THE ADOPTION OF AUTOMATED FiO2 CONTROL INTO POLISH NICUS: 2012-2019

The introduction and adoption of new technology in medicine is a continuous ever present process but it is often not studied. Insights gained from documenting such experiences can not only guide local practices but also provide valuable quality benchmarks. Automated control of FiO2 based on continuous SpO2 (A-FiO2) not only reduces the challenging task of manual oxygen titration, but also has the potential to greatly improve the morbidity and mortality of extremely preterm infants. First approved for use in Europe in 2012, it is now available on most infant ventilators outside the USA. Poland was the first region in Europe to implement its clinical use. We report experience from 619 infants from 12 centers recorded in a web-based registry established in 2013 to document its use. We found the A‑FiO2 was primarily used in the first week of life in intubated infants. However it is also successfully applied in both noninvasively supported infants and in those who were difficult to wean from oxygen and who exhibited frequent desaturations. We also found the SpO2 target range and alarm setting are not different from normal manual titration, although wider settings are also used and promise some benefit. Finally we report our plan to gather data from a national data base and detailed surveys. The surveys will document subjective aspects of this experience from a core group of centers. Details of the surveys are included and cover: experience with training and acceptance, changes in practice associated with the years of experience and barriers to broader use

Short‐term fully closed‐loop insulin delivery using faster insulin aspart compared to standard insulin aspart in type 2 diabetes

We evaluated the efficacy and safety of short‐term fully closed‐loop insulin delivery using faster versus standard insulin aspart in type 2 diabetes. Fifteen adults with insulin‐treated type 2 diabetes underwent 22 hours of closed‐loop insulin delivery with either faster or standard insulin aspart in a double‐blind randomised crossover design. Basal‐bolus regimen was replaced by model predictive control algorithm‐directed insulin delivery based on sensor glucose levels. The primary outcome was time with plasma glucose in target range (5.6‐10.0mmol/l) and did not differ between treatments (mean difference [95%CI] ‐3.3% [8.2;1.7], p=0.17). Mean glucose and glucose variability were comparable, as was time spent below and above target range. Hypoglycaemia (<3.5mmol/l) occurred once with faster insulin aspart and twice with standard insulin aspart. Mean total insulin dose was higher with faster insulin aspart (mean difference [95%CI] 3.7U [0.7;6.8], p=0.021). No episodes of severe hypoglycaemia or other serious adverse events occurred. In conclusion, short‐term fully closed‐loop in type 2 diabetes may require higher dose of faster insulin aspart compared to standard insulin aspart to achieve comparable glucose control.Swiss National Science Foundation (P1BEP3_165297), UDEM Scientific Fund, Cambridge Biomedical Research Centre - NIHR

Closed-Loop Insulin Delivery for Glycemic Control in Noncritical Care.

BACKGROUND: In patients with diabetes, hospitalization can complicate the achievement of recommended glycemic targets. There is increasing evidence that a closed-loop delivery system (artificial pancreas) can improve glucose control in patients with type 1 diabetes. We wanted to investigate whether a closed-loop system could also improve glycemic control in patients with type 2 diabetes who were receiving noncritical care. METHODS: In this randomized, open-label trial conducted on general wards in two tertiary hospitals located in the United Kingdom and Switzerland, we assigned 136 adults with type 2 diabetes who required subcutaneous insulin therapy to receive either closed-loop insulin delivery (70 patients) or conventional subcutaneous insulin therapy, according to local clinical practice (66 patients). The primary end point was the percentage of time that the sensor glucose measurement was within the target range of 100 to 180 mg per deciliter (5.6 to 10.0 mmol per liter) for up to 15 days or until hospital discharge. RESULTS: The mean (±SD) percentage of time that the sensor glucose measurement was in the target range was 65.8±16.8% in the closed-loop group and 41.5±16.9% in the control group, a difference of 24.3±2.9 percentage points (95% confidence interval [CI], 18.6 to 30.0; P<0.001); values above the target range were found in 23.6±16.6% and 49.5±22.8% of the patients, respectively, a difference of 25.9±3.4 percentage points (95% CI, 19.2 to 32.7; P<0.001). The mean glucose level was 154 mg per deciliter (8.5 mmol per liter) in the closed-loop group and 188 mg per deciliter (10.4 mmol per liter) in the control group (P<0.001). There was no significant between-group difference in the duration of hypoglycemia (as defined by a sensor glucose measurement of <54 mg per deciliter; P=0.80) or in the amount of insulin that was delivered (median dose, 44.4 U and 40.2 U, respectively; P=0.50). No episode of severe hypoglycemia or clinically significant hyperglycemia with ketonemia occurred in either trial group. CONCLUSIONS: Among inpatients with type 2 diabetes receiving noncritical care, the use of an automated, closed-loop insulin-delivery system resulted in significantly better glycemic control than conventional subcutaneous insulin therapy, without a higher risk of hypoglycemia. (Funded by Diabetes UK and others; ClinicalTrials.gov number, NCT01774565 .)

