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A Continuous Glucose Monitoring System (CGMS) - a promising approach for improving metabolic control in persons with type 1 Diabetes mellitus treated by insulin pumps.

This pilot study deals with the possibilities of a Continuous Glucose Monitoring System (CGMS, Minimed- Medtronic) to optimize insulin substitution. Ten persons with type 1 diabetes mellitus treated by means of an insulin pump entered the study and eight of them completed the protocol. CGMS was introduced for a period of 5 days. The standard dinner (60 g of carbohydrates) and overnight fasting were designed to ensure standard night conditions in all persons in the study while maintaining their usual daily eating routine, physical exercise and assessment of prandial insulin boluses. The only adaptation of basal rates of insulin pump was performed on day 3. Comparison of the mean plasma glucose concentration (0:00-24:00 hrs) between day 2 (before adaptation) and day 4 (following adaptation) was made. An independent comparison of the mean plasma glucose concentration between the night from day 2 till day 3 (22:00-6:00 hrs) and the night from day 4 till day 5 (22:00-6:00 hrs) was performed. The mean plasma glucose investigated by means of CGMS improved in the 24-hour period in 5 out of 8 persons and in the night fasting period (22:00 to 6 hrs) in 6 out of 8 persons. The CGMS is a useful means for assessment of the effectiveness of basal rate and prandial insulin doses in persons with type 1 diabetes treated by means of an insulin pump. However, further studies are necessary to improve the algorithm for insulin substitution.

Adult↗

Dugong (Dugong dugon) vocalization patterns recorded by automatic underwater sound monitoring systems.

To quantitatively examine the diurnal, or tidal, effects on dugong behavior, we employed passive acoustic observation techniques to monitor the animals. Automatic underwater sound monitoring systems for dugongs (AUSOMS-D) were deployed on the sea floor at depths of about 5 m south of Talibong Island, Thailand. The AUSOMS-D recorded underwater sound in stereo at a sampling frequency of 44.1 kHz for more than 116 consecutive hours. Dugong calls were automatically detected by newly developed software with a detection rate of 36.1% and a false alarm rate of 2.9%. In total, 3453 calls were detected during the 164 h of recording. The autocorrelation of the call rate indicated an attendance cycle of about 24 or 25 h, and the most frequent vocalizations were observed from 0300 to 0500 h. The calculated bearings of the sound sources, i.e., dugongs, were used as an indicator to track the relative numbers of dugongs during the monitoring periods.

Animals↗

Use of the Medication Event Monitoring System to estimate medication compliance in patients with schizophrenia.

OBJECTIVE: To determine the feasibility of using the Medication Event Monitoring System (MEMS) to estimate medication compliance in patients with schizophrenia or schizoaffective disorder. SUBJECTS AND SETTING: Fourteen of 35 consecutive patients admitted to a psychiatric inpatient hospital with schizophrenia or schizoaffective disorder who met eligibility requirements and gave informed consent. INTERVENTION: After random assignment to either risperidone or typical antipsychotic treatment, medication upon discharge from hospital was dispensed in a bottle with a MEMS cap which recorded the number of bottle openings and the date and time of each opening. The first 6 patients were asked to return monthly for data downloading. The next 8 were asked to return weekly during the first month and every 2 weeks thereafter; they were also paid $5 for returning each bottle. OUTCOME MEASURES: MEMS data collected over a 6-month period and hospital readmission data. RESULTS: Patient medication compliance data were collected from 10 (71%) of 14 patients during the first month, from 7 (58%) of 12 (2 patients dropped out) during the second and from 5 (45%) of 11 (a third patient dropped out) during months 3-6. Mean compliance rates were 63% for the first month and ranged from 56% to 45% over the next 5. First-month compliance rates were significantly lower for those who were subsequently readmitted to hospital (n = 7) than for those who were not (p < 0.01). CONCLUSIONS: Electronic monitoring devices can be used to estimate compliance with medication regimens in patients with severe schizophrenic disorders, but there are methodological improvements that can be made to increase data recovery and compliance, and these are discussed.

Adult↗

Development of a continuous monitoring system for PM10 and components of PM2.5.

