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Association of hypoglycemia and cardiac ischemia: a study based on continuous monitoring.

OBJECTIVE: In some studies intensive diabetes treatment in patients with type 2 diabetes may be associated with increased cardiovascular events. It is not clear whether these events are related to hypoglycemic episodes. To determine whether episodes of hypoglycemia were more likely to be associated with cardiac ischemia than normoglycemia or hyperglycemia, we carried out a study in 21 patients with coronary artery disease (CAD) and type 2 diabetes treated with insulin who had good glycemic control. RESEARCH DESIGN AND METHODS: We carried out 72-h continuous glucose monitoring along with simultaneous cardiac Holter monitoring for ischemia. Patients also recorded symptoms of cardiac ischemia (chest pain) and symptoms of hypoglycemia. RESULTS: Satisfactory continuous glucose monitoring system recordings were obtained in 19 patients. We recorded 54 episodes of hypoglycemia (blood glucose <70 mg/dl; 26 of these were symptomatic) and 59 episodes of hyperglycemia (blood glucose >200 mg/dl; none symptomatic). Of the 54 episodes of hypoglycemia, 10 were associated with symptoms of chest pain, during 4 of which electrocardiographic abnormalities were documented. In contrast, only 1 episode of chest pain occurred during 59 episodes of hyperglycemia. No chest pain or electrocardiographic abnormalities occurred when the blood glucose was within the normal range. The difference between the frequency of ischemia during hypoglycemia and the frequency during both hyperglycemia and normoglycemia was statistically significant (P < 0.01). There were 50 episodes during which the blood glucose changed by >100 mg over a 60-min period, and ischemic symptoms occurred during 9 of these episodes (P < 0.01 compared with stable normoglycemia or hyperglycemia). CONCLUSIONS: Hypoglycemia is more likely to be associated with cardiac ischemia and symptoms than normoglycemia and hyperglycemia, and it is particularly common in patients who experience considerable swings in blood glucose. These data may be important in the institution of insulin treatment and attempting near-normal glycemia in patients with known CAD. Further research is needed to determine strategies to prevent ischemia associated with hypoglycemia.

Blood Glucose↗

Continuous subcutaneous insulin infusion (CSII) of insulin aspart versus multiple daily injection of insulin aspart/insulin glargine in type 1 diabetic patients previously treated with CSII.

OBJECTIVE: Multiple daily injection (MDI) therapy of bolus insulin aspart and basal insulin glargine was compared with continuous subcutaneous insulin infusion (CSII) with aspart in type 1 diabetic patients previously treated with CSII. RESEARCH DESIGN AND METHODS: One hundred patients were enrolled in a randomized, multicenter, open-label, crossover study. After a 1-week run-in period with aspart by CSII, 50 subjects were randomly assigned to MDI therapy (aspart immediately before each meal and glargine at bedtime) and 50 subjects continued CSII. After 5 weeks of the first treatment, subjects crossed over to the alternate treatment for 5 weeks. During the last week of each treatment period, subjects wore a continuous glucose monitoring system for 48-72 h. RESULTS: Mean serum fructosamine levels were significantly lower after CSII therapy than after MDI therapy (343 +/- 47 vs. 355 +/- 50 micromol/l, respectively; P = 0.0001). Continuous glucose monitoring profiles over a 24-h time period showed that glucose exposure was 24 and 40% lower for CSII than MDI as measured by area under the curve (AUC) glucose >/=80 mg/dl (1,270 +/- 742 vs. 1,664 +/- 1,039 mg . h . dl(-1); P < 0.001) and AUC glucose >/=140 mg/dl (464 +/- 452 vs. 777 +/- 746 mg . h . dl(-1), CSII vs. MDI, respectively; P < 0.001). Similar percentages of subjects reported hypoglycemic episodes (CSII: 92%, MDI: 94%) and nocturnal (12:00 a.m. to 8:00 a.m.) hypoglycemic episodes (CSII: 73%, MDI: 72%). Major hypoglycemia was infrequent (CSII: two episodes, MDI: five episodes). CONCLUSIONS: In a trial of short duration, CSII therapy with insulin aspart resulted in lower glycemic exposure without increased risk of hypoglycemia, as compared with MDI with insulin aspart and glargine.

Adult↗

The effect of electrical stimulation of the hypothalamus on continuously-monitored blood glucose levels.

