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Introduction: Pre-hospital risk classification by the HEART score is performed with point of care troponin assessment. However, point of care troponin is less sensitive than high sensitive troponin measurement which is used in the hospital setting. In this study we compared pre-hospital HEART-score risk classification using point of care troponin versus high sensitive troponin.Methods: In 689 consecutive patients with suspected NSTE-ACS, point of care troponin and laboratory high-sensitive troponin were measured in pre-hospital derived blood. For every patient the HEART score with both point of care troponin (HEART-POC) and high sensitive troponin (HEART-hsTnT) was determined. Endpoint was MACE within 45 days.Results: Mean age was 64 (SD +/- 14), 163 (24%) patients were considered low-risk by HEART-hsTnT and 170 (25%) by HEART-POC. MACE was observed in 17%. Although high sensitive versus POC troponin scoring was different in 130 (19%) of patients, in 678 (98%) patients risk classification in low versus intermediate-high risk was similar. The predictive values of HEART-POC versus HEART-HsTnT was similar (AUC 0.75 versus 0.76, p=0.241).Conclusion: Although high sensitive versus POC troponin scoring was dissimilar in one fifth of patients, this resulted in different patient risk classification in only 2 percent of patients. Therefore POC troponin measurement suffices for pre-hospital risk stratification of suspected NSTE-ACS. (c) 2019 Elsevier Inc. All rights reserved.

Background: Pre-hospital risk stratification of non-ST-elevation acute coronary syndrome (NSTE-ACS) by the complete HEART score has not yet been assessed. We investigated whether pre-hospital risk stratification of patients with suspected NSTE-ACS using the HEART score is accurate in predicting major adverse cardiac events (MACE). Methods: This is a prospective observational study, including 700 patients with suspected NSTE-ACS. Risk stratification was performed by ambulance paramedics, using the HEART score; low risk was defined as HEART score ⩽ 3. Primary endpoint was occurrence of MACE within 45 days after inclusion. Secondary endpoint was myocardial infarction or death. Results: A total of 172 patients (24.6%) were stratified as low risk and 528 patients (75.4%) as intermediate to high risk. Mean age was 53.9 years in the low risk group and 66.7 years in the intermediate to high risk group ( pConclusions: In suspected NSTE-ACS, pre-hospital risk stratification by ambulance paramedics, including troponin measurement, is accurate in differentiating between low and intermediate to high risk. Future studies should investigate whether transportation of low risk patients to a hospital can be avoided, and whether high risk patients benefit from immediate transfer to a hospital with early coronary angiography possibilities.

Introduction: The coronavirus disease 2019 (COVID-19) pandemic has put tremendous pressure on the healthcare system, highlighting the need for a fast, highly sensitive and non-invasive test. The large number of infected healthcare workers results in a shortage of personnel and can become a source of infection for patients. In this study volatile molecules in exhaled air were analyzed in personnel using an electronic nose (Aeonose®). Objective: To rapidly differentiate COVID-19 infected and non-infected healthcare workers with mild symptoms. Methods: 724 healthcare workers from three large teaching hospitals were tested for COVID-19 according to routine hospital guidelines. Signed informed consent and data on sex, age and symptoms were collected before the COVID-19 test results were available. Follow-up ensured correct classification of infection status. Breath profiles were obtained with the Aeonose and analyzed using a neural network. Logistic regression analyses were performed in SPSS. Results: Of 724 participants, 107 (15%) tested positive for COVID-19. In the training set, a model based on symptoms (coughing, fever, headache and loss/change of smell) yielded an AUC of the ROC (AUROC) of 0.79. Aeonose breath profile analysis yielded an AUROC of 0.77. The integration of both models resulted in an AUROC of 0.90. This combined model distinguished between COVID-19 positive and negative personnel in 65% of the cases, with a negative predictive value of 98% (431/440) and a positive predictive value of 98% (41/42). Independent validation is ongoing. Conclusions: Combining breath analysis with symptoms is a rapid novel diagnostic tool to identify COVID-19 infection in healthcare workers with mild symptoms.

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.

There is increasing evidence that in patients presenting with acute chest pain, pre-hospital triage can accurately identify low-risk patients. It is, however, still unclear which diagnostics are performed in pre-hospital-adjudicated low-risk patients and what the contribution is of those diagnostic results in the healthcare process. The aim of this study was to quantify healthcare utilization, costs, and outcomes in pre-hospital-adjudicated low-risk chest-pain patients, and to extrapolate to total costs in the Netherlands. This was a prospective cohort study including 700 patients with suspected non-ST-elevation acute coronary syndrome in which pre-hospital risk stratification using the HEART score was performed by paramedics. Low risk was defined as a pre-hospital HEART score ≤ 3. Data on (results of) hospital diagnostics, costs, and discharge diagnosis were collected. A total of 172 (25%) patients were considered as low risk. Of these low-risk patients, the mean age was 54 years, 52% were male, and 84% of patients were discharged within 12 h. Repeated electrocardiography and routine laboratory measurements, including cardiac markers, were performed in all patients. Chest X-ray was performed in 61% and echocardiography in 11% of patients. After additional diagnostics, two patients (1.2%) were diagnosed as non-ST-elevation myocardial infarction and two patients (1.2%) as unstable angina. Other diagnoses were atrial fibrillation (n = 1) and acute pancreatitis/cholecystitis (n = 2); all other patients had non-specific/non-acute discharge diagnoses. Mean in-hospital costs per patient were €1580. The estimated yearly acute healthcare cost in low-risk chest-pain patients in the Netherlands is €30,438,700. In low-risk chest-pain patients according to pre-hospital risk assessment, acute healthcare utilization and costs are high, with limited added value. Possibly, if a complete risk assessment can be performed by ambulance paramedics, acute hospitalization of the majority of low-risk patients is not necessary, which can lead to substantial cost reduction. Dutch Trial Register [http://www.trialregister.nl]: trial number 4205.