Fully closed-loop insulin delivery in inpatients receiving nutritional support: a two-centre, open-label, randomised controlled trial.

BACKGROUND: Glucose management is challenging in patients who require nutritional support in hospital. We aimed to assess whether fully closed-loop insulin delivery would improve glycaemic control compared with conventional subcutaneous insulin therapy in inpatients receiving enteral or parenteral nutrition or both. METHODS: We did a two-centre (UK and Switzerland), open-label, randomised controlled trial in adult inpatients receiving enteral or parenteral nutrition (or both) who required subcutaneous insulin therapy. Patients recruited from non-critical care surgical and medical wards were randomly assigned (1:1) using a computer-generated minimisation schedule (stratified by type of nutritional support [parenteral nutrition on or off] and pre-study total daily insulin dose [<50 or ≥50 units]) to receive fully closed-loop insulin delivery with faster-acting insulin aspart (closed-loop group) or conventional subcutaneous insulin therapy (control group) given in accordance with local clinical practice. Continuous glucose monitoring in the control group was masked to patients, ward staff, and investigators. Patients were followed up for a maximum of 15 days or until hospital discharge. The primary endpoint was the proportion of time that sensor glucose concentration was in target range (5·6-10·0 mmol/L), assessed in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT01774565. FINDINGS: Between Feb 8, 2018, and Sept 21, 2018, 90 patients were assessed for eligibility, of whom 43 were enrolled and randomly assigned to the closed-loop group (n=21) or the control group (n=22). The proportion of time that sensor glucose was in the target range was 68·4% [SD 15·5] in the closed-loop group and 36·4% [26·6] in the control group (difference 32·0 percentage points [95% CI 18·5-45·5; p<0·0001]). One serious adverse event occurred in each group (one cardiac arrest in the control group and one episode of acute respiratory failure in the closed-loop group), both of which were unrelated to study interventions. There were no adverse events related to study interventions in either group. No episodes of severe hypoglycaemia or hyperglycaemia with ketonaemia occurred in either study group. INTERPRETATION: Closed-loop insulin delivery is an effective treatment option to improve glycaemic control in patients receiving nutritional support in hospital. FUNDING: Diabetes UK, Swiss National Science Foundation, National Institute for Health Research Cambridge Biomedical Research Centre, Wellcome Trust, and European Foundation for the Study of Diabetes

Psychological Well-Being of Parents of Very Young Children With Type 1 Diabetes – Baseline Assessment

Background: Type 1 diabetes in young children is a heavy parental burden. As part of pilot phase of the KIDSAP01 study, we conducted a baseline assessment in parents to study the association between hypoglycemia fear, parental well-being and child behavior. Methods: All parents were invited to fill in baseline questionnaires: hypoglycemia fear survey (HFS), WHO-5, Epworth Sleepiness Scale and Strength and Difficulties Questionnaire (SDQ). Results: 24 children (median age: 5-year, range 1-7 years, 63% male, mean diabetes duration: 3 ± 1.7 years) participated. 23/24 parents filled out the questionnaires. We found a higher score for the hypoglycemia fear behavior 33.9 ± 5.6 compared to hypoglycemia worry 34.6 ± 12.2. Median WHO-5 score was 16 (8 - 22) with poor well-being in two parents. Median daytime sleepiness score was high in five parents (>10). For six children a high total behavioral difficulty score (>16) was reported. Pro social behavior score was lower than normal in six children (<6). Parental well-being was negatively associated with HFS total (r = - 0.50, p <.05) and subscale scores (r = - 0.44, p <.05 for HFS-Worry and HFS-Behavior), child behavior (r = - 0.45, p = .05) and positively with child age and diabetes duration (r = 0.58, p <.01, r = 0.6, p <.01). HFS, parental well-being nor daytime sleepiness are associated with the HbA1c. Conclusion: Regular screening of parental well-being, hypoglycemia fear and child behavior should be part of routine care to target early intervention