The effects of hypothalamic stimulation on blood glucose levels were investigated in unanaesthetised rats with intracardiac catheters directly connected to a continuous glucose analyzer. Thirty sec of low level electrical stimulation produced hyperglycemia at 23 of the 34 sites stimulated. At the remaining 11 sites the electrical stimulation produced no changes in blood glucose levels. The hyperglycemia could be dissociated from the changes in motor activity produced by the stimulation. The highest probability of producing hyperglycemia was found at ventro-lateral sites although hyperglycemia was also observed after stimulation of dorsal and medial sites. Apart from this medio-lateral difference in the density of sites at which stimulation produced hyperglycemia, the effects were not well differentiated anatomically. In addition, in terms of latency, peak magnitude and duration of the hyperglycemia, stimulation of the various hypothalamic subdivisions appeared to be functionally equivalent. Thus with respect to hypothalamic involvement in the maintenance of blood glucose levels the present stimulation analysis suggests a medio-lateral functional similarity which is very different from the medio-lateral reciprocity of lesion effects on ingestive behaviour and body weight.

Animals↗

Monitoring exercise-induced changes in glycemic control in type 2 diabetes.

PURPOSE: The present study determined the efficacy of the Continuous Glucose Monitoring System (CGMS) during moderate exercise and monitored the changes in whole-day glucose profiles using the CGMS in individuals with and without type 2 diabetes. METHODS: Six, obese, diet-treated individuals with and four age-matched individuals without type 2 diabetes were monitored using the CGMS for 3 d. Subjects cycled at 90% of a predetermined lactate threshold for 1 h at approximately 09:00 h on day 2, during which venous blood was sampled at 10-min intervals and immediately analyzed for glucose concentrations. RESULTS: Venous blood glucose and CGMS values declined during exercise in the diabetes (P < 0.001) but not the control group (P = 0.085). The CGMS overestimated blood glucose in the control (P = 0.003) and the diabetes (P = 0.045) groups during exercise. The number of data points outside of the 95% confidence intervals was <5% in both groups, showing that there is a statistically acceptable level of agreement between venous blood glucose and CGMS values during exercise. Moderate exercise improved whole-day average glucose concentrations (P = 0.007) and whole-day area under the glucose curve (P = 0.016) values (AUCglu), and the time spent within +/-10% of fasting venous glucose (FVG) increased in the diabetes group (P = 0.021). No such effects were seen in the control group. CONCLUSION: Using continuous glucose monitoring we were able to demonstrate that a period of moderate exercise improved whole-day glycemic control in obese individuals with type 2 diabetes. The CGMS should only be used as an adjunct and not as an alternative to frequent blood glucose sampling when examining the changes in glucose values during exercise in individuals with and without type 2 diabetes.

Analysis of Variance↗

Social consumption of alcohol in adolescents with Type 1 diabetes is associated with increased glucose lability, but not hypoglycaemia.

AIM: To determine the effects of social consumption of alcohol by diabetic adolescents on glycaemic control. METHODS: Fourteen (five male) patients aged > 16 years were recruited from the diabetes clinic at the Royal Children's Hospital. The continuous glucose monitoring system (CGMS) was attached at a weekend when alcohol consumption was planned for one night only. For each patient, the 12-h period from 18.00 h to 06.00 h for the night with alcohol consumption (study period) was compared with the same period with non-alcohol consumption (control period) either 24 h before or after the alcohol study night. Thus, each subject was his/her own control. Glycaemic outcomes calculated from continuous glucose monitoring included mean blood glucose (MBG), percentage of time spent at low glucose levels (CGMS < 4.0 mmol/l), normal glucose levels (CGMS 4.0-10.0 mmol/l) and high glucose levels (> 10.0 mmol/l) and continuous overall net glycaemic action (CONGA). RESULTS: The mean number of standard alcohol drinks consumed during the study period was 9.0 for males and 6.3 for females. There was no difference in percentage of time at high and normal glucose levels in the study and control periods. During the control period, there was a higher percentage of time with low glucose levels compared with the study period (P < 0.05). There was an increased level of glycaemic variation during the study time when compared with the control period. CONCLUSIONS: In an uncontrolled, social context, moderately heavy alcohol consumption by adolescents with Type 1 diabetes appears to be associated with increased glycaemic variation, but not with low glucose levels.

Adolescent↗

Evaluation of conventional blood glucose monitoring as an indicator of integrated glucose values using a continuous subcutaneous sensor.

