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Few studies have been conducted among Asian children and adolescents with type 1 diabetes mellitus (T1DM) using do-it-yourself artificial pancreas system (DIY-APS). We evaluated real-world data of pediatric T1DM patients using DIY-APS. Data were obtained for 10 patients using a DIY-APS with algorithms. We collected sensor glucose and insulin delivery data from each participant for a period of 4 weeks. Average glycosylated hemoglobin was 6.2%±0.3%. The mean percentage of time that glucose level remained in the target range of 70 to 180 mg/dL was 82.4%±7.8%. Other parameters including time above range, time below range and mean glucose were also within the recommended level, similar to previous commercial and DIY-APS studies. However, despite meeting the target range, unadjusted gaps were still observed between the median basal setting and temporary basal insulin, which should be handled by healthcare providers.

Background: User-developed automated insulin delivery systems, also referred to as do-it-yourself artificial pancreas systems (DIY APS), are in use by people living with type 1 diabetes. In this work, we evaluate, in silico, the DIY APS Loop control algorithm and compare it head-to-head with the bio-inspired artificial pancreas (BiAP) controller for which clinical data are available. Methods: The Python version of the Loop control algorithm called PyLoopKit was employed for evaluation purposes. A Python-MATLAB interface was created to integrate PyLoopKit with the UVa-Padova simulator. Two configurations of BiAP (non-adaptive and adaptive) were evaluated. In addition, the Tandem Basal-IQ predictive low-glucose suspend was used as a baseline algorithm. Two scenarios with different levels of variability were used to challenge the algorithms on the adult (n = 10) and adolescent (n = 10) virtual cohorts of the simulator. Results: Both BiAP and Loop improve, or maintain, glycemic control when compared with Basal-IQ. Under the scenario with lower variability, BiAP and Loop perform relatively similarly. However, BiAP, and in particular its adaptive configuration, outperformed Loop in the scenario with higher variability by increasing the percentage time in glucose target range 70-180 mg/dL (BiAP-Adaptive vs Loop vs Basal-IQ) (adults: 89.9% ± 3.2%* vs 79.5% ± 5.3%* vs 67.9% ± 8.3%; adolescents: 74.6 ± 9.5%* vs 53.0% ± 7.7% vs 55.4% ± 12.0%, where * indicates the significance of P < .05 calculated in sequential order) while maintaining the percentage time below range (adults: 0.89% ± 0.37% vs 1.72% ± 1.26% vs 3.41 ± 1.92%; adolescents: 2.87% ± 2.77% vs 4.90% ± 1.92% vs 4.17% ± 2.74%). Conclusions: Both Loop and BiAP algorithms are safe and improve glycemic control when compared, in silico, with Basal-IQ. However, BiAP appears significantly more robust to real-world challenges by outperforming Loop and Basal-IQ in the more challenging scenario.

Background: Automated insulin delivery systems are associated with improved glycemic outcomes for patients with diabetes. Ultra rapid lispro (URLi), which has an accelerated pharmacokinetic profile...

Background: Achieving accurate and consistent acetabular component orientation remains a major challenge in total hip arthroplasty. Methods: We used a pelvic model to compare freehand techniques vs mechanical and anatomical alignment guides in achieving a target operative inclination (OI) and operative anteversion (OA). Thirty subjects comprising consultant orthopedic surgeons, orthopedic trainees, and nonsurgical staff positioned an acetabular component in a pelvic model using 3 different methods for guiding inclination and another 3 for guiding version. Results: Using either a standard mechanical alignment guide (MAG) or a spirit level MAG technique eliminated outliers from target OI, while the freehand method resulted in 46.7% of measurements outside the OI target range. The spirit level MAG technique significantly outperformed the standard MAG technique in median unsigned deviation from target OI (0.8° vs 2.1°, P < .001). Either method of referencing the transverse acetabular ligament for version yielded lower deviations from target OA than the freehand method and fewer outliers from the ±5° target range. Surgical experience was not a significant factor for accurately achieving target OI and OA. Conclusions: Even in an idealized in vitro model, a wide range of OI and OA is seen with the freehand technique of cup placement by subjects of all levels of surgical experience. Using either a standard MAG or a spirit level MAG reduces deviations in target OI, with the spirit level MAG method yielding the best accuracy. Using the transverse acetabular ligament to guide cup anteversion yields more accurate OA.

Supplemental Digital Content is available in the text., Longer time in target range (TTR) for systolic blood pressure (SBP) is associated with a lower risk of cardiovascular events. Team-based care improves SBP control but its effect on the consistency of SBP control over time is unknown. This post hoc analysis used data from a cluster-randomized trial of a physician/pharmacist collaborative model that randomized medical offices to either a 9- or 24-month pharmacist intervention or control group. TTR for SBP was calculated using linear interpolation and an SBP range of 110 to 130 mm Hg. TTR is reported as median values and group comparisons assessed using the Kruskal-Wallis test. Of the 625 participants enrolled, 524 had 9-month and 366 had 24-month SBP data. Participants were a median 59 years old, 59% female, and 52% minority. After 24 months, the median TTR for SBP was 31.9% and 29.8% for the 9- and 24-month intervention groups, respectively, compared with 19% in the control group (P=0.0068). This observation persisted in the subgroup of participants with diabetes or chronic kidney disease and minorities. A longer TTR was not associated with an increased risk of adverse drug events. Time to first observed SBP in the target range was shorter in the intervention group compared with control (270 versus 365 days; P=0.0047). A physician/pharmacist collaborative care model achieved longer TTR for SBP compared with control (usual care).