While particulate matter with aerodynamic diameters below 10 and 2.5 microns (PM10 and PM2.5) correlate with excess mortality and morbidity, there is evidence for still closer epidemiological associations with sulfate ion, and experimental exposure-response studies suggest that the hydrogen ion and ultrafine (PM0.15) concentrations may be important risk factors. Also, there are measurement artifacts in current methods used to measure ambient PM10 and PM2.5, including negative artifacts because of losses of sampled semivolatile components (ammonium nitrate and some organics) and positive artifacts due to particle-bound water. To study such issues, we are developing a semi-continuous monitoring system for PM10, PM2.5, semivolatiles (organic compounds and NH4NO3), particle-bound water, and other PM2.5 constituents that may be causal factors. PM10 is aerodynamically sorted into three size-fractions: (1) coarse (PM10-PM2.5); (2) accumulation mode (PM2.5-PM0.15); and (3) ultrafine (PM0.15). The mass concentration of each fraction is measured in terms of the linear relation between accumulated mass and pressure drop on polycarbonate pore filters. The PM0.15 mass, being highly correlated with the ultrafine number concentration, provides a good index of the total number concentration in ambient air. For the accumulation mode (PM2.5-PM0.15), which contains nearly all of the semivolatiles and particle-bound water by mass, aliquots of the aerosol stream flow into system components that continuously monitor sulfur (by flame photometry), ammonium and nitrate (by chemiluminescence following catalytic transformations to NO), organics (by thermal-optical analysis) and particle-bound water (by electrolytic hygrometer after vacuum evaporation of sampled particles). The concentration of H+ can be calculated (by ion balance using the monitoring data on NO3-, NH4+, and SO4=).

Air Pollution, Indoor↗

Assessment of glycemic control by continuous glucose monitoring system in 50 children with type 1 diabetes starting on insulin pump therapy.

OBJECTIVE: To report experience with a continuous glucose monitoring system (CGMS) and to identify factors influencing glycemic control in a large cohort of children and adolescents with type 1 diabetes and change to insulin pump therapy via continuous subcutaneous insulin infusion (CSII). RESEARCH DESIGN AND METHODS: In 50 patients [21 boys, 29 girls; median age 12.6 yr (range: 1.3-16.4 yr); diabetes duration 5.0 yr (0.2-13.3)], hemoglobin A1c (HbA1c) and ambulatory CGMS were performed before and 6 wk after starting CSII. Average glucose concentration per 24 h, during day and night time as well as number of excursions, duration, and area under the curve (AUC) of glucose values above 180 mg/dL and below 60 mg/dL were calculated from CGMS data. Simultaneously, metabolic control was documented by standardized self-monitoring of blood glucose (SMBG). RESULTS: In the total cohort, HbA1c improved from 8.1 +/- 1.2% at baseline to 7.7 +/- 0.9% after 6 wk of CSII (p <0.001). This effect was more distinct in boys (8.0 +/- 1.4 vs. 7.5 +/- 1.1%, p=0.007) than in girls (8.1 +/- 1.1 vs. 7.8 +/- 0.7%, p=0.039) as well as in patients with poor glycemic control (HbA1c >8.0%) at baseline (8.9 +/- 0.6 vs. 8.1 +/- 0.8%, p <0.001) and in those older than 12 yr (8.2 +/- 1.2 vs. 7.7 +/- 1.0%, p <0.001). At 6 wk of CSII, the values of glucose average per 24 h, AUC and time above 180 mg/dL, particularly during the day, improved. HbA1c was correlated with AUC above 180 mg/dL (r=0.742, p <0.001) and CGMS average glucose per 24 h (r=0.628, p=0.002), but to a lesser extent with SMBG values (r=0.418, p=0.054). CONCLUSION: With the change to CSII, HbA1c improved significantly after 6 wk of therapy. CGMS usage provided additional information about glycemic control in these patients.

Adolescent↗

Real-time patient weight monitoring system for chair based renal dialysis.