OBJECTIVE: To use a portable continuous glucose monitoring system (CGMS) to evaluate how well the customary intermittent self-monitoring of blood glucose (SMBG) correlates with integrated values during the surrounding time periods in ambulatory patients with type 1 diabetes. RESEARCH DESIGN AND METHODS: In the study, 18 young patients with type 1 diabetes were monitored with CGMS for up to 72 h, during which they continued to perform the four standard SMBG tests (preprandial and bedtime). Correlations were examined between each of the four standard SMBG tests and the mean CGMS values from defined periods that preceded and followed. We also tested how well a low bedtime SMBG predicted nocturnal hypoglycemia. RESULTS: Strong correlations were found between 1) SMBG at breakfast and the mean CGMS value for the preceding 8 h (r = 0.7514), 2) SMBG at dinner and the CGMS from lunch to dinner (r = 0.7538), 3) SMBG at bedtime and the CGMS from dinner to bedtime (r = 0.8145), and 4) SMBG at bedtime and the CGMS from bedtime to breakfast (r = 0.6463). The remaining correlations were weak and not statistically significant. These correlations seem independent of insulin-delivery method as virtually identical results were obtained when data from patients on conventional versus intensive regimes were separately analyzed. A bedtime SMBG <7 mmol/l did not predict nocturnal hypoglycemia (defined as at least one CGMS value <3). CONCLUSIONS: -The breakfast and dinnertime SMBG values are good indicators of integrated glucose values in the time period preceding them, while the bedtime test correlates well with the integrated values both preceding and following it. This information should aid in the meaningful use of SMBG to evaluate glycemic control and make insulin dose adjustments.

Adolescent↗

Treatment with continuous positive airway pressure may affect blood glucose levels in nondiabetic patients with obstructive sleep apnea syndrome.

STUDY OBJECTIVES: Obstructive sleep apnea syndrome (OSAS) is often associated with impaired glucose metabolism. Data on the effects of OSAS treatment with continuous positive airway pressure (CPAP) on blood glucose and insulin resistance are conflicting. The study aimed at assessing the immediate effect of CPAP on glucose control measured with a continuous glucose monitoring system (CGMS). PARTICIPANTS AND MEASUREMENTS: Nine non-diabetes subjects with OSAS (mean age 53.0 +/- 8.0 years; body mass index 34.8 +/- 5.3 kg/m2) underwent 2 overnight polysomnographic examinations: a diagnostic study and one with CPAP treatment. Continuous glucose monitoring system (CGMS) was applied overnight on both occasions. Glucose metabolism was assessed with a 75-g oral glucose tolerance test, plasma insulin and homeostatic model assessment of insulin resistance (HOMA-IR) index. RESULTS: The mean (+/- SD) apnoea-hypopnea index (AHI) at diagnostic polysomnography was 54.3 +/- 29.3 (range 16-81). Fasting plasma insulin levels in patients with OSAS was 84.3 +/- 43.4 pM at baseline, and the HOMA-IR was 3.6 +/- 2.2. CPAP treatment in the subjects with OSAS resulted in a significant reduction in the AHI to 4.5 +/- 7.1. All of the major saturation parameters improved significantly on CPAP. CGMS showed mean glucose values significantly higher during the CPAP night than during the diagnostic night: 80 +/- 11 mg/dL versus 63 +/- 7 mg/dL (P < .01). Fasting insulin and HOMA-IR measured after the CPAP night tended to be higher than at baseline (98.4 +/- 51.0 pmol vs 84.3 +/- 43.4 pmol and 3.9 pmol +/- 2.6 vs 3.6 +/- 2.2 pmol, respectively, P > .05). CONCLUSION: CPAP treatment in nondiabetic obese patients with OSAS may have an immediate elevating effect on blood glucose.

Adolescent↗

Influence of caffeine on frequency of hypoglycemia detected by continuous interstitial glucose monitoring system in patients with long-standing type 1 diabetes.