Backgraund: The total number of patients with type 2 diabetes mellitus (T2DM) in the Russian Federation as of 01.01.2019 is 4.24 million. The majority of patients with T2DM are elderly people and older, forming groups with high comorbidity and the risk of severe hypoglycemia, including those associated with excess hypoglycemic therapy. Foreign studies indicate that a significant proportion of older adults with diabetes are potentially exposed to excessive sugar-lowering therapy.Aims: to study the frequency of excessive decrease in HbA1c in a group of patients with T2DM according to a sample from the regional diabetes register.Materials and methods: A content analysis of the regional register of diabetes mellitus was carried out as of ­December 31, 2019. Based on the register data, an individual target level of HbA1c was calculated and the compliance of the achieved HbA1c level with the target level was assessed.Results: The analysis included data from 1202 patients with T2DM, which amounted to 2.35% of the total number of patients with T2DM in the region (n = 51,163). The age of the included individuals was 66 years (LQ 60.0; UQ 72), 360 men (29.95%). The duration of T2DM 8.0 years. The HbA1c level in the general group was 7.1%. Persons over 60 years of age accounted for 75.21% (n = 904). When analyzing HbA1c in the age groups, there were no statistically significant differences (p> 0.05). HbA1c was above the target level in 43.34% of cases (n = 521). The level of HbA1c 1c 1c 1c 1c 1c 1c Conclusion: According to our data, at least a quarter of patients in the older age group (24.58%) had overtreatment and need de-intensification of therapy. Perhaps that in this group of patients, the risks associated with treatment may outweigh the benefits of tight glycemic control, and these patients require planned de-intensification of glucose-lowering therapy. Taking into account the position of some expert communities on determining the target range of HbA1c in the older age group, the need for de-intensification of antihyperglycaemic therapy may be even higher. Further research is required in order to develop a full-fledged domestic concept of de-intensification of hypoglycemic therapy.

Aim The aim of the study was to determine the effect of self-care training and informational support of patients with a mechanical heart valve on the international normalized ratio (INR) and bleeding complications. Material and methods Design: A quasi-experimental study. Participants were recruited via convenience sampling and were randomly divided into two groups: control (n = 80) and intervention (n = 80). Participants in the control group received only routine training; in addition, the intervention group received 6 sessions of self-care training and 6 months of informational support. Monthly the level of INR and incidence of bleeding were determined. Data were analyzed using the independent t-test and χ2 in SPSS16 software at a significance level of 0.05. Results During 6 months of follow-up, except for the third month, the frequency of INR levels in the therapeutic target range (2.5–3.5) in the intervention group was significantly higher than that in the control group (p < 0.05). Also in the intervention group, the incidence of bleeding complications was lower than that in the control group, but this difference was not statistically significant (p > 0.05). Conclusions Proper self-care training and informational support in patients with mechanical heart valve replacement have positive results. By maintaining self-care, the level of a therapeutic target range of INR can be maintained and the incidence of bleeding complications can be reduced.

Background: Flash glucose monitoring (FGM) systems can reduce glycemic variability and facilitate blood glucose management within the target range. However, in critically ill patients, only small ( n < 30) studies have examined the accuracy of FGM and none have assessed the stability of FGM accuracy. We evaluated the accuracy and stability of FGM in critically ill patients. Method: This was a single-center, retrospective observational study. We included a total of 116 critically ill patients who underwent FGM for glycemic control. The accuracy of FGM was assessed as follows using blood gas glucose values as a reference: (1) numerical accuracy using the mean absolute relative difference, (2) clinical accuracy using consensus error grid analysis, and (3) stability of accuracy assessing 14-day trends in consensus error grid distribution. Results: FGM sensors remained in situ for a median of 6 [4, 11] days. We compared 2014 pairs of measurements between the sensor and blood gas analysis. Glucose values from the sensor were consistently lower, with a mean absolute relative difference of 13.8% (±16.0%), than those from blood gas analysis. Consensus error grid analysis demonstrated 99.4% of the readings to be in a clinically acceptable accuracy zone. The accuracy of FGM was stable across the 14 days after device insertion. Conclusions: FGM had acceptable reliability and accuracy to arterial blood gas analysis in critically ill patients. In addition, the accuracy of FGM persisted for at least 14 days. Our study promotes the potential usefulness of FGM for glycemic monitoring in critically ill patients.

Aims: The aim of this retrospective observational study was to report on the impact of adopting the Joint British Diabetes Society for Inpatients (JBDS-IP) guidelines on the achievement of targets recommended by the National Institute for Health and Care Excellence (NICE) and the maternal and neonatal outcomes.Methods: We analysed case records of pregnant women with diabetes who delivered in the period between November 2017 and October 2018 from our data base ‘Euroking’ (Wellbeing Software Ltd, Mansfield). Data were collected in relation to the availability of a dedicated prescription chart in the notes, capillary blood glucose (CBG) monitoring, use of variable rate intravenous insulin infusion (VRIII), maintenance of CBG targets within 4.0–7.0 mmol/L, maternal hypoglycaemia during labour when on VRIII and neonatal hypoglycaemia.Results: Sixty women with diabetes in our database delivered during this period. Thirty-six (60%) were monitored with hourly CBG monitoring and 30 (50%) achieved CBG levels within the NICE recommended target range. Only five women (8.3%) were started on VRIII. There was no maternal hypoglycaemia in the VRIII group. One baby (1.7%) developed mild neonatal hypoglycaemia.Conclusion: Adoption of JBDS guidelines contributed to 60% of women with diabetes receiving complete CBG monitoring, of whom 70% achieved the NICE recommended target of 4.0–7.0 mmol/L during labour and birth. Repeat CBG measurements before starting VRIII, strict adherence to clear JBDS guidelines and protocols, daily review by the diabetes team during the working week and appropriate use of VRIII was associated with good maternal and neonatal outcomes.

Aims and methodRoutine therapeutic drug monitoring in clozapine therapy has previously not been considered justifiable. Using observational data, the clinical utility of annual clozapine assay monitoring is explored within a large mental health trust.ResultsAfter the introduction of routine monitoring, the rate of clozapine assays rose to 2.3 per patient per year, with a consistent reduction in high-risk clozapine assays (1.0 mg/L or any result more than 24 months old). High-risk assays are associated with a mortality rate of 31.6 deaths per 1000 patients, more than twice that of those within the target range (0.35–0.60 mg/L and conducted within the past 12 months) (P = 0.048).Clinical implicationsRoutine clozapine assay monitoring has significant clinical utility. Our simple but targeted approach can be readily implemented to reduce the number of patients with high-risk clozapine assay levels, potentially reduce all-cause mortality and provide optimal treatment for those with treatment-resistant schizophrenia.

