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Development of a miniaturized glucose monitoring system by combining a needle-type glucose sensor with microdialysis sampling method. Long-term subcutaneous tissue glucose monitoring in ambulatory diabetic patients.

OBJECTIVE: To develop a reliable and practical glucose monitoring system by combining a needle-type glucose sensor with a microdialysis sampling technique for long-term subcutaneous tissue glucose measurements. RESEARCH DESIGN AND METHODS: A microdialysis Cuprophan hollow-fiber probe (inner diameter, 0.20 mm; length, 15 mm) was perfused with isotonic saline solution (120 microliters/h) and glucose concentrations in the dialysate were measured by a needle-type glucose sensor extracorporeally. This system was tested both in vitro and in vivo. Subcutaneous tissue glucose concentrations were then monitored continuously in 5 healthy and 8 diabetic volunteers for 7 to 8 days. A hollow-fiber probe was inserted into the abdominal subcutaneous tissue. RESULTS: This monitoring system achieved excellent results in vitro. Subcutaneous tissue glucose concentrations were measured in a wide range from 1.7 to > 27.8 mM glucose, with a time delay of 6.9 +/- 1.2 min associated with a rise in glucose and 8.8 +/- 1.6 min with a fall in the glucose level (means +/- SE). The overall correlation between subcutaneous tissue (Y) and blood (X) glucose concentration was Y = 1.08X + 0.19 (r = 0.99). The subcutaneous tissue glucose concentration could be monitored precisely for 4 days without any in vivo calibrations and for 7 days by introducing in vivo calibrations. CONCLUSIONS: Glycemic excursions could be monitored precisely in the subcutaneous tissue by this microdialysis sampling method with a needle-type glucose sensor in ambulatory diabetic patients.

Adult↗

Telemetry glucose monitoring device with needle-type glucose sensor: a useful tool for blood glucose monitoring in diabetic individuals.

For continuous monitoring of glucose concentration in ambulant diabetic patients, a telemetry glucose monitoring system with a needle-type glucose sensor has been developed. The system consists of a sensor transmitter (4 X 6 X 2 cm, 50 g) that converts current signals generated in a needle-type glucose sensor to high-frequency audio signals and a receiver that continuously calculates glucose concentrations from the received audio signals. The noise range of a monitoring record with the telemetry system (0.3 +/- 0.04%, mean +/- SEM) was significantly smaller than that with a wire-connected system, the wearable artificial endocrine pancreas (2.5 +/- 0.3%). Postprandial tissue glucose concentration responded well to the plasma glucose concentration, with a time lag of 5 min. Continuous glucose monitoring of five diabetic subjects for 77 +/- 22 h revealed that a significant correlation existed between the subcutaneous tissue glucose concentration and the plasma glucose concentration measured simultaneously in each patient. These data indicate the usefulness of the telemetry glucose monitoring system in strict glycemic control of diabetic individuals.

Autoanalysis↗

Infant respiration monitoring--evaluation of a simple home monitor.

A new, inexpensive commercial infant respiration monitor, the Baby-Sitter by Direct Diagnostics Ltd, has been evaluated and subjected to clinical trial. Dual respiration recordings were made from infants exhibiting apnoeic episodes to compare the new monitor with an acceptable reference monitor (Graesby Medical Model MR10). Both monitors are designed to detect respiration movement by means of pressure pulses produced in an air-filled sensor attached to the infant's abdomen. The new monitor is found to have unacceptable performance.

Apnea↗

[Recent advances in regional cerebral monitoring in the neurocritical patient: brain tissue oxygen pressure monitoring, cerebral microdialysis and near-infrared spectroscopy].