Aims Although pre-hospital risk stratification of patients with suspected non-ST-elevation acute coronary syndrome (NSTE-ACS) by ambulance paramedics is feasible, it has not been investigated in daily practice whether referral decisions based on this risk stratification is safe and does not increase major adverse cardiac events (MACE). In Phase III of the FamouS Triage study, it was investigated whether referral decisions by ambulance paramedics based on a pre-hospital HEART score, is non-inferior to routine management. Methods and results FamouS Triage Phase III is a non-inferiority study, comparing the occurrence of MACE before (Phase II) and after (Phase III) implementation of referral decisions based on a pre-hospital HEART score. In Phase II, all patients were risk-stratified and referred to the hospital; in Phase III, low-risk patients (HEART score ≤ 3) were not referred. Primary endpoint was MACE (acute coronary syndrome, revascularization, or death) within 45 days. A total of 1236 patients were included. Mean age was 63 years, 43% were female, 700 patients were included in the second phase and 536 in the third phase in which 149 low-risk patients (28%) were not transferred to the hospital. Occurrence of 45 days MACE was 16.6% in Phase II and 15.7% in Phase III (P = 0.67). Percentage MACE in low-risk patients was 2.9% in Phase II and 1.3% in Phase III. After adjustments for differences in baseline variables, the hazard ratio of 45 days MACE in Phase III was 0.88 (95% confidence interval 0.63–1.25) as compared to Phase II. Conclusion Pre-hospital risk stratification of patients with suspected NSTE-ACS, avoiding hospitalization of a substantial number of low-risk patients, seems feasible and non-inferior to transferring all patients to the hospital.

Background Troponin composition characterization has been implicated as a next step to differentiate among non-ST elevation myocardial infarction (NSTEMI) patients and improve distinction from other conditions with troponin release. We therefore studied coronary and peripheral troponin compositions in relation to clinical variables of NSTEMI patients. Methods Samples were obtained from the great cardiac vein (GCV), coronary sinus (CS), and peripheral circulation of 45 patients with NSTEMI. We measured total cTnI concentrations, and assessed both complex cTnI (binary cTnIC + all ternary cTnTIC forms), and large-size cTnTIC (full-size and partially truncated cTnTIC). Troponin compositions were studied in relation to culprit vessel localization (left anterior descending artery [LAD] or non-LAD), ischemic time window, and peak CK-MB value. Results Sampling occurred at a median of 25 hours after symptom onset. Of total peripheral cTnI, a median of 87[78-100]% consisted of complex cTnI; and 9[6-15]% was large-size cTnTIC. All concentrations (total, complex cTnI, and large-size cTnTIC) were significantly higher in the CS than in peripheral samples (P Conclusions In coronary veins draining the infarct area, concentrations of both full-size and degraded troponin were higher than in the peripheral circulation. This finding, and the observed associations of troponin composition with the ischemic time window and the extent of sustained injury may contribute to future characterization of different disease states among NSTEMI patients.

Aims: To identify factors predicting HbA1c reduction in patients with diabetes mellitus (DM) using FreeStyle Libre Flash Glucose Monitoring (FSL-FGM).Methods: Data from a 12-month prospective nation-wide FSL registry were used and analysed with multivariable regression. For the present study we included patients with hypoglycaemia unawareness or unexpected hypoglycaemias (n = 566) and persons who did not reach acceptable glycaemic control (HbA1c > 70 mmol/mol (8.5%)) (n = 294). People with other indications for use, such as sensation loss of the fingers or individuals already using FSL-FGM or rtCGM, were excluded (37%).Results: Eight hundred and sixty persons (55% male with a mean age of 46.7 (+/- 16.4) years) were included. Baseline HbA1c was 65.1 (+/- 14.5) mmol/mol (8.1 +/- 1.3%), 75% of the patients had type 1 DM and 37% had microvascular complications. Data concerning HbA1c was present for 482 (56.0%) at 6 months and 423 (49.2%) persons at 12 months. A significant reduction in HbA1c (>= 5 mmol/mol (0.5%)) was present in 187 (22%) persons. For these persons, median HbA1c reduction was -9.0 [-13.0, -4.0] mmol/mol (-0.82 [-1.19, -0.37]%) at 6 months and -9.0 [-15.0, -7.0] mmol/mol (-0.82 [-1.37, -0.64]%) at 12 months. In multi-variable regression analysis with age, gender and SF-12 physical and mental component scores as covariates, only baseline HbA1c was significant: -0.319 (SE 0.025; p Conclusions: Among the variables we analysed in the present study, only high HbA1c at baseline predicts significant HbA1c reduction during FSL-CGM use.