The revised vancomycin guidelines recommend implementing AUC24-based therapeutic drug monitoring (TDM) using Bayesian methods in both adults and paediatrics. The motivation for this change was accumulating evidence showing aggressive dosing to achieve high troughs, as recommended in the first guidelines for adults and extrapolated to paediatrics, is associated with increased nephrotoxicity without improving clinical outcomes. AUC24-based TDM requires substantial resources that may need to be diverted from other valuable interventions. It can therefore be justified only after certain assumptions are shown to be true: (i) there is a clear relationship between vancomycin efficacy and/or toxicity and the proposed therapeutic range; and (ii) maintaining exposure within the target range with AUC24-based TDM improves clinical outcomes and/or decreases toxicity. In this review, we critically appraise the scientific basis for these assumptions. We find studies evaluating the relationship between vancomycin AUC24/MIC and efficacy in adults and children do not offer strong support for the recommended lower limit of the proposed therapeutic range (i.e. AUC24/MIC ≥400). Nephrotoxicity in children increases in a stepwise manner along the vancomycin exposure continuum but it is unclear if one parameter (AUC24 versus trough) is a superior predictor. Overall, evidence in children suggests good-to-excellent correlation between AUC24 and trough. Most importantly, there is no convincing evidence that the method of vancomycin TDM has a causal role in improving efficacy or reducing toxicity. These findings question the need to transition to resource-intensive AUC24-based TDM over retaining trough-based TDM with lower targets to minimize nephrotoxicity in paediatrics.

A method and a system for automatic regulation of the basal insulin administration rate for maintenance of glycemia in the target range are proposed. The method is based on proportional regulation of the infusion rate using feedback. It suspends the insulin delivery when the glucose level falls below a threshold value. According to the modeling results, the proposed method can be used to compensate hyperglycemia of different etiologies with reduction of the settling time in comparison with constant rate insulin infusion.

Tip 1 diyabet (T1D) tanılı küçük çocuklar diyabet yönetimi ve glisemik değişkenlik bakımından ayrı bir yere sahiptir. Küçük çocuklar (

The mechanical loading technology has been developed for the pre-compression of central solenoid for the tokamak device of JT-60 super advanced (JT-60SA) being constructed in Japan. Four central solenoid modules were manufactured one by one, then 4 modules were stacked. The pre-compression were conducted to bind stacked 4 modules by support structure called tie-plate as a final process of the central solenoid manufacturing. The pre-compression jigs were designed by using the finite element analysis taking into account of plastic deformation of the jigs and the tie-plate. The pre-compression was performed using developed jigs. The hydraulic jacks and pumps were separately installed to the each tie-plate to control the pre-compress load individually. Since the pre-compress load changed by insulation creeping after initial loading, additional shims were inserted for the tie-plate with small load. Finally, pre-compress load of all tie-plate became within the target range. These results indicate that the pre-compression has been successfully completed using the developed jigs. In this paper, the design and analysis of the pre-compression jigs and the result of the pre-compression are reported.

Objectives In women with gestational diabetes mellitus (GDM), glycemic control is typically assessed by capillary blood glucose (BG) self-monitoring. Currently, the standard method of monitoring is by 4-times-daily self-measurements. The goal of our study was to determine whether twice-daily capillary BG testing is comparable with 4-times-daily testing in women with GDM. Methods Thirty-two women with GDM completed initial dietary counselling and recorded consecutive fasting and 2-h postprandial BG over a 14-day period. We randomly selected 2 of 4 BG measurements on each given day and compared mean (95% confidence interval [CI]) twice-daily vs 4-times-daily BG measurements using paired t tests and Bland-Altman plots. The proportion of 14-day BG measurements above glycemic targets was also compared between twice-daily vs 4-times-daily testing for fasting and postprandial readings. Results Comparing twice-daily vs 4-times-daily mean BG, there was a small difference for fasting BG (0.09 mmol/L; 95% CI, 0.03 to 0.14), but not for 2-h postbreakfast (−0.05 mmol/L; 95% CI, −0.17 to 0.06), 2-h postlunch (−0.03 mmol/L; 95% CI, −0.13 to 0.08) or 2-h postdinner (0.05 mmol/L; 95% CI, −0.09 to 0.19) BG. Bland-Altman plots showed general agreement and minimal bias between twice-daily vs 4-times-daily BG, whether fasting or postprandial. There was no significant difference in the proportion of 14-day BG measurements above glycemic targets comparing twice-daily vs 4-times-daily testing in the fasting or postprandial states. Conclusions Twice-daily BG testing appears to generate 14-day average values similar to 4-times-daily BG testing. In women with GDM, whose BG is in target range, twice-daily BG monitoring may reduce inconvenience and cost.

BackgroundA knowledge gap exists for dolutegravir (DTG) pharmacokinetics and safety during the first 4 weeks of life, preventing safe and effective DTG use in neonates.SettingPopulation pharmacokinetic modeling and simulation were used to assess newborn DTG dosing requirements during the first few days of life as a function of maternal DTG dosing history before delivery.MethodsDTG PK data were obtained from pregnant women and infants enrolled in the International Maternal Pediatric Adolescent AIDS Clinical Trials Network P1026S study. Maternal and neonate population pharmacokinetic models were separately developed. Monte Carlo simulations were performed to simulate neonatal concentrations after 2 doses of DTG after birth for infants born to mothers either receiving or not receiving DTG before delivery.ResultsIn DTG-naïve infants, a 5-mg DTG dose at birth with a second dose after 48 hours maintained median concentrations above the lower bound of the target range (0.77 μg/mL) and below the upper bound of the target range (7.34 μg/mL representing 2-fold above the adult Cmax value). In DTG-exposed infants, a 5-mg DTG dose at 24 hours after birth with a second dose after 48 hours maintained median concentrations within or nearly within the target range, even if the last maternal DTG dose was taken as soon as 6 hours or as long as 24 hours before delivery.ConclusionsNewborn DTG dosing requirements during the first few days of life depend on maternal DTG dosing history before delivery. These results may help the design of future clinical studies of DTG in the neonatal population.

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.