The long term outcome of head-injured patients depends not only on the primary brain lesions but also to a large extent on the secondary lesions. The diagnosis of many secondary lesions, and specially that of brain ischemia, is based on simultaneous monitoring of several intracranial and systemic variables. Continuous intracranial pressure (ICP) monitoring is currently considered indispensable in the management of all patients with a severe head injury and intracranial lesions. However, the information provided by this technique is insufficient to diagnose some of the complex physiopathological processes that characterize traumatic brain lesions. Consequently, the use of methods to estimate cerebral blood flow such as transcranial Doppler and jugular oximetry to complement ICP monitoring is becoming increasingly widespread. Nevertheless, determining the effect of tissue lesions and therapeutic measures on cerebral metabolism currently requires direct access to the brain parenchyma at the bedside. In this review we focus on three methods of regional cerebral monitoring: oxygen tissue pressure (PtiO(2)) monitoring, microdialysis and near-infrared spectroscopy. The bases of each method and reference values for the variables analyzed will be discussed. We also make a series of recommendations on how results should be interpreted in light of current knowledge.

Brain↗

Monitoring methodology for gaseous hazards. Passive monitors and portable instruments.

Reliable sampling and analytical procedures for monitoring workplace hazards must be developed and evaluated. In the present communication three studies involving the evaluation and development of personal monitoring techniques were presented. The first study described an evaluation of three passive monitors for organic solvent vapors. Toluene, trichloroethylene, n-hexane, acetone, methylene chloride, and vinyl chloride, each at three concentrations, as well as effects of temperature, humidity, linear adsorption capacity, variable concentration, complex solvent mixture, and storage time, were addressed. The results indicated that under specified conditions passive monitors are viable monitoring methods. The second study was an evaluation of two carbon monoxide dosimeters. Instrument accuracy, precision, and performance under a variety of experimental conditions were examined. Sufficient samples were taken to show that the Energetics Science series 9000 dosimeter was within +/- 25% of the true value 95% of the time. The General Electric model 15ECS1CO2 did not meet this same criterion. The third study describes the development of a unique sampling method for nitrogen dioxide using Poroplastic film impregnated with the absorbing liquid and a spacing material which allows for airflow and distribution to the absorber. The overall method, evaluated over the concentration range of 0.9 to 19 micrograms/1 in 36-1 samples, had an average bias of 7% with a coefficient of variation of 10%.

Biomedical Engineering↗

Newer trends in monitoring: the esophageal Doppler monitor.

The esophageal Doppler monitor is a recent development in hemodynamic monitoring that is used for surgical patients. It is relatively noninvasive and measures descending aortic blood flow by the Doppler effect. A comparison of this new monitor with the pulmonary artery catheter is cited numerous times throughout the literature and overall correlates well. Studies of the esophageal Doppler monitor show it to be a safe addition to operating room monitors for use by the anesthetist.

Adult↗

Effect on compliance, acceptability of blood glucose self-monitoring and HbA(1c) of a self-monitoring system developed according to patient's wishes. The ACCORD study.

OBJECTIVES: To test a blood glucose monitor developed upon diabetic's recommendations (Glucotrend Premium). Self-monitoring of blood glucose (SMBG) generates hope when introduced, however several studies questioned its efficacy and many diabetics judge it too constraining. MATERIAL AND METHODS: Thirty diabetes centres in France, for 6 months in 179 insulin-treated diabetics, using SMBG but non optimally and with HbA(1c) (>=130% of the upper limit). Randomisation to 3 groups: either their previous system (Group A), or to the Glucotrend Premium monitor with a memory to assess compliance (Group B), or to another monitor, new for the patient, and with a memory too, the One Touch Profile (Group C). At entry, and then at 3 and 6 months, patients had an acceptability and compliance questionnaire, HbA(1c), count of weekly hypoglycaemia, record of insulin doses and an assessment of the key compliance factors. RESULTS: HbA(1c) improved significantly in the 3 groups, more markedly in groups B (Glucotrend) and C (One Touch), e.g. - 0.6 +/- 1.1% (group A), - 0.9 +/- 1.2% (group B) and - 1.0 +/- 0.9% (group C) at M6. Acceptability was judged better for groups B and C, an additional benefit for Glucotrend: better accuracy vs laboratory blood glucose (C/L) determinations and a lower utilisation cost. Intermediate (lente) and regular insulin doses only significantly decreased (26% and 10% respectively) in group B (Glucotrend) despite a decrease in HbA(1c). Compliance (defined as 75-150% of recommended self-monitoring) improved within the 3 groups (from 34% to 65%), this improvement was maintained after month 3 (M6: 76%) only in group B (Glucotrend), vs a worsening in groups A and C (M6: 62 and 57% respectively). A better accuracy of C/L was observed with Glucotrend at M0, M3 and M6. CONCLUSION: SMBG has limits due to various causes, and to specific difficulties of this invasive and repetitive technique. The development of a system based on advices formulated by patients themselves, Glucotrend Premium, has resulted in a marked improvement on acceptability, compliance and glucose control.