OBJECTIVE: The aim of this study was to investigate the effect of caffeine (in doses equivalent to normal daily ingestion) on rates and severity of hypoglycemia in patients with long-standing type 1 diabetes to determine the relationship between caffeine, autonomic function, and hypoglycemia. RESEARCH DESIGN AND METHODS: Using a double-blinded randomized study, we investigated the effect of caffeine versus placebo in 19 patients with long-standing type 1 diabetes using continuous glucose sensing technology and simultaneous assessment of autonomic function using Holter monitoring. RESULTS: Caffeine reduced the duration of nocturnal hypoglycemia with a mean duration of 49 minutes (range 0-235) versus 132 (0-468) minutes (P = 0.035). The reduction in duration of nighttime hypoglycemia was due to a decline in the number of episodes of moderate hypoglycemia at the expense of mild hypoglycemic episodes (P = 0.04). There was no overall correlation between reduced heart rate variability (a marker of autonomic dysfunction) and hypoglycemic events (r(s) = 0.12, P = 0.62). CONCLUSIONS: Our results suggest that caffeine is associated with a significant reduction in nocturnal hypoglycemia. The reduction in nocturnal hypoglycemia was not linked to the concomitant rise in parasympathetic activity associated with caffeine.

Adult↗

Gadobenate dimeglumine and cerebral glucose metabolism. Continuous monitoring of striatal lactate levels in freely moving rats.

PURPOSE: Brain contrast-enhanced MR imaging reflects the leakage of contrast material into the brain tissue due to blood-brain barrier (BBB) disruption. The contact between brain tissue and contrast material requires a high level of neurotolerability of the contrast agent (CA). In the present study, we investigated the neurotolerability of the paramagnetic CA gadobenate dimeglumine, locally applied into the corpus striatum of freely moving rats, by evaluating its potential effects on cerebral glucose metabolism based on lactate levels. MATERIAL AND METHODS: Lactate levels were monitored using a microdialysis technique coupled with an enzyme reaction. A microdialysis probe for extracellular fluid sampling, together with a stainless steel cannula for CA administration, were inserted into the right corpus striatum of rats. Lactate levels were monitored for 2 h after gadobenate dimeglumine administration at 120 nmol/rat, at fixed volume of 1.2 microl. The same volume of artificial cerebrospinal fluid (aCSF) was administered to control rats. RESULTS: Gadobenate dimeglumine did not induce any significant changes in the lactate striatal levels over the 30-min period after administration. Small, but significant, reductions in lactate concentration were found from the 45-min control point after gadobenate dimeglumine administration. Lactate response showed the same pattern in rats given aCSF. CONCLUSION: Gadobenate dimeglumine, intracerebrally administered, did not affect cerebral glucose metabolism in rats as it showed the same behaviour as aCSF on cerebral glucose utilization. The gradual attenuation in the endogenous lactate release observed 45 min after test compound administration is possibly due to a slight reduction in the probe recovery. The present findings confirm the neurotolerability of gadobenate dimeglumine previously shown in behavioural and electrophysiological studies.

Animals↗

Alarms based on real-time sensor glucose values alert patients to hypo- and hyperglycemia: the guardian continuous monitoring system.

The purposes of this study were to demonstrate the accuracy and effectiveness of the Guardian Continuous Monitoring System (Medtronic MiniMed, Northridge, California) and to demonstrate that the application of real-time alarms to continuous monitoring alerts users to hypo and hyperglycemia and reduces excursions in people with diabetes. A total of 71 subjects with type 1 diabetes, mean hemoglobin A1c of 7.6 +/- 1.1%, age 44.0 +/- 11.4 years, and duration of diabetes 23.6 +/- 10.6 years were enrolled in this two-period, randomized, multicenter study. Subjects were randomized into either an Alert group or a Control group. The accuracy of the Guardian was evaluated by treating the study data as a single-sample correlational design. Effectiveness of the Guardian alerts was evaluated by comparing the Alert group with the Control group. The mean (median) absolute relative error between home blood glucose meter readings and sensor values was 21.3% (17.3%), and the Guardian, on average, read 12.8 mg/dL below the concurrent home blood glucose meter readings. The hypoglycemia alert was able to distinguished glucose values < or =70 mg/dL with 67% sensitivity, 90% specificity, and 47% false alerts. The hyperglycemia alert showed a similar ability to detect sensor values > or =250 mg/dL with 63% sensitivity, 97% specificity, and 19% false alerts. The Alert group demonstrated a median decrease in the duration of hypoglycemic excursions (-27.8 min) that was significantly greater than the median decrease in the duration of hypoglycemic excursions in the Control group (-4.5 min) (P = 0.03). A marginally significant increase in the frequency of hyperglycemic excursions (P = 0.07) between Period 1 and Period 2 was accompanied by a decrease of 9.6 min in the duration of hyperglycemic excursions in the Alert group. Glucose measurements differ between blood samples taken from the finger and interstitial fluid, especially when levels are changing rapidly; however, these results demonstrate that the Guardian is reasonably accurate while performing continuous glucose monitoring. The subjects' responses to hypoglycemia alerts resulted in a significant reduction in the duration of hypoglycemic excursions; however, overtreating hypoglycemia may have resulted in a marginally significant increase in the frequency of hyperglycemic excursions.