A system is described for monitoring weight changes in patients undergoing renal dialysis. Relatively fit patients dialyse in easy chairs rather than in bed but no commercial system is currently available to monitor weight changes under these conditions. The authors have considered basic requirements and have developed a cost effective system based on a Single Point Off-Centre load cell, all components being mounted under a platform on which the easy chair is located. There is an electrical output signal which may be used to drive a display or be sampled by a computer system.

Body Weight↗

Importance of metabolic monitoring systems as an early prognostic indicator in severe head injured patients.

We have analyzed and evaluated what is the best metabolic monitoring system to determine the prognosis for maintenance of neurological function in severe head injured patients. Acute subdural hematoma (ASDH) was recognized in fifteen of 22 patients and cerebral contusion in seven in this series. Intracranial pressure (ICP), jugular venous pH and jugular bulb venous oxygen saturation (SjO2) were continuously monitored as soon as possible following stabilization. The measurement of cerebral blood flow (CBF) was carried out using a stable Xenon-computerized tomography (Xe-CT). After measuring CBF, 3% carbon dioxide (CO2) loading was conducted to determine CO2 responses (delta CBF/delta CO2). In patients who died (D), jugular venous pH showed evidence of acidosis (6.3-7.2) with delta CBF/delta CO2 < 1 and cerebral metabolic rate of oxygen (CMRO2) < 1.21 within several hours of the trauma. On the other hand, arterial pH was shown to be within the normal range. In vegetative state (VS) and severe disability (SD) patients, jugular venous pH was shown to be within normal range, with delta CBF/delta CO2 < 1 and 1.44 < CMRO2 < 1.79. In all of moderate disability (MD) and good recovery (GR) patients, jugular venous pH was shown to be within the normal range, with delta CBF/delta CO2 > 1 and 1.65 < CMRO2 < 1.85. These results suggest that jugular venous pH, CO2 response and CMRO2, were useful as early prognostic indicators in the maintenance of neurological function.

Acidosis↗

The accuracy of the FreeStyle Navigator continuous glucose monitoring system in children with type 1 diabetes.

OBJECTIVE: To evaluate the accuracy and precision of the FreeStyle Navigator continuous glucose monitoring system in children with type 1 diabetes. RESEARCH DESIGN AND METHODS: In 30 children with type 1 diabetes (mean age 11.2 +/- 4.1 years), the Navigator glucose values were compared with reference serum glucose values of blood samples obtained in an inpatient clinical research center and measured in a central laboratory using a hexokinase enzymatic method and in an outpatient setting with a FreeStyle meter. Median absolute difference (AD) and median relative absolute difference (RAD) were computed for sensor-reference and sensor-sensor pairs. RESULTS: The median AD and RAD were 17 mg/dl and 12%, respectively, for 1,811 inpatient sensor-reference pairs and 20 mg/dl and 14%, respectively, for 8,639 outpatient pairs. The median RAD between two simultaneous Navigator measurements (n = 1,971) was 13%. Ninety-one percent of sensors in the inpatient setting and 81% of sensors in the outpatient setting had a median RAD < or = 20%. CONCLUSIONS: The Navigator's accuracy does not yet approach the accuracy of current-generation home glucose meters, but it is sufficient to believe that the device has the potential to be an important adjunct to treatment of youth with type 1 diabetes.

Adolescent↗

Implementation of a statewide outcome monitoring system: lessons learned from substance abuse treatment provider staff.

The authors analyze the pilot implementation of a statewide automated outcome monitoring system (OMS) in California, using the perspectives of substance abuse treatment providers responsible for its day-to-day operation. To gain a better understanding of changes experienced by staff and their perceptions of barriers and facilitators of implementation, they conducted 28 focus groups designed to inform midstream adjustments to the system prior to its possible roll-out. Qualitative analysis of the focus group data revealed five important factors influencing implementation: the treatment provider's ethos, the time-consuming nature of the OMS, staff buy-in, resources, and counselor and program discretion. Lessons learned underscored the importance of taking into consideration aspects of organizational change and institutional resources and infrastructure when implementing a major change such as an automated OMS. Findings might be useful to those designing and implementing similar systems or other large organizational change initiatives.

Confidentiality↗

A laboratory productivity monitoring system.