Adult↗

Foraminifera as bioindicators in coral reef assessment and monitoring: the FORAM Index. Foraminifera in Reef Assessment and Monitoring.

Coral reef communities are threatened worldwide. Resource managers urgently need indicators of the biological condition of reef environments that can relate data acquired through remote-sensing, water-quality and benthic-community monitoring to stress responses in reef organisms. The "FORAM" (Foraminifera in Reef Assessment and Monitoring) Index (FI) is based on 30 years of research on reef sediments and reef-dwelling larger foraminifers. These shelled protists are ideal indicator organisms because: Foraminifers are widely used as environmental and paleoenvironmental indicators in many contexts. Reef-building, zooxanthellate corals and foraminifers with algal symbionts have similar water-quality requirements. The relatively short life spans of foraminifers as compared with long-lived colonial corals facilitate differentiation between long-term water-quality decline and episodic stress events. Foraminifers are relatively small and abundant, permitting statistically significant sample sizes to be collected quickly and relatively inexpensively, ideally as a component of comprehensive monitoring programs; and, collection of foraminifers has minimal impact on reef resources. USEPA guidelines for ecological indicators are used to evaluate the Fl. Data required are foraminiferal assemblages from surface sediments of reef-associated environments. The Fl provides resource managers with a simple procedure for determining the suitability of benthic environments for communities dominated by algal symbiotic organisms. The FI can be applied independently, or incorporated into existing or planned monitoring efforts. The simple calculations require limited computer capabilities and therefore can be applied readily to reef-associated environments worldwide. In addition, the foraminiferal shells collected can be subjected to morphometric and geochemical analyses in areas of suspected heavy-metal pollution, and the data sets for the index can be used with other monitoring data in detailed multidimensional assessments.

Animals↗

Cytoimmunologic monitoring as an adjunct in monitoring rejection after heart transplantation: results of a 6-year follow-up in heart transplant recipients.

The cytoimmunologic monitoring assay has been proposed as a useful noninvasive technique in the diagnosis of rejection and infection after heart transplantation. In this study, we have analyzed the diagnostic usefulness of cytoimmunologic monitoring in 73 patients after heart transplantation. For individual patients, the follow-up varied between 2 and 78 months. Data were related to histopathologic characteristics of the endomyocardial biopsy. Significantly different cytoimmunologic monitoring results were not observed between groups according to endomyocardial biopsy histopathologic evaluation. The diagnostic usefulness of cytoimmunologic monitoring depended on the cutoff value applied. With higher cutoff values, the sensitivity decreased and the specificity and predictive value increased. For the previously reported cutoff value of 5%, the sensitivity was 0.29, the specificity was 0.73, and the predictive value was 0.66. Values of sensitivity, specificity, and predictive value were similar when only the first acute rejection was taken into account, or when only data on the first 4 weeks and the first 6 months after transplantation were considered. In calculating the diagnostic usefulness of the sensitivity, specificity, and predictive values were observed. We concluded that cytoimmunologic monitoring has a limited value for diagnosing acute rejection after heart transplantation.

Acute Disease↗

ST segment monitoring for coronary artery reocclusion following thrombolytic therapy and coronary angioplasty: identification of optimal bedside monitoring leads.

