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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↗

Continuous glucose monitoring and the reality of metabolic control in preschool children with type 1 diabetes.

OBJECTIVE: To determine using the MiniMed continuous glucose monitoring system (CGMS) 1) whether twice-daily insulin injection therapy achieves adequate control in preschool children with type 1 diabetes and 2) whether the CGMS is more informative than self-monitoring of blood glucose (SMBG) regarding glucose control and well tolerated by preschool children and their families. RESEARCH DESIGN AND METHODS: Ten children <6 years of age with type 1 diabetes were monitored twice using the CGMS. The distribution of glucose values was analyzed, particularly the frequency, duration, and distribution of hypoglycemia. We analyzed the accuracy of the CGMS in detecting hypoglycemia as well as the clinical relevance of the difference between CGMS and SMBG values. RESULTS: Although hypoglycemia was more frequent during the night (0.8 nighttime episodes . subject(-1) . 24 h(-1) vs. 0.3 daytime episodes . subject(-1) . 24 h(-1)), the difference did not reach statistical significance (P=0.07). However, nighttime episodes lasted longer than daytime episodes (1.2 vs. 0.2 h . subject(-1) . 24 h(-1), P=0.006). Hypoglycemia accounted for 7% and normoglycemia for 24%, while hyperglycemia occurred 64% of the time, with postprandial hyperglycemia being an almost universal feature (94 +/- 7% of all postmeal values). The CGMS correlated well with SMBG without significant clinical discrepancy. The CGMS sensitivity to detect hypoglycemia was 70% with a specificity of 99%; however, the CGMS detected twice as many total episodes as SMBG (82 vs. 40). CONCLUSIONS: Twice-daily insulin injection rarely achieves control in preschool children with type 1 diabetes. The CGMS is well tolerated by patients and has the advantage of revealing daily glucose trends missed by SMBG.

Blood Glucose↗

Efficacy of continuous glucose monitoring system (CGMS) to detect postprandial hyperglycemia and unrecognized hypoglycemia in type 1 diabetic patients.

BACKGROUND: To evaluate the efficacy of continuous glucose monitoring system (CGMS) to detect postprandial hyperglycemia and unrecognized hypoglycemia in type 1 diabetes mellitus (DM1) patients. METHODS: We studied 46 patients (43.4%M/56.6%F), average age of 25.9+/-12.8 years, submitted to 72 h CGMS. It were analyzed: capillary glycemia (CG) and CGMS sensor's value, glycemic excursions, postprandial hyperglycemia, asymptomatic hypoglycemia and therapeutic management after CGMS. Correlation coefficient during hypo and hyperglycemia and sensitivity/specificity were determined. RESULTS: The mean capillary glucose values were 191.8+/-46.2mg/dl versus 190.9+/-42.1mg/dl by CGMS sensor, with no statistical difference by T-test (T=-0.6; p=0.79). The CGMS was significantly more efficient in detection of glycemic excursion than CG (p=0.001). The postprandial hyperglycemia was identified in 76.9% of diabetic patients and asymptomatic hypoglycemia was detected in 58.2% of these patients. The correlation coefficient presented no significance (p=0.16) during hypoglycemia versus during hyperglycemia (p=0.002). The CGMS sensor presented low sensitivity (79.1%) to detect hypoglycemia versus hyperglycemia (96.8%). CONCLUSIONS: The CGMS showed to be a good method to identify postprandial hyperglycemia, to improve therapeutics management and confirmed the low sensitivity of CGMS to detect unrecognized hypoglycemia in DM1 patients.

Adolescent↗

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↗

Continuous glucose monitoring in adolescents with cystic fibrosis.

The presence of cystic fibrosis (CF)-related diabetes was evaluated in 19 adolescents with CF by continuous glucose monitoring system (CGMS) and oral glucose tolerance testing. CGMS confirmed diabetic glucose excursions in 7/19 subjects deemed diabetic on oral glucose tolerance testing. CGMS is a useful tool for detecting hyperglycemia in CF.

Adolescent↗

Continuous glucose monitoring in children with type 1 diabetes: before and after insulin pump therapy.