Background: It is not yet investigated whether referral decisions based on prehospital risk stratification of non-ST-elevation Acute Coronary Syndrome (NSTE-ACS) by the complete History, ECG, Age, Risk factors and initial Troponin (HEART) score are feasible and safe. Hypothesis: Implementation of referral decisions based on the prehospital acquired HEART score in patients with suspected NSTE-ACS is feasible and not inferior to routine management in the occurrence of major adverse cardiac events within 45 days. Study design & methods: FamouS Triage 3 is a feasibility study with a before–after sequential design. The aim is to assess whether prehospital HEART-score management including point-of-care troponin measurement is feasible and noninferior to routine management. Primary end point is the occurrence of major adverse cardiac events within 45 days. Conclusion: If referral decisions based on prehospital acquired risk stratification are feasible and noninferior this can become the new prehospital management in suspected NSTE-ACS.

There is an increasing awareness that prehospital risk stratification in patients with suspected non-ST-elevation acute coronary syndrome (NSTE-ACS) is important. The HEART score accurately identifies patients at low risk and is nowadays fully assessable outside the hospital after the development of point-of-care (POC) troponin tests. However, the added value of the troponin component to the prehospital HEART score has not yet been assessed. This is a prospective cohort study including 700 patients with suspected NSTE-ACS in which prehospital risk stratification using the HEART score was performed by paramedics. Low risk was defined as HEAR or HEART score ≦3. Troponin was measured by a POC troponin T Test device (Roche Cobas h232). Troponin40 ng/l scored 0 point, troponin ≥40 ng/l scored 2 points. Primary end point was major adverse cardiac events (MACE) within 45 days after inclusion. Mean HEAR score was 4.5 ± 1.6, mean HEART score was 4.7 ± 1.7. Using the HEAR score, a total of 183 patients (26%) were stratified as low risk, whereas using the HEART score, 172 patients (25%) were stratified as low risk (p = 0.001). In both low-risk groups, there were no deaths within 45 days. Using HEAR, MACE occurred in 13 patients (7%) in the low-risk group, whereas using HEART, MACE occurred in 5 patients in the low-risk group (3%, p0.001). The use of HEART (Area under the curve 0.74) obtained a higher predictive value compared to HEAR (Area under the curve 0.65, p0.001) for MACE. In conclusion, in patients with suspected NSTE-ACS, the prehospital troponin component of the HEART score has important added predictive value.

IntroductionThe FreeStyle Libre (FSL) is a flash glucose monitoring (FGM) system. The Flash Monitor Register in the Netherlands (FLARE-NL-4) study previously demonstrated the positive effects of FSL-FGM use during 1 year on glycemic control, quality of life and disease burden among persons with diabetes mellitus (DM). The present follow-up study assesses the effects of FSL-FGM after 2 years.Research design and methodsPatients included in the FLARE-NL-4 study who continued FSL-FGM during the 1-year study period were invited to participate (n=687). Data were collected using questionnaires (the 12-Item Short Form Health Survey version 2 (SF-12v2) and the EuroQol 5-Dimension 3-Level (EQ-5D-3L) for quality of life), including self-reported hemoglobin A1c (HbA1c).ResultsA total of 342 patients agreed to participate: mean age 48.0 (±15.6) years, 52% men and 79.5% with type 1 DM. HbA1c decreased from 60.7 (95% CI 59.1 to 62.3) mmol/mol before use of FSL-FGM to 57.3 (95% CI 55.8 to 58.8) mmol/mol after 1 year and 57.8 (95% CI 56.0 to 59.5) mmol/mol after 2 years. At the end of the 2-year follow-up period, 260 (76%) persons were still using the FSL-FGM and 82 (24%) had stopped. The main reason for stopping FSL-FGM was financial constraints (55%). Concerning the whole 2-year period, there was a significant decrease in HbA1c among persons who continued use of FSL-FGM (−3.5 mmol/mol, 95% CI −6.4 to –0.7), while HbA1c was unaltered compared with baseline among persons who stopped FSL-FGM (−2.4 mmol/mol, 95% CI −7.5 to 2.7): difference between groups 2.2 (95% CI −1.3 to 5.8) mmol/mol. After 2 years, persons who continued use of FSL-FGM had higher SF-12 mental component score and higher EQ-5D Dutch tariff score and felt less often anxious or depressed compared with persons who discontinued FSL-FGM.ConclusionsAlthough the considerable number of non-responders limits generalizability, this study suggests that persons who continue to use FSL-FGM for 2 years may experience sustained improvement in glycemic control and quality of life.