BACKGROUND: Bedside ST segment monitors analyze only one precordial lead and one, two or three limb leads. The precordial lead V1 (or V6 if V1 is not feasible) has been recommended for bedside monitoring because of its value in diagnosing cardiac rhythms with a wide QRS complex. Thus, the remaining lead choices for ST monitoring are limited to the six limb leads. PURPOSE: To determine which of the limb leads in conjunction with V1 or V6 provides the greatest sensitivity for myocardial ischemia, a study was undertaken. METHOD: A total of 30 vessel-unique ischemic episodes were analyzed prospectively using continuous 12-lead electrocardiographic recordings in patients with acute myocardial infarction (n = 2) and patients undergoing coronary angioplasty (n = 25). RESULTS: Ischemic changes were evident in all cases using the full 12-lead electrocardiogram. Right coronary artery-related ischemia was detected in all cases using a single-lead III or aVF. In the group as a whole, the best combinations were: V1 + aVF, V1 + III, V6 + III, and V6 + aVF. Two patients developed sudden coronary artery reocclusion in the cardiac care unit after successful angioplasty. In both, leads identified in the cardiac catheterization laboratory as sensitive for recording ischemia were excellent choices for detection of reocclusion in the cardiac care unit. CONCLUSIONS: 12-lead electrocardiogram recordings during coronary angioplasty balloon inflation provide excellent guidance for postprocedure lead selection decisions. The most valuable limb leads for detecting ischemia due to abrupt artery closure are leads III and aVF, either of which is more sensitive than the routinely monitored lead II. The precordial leads valuable for arrhythmia monitoring, V1 and V6, are seldom sensitive in detecting ischemia in these patients.

Adult↗

Wearable wrist-watch type cuff oscillometric blood pressure monitors: consensus statement by the European Society of Hypertension Working Group on blood pressure monitoring.

Wearable wristwatch-type cuff oscillometric blood pressure (BP) monitors represent a new category of BP devices and are the first wearable monitors to use established cuff-oscillometric BP measurement technology. This consensus statement by the European Society of Hypertension Working Group on BP Monitoring reviews the published evidence on their design, accuracy, validation, clinical application, and remaining research questions. Of 281 articles identified through a systematic PubMed search, 26 were relevant. Several devices are currently available; however, only two have published validation studies performed according to established standards (Omron HeartGuide and Huawei Watch D/D2). Static validation studies generally showed acceptable accuracy, whereas data on 24-h ambulatory use, in special populations, and clinical applications remain limited. Potential advantages include self-initiated measurement at home, at work, and in other settings and conditions; more convenient and repeatable 24-h ambulatory monitoring; more convenient and accurate assessment of asleep BP; capture of stress-related and other BP-related episodes. However, proper wrist position, user adherence, ambulatory performance, and clinical applications require further investigation. More research is needed to establish the accuracy and clinical utility of these novel devices and their role in improving the diagnosis and management of hypertension.

Humans↗

Advances in the Monitoring of Oral Anticoagulation: Point-of-Care Testing, Patient Self-Monitoring, and Patient Self-Management.

Oral anticoagulation with warfarin sodium has proven to be an effective therapy for patients at risk for thromboembolic disease, but due to its high risk/benefit ratio, many physicians are reluctant to prescribe the drug. The development of capillary whole-blood prothrombin time (PT) monitors provides a potential means to decrease this risk/benefit ratio and to encourage the use of warfarin. Studies show that this technology is accurate, precise, and correlates closely with standard laboratory methods. Given that these monitors are simple and portable, investigators have conducted studies to determine their suitability for patient self-testing and home monitoring. Investigations show that patients can accurately and precisely perform the PT test at home, and that this mode of therapy appears to be at least as safe and effective as standard management. Furthermore, limited studies also suggest that patients can also manage their own dosing based on personalized guidelines designed by a physician. Given the theoretical potential for improved patient outcomes and overall cost reduction, patient self-monitoring and self-management are not far off. Large randomized prospective trials are now needed to confirm that the future of anticoagulation management should include patient self-monitoring and patient self-management of therapy.

Journal Article↗

Is ambulatory monitoring for "community-acquired" syncope economically attractive? A cost-effectiveness analysis of a randomized trial of external loop recorders versus Holter monitoring.

