants significantly improved and showed TIR 70–180 mg/dl 82.1 ± 5.6%, 95%CI(78.9–85.3), time <54 mg/dl 0.30 (0.20–0.55)%, median 95%CI(0.1–0.7) and <70 mg/dl 1.90 (1.10–3.05)%, median 95%CI(0.7–3.2). The insulin requirement and body weight did not change in the study. Conclusions The study revealed safety of the Do-It-Yourself HCL system AndroidAPS in adults with T1D, limited to well-controlled, highly selected and closely monitored patients. The use of AndroidAPS significantly improved HbA1c, time in range and average sensor glycemia without increasing hypoglycemia. As both patients and their medical team are gaining experience using the system over time, they improve glycemic control. Trial registration German Clinical Trials Register: no. DRKS00015439; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00015439.

The aim of this study was to assess the blood vessel density and maturity in the skin of adults with type 1 diabetes in relation to the presence of late neurovascular complications. We included 148 patients (87 men) with a median (interquartile range) age of 41 (31–49) and median diabetes duration of 21 (17–30) years. Microvessel (CD133, CD34, CD31 and von Willebrand factor) markers were evaluated by indirect immunohistochemistry assay in material from a skin biopsy. Diabetic retinopathy was diagnosed using direct ophthalmoscopy, and diabetic kidney disease was estimated in people with increased albuminuria and a 10-year duration of diabetes or evidence of diabetic retinopathy . Diabetic peripheral neuropathy diagnosis was based on Toronto definition, cardiac autonomic neuropathy on validated ProSciCard III program. Microvessel density, assessed by CD34 and CD133, was significantly higher in patients with cardiac autonomic neuropathy [160 (125–175) vs 121 (100–154)/1 mm2, p = 0.001 and 92 (83–104) vs 79 (63–92)/1 mm2, p = 0.007, respectively] and CD34 in patients with diabetic peripheral neuropathy [135 (106–168) vs 121 (95–145)/1 mm2, p = 0.018], as compared with subjects without complications. In multivariate logistic regression, density of CD34 and CD133 positive vessels was associated with presence of cardiac autonomic neuropathy [odds ratio 1.016 (95% confidence interval: 1.002–1.029), p = 0.019 and odds ratio 1.037 (95% confidence interval: 1.008–1.067), p = 0.011, respectively]. It was independent from age, sex, diabetes duration, smoking status, body mass index and HbA1c value. Density of CD34 positive vessels was also associated with diabetic peripheral neuropathy, independently from sex and diabetes duration [odds ratio 1.009 (95% confidence interval: 1.001–1.020), p = 0.037]. Skin microvessel density is increased in adults with clinical evidence of neurovascular complications of type 1 diabetes. This is associated with predominance of the vessels of low maturity.

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Purpose: To assess glycemic control and safety of children and adolescents with type 1 diabetes participating in a 2-day football tournament. Methods: In total, 189 children with type 1 diabetes from 11 diabetes care centers, in Poland, participated in a football tournament in 3 age categories: 7–9 (21.2%), 10–13 (42.9%), and 14–17 (36%) years. Participants were qualified and organized in 23 football teams, played 4 to 6 matches of 30 minutes, and were supervised by a medical team. Data on insulin dose and glycemia were downloaded from personal pumps, glucose meters, continuous glucose monitoring, and flash glucose monitoring systems. Results: The median level of blood glucose before the matches was 6.78 (4.89–9.39) mmol/L, and after the matches, it was 7.39 (5.5–9.87) mmol/L (P = .001). There were no episodes of severe hypoglycemia or ketoacidosis. The number of episodes of low glucose value (blood glucose ≤3.9 mmol/L) was higher during the tournament versus 30 days before: 1.2 (0–1.5) versus 0.7 (0.3–1.1) event/person/day, P < .001. Lactate levels increased during the matches (2.2 [1.6–4.0] mmol/L to 4.4 [2.6–8.5] mmol/L after the matches, P < .001). Conclusions: Large football tournaments can be organized safely for children with type 1 diabetes. For the majority of children, moderate mixed aerobic–anaerobic effort did not adversely affect glycemic results and metabolic safety.

No clear criteria have yet been established to guide decision-making for patient selection and the optimal timing of adaptive radiotherapy (ART) based on image-guided radiotherapy (IGRT). We have developed a novel protocol—the Best for Adaptive Radiotherapy (B-ART) protocol—to guide patient selection for ART. The aim of the present study is to describe this protocol, to evaluate its validity in patients with head and neck (HN) cancer, and to identify the anatomical and clinical predictors of the need for replanning. We retrospectively evaluated 82 patients with HN cancer who underwent helical tomotherapy (HT) and subsequently required replanning due to soft tissue changes upon daily MVCT. Under the proposed criteria, patients with anatomical changes >3 mm on three to four consecutive scans are candidates for ART. We compared the volumes on the initial CT scan (iCT) and the replanning CT (rCT) scan for the clinical target volumes (CTV1, referring to primary tumor or tumor bed and CTV2, metastatic lymph nodes) and for the parotid glands (PG) and body contour (B-body). The patients were stratified by primary tumor localization, clinical stage, and treatment scheme. The main reasons for replanning were: (1) a planning target volume (PTV) outside the body contour (n = 70; 85.4%), (2) PG shrinkage (n = 69; 84.1%), (3) B-body deviations (n = 69; 84.1%), and (4) setup deviations (n = 40; 48.8%). The replanning decision was made, on average, during the fourth week of treatment (n = 47; 57.3%). The mean reductions in the size of the right and left PG volumes were 6.31 cc (20.9%) and 5.98 cc (20.5%), respectively (p < 0.001). The reduction in PG volume was ≥30% in 30 patients (36.6%). The volume reduction in all of the anatomical structures was statistically significant. Four variables—advanced stage disease (T3–T4), chemoradiation, increased weight loss, and oropharyngeal localization—were significantly associated with the need for ART. The B-ART protocol provides clear criteria to eliminate random errors, and to allow for an early response to relevant changes in target volumes.