Background: The first study of the FamouS Triage project investigates the feasibility of ruling out a myocardial infarction in pre-hospital chest pain patients without electrocardiographic ST-segment elevation by using the modified HEART score at the patient’s home, incorporating only a single highly sensitive troponin T measurement. Methods: A venous blood sample was drawn in the ambulance from 1127 consecutive chest pain patients for measurement of the pre-hospital highly sensitive troponin T levels, in order to establish a pre-hospital HEART score (i.e. the modified HEART score) and evaluate the possibility of triage at the patient’s home. The primary endpoint was the occurrence of a major adverse cardiac event (MACE) i.e. acute myocardial infarction, percutaneous coronary intervention, coronary artery bypass grafting or death within 30 days after initial presentation. Results: Two hundred and six patients (18%) developed a MACE during 30 days of follow-up. Thirty-six per cent of the patients ( n=403) had a low modified HEART score (0–3 points) and none of them developed a MACE during follow-up. Forty-four per cent of the patients ( n=494) had an intermediate modified HEART score (4–6 points) and 18% of them developed a MACE. Twenty per cent of the patients ( n=230) had a high modified HEART score (7–10 points) of which 52% developed a MACE during follow-up. Conclusion: It seems feasible to rule out a myocardial infarction at home in chest pain patients without ST-segment elevation by using the modified HEART score. TRIAL ID: NTR4205. Dutch Trial Register [ http://www.trialregister.nl ]: trial number 4205.

With increasing use of both flash glucose monitoring and real-time continuous glucose monitoring and the reliance of users on these readings, accuracy is important, in particular during intensive exercise. We investigated the performance of the FreeStyle Libre 1 flash glucose monitor and the Guardian Connect EnliteTM real-time continuous glucose monitor by comparing readings with self-monitored blood glucose values during intensive exercise.

IntroductionThe FreeStyle Libre is a flash glucose monitoring (FSL-FGM) system. Compared with finger-prick based self-monitoring of blood glucose, FSL-FGM may provide benefits in terms of improved glycemic control and decreased disease burden.MethodsProspective nationwide registry. Participants with diabetes mellitus (DM) used the FSL-FGM system for a period of 12 months. End points included changes in HbA1c, hypoglycemia, health-related quality of life (12-Item Short Form Health Surveyv2 (SF-12v2) and 3-level version of EuroQol 5D (EQ-5D-3L)), a specifically developed patient-reported outcome measures (PROMs) questionnaire, diabetes-related hospital admission rate and work absenteeism. Measurements were performed at baseline, and after 6 months and 12 months.Results1365 persons (55% male) were included. Mean age was 46 (16) years, 77% of participants had type 1 DM, 16% type 2 DM and 7% other forms. HbA1c decreased from 64 (95%CI 63 to 65) mmol/mol to 60 (95%CI 60 to 61) mmol/mol with a difference of −4 (95% CI −6 to 3) mmol/mol. Persons with a baseline HbA1c >70 mmol/mol had the most profound HbA1c decrease: −9 (95% CI −12 to to 5) mmol/mol. EQ-5D tariff (0.03 (95%CI 0.01 to 0.05)), EQ-VAS (4.4 (95%CI 2.1 to 6.7)) and SF-12v2 mental component score (3.3 (95%CI 2.1 to 4.4)) improved. For most, PROMs improved. Work absenteeism rate (/6 months) and diabetes-related hospital admission rate (/year) decreased significantly, from 18.5% to 7.7% and 13.7% to 2.3%, respectively.ConclusionsReal world data demonstrate that use of FSL-FGM results in improved well-being and decreased disease burden, as well as improvement of glycemic control.

Background There is increasing evidence that in patients presenting with acute chest pain, pre-hospital triage can accurately identify low-risk patients. It is, however, yet unclear which diagnostics are performed in pre-hospital adjudicated low-risk patients and what the contribution is of those diagnostic results in the healthcare process. Objectives The aim of this study is to quantify health care utilization, costs and outcomes in pre-hospital adjudicated low-risk chest pain patients, and to extrapolate to costs on a national level. Methods This is a prospective cohort study including 700 patients with suspected NSTE-ACS in which pre-hospital risk stratification using the HEART score was performed by paramedics. Low risk was defined as a pre-hospital HEART score ≤3. Data on (results of) hospital diagnostics, costs and discharge diagnosis were collected. Results A total of 172 (25%) patients were considered as low risk. Of these low-risk patients, mean age was 54 years, 52% were male, 84% of patients were discharged within 12 hours. Repeated electrocardiography and routine laboratory measurements, including cardiac markers were performed in all patients. Chest X-ray was performed in 61%, echocardiography in 11% of patients. After additional diagnostics, 2 patients (%) were diagnosed as non-STEMI, 2 patients (%) as unstable angina. Other diagnoses were atrial fibrillation (n=1) and acute pancreatitis/cholecystitis (n=2), all other patients had non-specific/non-acute discharge diagnoses. Mean in-hospital costs per patient were €1.580,-. The estimated yearly acute healthcare costs in low-risk chest pain patients in the Netherlands are € 30.438.700,- Conclusion In low-risk chest pain patients according to pre-hospital risk assessment, acute healthcare utilization and costs are high, with limited added value. Possibly, if a complete risk assessment can be performed by ambulance paramedics, acute hospitalization of the majority of low-risk patients is not necessary which can lead to substantial cost reduction.