BACKGROUND: Out patient ambulatory monitoring is often performed in patients with syncope that present in the primary care setting to include or exclude an arrhythmia. The cost-effectiveness of 2 monitoring strategies was assessed in a prospective randomized trial. METHODS: One hundred patients referred for ambulatory monitoring with syncope or presyncope were randomized to a 1-month external loop recorder (n = 49) or 48-hour Holter monitor (n = 51). Patients were offered crossover if there was failed activation or no symptom recurrence. The primary end point was symptom-rhythm correlation during monitoring. Direct costs were calculated based on the 2003 Ontario Health Insurance Plan fee schedule, combined with calculation of labor, materials, service, and overhead for diagnostic testing and related equipment. RESULTS: Before enrollment, the cost of all previous health care resource use was USD 472 +/- USD 397 (range USD 21-USD 1965). In the loop recorder group, 63% of patients had symptom recurrence and successful activation, compared with 24% in the Holter group (P < .0001). The cost per Holter was USD 177.64, and per loop recorder, USD 533.56, with a similar cost per diagnosis with the 2 techniques. The incremental cost-effectiveness ratio of the loop recorder was USD 901.74 per extra successful diagnosis. A strategy of Holter followed by offered loop recorder trended toward lower cost than initial loop recorder followed by Holter (USD 481 +/- USD 267 vs USD 551 +/- USD 83, P = .08), but was associated with a lower overall diagnostic yield (49% vs 63%) and a resultant higher cost per diagnosis (USD 982 vs USD 871, P = .08). Bootstrapping suggested that 90% of incremental cost-effectiveness ratios were less than USD 1250. CONCLUSION: Despite the increased upfront cost of external loop recorders, the marked improvement in diagnostic yield offsets the cost. External loop recorders are an economically attractive alternative. First-line use of external loop recorders in patients with "community-acquired" syncope and presyncope should be considered to optimize diagnostic yield given its value.

Cost-Benefit Analysis↗

Real-time monitoring of coronary care mortality: a comparison and combination of two monitoring tools.

BACKGROUND: Quality control in clinical care is becoming increasingly more prevalent, resulting in a need for tools that can be readily used by clinical teams for monitoring their own performance. The aim of this study was to devise a practical and effective scheme for monitoring coronary care mortality in real-time. METHODS: We obtained data for 2153 consecutive patients admitted after acute myocardial infarction between 1st September and 30th November 1995 to one of 20 acute hospitals in West Yorkshire participating in the NHS R and D funded EMMACE-1 study. We developed control charts for each centre to monitor 30-day mortality. These control charts used two complementary tools: the Risk-Adjusted Cumulative Sum chart (CUSUM) and a new 'Rocket Tail' chart based upon the Variable Life-Adjusted Display (VLAD). We also combined information from each of these to devise a further chart. RESULTS: Control charts are shown for two centres in order to illustrate the important features of the different but complimentary monitoring tools. The Risk-Adjusted CUSUM is shown to be useful for detecting isolated runs of unsatisfactory outcome results but is not 'intuitive', and does not give any indication of the preceding history of outcomes. The Rocket Tail chart is shown to give a good summary of outcome history and also how overall performance compares with what would be expected for the case-mix. A chart that combines both approaches appeals to the advantages of each. CONCLUSIONS: We propose a visual approach to health-care monitoring that beneficially combines and extends the different information of the previously used CUSUM and VLAD charts.

Data Collection↗

Antibiotic resistance monitoring in bacteria of animal origin: analysis of national monitoring programmes.

Methods of antibiotic resistance monitoring of bacteria from animals in 12 European countries were surveyed in 1998. Most laboratories used disk diffusion methods, usually expressing results qualitatively, although a few also expressed the results either as MICs or zone diameters. The number of antibiotics used ranged from 5 to 37 (mean 15) and the most common antibacterials were streptomycin, gentamicin, neomycin, ampicillin, tetracyclines, chloramphenicol and sulphonamides. Salmonellae were monitored by most centres but few-tested campylobacter regularly. Escherichia coli from a wide range of animal species were tested in nine countries. Enterococci were tested on a limited ad hoc basis in six countries. Staphylococci, streptococci and pasteurellae were also frequently monitored but the number of isolates tested showed wide variation. Overall the presentation of the results differed, but most programmes used disk diffusion, control strains and monitored similar bacteria. Thus, it may be possible to harmonise monitoring programmes within the EU.