Over the years, hospitals have attempted to organize and install systems for measuring laboratory workloads and evaluating personnel needs. However, successful accomplishment of this goal has eluded many facilities because of failure to integrate such systems into the normal operating management routine of the laboratory and the hospital. This paper focuses on how to develop a personnel productivity monitoring system that surmounts the classical errors. It includes an overview of procedures that should be used to quantify personnel needs and presents a reporting system which can be utilized by laboratory management to monitor personnel productivity on an ongoing basis.

Efficiency↗

Performance assessment of the Medtronic-MiniMed Continuous Glucose Monitoring System and its use for measurement of glycaemic control in Type 1 diabetic subjects.

AIMS: To assess the accuracy, reliability and measurement of glycaemic control associated with the Medtronic-MiniMed Continuous Glucose Monitoring System (CGMS) in comparison with blood glucose self-monitoring (BGSM) in Type 1 diabetic patients. METHODS: Type 1 diabetic patients (n = 18) underwent glucose monitoring by the CGMS for up to 3 days, when control was also assessed by BGSM performed eight times daily. RESULTS: Ninety-five per cent of paired non calibration samples were in the clinically acceptable zones of the Clarke error grid, and 97% in a consensus grid. The median bias was 0.1 mmol/l and relative bias 15%. The failure rate of sensors was 28% of those initially inserted. The CGMS detected significantly more hypoglycaemia and post-prandial hyperglycaemia, but total duration of hyperglycaemia, blood glucose oscillations and day-to-day variability were similarly assessed by CGMS and BGSM. CONCLUSIONS: The CGMS has acceptable clinical accuracy. Detection by the CGMS of more hypoglycaemia and post-prandial hyperglycaemia than BGSM promises a valuable tool for control assessment and optimization of treatment.

Adult↗

Evaluation of metabolic control using a continuous subcutaneous glucose monitoring system in patients with type 1 diabetes mellitus who achieved insulin independence after islet cell transplantation.

This study evaluated the Medtronic MiniMed Continuous Glucose Monitoring System (CGMS) in patients with type 1 diabetes mellitus who underwent successful islet cell transplantation (ICT). The results are compared to standardized self-monitoring (SMBG) of hyperglycemia and mean amplitude of glycemic excursions (MAGE). We studied 19 patients (mean age 40.0 +/- 6.7 years) in three groups: six patients post-ICT, seven patients awaiting ICT, and six normal volunteers (controls). Continuous glucose monitoring post-ICT showed remarkable glucose stability compared with patients awaiting ICT. The CGMS group showed modestly higher glucoses (mean 111.5 mg/dl) compared with controls (88 mg/dl). Postprandial glucoses in ICT recipients rarely exceeded 180 mg/dl and were similar to controls. There was no difference in asymptomatic hypoglycemia between control and post-ICT groups. However, a higher incidence of hypoglycemia was observed in patients awaiting ICT. HbA1c and MAGE pre- and post-ICT were 8.3 +/- 0.9% and 6 +/- 0.3% (p < 0.001) and 109 +/- 34 and 41 +/- 11 (p < 0.001), respectively. No complications were associated with CGMS. This study suggests ICT significantly improves metabolic control and rate of hypoglycemia when compared with controls and patients awaiting ICT. Similar improvement in metabolic control was observed with SMBG, HbA1c, and MAGE. Although CGMS was not demonstrated to be a superior tool for routine assessment in ICT, it is very helpful in special clinical situations.

Adult↗

The evaluation of a new intravascular blood gas monitoring system in the pig.