Adult↗

Can interstitial glucose assessment replace blood glucose measurements?

Current treatment regiments for individuals depending on exogenous insulin are based on measurements of blood glucose obtained through painful finger sticks. The shift to minimal or noninvasive continuous glucose monitoring primarily involves a shift from blood glucose measurements to devices measuring subcutaneous interstitial fluid (ISF) glucose. As the development of these devices progresses, details of the dynamic relationship between blood glucose and interstitial glucose dynamics need to be firmly established. This is a challenging task insofar as direct measures of ISF glucose are not readily available. The current article investigated the dynamic relationship between plasma and ISF glucose using a model-based approach. A two-compartment model system previously validated on data obtained with the MiniMed Continuous Glucose Monitoring System (CGMS) is reviewed and predictions from the original two-compartment model were confirmed using new data analysis of glucose dynamics in plasma and hindlimb lymph (lymph is derived from ISF) in the anesthetized dog. From these data sets, the time delay between plasma and ISF glucose in dogs was established (5-12 minutes) and a simulation study was performed to estimate the errors introduced if ISF is taken as a surrogate for blood. From the simulation study, the error component resulting from the differences in plasma and ISF glucose was estimated to be < 6% during normal day-to-day use in an individual with diabetes (error component calculated as the standard deviation of the ISF/plasma glucose differences under conditions where the maximal time delay was used). This difference is most likely within the variance between arterial and venous blood glucose. We conclude that the differences between plasma and ISF glucose will not be a significant obstacle in advancing the use of ISF as an alternative to blood glucose measurements.

Biosensing Techniques↗

Performance of subcutaneously implanted glucose sensors: a review.

Despite a considerable amount of research attributed to the development of an implantable glucose sensor, to date there is no clinically applicable concept for continuous glucose monitoring. Investigations to validate the subcutaneous tissue for continuous glucose sensing mostly comprise short-term implantations of glucose sensors. Most implanted glucose sensors showed a significant decay in sensitivity over the implantation period. This bioinstability was not to be expected from the in vitro performance of the sensors. In this article, the influence of possible failure mechanisms on the poor in vivo performance of subcutaneously implanted glucose sensors is reviewed.

Animals↗

Youth and parent satisfaction with clinical use of the GlucoWatch G2 Biographer in the management of pediatric type 1 diabetes.

OBJECTIVE: A continuous glucose monitor satisfaction scale (CGM-SAT) was evaluated during a 6-month randomized controlled trial of the GlucoWatch G2 Biographer (GW2B) in youths with type 1 diabetes. RESEARCH DESIGN AND METHODS: At the end of the 6-month trial, 97 parents and 66 older children who had been randomized to the GW2B group completed the CGM-SAT, which assesses satisfaction on 37 items using a five-point Likert scale. Descriptive analysis, calculation of several reliability estimates, and assessment of concurrent validity were performed. RESULTS: The CGM-SAT demonstrated high internal reliability (Cronbach's alpha = 0.95 for parents and 0.94 for youths aged > or = 11 years), split-half reliability (rho = 0.91 for parents and 0.93 for youths), and parent-adolescent agreement (rho = 0.68, P < 0.001). Convergent validity was supported by marginally significant associations with treatment adherence and frequency of GW2B use. CGM-SAT scores did not correlate significantly with changes in treatment adherence, quality of life, or diabetes-related anxiety from baseline to 6 months. Mean scores on CGM-SAT items indicated that 81% of parental responses and 73% of youths' responses were less favorable than "neutral." Descriptive analysis indicated the GW2B requires substantial improvement before it can achieve widespread clinical utility and acceptance. CONCLUSIONS: The results supported the psychometric properties of the CGM-SAT. The CGM-SAT warrants further research use and cross-validation with other continuous glucose monitors. This study provides a benchmark for comparison with new glucose sensors.

Adolescent↗

Calibration of a subcutaneous amperometric glucose sensor implanted for 7 days in diabetic patients. Part 2. Superiority of the one-point calibration method.