Introduction Although increasing evidence shows that in patients with suspected non-ST-elevation acute coronary syndrome (NSTE-ACS) both hospital and pre-hospital acquired HEART (History, ECG, Age, Risk factors, Troponin) scores have strong predictive value, pre-hospital and hospital acquired HEART scores have never been compared directly. Methods In patients with suspected NSTE-ACS, the HEART score was independently prospectively assessed in the pre-hospital setting by ambulance paramedics and in the hospital by physicians. The hospital HEART score was considered the gold standard. Low-risk (HEART score ≤3) was considered a negative test. Endpoint was occurrence of major adverse events within 45 days. Results A total of 699 patients were included in the analyses. In 516 (74%) patients pre-hospital and hospital risk classification was similar, in 50 (7%) pre-hospital risk classification was false negative (45 days mortality 0%) and in 133 (19%) false positive (45 days mortality 1.5%). False negative risk classifications were caused by differences in history (100%), risk factor assessment (66%) and troponin (18%) and were more common in older patients. Occurrence of major adverse events was comparable in pre-hospital and hospital low-risk patients (2.9% vs. 2.7%, p = 0.9). Incidence of major adverse events was 0% in the true negative group, 26% in the true positive group, 10% in the false negative group and 5% in the false positive group. Predictive value of both pre-hospital and hospital acquired HEART scores was high, although the ‘area under the curve’ of hospital acquired HEART score was higher (0.84 vs. 0.74, p Conclusion In approximately 25% of patients hospital and pre-hospital HEART score risk classifications disagree, mainly by risk overestimation in the pre-hospital group. Since disagreement is primarily caused by different scoring of history and risk factors, additional training may improve pre-hospital scoring.

Everyone with insulin-dependent diabetes wants to know as reliably and easily as possible the course of glucose levels during exercise. Several CGM sensors are on the market, recently the Free Style Libre Flash Monitor (FLM) has been introduced. Objective: what is the effect of use during extreme exercise on the accuracy of both the CGM and the FLM. Methods: Both CGM (Medtronic) and FLM (Abbott) were compared to the finger prick/strip (cBGMstrip) during a Bas van de Goor Foundation mountainbike challenge in the Mont-Blanc massif (218km, 7900hm). Results: CGM and FLM are clearly less accurate during a period of intensive efforts compared to normal daily activities. In addition, glucose values in the interstitial fluid frequently were higher than found with capillary measurements, also in the lower glucose concentrations. This makes the signaling of hypoglycemia through CGM use less reliable during extreme exercise. Clinically relevant differences were also seen when comparing CGM and FLM (see Table). Conclusions: During extreme exercise, CGM and FLM often showed higher interstitial glucose concentrations than actually present, also at the hypoglycemic range. This is in contrast to measurements taken under normal conditions. In addition, results of the continuous measurement technics differed considerably. This makes the use of CGM and FLM less reliable during extreme exercise. Disclosure E. Delgado: Advisory Panel; Self; Abbott, Almirall, S.A., AstraZeneca, Esteve, Novo Nordisk A/S, Sanofi. Research Support; Self; AstraZeneca, Menarini Group. Speaker's Bureau; Self; Boehringer Ingelheim International GmbH, Lilly Diabetes. M.M. Fokkert: None. P. van Dijk: None. M.A. Edens: None. A. Diez: None. R.J. Slingerland: None. H. Bilo: None.

To the Editor:In an editorial that appeared in the recent issue of Critical Care Medicine, Rice et al (1) discuss glucose measurement and capillary testing in the ICU. The authors reference our study (2) on the safety of bedside glucose monitoring that was published in a recent issue of Critical Car

IntroductionAccurate blood glucose measurements are important in persons with diabetes during normal daily activities (NDA), even more so during exercise. We aimed to investigate the performance of fluorescence sensor-based and glucose oxidase-based interstitial glucose measurement during (intensive) exercise and NDA.Research design and methodsProspective, observational study in 23 persons with type 1 diabetes when mountain biking for 6 days, followed by 6 days of NDA. Readings of the Eversense (fluorescence-based continuous glucose monitoring (CGM); subcutaneously implanted) and of the Free Style Libre (FSL; glucose oxidase-based flash glucose monitoring (FGM); transcutaneously placed) were compared with capillary glucose levels (Free Style Libre Precision NeoPro strip (FSLCstrip)).ResultsMean average differences (MAD) and mean average relative differences (MARD) were significantly different when comparing exercise with NDA (reference FSLCstrip); Eversense MAD 25±19 vs 17±6 mg/dL (pWhen analyzing the data according to the Integrated Continuous Glucose Monitoring Approvals (class II–510(K) guidelines), the overall performance of interstitial glucose readings within 20% of the FSLCstrip during exercise compared with NDA was 69% vs 81% for the Eversense and 59% vs 83% for the FSL, respectively. Within 15% of the FSLCstrip was 59% vs 70% for the Eversense and 46% vs 71% for the FSL.ConclusionsDuring exercise, both fluorescence and glucose oxidase-based interstitial glucose measurements (using Eversense and FSL sensors) were less accurate compared with measurements during NDA. Even when acknowledging the beneficial effects of CGM or FGM, users should be aware of the risk of diminished accuracy of interstitial glucose readings during (intensive) exercise.