Extremely Preterm Infant Admissions Within the SafeBoosC-III Consortium During the COVID-19 Lockdown

Objective: To evaluate if the number of admitted extremely preterm (EP) infants (born before 28 weeks of gestational age) differed in the neonatal intensive care units (NICUs) of the SafeBoosC-III consortium during the global lockdown when compared to the corresponding time period in 2019. Design: This is a retrospective, observational study. Forty-six out of 79 NICUs (58%) from 17 countries participated. Principal investigators were asked to report the following information: (1) Total number of EP infant admissions to their NICU in the 3 months where the lockdown restrictions were most rigorous during the first phase of the COVID-19 pandemic, (2) Similar EP infant admissions in the corresponding 3 months of 2019, (3) the level of local restrictions during the lockdown period, and (4) the local impact of the COVID-19 lockdown on the everyday life of a pregnant woman. Results: The number of EP infant admissions during the first wave of the COVID-19 pandemic was 428 compared to 457 in the corresponding 3 months in 2019 (−6.6%, 95% CI −18.2 to +7.1%, p = 0.33). There were no statistically significant differences within individual geographic regions and no significant association between the level of lockdown restrictions and difference in the number of EP infant admissions. A post-hoc analysis based on data from the 46 NICUs found a decrease of 10.3%in the total number of NICU admissions (n = 7,499 in 2020 vs. n = 8,362 in 2019). Conclusion: This ad hoc study did not confirm previous reports of a major reduction in the number of extremely pretermbirths during the first phase of the COVID-19 pandemic. Clinical Trial Registration: ClinicalTrial.gov, identifier: NCT04527601 (registered August 26, 2020), https://clinicaltrials.gov/ct2/show/NCT04527601

Psychological Well-Being of Parents of Very Young Children With Type 1 Diabetes – Baseline Assessment

Background: Type 1 diabetes in young children is a heavy parental burden. As part of pilot phase of the KIDSAP01 study, we conducted a baseline assessment in parents to study the association between hypoglycemia fear, parental well-being and child behavior. Methods: All parents were invited to fill in baseline questionnaires: hypoglycemia fear survey (HFS), WHO-5, Epworth Sleepiness Scale and Strength and Difficulties Questionnaire (SDQ). Results: 24 children (median age: 5-year, range 1-7 years, 63% male, mean diabetes duration: 3 ± 1.7 years) participated. 23/24 parents filled out the questionnaires. We found a higher score for the hypoglycemia fear behavior 33.9 ± 5.6 compared to hypoglycemia worry 34.6 ± 12.2. Median WHO-5 score was 16 (8 - 22) with poor well-being in two parents. Median daytime sleepiness score was high in five parents (>10). For six children a high total behavioral difficulty score (>16) was reported. Pro social behavior score was lower than normal in six children (<6). Parental well-being was negatively associated with HFS total (r = - 0.50, p <.05) and subscale scores (r = - 0.44, p <.05 for HFS-Worry and HFS-Behavior), child behavior (r = - 0.45, p = .05) and positively with child age and diabetes duration (r = 0.58, p <.01, r = 0.6, p <.01). HFS, parental well-being nor daytime sleepiness are associated with the HbA1c. Conclusion: Regular screening of parental well-being, hypoglycemia fear and child behavior should be part of routine care to target early intervention

The Soviet Union and Communist Ideology in Gustaw Herling Grudziński's Thought

reservedQuesta tesi si propone di introdurre la figura di Gustaw Herling-Grudziński e la sua visione del comunismo nella Russia sovietica. Era uno dei pochi scrittori che osarono equiparare il nazismo allo stalinismo, concentrandosi su ciò che rappresentavano questi sistemi totalitari piuttosto che sulle ideologie che seguivano. Questo lavoro presenta i pensieri di Gustaw Herling-Grudziński sul comunismo, contenuti nelle sue opere letterarie più importanti, e confronta il suo punto di vista con due importanti scrittori di guerra polacchi: Tadeusz Borowski e Czesław Miłosz. Questo lavoro analizza anche l'opinione di Herling sulla visione del sistema comunista contenuta nelle opere di eminenti scrittori russi come Aleksandr Isaevič Solženicyn e Varlam Tichonovič Šalamov. La tesi presenta anche le riflessioni di Herling sulle origini e sulla caduta del comunismo sovietico, presente anche in Polonia nella seconda metà del XX secolo. La tesi evidenzia anche l'importante distinzione operata da Herling tra Russia e Unione Sovietica.This thesis aims to introduce the figure of Gustaw Herling-Grudziński and his view of communism in Soviet Russia. He was one of the few writers who dared to equate Nazism with Stalinism, focusing on what these totalitarian systems represented rather than the ideologies they followed. This work presents Gustaw Herling-Grudziński's thoughts on communism, contained in his most important literary works, and confronts his point of view with two important Polish war writers - Tadeusz Borowski and Czesław Miłosz. This work also analyzes Herling's opinion on the vision of the communist system contained in the works of eminent Russian writers such as Aleksandr Isaevič Solženicyn and Varlam Tichonovič Šalamov. The thesis also presents Herling's reflections on the origins and fall of Soviet communism, also present in Poland in the second half of the 20th century. The paper also highlights the important distinction Herling made between Russia and the Soviet Union