OBJECTIVE: Our objective was to investigate the accuracy of a new intravascular blood gas sensor, the Paratrend 7 (P7) (Biomedical Sensors Ltd, Pfizer Hospital Products Group, High Wycombe, England) in a porcine model. METHODS: A total of 12 sensors were inserted into 10 animals under total intravenous anesthesia. Changes in blood gas chemistry were produced over a wide range by manipulating the inspired oxygen and carbon dioxide concentrations and by adjustments in minute ventilation. Blood gas samples (BGA) were taken and analyzed during periods of stability; the results obtained were compared with the readings from the intravascular sensor. RESULTS: A total of 292 blood gas samples were taken and analyzed for pHa, PaCO2, and Po2; the results were compared with the readings from the intravascular sensor. Correlation coefficients of r = 0.98 for PCO2 and r = 0.99 for PO2 were obtained. Analysis of bias and precision as mean +/- SD of the difference (P7 - BGA) gave the following results: pH bias = -0.03, precision = +/- 0.04; PCO2 bias = 0.65 mm Hg, precision = +/- 3.1 mm Hg; and PO2 bias = -6.50 mm Hg, precision = +/- 0.6 mm Hg. No problems with clot formation on the sensor were seen, and the sensors did not appear to show the "wall effect" seen with other systems. CONCLUSIONS: The results obtained were well within the requirements for a clinically useful blood gas monitoring system.

Animals↗

A pilot study of the continuous glucose monitoring system: clinical decisions and glycemic control after its use in pediatric type 1 diabetic subjects.

OBJECTIVE: To determine whether the continuous glucose monitoring system (CGMS) (MiniMed, Sylmar, CA) could be used to make clinical decisions and whether it has an impact on glycemia in pediatric type 1 diabetic subjects. RESEARCH DESIGN AND METHODS: Pediatric subjects were recruited if they had HbA(1c) >8.0% with management problems (n = 35) or episodes of severe or nocturnal hypoglycemia or hypoglycemia unawareness associated with HbA(1c) < or =8.0% (n = 12). A total of 47 patients with a mean HbA(1c) value of 8.6 +/- 1.6% (mean age 11.8 +/- 4.6 years, youngest 2.7 years, and diabetes duration 5.5 +/- 3.5 years) on three to four insulin injections/day (n = 24) or insulin pump therapy (n = 23) were followed with the CGMS for a mean of 69.5 +/- 28 h. Comparisons were made between the number of high (>150 mg/dl) and low (<70 mg/dl) glucose patterns discerned with the sensor or the logbook, and HbA(1c) levels were evaluated. RESULTS: In patients on injection therapy, 30 high or low glucose patterns were discerned with the logbook records and 120 patterns with the CGMS. Specific alterations of the diabetes regimen were made. An overall significant change in HbA(1c), from 3 months before wearing the sensor to 6 months after (analysis of variance 0.04), was found in the subjects. Post hoc analysis showed a significant change in HbA(1c) from 8.6 +/- 1.5% at baseline to 8.4 +/- 1.3% at 3 months (paired Student's t test 0.03). CONCLUSIONS: The CGMS can be used by pediatric patients to detect abnormal patterns of glycemia. The information that was obtained could be used to alter the diabetes regimen and impact glycemic outcome.

Adolescent↗

[Usefulness of continuous glucose monitoring system in detection of hypoglycaemic episodes in patients with diabetes in course of chronic pancreatitis].

BACKGROUND: Recently introduced method of glucose monitoring--Continuous Glucose Monitoring System (CGMS, Medtronic MiniMed) now offers new possibilities of assessing metabolic control of diabetes as it records blood glucose values 288 times per day. CGMS is particularly helpful in pancreatogenic diabetes, which is associated with essentially poor metabolic control and higher number of hypoglycemic events. AIM: The study aimed at assessing number of hypoglycemic episodes, including symptom-free hypoglycemic episodes detected with CGMS and glucose meter (GM). TURESTIGALED GROUP AND METHODS: The study comprised 60 diabetic out-patients, treated with insulin in age mean 53.8 +/- 5.1 years, with chronic pancreatitis lasting mean 10.6 +/- 4.6 years and diabetes mellitus-- 4.9 +/- 2.4 years. Serum glucose concentration values were measured with the use of CGMS. Ten measurements of capillary blood glucose concentration with GM were performed daily during the period of CGMS use. Observation period of hypoglycemic episodes lasted 3 days. Hypoglycemic event was detected when glucose value decreased below 60 mg/dl. The number of hypoglycemic episodes, including symptom-free hypoglycemic episodes detected with CGMS and GM was compared. RESULTS: Number of hypoglycemic events detected with CGMS was five times higher than in GM measurements (p < 0.001). Episodes of symptom--free hypoglycemia were noted in CGMS six times higher than in GM measurements (p < 0.001). Hypoglycemia was found in twice as many patients when diagnosed upon CGMS results as when found upon GM results (p < 0.01). Episodes of symptom-free hypoglycemia were detected in six times as many patients when diagnosed upon CGMS as when analysed upon GM measurements (p < 0.001). CONCLUSION: CGMS offers more complete data on low blood glucose incidents, including symptom-free hypoglycemia, than intensive blood glucose monitoring with the use of glucose meter.