There is an association between hypocapnia and adverse neurodevelopmental outcome in infants with neonatal encephalopathy (NE). Our aim was to test the safety and feasibility of 5% CO2 and 95% air inhalation to correct hypocapnia in mechanically ventilated infants with NE undergoing therapeutic hypothermia. Ten infants were assigned to this open-label, single-center trial. The gas mixture of 5% CO2 and 95% air was administered through patient circuits if the temperature-corrected PCO2 ≤40 mm Hg. The CO2 inhalation was continued for 12 h or was stopped earlier if the base deficit (BD) level decreased 40 mm Hg, the lower value of the target range. Regression modeling revealed that BD and lactate had a tendency to decrease during the intervention (by 0.61 and 0.55 mmol/L/h, respectively), whereas pH remained stable. The rate of moderate disabilities and normal outcome was 50%. Our results suggest that inhaled 5% CO2 administration is a feasible and safe intervention for correcting hypocapnia.

Background Both inadequate and excessive administration of oxygen to acutely unwell patients results in risk of harm. Guidelines recommend titration of oxygen to achieve a target oxygen saturation (SpO2) range. Information regarding whether this is being achieved is limited. Methods In this two-centre non-interventional study we used continuous pulse oximetry in acutely unwell medical patients over a 24-h period to determine the proportion of time spent with SpO2 within the prescribed target range and whether this is influenced by the target range, age, care in a high-dependency area and the number of oxygen adjustments. Results Eighty participants were included in the analysis. The mean (SD) proportion of time spent in target range was 55.6% (23.6), this was lower in those with a reduced hypercapnic target range (88–92% or below) compared to those with a range of 92–96%; difference − 13.1% (95% CI − 3.0 to − 23.2), P = 0.012. The proportion of time spent above range was 16.2% (22.9); this was higher in those with a reduced hypercapnic range; difference 21.6% (31.4 to 12), P P = 0.02. Conclusions Medical patients receiving oxygen in a ward setting spend significant periods of time with SpO2 both above and below the prescribed target range while receiving oxygen therapy.

Background Supplemental oxygen is the commonest ‘drug’ used in the NICU; goals of therapy is to maintain normoxia whilst minimising hyperoxemia and hypoxemia. Objectives To determine the percentage of time preterm infants, spend with oxygen saturation (SpO2) 95%, and to assess whether 4-hour SpO2 histograms are predictive of 24-hour SpO2 histogram profiles. Methods This prospective audit reviewed 100 SpO2 histogram profiles for 60 preterm infants (birth gestation between 23+0 and 33+6 weeks) admitted to the NICU, requiring invasive and non-invasive respiratory support, at different points of their neonatal course, between 01/01/2020 to 01/11/2020. Preterm SpO2 target range within this NICU is 90–95%. We collected SpO2 histogram data from bedside Phillips monitors at 5% intervals displaying the percentage of time spent in SpO2 ranges, at 4-, 8-, 12- and 24-hour intervals. Results Mean birth gestation was 26.8 ± 2.4 weeks and mean corrected gestational age at the time of the study was 30.4 ± 2.5 weeks. Twenty preterm infants required conventional mechanical ventilation, 28 CPAP, 26 HFNC, 14 low flow oxygen and 12 had no respiratory support at the point of the study. Table 1 shows preterm infants spend substantial amounts of time outside of their SpO2 target range; hyperoxemia was especially marked. Infants 27 weeks spent more time with SpO2 95%. Infants >28 days spent significantly more time with SpO2 95%. Ventilated infants spent significantly more time with SpO2 Conclusions Maintaining normoxia for preterm infants is challenging, with substantial amounts of time spent outside of the SpO2 target range. There is strong correlations between 4-hour and 24-hour histograms, which could help in assessing a preterm infants’ response to changes in respiratory management.

Blood phenylalanine (Phe) is used as the primary marker to evaluate metabolic control. Our study aimed to describe the metabolic control of patients with phenylketonuria (PKU) comparing three different treatment recommendations (European guidelines/US guidelines/Portuguese consensus). This was a retrospective, observational, single centre study in patients with PKU collecting data on blood Phe levels from 2017. Nutritional intake data and sapropterin (BH4) prescription were collected at the last appointment of 2017. The final sample studied included 87 patients (48% females) [13 hyperphenylalaninemia, 47 mild PKU, 27 classical PKU] with a median age of 18 y (range: 1–36 y). The median number of blood Phe measurements for patients was 21 (range: 6–89). In patients aged &lt, 12 y, the median blood Phe level was 300 μmol/L (range 168–480) and 474 μmol/L (range 156–1194) for patients ≥ 12 y. Overall, a median of 83% of blood Phe levels were within the European PKU guidelines target range. In patients aged ≥ 12 years, there was a higher median % of blood Phe levels within the European PKU guidelines target range (≥12 y: 84% vs. &lt, 12 y: 56%). In children &lt, 12 y with classical PKU (n = 2), only 34% of blood Phe levels were within target range for all 3 guidelines and 49% with mild PKU (n = 11). Girls had better control than boys (89% vs. 66% median Phe levels within European Guidelines). Although it is clear that 50% or more patients were unable to achieve acceptable metabolic control on current treatment options, a globally agreed upper Phe target associated with optimal outcomes for age groups is necessary. More studies need to examine how clinics with dissimilar resources, different therapeutic Phe targets and frequency of monitoring relate to metabolic control.

Purpose: To evaluate the long-term effectiveness of iTrack (Nova Eye Medical, Fremont, USA) ab-interno canaloplasty performed as a standalone procedure, or combined with cataract surgery, in reducing antiglaucoma medication dependence and maintaining intraocular pressure within target range in patients with controlled primary open-angle glaucoma. Methods: This is a retrospective, single-center, case series study of patients who underwent iTrack ab-interno canaloplasty as a standalone procedure ( n = 34) or in combination with cataract surgery ( n = 11). Eyes with controlled mild or moderate glaucoma (intraocular pressure ⩽17 mmHg) were included; those with prior glaucoma surgeries were excluded. The primary outcome was the mean reduction in glaucoma medication and the secondary outcome was the maintenance of controlled intraocular pressure postoperatively. Results: A total of 35 patients (45 eyes) with a mean age of 73 ± 9.7 years were included in the study. For all eyes, a significant decrease (61%) in the mean number of medications was seen at 36 months (1.89 ± 0.93 versus 0.60 ± 0.82; p Conclusion: The iTrack ab-interno canaloplasty significantly reduced medication dependency and maintained intraocular pressure within target range in patients with controlled mild or moderate primary open-angle glaucoma, while showing a good safety profile, both as a standalone procedure or in combination with cataract surgery.