Background and aims: Inflammation has become a key element in cardiovascular disease, and recently, new anti-inflammatory interventions have shown promising results. In this context, CRP levels have been thoroughly studied in vitro and in animals, but studies in humans are scarce and insights into its release, site(s) of production and uptake are not uniform.Methods: We performed a biomarker study with multi-site sampling in the coronary circulation, in non-ST elevation MI (NSTEMI) patients with coronary angiography and right-sided catheterisation. Trans-lesional gradients were obtained by sampling distal to the culprit lesion, in patients with a suitable anatomy. To asses trans-cardiac gradients, blood was sampled from the systemic circulation, coronary sinus (CS) and great cardiac vein. Concentrations of CRP were measured with a high-sensitivity assay.Results: In 42 patients, a median systemic venous CRP concentration of 4.97 mg/L was observed. There was no evidence of a trans-lesional gradient (4.59 mg/L versus 4.56 mg/L, p = 0.278; n = 14). A significant decrease in CRP concentration was observed between systemic arterial and CS samples (4.88 mg/L versus 4.44 mg/L; p Conclusions: In the context of NSTEMI, we observed a trans-cardiac decrease in CRP, which may indicate the first human in vivo proof of a net CRP uptake by the myocardium, with a role for CRP both in the injured and adjacent myocardium.

To evaluate the performance of the ACCU-CHEK Inform II glucose meter system for use in critically ill patients, and to assess the effects of blood oxygen tension, hematocrit, sodium levels on glucose measurements. A multicenter study involving the collection and testing of remnant deidentifi

Supplemental Digital Content is available in the text., Objectives: New data have emerged from ambulatory and acute care settings about adverse patient events, including death, attributable to erroneous blood glucose meter measurements and leading to questions over their use in critically ill patients. The U.S. Food and Drug Administration published new, more stringent guidelines for glucose meter manufacturers to evaluate the performance of blood glucose meters in critically ill patient settings. The primary objective of this international, multicenter, multidisciplinary clinical study was to develop and apply a rigorous clinical accuracy assessment algorithm, using four distinct statistical tools, to evaluate the clinical accuracy of a blood glucose monitoring system in critically ill patients. Design: Observational study. Setting: Five international medical and surgical ICUs. Patients: All patients admitted to critical care settings in the centers. Interventions: None. Measurements and Main Results: Glucose measurements were performed on 1,698 critically ill patients with 257 different clinical conditions and complex treatment regimens. The clinical accuracy assessment algorithm comprised four statistical tools to assess the performance of the study blood glucose monitoring system compared with laboratory reference methods traceable to a definitive standard. Based on POCT12-A3, the Clinical Laboratory Standards Institute standard for hospitals about hospital glucose meter procedures and performance, and Parkes error grid clinical accuracy performance criteria, no clinically significant differences were observed due to patient condition or therapy, with 96.1% and 99.3% glucose results meeting the respective criteria. Stratified sensitivity and specificity analysis (10 mg/dL glucose intervals, 50–150 mg/dL) demonstrated high sensitivity (mean = 95.2%, sd = ± 0.02) and specificity (mean = 95. 8%, sd = ± 0.03). Monte Carlo simulation modeling of the study blood glucose monitoring system showed low probability of category 2 and category 3 insulin dosing error, category 2 = 2.3% (41/1,815) and category 3 = 1.8% (32/1,815), respectively. Patient trend analysis demonstrated 99.1% (223/225) concordance in characterizing hypoglycemic patients. Conclusions: The multicomponent, clinical accuracy assessment algorithm demonstrated that the blood glucose monitoring system was acceptable for use in critically ill patient settings when compared to the central laboratory reference method. This clinical accuracy assessment algorithm is an effective tool for comprehensively assessing the validity of whole blood glucose measurement in critically ill patient care settings.

OBJECTIVE: To evaluate the performance of the FreeStyle Libre Flash continuous glucose monitoring (FSL-CGM) system against established central laboratory methods.RESEARCH DESIGN AND METHODS: 20 subjects (8 type 1 diabetes mellitus, 12 type 2 diabetes mellitus) were analyzed. FSL-CGM sensor measurements (inserted in arm and abdomen) were compared with capillary blood glucose results analyzed with StatStrip as semigold standard. The glucose response after a standardized oral glucose load was measured by FSL-CGM and capillary samples analyzed by perchloric acid hexokinase (PCA-HK) method, StatStrip and FSL test strip (FSLC), and a commonly used CGM system (iPro2).RESULTS: FSL-CGM arm sensor readings showed 85.5% of paired readings falling within Clarke Error Grid (ISO 15197:2013) zone A when compared with StatStrip. For FSL-CGM abdomen and FSLC, these percentages were 64% and 98%, respectively. The overall correlation of FSL-CGM in the arm and the StatStrip indicates a performance with lower results with the FSL-CGM in the arm than expected based on the StatStrip in the lower glucose ranges, and higher results than expected in the higher ranges. Following a standardized glucose load, a slower rise in glucose level was observed for FSL-CGM arm as compared with PCA-HK, StatStrip, FSLC, and iPro2 during the first 45-60 min after glucose load ingestion.CONCLUSIONS: Certain matters need attention while using the FSL-CGM in daily life including the observed lower values in the lower ranges, and the underestimation of the effect of a meal on glucose response. These effects of such deviations can partly be overcome by optimizing the available user instructions.TRIAL REGISTRATION NUMBER: TC5348; results.