Ageing well? A cross-country analysis of the way older people are visually represented on websites of organizations for older people

The ‘aging well’ discourse advances the idea of making older people responsible for their capability to stay healthy and active. In the context of an increased ageing population, which poses several challenges to countries’ government, this discourse has become dominant in Europe. We explore the way older people are visually represented on websites of organizations for older people in seven European countries (Finland, UK, the Netherlands, Spain, Italy, Poland and Romania), using an analytical approach based on visual content analysis, inspired by the dimensional model of national cultural differences from the Hofstede model (1991; 2001; 2011). We used two out of the five Hofstede dimensions: Individualism/Collectivism (IDV) and Masculinity/Femininity (MAS). The results demonstrated that in all seven countries older people are mostly visually represented as healthy/active, which reflects a dominant ‘ageing well’ discourse in Europe. The results also demonstrated that in most cases older people tend to be represented together with others, which is not consonant with the dominant ‘ageing well’ discourse in Europe. A last finding was that the visual representation of older peopleis in about half of the cases in line with these Hofstede dimensions. We discuss the implications of these findings claiming that the ‘ageing well’ discourse might lead to ‘visual ageism’. Organizations could keep this in mind while using pictures for their website or in other media and consider to use various kind of pictures, or to avoid using pictures of older people that stigmatize, marginalize or injure. They could look into the cultural situatedness and intersectional character of age relations and consider alternative strategies of both visibility and invisibility to talk with and about our ageing societies

Evaluation of two SpO2 alarm strategies during automated FiO2 control in the NICU: a randomized crossover study

Abstract Background Changes in oxygen saturation (SpO2) exposure have been shown to have a marked impact on neonatal outcomes and therefore careful titration of inspired oxygen is essential. In routine use, however, the frequency of SpO2 alarms not requiring intervention results in alarm fatigue and its corresponding risk. SpO2 control systems that automate oxygen adjustments (Auto-FiO2) have been shown to be safe and effective. We speculated that when using Auto-FiO2, alarm settings could be refined to reduce unnecessary alarms, without compromising safety. Methods An unblinded randomized crossover study was conducted in a single NICU among infants routinely managed with Auto-FiO2. During the first 6 days of respiratory support a tight and a loose alarm strategy were switched each 24 h. A balanced block randomization was used. The tight strategy set the alarms at the prescribed SpO2 target range, with a 30-s delay. The loose strategy set the alarms 2 wider, with a 90-s delay. The effectiveness outcome was the frequency of SpO2 alarms, and the safety outcomes were time at SpO2 extremes ( 98%). We hypothesized that the loose strategy would result in a marked decrease in the frequency of SpO2 alarms, and no increases at SpO2 extremes with 20 subjects. Within subject differences between alarm strategies for the primary outcomes were evaluated with Wilcoxon signed-rank test. Results During a 13-month period 26 neonates were randomized. The analysis included 21 subjects with 49 days of both tight and loose intervention. The loose alarm strategy resulted in a reduction in the median rate of SpO2 alarms from 5.2 to 1.6 per hour (p <  0.001, 95%-CI difference 1.6–3.7). The incidence of hypoxemia and hyperoxemia were very low (less than 0.1%-time) with no difference associated with the alarm strategy (95%-CI difference less than 0.0–0.2%). Conclusions In this group of infants we found a marked advantage of the looser alarm strategy. We conclude that the paradigms of alarm strategies used for manual titration of oxygen need to be reconsidered when using Auto-FiO2. We speculate that with optimal settings false positive SpO2 alarms can be minimized, with better vigilance of clinically relevant alarms. Trial registration Retrospectively registered 15 May 2018 at ISRCTN (49239883)