Introduction: Hypertension associates with both kidney and cardiovascular (CV) disease risk. Time-in-target range (TTR) associates with CV risk independent of mean SBP and SBP variability. We hypothesized that SBP TTR predicts both adverse kidney and CV outcomes. Methods: ACCORD BP and SPRINT trial participants with >=2 SBP measurements were eligible, except ACCORD standard BP lowering participants due fewer SBP measurements. SBP TTR for months 0-3 was calculated using Rosendaal linear interpolation with target ranges of 110-130 mm Hg and 120-140 mm Hg for participants in the intensive or standard arms, respectively. Adverse kidney outcomes included dialysis, kidney transplant, serum creatinine > 3.3 mg/dL, sustained eGFR of < 15 mL/min per 1.73 m 2 or sustained eGFR decline >40% after month 3. Adverse CV outcomes included myocardial infarction, stroke, heart failure and CV death. Cox proportional hazards regression models were used to estimate the association between TTR and adverse outcomes after demographics, clinical risk factors and baseline SBP adjustment Results: Participants with higher TTR were younger, less likely to have preexisting CV disease and had less albuminuria, higher eGFR and lower baseline SBP. In fully adjusted models accounting for baseline SBP, higher TTR independently associated with a lower risk of adverse kidney and CV outcomes (P-trend < .001 for each). Whereas the relationship between TTR and CV risk increased monotonically with higher TTR, the TTR association with kidney risk was greatest at the extremes of TTR ( Figure ). Conclusions: Further reductions in adverse kidney and CV outcomes may be achievable through sustained SBP control.

Highlights A clinical pharmacist using recommendations of Food and Drug Administration-cleared computerized insulin dose adjustment algorithms based on analyses of glucose readings from continuous glucose monitoring (Abbot Free Style Pro) in 13 poorly controlled insulin-requiring diabetic patients increased time in target range of 3.9 to 10.0 mmol/L from 29% to 51% and decreased time in range of >13.9 mmol/L from 43% to 23% (both P = 0.01) after 3 months. Glycated hemoglobin (HbA1c) levels (±SD) fell from 102 (±15) to 67 (±10) mmol/mol (P < 10-6 ).

AIMS: To evaluate the association between flash glucose monitoring (FLASH) frequency and glycemic parameters during real-life circumstances in the Netherlands.METHODS: Obtained glucose readings were de-identified and uploaded to a dedicated database when FLASH reading devices were connected to internet. Data between September 2014 and March 2020, comprising 16,331 analyzable readers (163,762 sensors) were analyzed. Scan rate per reader was determined and each reader was sorted into 20 equally sized rank ordered groups (n=817 each).RESULTS: Users performed a median of 11.5 [IQR 7.7-16.7] scans per day. Those in the lowest and highest ventiles scanned on average 3.7 and 40.0 times per day and had an eHbA1c of 8.6% (71 mmol/mol) and 6.9% (52 mmol/mol), respectively. Increasing scan rates were associated with more time in target range (3.9-10 mmol/L), less time in hyperglycemia (>10 mmol/L), and a lower standard deviation of glucose. An eHbA1c of 7.0% (53 mmol/mol) translated in approximately 65% time in target range, 30% time in hyperglycemia and 5% time in hypoglycemia (CONCLUSIONS: These outcomes among Dutch FLASH users suggest that with higher scan rate glycemic control improves.

ObjectiveTo compare the effect of two different automated oxygen control devices on target range (TR) time and occurrence of hypoxaemic and hyperoxaemic episodes.DesignRandomised cross-over study.SettingTertiary level neonatal unit in the Netherlands.PatientsPreterm infants (n=15) born between 24+0 and 29+6 days of gestation, receiving invasive or non-invasive respiratory support with oxygen saturation (SpO2) TR of 91%–95%. Median gestational age 26 weeks and 4 days (IQR 25 weeks 3 days–27 weeks 6 days) and postnatal age 19 (IQR 17–24) days.InterventionsInspired oxygen concentration was titrated by the OxyGenie controller (SLE6000 ventilator) and the CLiO2 controller (AVEA ventilator) for 24 hours each, in a random sequence, with the respiratory support mode kept constant.Main outcome measuresTime spent within set SpO2 TR (91%–95% with supplemental oxygen and 91%–100% without supplemental oxygen).ResultsTime spent within the SpO2 TR was higher during OxyGenie control (80.2 (72.6–82.4)% vs 68.5 (56.7–79.3)%, p2 2 deviations occurred less frequently during OxyGenie control.ConclusionsThe OxyGenie control algorithm was more effective in keeping the oxygen saturation within TR and preventing hyperoxaemia and equally effective in preventing hypoxaemia (SpO2 Trial registry numberNCT03877198