Animal Population Groups↗

Continuous ST monitoring: a bedside instrument? A report from the Assessment of the Safety of a New Thrombolytic (ASSENT 2) ST monitoring substudy.

BACKGROUND: Continuous ST monitoring has during the past decade become widespread in coronary care units (CCU) and is now even recommended by international task forces to survey patients with acute coronary syndromes. ST monitoring has also been shown to be a well-validated technology to predict prognosis and coronary artery patency in patients with acute ST-elevation infarction. However, all evaluations in previously presented trials have been made inside a core laboratory by specially trained personnel. METHODS: In the Assessment of the Safety and Efficacy of a New Thrombolytic (ASSENT 2) ST-monitoring substudy, 448 patients with ST-elevation infarction from 22 hospitals were monitored by vectorcardiography. The local nurse responsible for the patient made an evaluation of the ST trend curve. This was compared with a blinded core laboratory evaluation and examined versus 30-day mortality. RESULTS: No significant differences were found between the local and central evaluations of ST-segment recovery. The accuracy of the local evaluation, compared with the central one, in deciding whether patients had > or = 50% ST-segment recovery at 60 or 90 minutes was > 90%. A large low-risk group (30% of the patients) with 0.8% 30-day mortality could be identified by the local evaluation. CONCLUSIONS: ST monitoring with vectorcardiography can accurately be done in the clinical setting. The local evaluation was as least as accurate as the core laboratory evaluation in predicting prognosis.

Chi-Square Distribution↗

Comparison of target monitoring and two-ear monitoring dichotic listening procedures.

The dichotic listening performance of 40 listeners was assessed for consonant-vowel (CV) nonsense syllables with two procedures. One was a conventional two-ear monitoring task in which listeners attended to both ears and provided two responses for each pair of syllables. The ear advantage was described by % RE-% LE. The second was target monitoring, a yes/no task in which listeners attended to only one ear and listened for the presence of a target syllable. That procedure provided both hit and false alarm rates for each ear, and the ear advantage was described by P(C)maxRE-P(C)maxLE, which is insensitive to decision variables. Although both procedures yielded mean right-ear advantages (REA), the mean REA of +7.5% with two-ear monitoring was significantly different from the mean REA of +2.6% with target monitoring. In addition, although 62% of the listeners had a significant REA with the conventional procedure, only 40% had a significant REA with target monitoring. Decision variables, which are not controlled with conventional dichotic testing methods, may contribute to the ear advantage as it is described frequently in the literature.

Adult↗

Simultaneous monitoring of gastric and oesophageal pH reveals limitations of conventional oesophageal pH monitoring in milk fed infants.

BACKGROUND: Monitoring oesophageal pH conventionally detects "acid reflux" (pH less than 4). The pH of the gastric contents determines whether or not reflux can be detected. AIM: To monitor gastric and oesophageal pH simultaneously in order to determine the effect of milk feeds on gastric pH and how this would influence interpretation of the oesophageal pH record. METHODS: Milk fed infants for whom oesophageal pH monitoring was requested underwent simultaneous gastric and oesophageal pH monitoring using a dual channel pH probe. RESULTS: Twenty of 24 records were technically satisfactory. Mean reflux index was 1.0%, range 0.0-4.0%. Gastric pH was less than 4 for 24.5% (range 0.6-69.1%) of the total time. The average time the gastric pH was greater than 4 after feeds was 130 minutes (range 29-212 minutes). The corrected reflux index (limited to the time the gastric pH was less than 4) was 2.6% (range 0.0-11.0%). CONCLUSION: The pH of the gastric contents may be greater than 4 for prolonged intervals, during which oesophageal pH monitoring using current criteria cannot detect reflux nor correlate it with clinical events. A low reflux index may reflect prolonged buffering of gastric acidity rather than the absence of reflux.

Animals↗