Aged↗

Are computerised monitoring systems of value to improve pharmacovigilance in paediatric patients?

OBJECTIVE: The aim of the present study was to evaluate a computerised monitoring system (CMS) based on laboratory test results for the detection of adverse drug reactions (ADRs) on a paediatric ward. METHODS: A prospective, 6-month pharmacoepidemiological survey was performed on a 22-bed paediatric isolation ward. ADRs were identified by intensive chart review. In addition to spontaneous reporting by the treating physician, automatic laboratory signals generated by a CMS were evaluated for their association with ADRs. ADRs were classified by the affected target organs according to the WHO-ART system organ classes. RESULTS: A total of 73 ADRs were identified in 439 admissions (396 patients) by chart review. The CMS alerted 31 (42.4%) ADRs while 23 (31.5%) ADRs were found solely by treating physicians. Eight ADRs were detected by both approaches resulting in a total detection rate of 74% (compared with intensive pharmacovigilance). Out of a total of 27,434 laboratory tests performed routinely, 1,563 were classified as abnormal by the predefined CMS and used as the basis of alerts. The sensitivity of the system with respect to patients alerted was 90.3% and the specificity only 19.6%. CONCLUSION: This study demonstrates that, using CMS, a different kind of mild adverse events were detected compared to the observation by the treating physician. The system presented appears to be sufficiently sensitive, but the specificity is too low to make it acceptable for physicians in daily practice. In children, clinically important ADRs can be detected best by intensified surveillance.

Adolescent↗

Differences in oscillometric non-invasive blood pressure measurements recorded by different revisions of the Philips Component Monitoring System.

OBJECTIVE: To investigate whether a simulator can detect differences in oscillometric noninvasive blood pressure measurements in different revisions of the Philips Component Monitoring System. Philips revised the intraarterial-based algorithm with software revision C.0, and added an auscultation-based algorithm in revision C.1. METHODS: Three methods were adopted. Firstly, differences were assessed using the Dynatech Nevada CuffLink simulator. Five noninvasive blood pressure modules were tested on monitors with software revision C (software revision prior to C.0) and revision C.0. Monitor C.1 allows the selection of the original intraarterial algorithm (as for revision C), the improved intraarterial (revision C.0) or auscultation; two noninvasive blood pressure modules were tested on it.Secondly, pressures were recorded simultaneously from a participant's left and right arms by monitors C and C.0. The monitors were then swapped between arms and a second set of six pressures were recorded. The two sets were subtracted to calculate the differences between monitors, removing interarm differences. The experiment was carried out on two participants.Thirdly, pressures were recorded from three participants with a simultaneous reference auscultatory measurement. Six sets of simultaneous oscillometric and auscultatory determinations were recorded from monitors C and C.0. RESULTS AND CONCLUSIONS: All three methods revealed that the 'original' intraarterial-based algorithm in revision C recorded lower systolic, diastolic and mean arterial pressures than revision C.0, with the difference in diastolic pressure being the greatest. The difference in diastolic pressures between C and C.0 was up to 15 mmHg. The simulator evaluation finding of higher systolic and diastolic pressures recorded by the revised intraarterial algorithm (C.1 option 3) than by the auscultation-based algorithm (C.1 option 2) is in qualitative agreement with the regression equations of the clinical validation studies. The results suggest that simulators can identify the existence of differing algorithms used to measure blood pressure by the CMS monitor. Philips has continued to develop the algorithms used to determine the pressure by the oscillometric method. While significantly different pressures were recorded by the different revisions, it is interesting that each revision passed clinical validation studies.

Algorithms↗