T1D accounts for 10% of all diabetes and DKA accounts for 8.1 per 1,000 hospitalizations. Glycemic outcomes have not been reported for adults with specifically T1D. We describe hospital glycemic outcomes for patients with T1D with and without DKA. Individual-level data from the Glytec Inpatient Database was examined for glycemic outcomes based on pre-specified target blood glucose (BG) ranges (Table 1). All patients were treated with Glucommander IV. Data was extracted from 154 hospitals located in 17 different states in the United States (2015-2020). T1D was determined based on ICD E10.XX. The DKA group (n=4592) included patients with age > 18 years met criteria for DKA: bicarbonate 250 mg/dl, and anion gap >12 mEq/L. The non DKA group (n=10,886) included patients who did not meet the DKA criteria. Prevalence of hypoglycemia and time to target (TTT) BG were stratified by target BG ranges. In patients with DKA, % BG This largest descriptive analysis of adult T1D patients with DKA and without DKA showed that Glucommander IV can safely get patients into prespecified target range, with minimal rates of hypoglycemia. Disclosure J. Messler: Employee; Self; Glytec, LLC. P. Vellanki: Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc. B. W. Bode: Advisory Panel; Self; Eli Lilly and Company, Consultant; Self; Bigfoot Biomedical, Inc., Companion Medical, Lexicon Pharmaceuticals, Inc., Medtronic, Novo Nordisk Inc., Zealand Pharma A/S, Research Support; Self; Abvance Therapeutics, Dexcom, Inc., Diasome Pharmaceuticals, Inc., Dompe, Eli Lilly and Company, Eyenuk, Inc., Insulet Corporation, Jaeb Center for Health Research, Medtronic, Nova Biomedical, Novo Nordisk, Provention Bio, Inc., REMD Biotherapeutics, Sanofi, Senseonics, Viacyte, Inc., vTv Therapeutics, Xeris Pharmaceuticals, Inc., Speaker’s Bureau; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, MannKind Corporation, Medtronic, Novo Nordisk, Sanofi, Stock/Shareholder; Self; AgaMatrix, Aseko, Inc., Glytec, LLC. R. Booth: Employee; Self; Glytec, LLC. J. Clarke: Employee; Self; Aseko, Inc., Stock/Shareholder; Self; Aseko, Inc.

Aims: To compare derived time in range (dTIR) with insulin degludec/liraglutide (IDegLira) and insulin glargine 100 units/mL (IGlar U100) in patients with type 2 diabetes (T2D). Methods: Data from DUAL V, a trial of patients with T2D uncontrolled on IGlar U100 randomized to switch to IDegLira or up-titration of IGlar U100 (+metformin; n=557), and DUAL VIII, a durability trial of insulin-naive patients with T2D randomized to either IDegLira or IGlar U100 (+ oral antidiabetic drugs; n=1012), were evaluated post hoc. Self-monitored blood glucose profiles (weeks 0, 12, and 26 [DUAL V] or weeks 0, 26, and 104 [DUAL VIII]) were used to derive the proportion of available readings within (dTIR: 70-180 mg/dL [3.9-10 mmol/L]), below (dTBR: 180 mg/dL [>10 mmol/L]) target range. Results: Estimated treatment differences (IDegLira− IGlar U100) for change from baseline to end of treatment (EOT) in dTIR were significantly greater with IDegLira vs. IGlar U100 (Figure). The proportion of patients achieving ≥70% dTIR at EOT with IDegLira and IGlar U100, respectively, was 62% and 60% in DUAL V, and 50% and 26% in DUAL VIII; the proportion achieving a ≥5% increase in dTIR from baseline to EOT was 63% in both groups in DUAL V, and 44% and 25%, respectively, in DUAL VIII. Conclusion: IDegLira was associated with significantly greater dTIR vs. IGlar U100 in insulin-experienced and insulin-naive patients with T2D. Disclosure A. Philis-tsimikas: Advisory Panel; Self; Bayer Inc., Lilly Diabetes, Medtronic, Novo Nordisk, Consultant; Self; Sanofi-Aventis, Employee; Spouse/Partner; Ionis, Other Relationship; Self; Merck & Co., Inc., Research Support; Self; Dexcom, Inc., Lilly Diabetes, Medtronic, Novo Nordisk, Sanofi-Aventis. V. R. Aroda: Consultant; Self; Applied Therapeutics, Duke, Novo Nordisk, Pfizer Inc., Sanofi, Employee; Spouse/Partner; Janssen , Merck , Research Support; Self; Applied Therapeutics, Eli Lilly and Company, Fractyl , Medpace, Medpace, Novo Nordisk, Premier , Sanofi, Stock/Shareholder; Spouse/Partner; Janssen, Merck. C. De block: Advisory Panel; Self; A. Menarini Diagnostics, Abbott Diagnostics, AstraZeneca, Boehringer Ingelheim , Eli Lilly and Company, MSD, Novartis AG, Novo Nordisk, Roche Diagnostics, Sanofi, Research Support; Self; AstraZeneca, Novo Nordisk, Speaker9s Bureau; Self; A. Menarini Diagnostics, Abbott Diagnostics, Boehringer Ingelheim , Eli Lilly and Company, Novo Nordisk, Sanofi. L. K. Billings: Advisory Panel; Self; Bayer Inc., Lilly Diabetes, Novo Nordisk, Sanofi. E. Hachmann-nielsen: Employee; Self; Novo Nordisk A/S. A. Liebl: Advisory Panel; Self; AstraZeneca, Becton, Dickinson and Company, Boehringer Ingelheim International GmbH, Eli Lilly and Company, MSD, Novo Nordisk, Roche, Speaker9s Bureau; Self; AstraZeneca, Bayer, Becton, Dickinson and Company, Boehringer Ingelheim International GmbH, Bristol Myers Squibb , Dexcom, Inc., Eli Lilly and Company, Medtronic, MSD, Novo Nordisk, OmniaMed, Roche, Sanofi. R. Sivarathinasami: Employee; Self; Novo Nordisk Service Centre India Private Ltd. J. M. D9cruz: Employee; Self; NovoNordisk GBS. I. Lingvay: Advisory Panel; Self; Bayer Healthcare Pharmaceuticals Inc., Lilly Diabetes, Consultant; Self; TARGET PharmaSolutions, Other Relationship; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Novo Nordisk, Pfizer Inc., Zealand Pharma A/S, Research Support; Self; Mylan N. V., Sanofi. Funding Novo Nordisk A/S

The technology needed to “close the loop,” that is, a system for continuous glucose monitoring and a pump that infuses insulin, are only 2 of the 3 components needed for each system for automated insulin delivery (AID), the other is a “translation” of the glucose information into the appropriate amount of insulin to be applied at a given point in time to keep glucose levels in the body in the target range. It might look straightforward to calculate the required insulin dose and control the pump to apply this immediately; however, once a given amount of insulin is in the body, it will be absorbed and become metabolically active. To avoid lowering glucose levels toward too low levels, the algorithms used to calculate the insulin dose have to take a number of other factors into account. This is needed to make sure that AID systems are not only efficient but also safe, that is, not only Time-in-Range should be maximal, also Time-below-Range should be minimal. The review characterizes the different types of AID algorithms that were developed in the last decades. Using a structured approach, the different algorithms are classified. A systematic evaluation of the performance of the different algorithms is missing, not only during the clinical development of AID systems, but also in daily practice. However, it might very well be that other factors determine which AID algorithms will be used in practice.