Background: Self-monitoring of glucose is important for managing diabetes. Noninvasive glucose monitors are not yet available, but patients would benefit highly from such a device. Methods: We present results that may lead to a novel, point-of-care noninvasive system to measure blood glucose based on Raman spectroscopy. A hospitalized cohort of 111 subjects was measured using a custom-made Raman spectrometer system. Blood glucose reference samples were used to correlate Raman data to glucose levels, using advanced preprocessing and analysis algorithms. Results: A correlation coefficient ( R2) of .83 was found correlating independent Raman-based predictions on reference blood glucose for the full cohort. Stratification of the cohort in gender-specific groups raised correlation levels to .88 (females) and .94 (males). Glucose could be measured noninvasively with average errors as low as 0.9 mM. Conclusion: We conclude that this novel system shows promising results for the advance of noninvasive, point-of-care glucose monitoring.

Background Measurement of adequate glucose concentrations is complicated by in vitro breakdown of glucose due to glycolysis. Unlike the commonly used NaF-EDTA and NaF-oxalate phlebotomy tubes, citrated NaF-EDTA tubes are reported to directly and thereby completely inhibit glycolysis. Recently, Greiner introduced the Vacuette® FC-Mix NaF-EDTA-citrate tube, currently the only NaF-citrate tube without volume-disturbing liquid additions available on the European market. Here we present its potential as alternative for the laborious and therefore unfeasible conditions for glucose sampling as recommended by the World Health Organization (WHO). Methods The FC-Mix tube was tested against the WHO recommended method of optimal laboratory conditions, both in healthy volunteers and pregnant woman undergoing oral glucose tolerance test (oGTT) for screening of gestational diabetes mellitus (GDM). Glucose concentrations were measured after different incubation times (0-48 h) and temperatures (room temperature, 37 °C), both in uncentrifuged whole blood and centrifuged material. Results Deming regression analysis shows that glucose concentrations measured in the FC-Mix tube correlate to the WHO recommended method. Stability is maintained at room temperature for 48 h and at least 24 h at 37 °C. The use of the FC-Mix tube was also validated in screening for GDM and proved comparable to the WHO recommended method in diagnostic outcome. Conclusions The new Greiner FC-Mix tube combines the easy handling of a routine tube with dry additive with the ability to immediately inhibit glycolysis as in the WHO method for optimal pre-analytical and analytical conditions and performs equally to those conditions when screening for GDM.

BACKGROUND: For chest pain patients without ST-segment elevation in the pre-hospital setting, current clinical guidelines merely offer in-hospital risk stratification and management, as opposed to chest pain patients with ST-segment elevation for whom there is a straightforward pre-hospital strategy for diagnosis, medication regimen and logistics. The FAMOUS TRIAGE study will assess the effects of introducing a pre-hospital triage system that reliably stratifies chest pain patients without ST-segment elevation into 1) patients at high risk for NSTEMI requiring a direct transfer to a PCI-hospital; 2) patients at intermediate risk for a major adverse cardiac event (MACE) who could be evaluated at the nearest non-PCI hospital; and 3) patients at low risk for MACE (benign non-cardiac chest pain) who could have further evaluation at home or in a primary care setting. METHODS: The FAMOUS TRIAGE study will be performed in three phases. In the first phase an appropriate pre-hospital risk stratification tool will be designed for chest pain patients without ST-segment elevation by means of a retrospective and a prospective study. The second phase of the project represents the external validation of the risk stratification models, and in the third and final phase an optimal risk stratification tool will be implemented into clinical practice. Clinical and economical endpoints before and after implementation of the pre-hospital risk stratification tool will be compared to assess clinical benefit and cost-effectiveness. CONCLUSION: The FAMOUS TRIAGE project is a triple phase study that aims to optimize the pre-hospital management of chest pain patients without ST-segment elevation by providing tools for pre-hospital identification of NSTEMI or exclusion of acute coronary syndrome at home. TRIAL ID: NTR4205. Dutch Trial Register [http://www.trialregister.nl]: trial number 4205.

Suzanna T. de Vries1*, Pieter de Mol2, Bert D. Dikkeschei3, Marion J. Fokkert3, Hans G. Krabbe3, Eelco JP. de Koning4, Rijk OB. Gans5 and Henk JG. Bilo5,6 1Department of Cardiology, Tjongerschans Hospital, Heerenveen, Netherlands 2Department of Internal Medicine, University Medical Centre St. Radboud, Nijmegen, Netherlands 3Department of Clinical Chemistry, Isala Klinieken, Zwolle, Netherlands 4Department of Nephrology, University Medical Centre, Leiden, Netherlands 5Department of Internal Medicine, University Medical Centre, Groningen, Netherlands 6Department of Internal Medicine, Isala Klinieken, Zwolle, Netherlands Journal of Exercise, Sports & Orthopedics Open Access Research Article