UNLABELLED: Calibration, i.e. the transformation in real time of the signal I(t) generated by the glucose sensor at time t into an estimation of glucose concentration G(t), represents a key issue for the development of a continuous glucose monitoring system. OBJECTIVE: To compare two calibration procedures. In the one-point calibration, which assumes that I(o) is negligible, S is simply determined as the ratio I/G, and G(t) = I(t)/S. The two-point calibration consists in the determination of a sensor sensitivity S and of a background current I(o) by plotting two values of the sensor signal versus the concomitant blood glucose concentrations. The subsequent estimation of G(t) is given by G(t) = (I(t)-I(o))/S. RESEARCH DESIGN AND METHODS: A glucose sensor was implanted in the abdominal subcutaneous tissue of nine type 1 diabetic patients during 3 (n = 2) and 7 days (n = 7). The one-point calibration was performed a posteriori either once per day before breakfast, or twice per day before breakfast and dinner, or three times per day before each meal. The two-point calibration was performed each morning during breakfast. RESULTS: The percentages of points present in zones A and B of the Clarke Error Grid were significantly higher when the system was calibrated using the one-point calibration. Use of two one-point calibrations per day before meals was virtually as accurate as three one-point calibrations. CONCLUSION: This study demonstrates the feasibility of a simple method for calibrating a continuous glucose monitoring system.

Biosensing Techniques↗

Hypoglycemia warning signal and glucose sensors: requirements and concepts.

Hypoglycemia is the most feared side effect of diabetes therapy with blood glucose-lowering agents. The fear of hypoglycemia often contributes to poor metabolic control of patients with diabetes. Therefore, integration of a hypoglycemia warning signal into continuous glucose monitoring systems represents an important additional help for patients with diabetes. The warning signal can be triggered at a preset level based on the current glucose values (as provided with the presently available glucose monitoring systems) or on prospective trend analysis offering the possibility to predict the risk of a hypoglycemic event in an anticipatory manner. Using the approach of a "Finite State Machine," such a more advanced warning system can completely be described as a finite collection of four states and possible transitions in-between. Most of the currently available glucose monitoring systems measure glucose in the interstitial fluid (ISF) of the dermal or subcutaneous tissue but are calibrated to blood glucose levels. This requires a number of factors to be taken into account: precision and accuracy of the glucose measurements, physiological and physical lag time, and calibration of the glucose monitoring system. From our point of view, the analytical performance of the system should be such that the majority of all hypoglycemic episodes are correctly diagnosed (>75%). Inconsistent findings regarding physiological discrepancies between blood and ISF glucose, which usually are described as a physiological lag time, range from some seconds up to 15 min. They can be observed especially during dynamic blood glucose changes (>3 mg/dL/min) and may represent major challenges for the development of a reliable hypoglycemia warning signal. In addition to possible physiological time lags, device-inherent physical lag times must be considered when selecting the threshold for the warning signal. Despite these problems, most probably all patients with diabetes who are treated with blood glucose-lowering agents will benefit from such a system since their safety and quality of life can be greatly improved, including an optimized metabolic control and lowered diabetes-related mortality. The benefit will be greatest for patients with hypoglycemia unawareness or impaired perception of hypoglycemic symptoms. The risks related to the use of a hypoglycemia warning signal seem to be low if certain precautionary measures are taken. In any case, additional clinical-experimental studies in healthy subjects as well as long-term clinical studies in diabetic patients are necessary to further evaluate the efficacy, benefits, and risks of different hypoglycemia warning concepts implemented in the different continuous glucose monitoring systems.

Biosensing Techniques↗

A microdialysis technique for continuous subcutaneous glucose monitoring in diabetic patients (part 1).

The performances and the stability of a novel subcutaneous glucose monitoring system have been evaluated. GlucoDay (A. Menarini I.F.R. S.r.l, Florence Italy) is a portable instrument provided with a micro-pump and a biosensor coupled to a microdialysis system capable of recording the subcutaneous glucose level every 3 min. Long and short term stability of the biosensor are discussed and the results of some critical in vitro and in vivo (on rabbits) experiments are reported. A linear response up to 30 mM has been found for in vivo glucose concentration. The sensitivity referred to blood glucose is better than 0.1 mM and the zero current is typically below the equivalent of 0.1 mM. In the accuracy study a mean bias of 2.7 mg/dl and a correlation coefficient equal to 0.9697 have been found. At room temperature, an excellent membrane stability assures good performances up to 6 months from the first use.

Animals↗