For the success of the treatment with a left ventricular assist device (LVAD), both adequate self-management by the patient and an optimum level of support from the implanting hospital are crucial. A smartphone application has recently been developed within the framework of a European research project for the close monitoring of LVAD patients in order to improve upon their current aftercare situation. Using this new tool, different relevant parameters (eg, weight, international normalized ratio [INR], medication, LVAD parameters, symptoms, and photos of the driveline exit) can be sent daily or as required to a corresponding clinical application at the hospital for evaluation. The objective of this study was to monitor the functionality, acceptance, and usability of this smartphone application in LVAD patients. Prospective single-center study: in total, 13 patients (60 ± 7 years, 92% male, 1027 ± 653 days after LVAD implantation) were requested to test the application for approx. 4 weeks. At the end of the study, all entered data were evaluated and the patients were questioned regarding the acceptance and the usability. During the study period of mean 34 ± 8 days, a total of 453 data records (mean 35 ± 7 per patient) arrived at the hospital. In addition, a total of 19 photos of the driveline exit site were also sent via smartphone. The clinical application registered a total of 160 conspicuities. These comprised 126 INR deviations (target range 2.3-2.8) and 34 symptoms (mainly nosebleeds). The smartphone application functioned reliably, was well received by the patients and was graded highly for acceptance and usability. The results show that smartphone applications can definitely be used to improve aftercare in LVAD therapy in selected patients. Long-term studies are now needed to investigate the extent to which complications can be prevented, healthcare costs reduced, and quality of life increased.

BackgroundAlthough hemodialysis (HD) adequacy, single-pool Kt/Vurea(spKt/V), is inversely correlated with body size, each is known to affect patient survival in the same direction. Therefore, we sought to examine the relationship between HD adequacy and mortality according to body mass index (BMI) in HD patients and explore a combination effect of BMI and HD adequacy on mortality risk.MethodsWe retrospectively reviewed patient data from the Korean Society of Nephrology registry, a nationwide database of medical records of HD patients, from January 2001 to June 2017. We included patients ≥18 years old who were receiving maintenance HD. Patients were categorized into three groups according to baseline BMI (2). Baseline spKt/V was divided into six categories.ResultsAmong 18,242 patients on HD, the median follow-up duration was 5.2 (IQR, 1.9–8.9) years. Cox regression analysis showed that, compared to the reference (spKt/V 1.2–1.4), lower and higher baseline spKt/V were associated with greater and lower risks for all-cause mortality, respectively. However, among patients with high BMI (n = 5588), the association between higher spKt/V and lower all-cause mortality was attenuated in all adjusted models (Pinteraction ConclusionsThe association between spKt/V and mortality in HD patients may be modified by BMI.

Introduction: Vitamin K antagonist therapy is safest and most effective with a high time within the therapeutic range (TTR). The TTR is difficult to calculate in the consultation room, therefore physicians need an easier-to-use tool to predict poor VKA control.We explored the prognostic value of subtherapeutic INRs on future TTR in two settings:(1) Clinical review setting, where a physician (bi) annually reviews a patient and uses the INRs since the last visit to predict the TTR up to the next visit;(2) Day-to-day INR management setting, where every new INR measurement prompts a new prediction over the next 90 days.Materials and methods: Retrospective cohort of 17,711 patients from a dedicated thrombosis service, using acenocoumarol (target range 2.0-3.0), with a "streak" defined as four consecutive INRs(1) Odds ratios of any streak in the last 180 days or 1 year on a TTR (2) Odds ratio of a current streak on a TTR Results and conclusions: Clinical review setting: The occurrence of any streak in the last 180 days or 1 year increased the odds of a TTR Day-to-day INR management setting: A current streak increases the odds of poor TTR over the next 90 days 3.58 (95% CI 2.64-4.87) fold.We conclude that a streak of four consecutive subtherapeutic INRs can aid physicians in flagging at-risk patients.

الملخص: أهداف البحث: ينبغي إعطاء العلاج بالأكسجين، الذي يشيع استخدامه سريريا، وفقا لوصفة طبية؛ غير أن أدلة متراكمة تشير إلى وجود درجة من سوء الممارسة الطبية في هذا المجال. هدفت هذه الدراسة إلى تقييم الممارسة الحالية لكتابة الوصفة واستخدام العلاج بالأكسجين. طرق البحث: أُجْرِيَت هذه الدراسة الرصدية في مستشفى تعليمي في المنطقة الشرقية بالمملكة العربية السعودية. شملت جميع المرضى المنومين في الأجنحة العامة الذين كانوا يُعطَون أُكسجينا إضافيا. تم جمع البيانات الديموغرافية للمرضى وعناصر وصفات الأطباء من ملفات قسم الرعاية التنفسية ومن الملفات الطبية للمرضى. كما تم رصد إعطاء الأكسجين للمرضى المنومين ومطابقتها مع وصفات الأوكسجين المسجلة في الملفات الطبية وملفات قسم الرعاية التنفسية. النتائج: من بين ١٥٢ مريضا منوما، كان ٢١ منهم على أكسجين إضافي. وكان لـ ٢٠ من بين هؤلاء، وصفة طبية مكتوبة في الملف الطبي، ولكن فقط ١٨ كان لديهم معلومات مسجلة في ملفات قسم الرعاية التنفسية. من بين خمسة عناصر لوصفات العلاج بالأكسجين، توفر ٣ منها عند ٣٠٪ من المرضى، بينما لم تتوفر سوى ٢ منها لدى ٧٠٪ من المرضى. تمت التوصية بوسيلة إيصال الأكسجين في جميع وصفات الأطباء، بينما تم تحديد معدل التدفق ونسبة الأكسجين المستنشق في ٣٠٪ فقط من الوصفات. من بين ستة مرضى كان لديهم تسجيل مكتوب لتشبع الشعيرات الدموية الطرفية بالأكسجين المستهدف، كان لدى ٢ منهم قيمة خارجة عن النطاق المستهدف، وكان لدى ٢ من ٦ مرضى معدل تدفق مختلف عن المعدل المطلوب في الوصفة. الاستنتاجات: كانت الممارسة الحالية لوصفة العلاج بالأكسجين وإعطائها دون المستوى الأمثل. هناك حاجة إلى إجراء تحقيقات ومراجعات وطنية فيما يتعلق بممارسة العلاج بالأكسجين لتحسين رعاية المرضى. Abstract: Objectives: Oxygen therapy, commonly used clinically, should be administered according to the physician's prescription; however, accumulating evidence signals some degree of inaccuracy in this perspective. This study aimed to evaluate the current practice of prescription and administration of oxygen therapy. Methods: This observational study was conducted at a teaching hospital in the Eastern province of KSA. All inpatients in general wards who were on supplemental oxygen (O2) were included. Patient's demographic data and physician's prescription items were collected from patient medical charts and the respiratory care (RC) department charts. Oxygen administration to inpatients was monitored and matched with oxygen prescriptions recorded on the medical and RC charts. Results: Among 152 inpatients, 21 were on supplemental O2. Of these, 20 had written prescriptions in their medical charts, but only 18 had information recorded in the RC charts. Of the 5 items required by hospital guidelines for oxygen prescription, 30% of patients had 3 items; whereas 70% of patients had only 2 items. Mode of oxygen delivery was recommended in all physicians' prescriptions, but flow rate and FiO2 were ordered in only 30% of prescriptions. Among the 6 patients with a written record of target SpO2 range, 2 had a value outside of the target range and 2 of 6 patients had a flow rate that differed from the prescribed rate. Conclusion: Current practice for oxygen therapy prescription and administration was suboptimal. Nation-wide investigations and remediations of oxygen therapy practice is needed to improve patient care. الكلمات المفتاحية: العلاج بالأكسجين, إعطاء الأكسجين, وصفة طبية, العلاج التنفسي, Keywords: Oxygen administration, Oxygen therapy, Prescription, Respiratory therapy