OBJECTIVE Limited information is available regarding the metabolic effects of high altitude trekking in patients with type 2 diabetes. RESEARCH DESIGN AND METHODS Thirteen individuals with type 2 diabetes took part in a 12-day expedition to the summit of Mount Toubkal (altitude, 4,167 m), Morocco, after 6 months of exercise training. Energy expenditure, body weight, blood glucose, fasting insulin, lipids, and HbA1c were assessed. RESULTS Training reduced fasting glucose (−0.7 ± 0.9 mmol/L, P = 0.026) and increased exercise capacity (+0.3 ± 0.3 W/kg, P = 0.005). High altitude trekking decreased fasting insulin concentrations (−3.8 ± 3.2 μU/L, P = 0.04), total cholesterol (−0.7 ± 0.8 mmol/L, P = 0.008), and LDL cholesterol (−0.5 ± 0.6 mmol/L, P = 0.007). CONCLUSIONS High altitude trekking preceded by exercise training is feasible for patients with type 2 diabetes. It improves blood glucose, lipids, and fasting insulin concentrations, while glucose control is maintained.

BACKGROUND: Due to increasing numbers of people with diabetes taking part in extreme sports (e.g., high-altitude trekking), reliable handheld blood glucose meters (BGMs) are necessary. Accurate blood glucose measurement under extreme conditions is paramount for safe recreation at altitude. Prior studies reported bias in blood glucose measurements using different BGMs at high altitude. We hypothesized that glucose-oxidase based BGMs are more influenced by the lower atmospheric oxygen pressure at altitude than glucose dehydrogenase based BGMs. METHODOLOGY/PRINCIPAL FINDINGS: Glucose measurements at simulated altitude of nine BGMs (six glucose dehydrogenase and three glucose oxidase BGMs) were compared to glucose measurement on a similar BGM at sea level and to a laboratory glucose reference method. Venous blood samples of four different glucose levels were used. Moreover, two glucose oxidase and two glucose dehydrogenase based BGMs were evaluated at different altitudes on Mount Kilimanjaro. Accuracy criteria were set at a bias 6.5 mmol/L) and

Purpose: Triage of patients with chest pain after an Emergency Medical System (EMS) call normally occurs in the hospital emergency room (ER). It has been shown that the HEART-score offers a simple and quick risk-stratifying tool in these patients. Additionally the "high-sensitive" Troponin T (hs-cTnT) provides a greater diagnostic accuracy and detection of Acute Myocardial Infarction (AMI) compared to the fourth generation TnT. This study investigates whether pre-hospital chest pain triage is feasible, in terms of ruling out AMI already in the ambulance by paramedics using a single hs-TnT measurement in combination with the HEART score. Methods: Patients with acute onset chest pain (with the exclusion of STEMI) who called the EMS, from June -to November 2012 were prospectively evaluated at First Medical Contact (FMC), often at home, by ambulance paramedics including hs-TnT assessment. All patients were then transported immediately to the ER and managed by emergency physicians without knowledge of the HEART score as assessed by the ambulance crew at FMC. Follow-up was performed at 30 days in terms of MACE. Discharge diagnoses were evaluated in case AMI was ruled out. Results: A total of 207 patients were included. The hs-cTnT values was negative (< 0.014 ng/mL) in 123 patients (59%) and the HEART score was 3 or less in 42 patients (34%), as shown in the table. None of the patients with a HEART score of 3 or less had an AMI. The discharge diagnoses of patients with a HEART score of 3 or less were benign, non-cardiac chest pain in 39 patients (93%), a suspicion of supraventicular arrythmia in 2 patients (3.1%) and a suspected biliary colic in 1 patient. View this table: Conclusion: A large number of patients (34%) with symptoms suspicious of AMI who were presented to the EMS system could be identified as being low risk already in the ambulance. This pre-hospital triage provides an excellent tool in identifying both low- and high-risk patients and might help in optimizing logistics and cost-effectiveness for patients with chest pain before hospital admission.

The number of individuals with impaired glucose metabolism (‘pre-diabetes’) and type 2 diabetes is reaching epidemic proportions. This increase is associated with higher cardiovascular morbidity and mortality. Early screening for diabetes and pre-diabetes (i.e. elevated glucose and/or glycated haemoglobin [HbA1c]) may aid in the reduction of diabetes-related complications. Point-of-care testing, defined as testing at or near the site of the patient, is able to bring diagnostic tests and its associated therapeutic actions immediately to the patient and may aid in the detection of diabetes and the reduction of complications. However, the majority of available point-of-care testing devices for glucose and HbA1cdo not meet generally accepted analytical performance criteria and may underestimate the true risk of diabetes. Until these analytical performance issues have been addressed properly, caution should be exercised in the use of point-of-care testing of glucose and HbA1c in the diagnosis of and screening for pre-diabetes and diabetes.

The use of point-of-care blood glucose monitoring systems (BGM) has become a worldwide diagnostic routine procedure. Many commonly used systems were developed for ambulatory use and have found their way into use in hospital settings. However it is recognised that the biochemical composition and matrix of blood can be more challenging to the specificity of BGM‘s in hospitalised patients. Fluctuations in hematocrit levels can cause interference with conventional glucose meters giving rise to potentially erroneous results. In addition biochemical substances associated with patient regimes can also cause interference effects. A new generation BGM, StatStrip® from Nova Biomedical is specifically designed to correct for interfering substances.