The landscape of the federal funds market changed drastically in the wake of the Great Recession as large-scale asset purchase programs left depository institutions awash with reserves, and new regulations made it more costly for these institutions to lend. As traditional levers for implementing monetary policy became less effective, the Federal Reserve introduced new tools to implement the target range for the federal funds rate, changing this landscape even more. In this paper, we develop a model that is capable of reproducing the main features of the federal funds market, as observed before and after 2008, in a single, unified framework. We use this model to quantitatively evaluate the evolution of interest rates and trading volume in the federal funds market as the supply of aggregate reserves shrinks. We find that these outcomes are highly sensitive to the dynamics of the distribution of reserves across banks.

Type 1 diabetic patients need a strict treatment to regulate blood glucose concentration in a target range. Despite the development of different control strategies, the model parameter variations, given by physiological changes, can generate an inaccurate treatment and in consequence hyperglycemia and hypoglycemia episodes. Therefore, it is necessary to use control techniques that compensate such effects and maintain the control goals. Here, the effect of parametric variations is examined by the sensitivity analysis from which the most influential parameters in glycemia dynamics are detected. Based on that, an offset-free MPC strategy for impulsive systems is given for the first time in literature and simulated for type 1 diabetes treatment. This scheme along with the impulsive zone MPC with artificial variables reestablishes the normoglycemia behavior since the parameter variations are adequately rejected. However, only parametric variations up to 50% from their nominal values are well compensated, which suggests that more robust formulations are needed to ensure a greater rejection of physiological variations.

Introduction: Growth in patients with isolated growth hormone (GH) deficiency is heterogeneous despite treatment due to the low specificity of diagnostic tests, making it necessary to define efficacy variables. Aims: To evaluate efficacy of hormone replacement therapy in children with isolated GH deficiency. Methods: Observational-ambispective study of patients treated in our department in the last 14 years for isolated GH deficiency. This was defined as a GH level less than 7.4 mg/dL in response to 2 stimulation tests in patients with height

Parathyroidectomy (PTX) is the standard treatment for secondary hyperparathyroidism (SHPT); however, the administration of cinacalcet has gained prominence as a noninvasive treatment. We aimed to determine whether PTX or cinacalcet is more effective in preventing morbidity and mortality through reviewing follow-up data concerning surgical management of SHPT. We retrospectively analyzed and divided 209 patients with SHPT into two treatment groups: PTX (n = 78) and cinacalcet (n = 131) groups. We compared clinical features, the over-the-target range rate during pre- and post-intervention periods, new cardiovascular events, and all-cause mortality between both groups. Almost all biochemical parameters were well controlled in the post-intervention period, and were within the recommended target range for the PTX group but not for the cinacalcet group. A significant difference was observed in the over-the-target range rate during the post-intervention period between the groups. PTX and cinacalcet interventions significantly lowered the over-the-target range rates for serum intact parathyroid hormone (iPTH) (>300 pg/mL), corrected calcium (>10.5 mg/mL), serum phosphorus (>5.5 mg/dL), and calcium-phosphorus product (>55) in both groups (p = 0.001). PTX reduced the risk of new cardiovascular events by 86% compared to cinacalcet (p = 0.001); however, all-cause mortality did not differ significantly (14.1% vs. 7.6%, p = 0.132). For patients with SHPT, PTX helps prevent cardiovascular events through normalizing biochemical variables, according to recommended guidelines. PTX should be considered before cinacalcet treatment to prevent new cardiovascular events. Early PTX for appropriate patients can help prevent immediate postoperative complications and mortality.

Abstract: Introduction: Being entitled for no patient co-payment, the Hungarian reimbursement condition of analogue insulins as part of basal-bolus treatment in type 2 diabetes mellitus (T2DM) requires that two HbA1c levels should achieve 1c >9.0%). Method: This one-year, non-interventional study included patients with T2DM inadequately controlled (HbA1c >9.0%) on previous human basal-bolus treatment. The main outcomes were the proportion of patients who achieved the adequate glycaemic control (defined by the reimbursement rules) and the proportion of patients who achieved reimbursement rules defined HbA1c 1c value 1c measurements had not met the reimbursement requirements in a significant part of patients. Orv Hetil. 2018; 159(50): 2122–2128.