OBJECTIVE: The aim of continuous subcutaneous insulin infusion (CSII) therapy in patients with type 1 diabetes mellitus (T1DM) is to mimic as closely as possible the normal physiologic pattern seen in individuals without diabetes. This study was undertaken to determine the specific areas of improved glycemic control in subjects after initiation of insulin pump therapy and times where further improvement is needed. RESEARCH DESIGN AND METHODS: Eight patients with T1DM (age 7.5-17 yr) wore the Continuous Glucose Monitoring System (CGMS) (Medtronic MiniMed, Northridge, CA, USA) for 3 d before and 3 months after initiation of insulin pump therapy. The CGMS, which measures inter- stitial glucose concentrations every 5 min for a 72-h period, was used to evaluate glucose profiles. Patients entered 4-5 fingerstick blood glucose measurements daily into the sensor for calibration. Detailed logs of food intake, exercise, and hypoglycemic symptoms were also recorded. RESULTS: Hemoglobin A1c (HbA1C) was reduced (p < 0.007) following 3 months of insulin pump therapy. Post-CSII continuous glucose profiles demonstrated an overall improvement in hourly mean glucose over a 24-h period (p < 0.001) as well as a reduction in the area under the curve for glucose (27 +/- 4 prepump vs. 8.6 +/- 1.4 mg/dL/d postpump, p < 0.004). This improvement was a result of an attenuation of the maximal postprandial glycemic excursions. Postbreakfast 349 +/- 24 vs. 267 +/- 16 mg/dL, p < 0.003; lunch 340 +/- 16 vs. 217 +/- 20 mg/dL, p < 0.003. Postdinner average similarly decreased after 3 months of CSII by 22%, p < 0.04. CONCLUSIONS: Pump therapy specifically improved the postprandial glucose excursions in children.

Adolescent↗

The glucose area under the profiles obtained with continuous glucose monitoring system relationships with HbA(lc) in pediatric type 1 diabetic patients.

OBJECTIVE: The purpose of this study was to determine whether the continuous glucose monitoring system (CGMS) (MiniMed, Sylmar, CA) 1) is sufficiently representative of the overall metabolic control as assessed by HbA(1c), 2) could be used to identify a particular blood glucose threshold value affecting hemoglobin glycation; and 3) is able to show any relationship between particular glycemic profiles and HbA(1c) levels. RESEARCH DESIGN AND METHODS: Of 44 pediatric patients with type 1 diabetes who wore CGMS devices, 28 subjects were selected for the study. Criteria for inclusion were high levels of HbA(1c) (> or =8%) for more than 1 year or a history of frequent hypoglycemic episodes and a complete CGMS registration for 72 h. Age of the subjects ranged from 5.7 to 24.8 years, the mean duration of disease was 7.63 +/- 4.75 years, and the mean HbA(1c) value was 8.7 +/- 1.3%. CGMS data were downloaded and glucose profiles were analyzed. The area under each glucose profile was calculated by means of a professional digital planimeter. RESULTS: The glucose profiles showed a high frequency of prolonged hyperglycemic periods (80% of subjects) and a low frequency of postmeal glycemic peaks (29% of subjects). Postlunch values were significantly correlated with HbA(1c) levels, but the correlation disappeared when controlling for glucose area values. Glucose area values significantly correlated with HbA(1c) levels both when considered as a whole (40-400 mg/dl; r = 0.53, P = 0.002) and when considered fractioned (40-150, 40-200, 40-250, 40-300 mg/dl), apart from the 40-90 mg/dl partial area. HbA(1c) levels were significantly decreased 3 and 6 months after use of CGMS (P = 0.05 and 0.03, respectively, paired Student's t test). CONCLUSIONS: HbA(1c) levels may be decreased by using the information obtained with the CGMS. Three-day glucose profiles are representative of the overall glucose control, because glucose area values correlate with HbA(1c) levels. The only glucose threshold below which there seems to be no correlation with HbA(1c) is 90 mg/dl. Only glucose area, and not postprandial glucose values, are directly and independently correlated with HbA(1c). Therefore, to improve metabolic control, it is necessary to lower the whole mean 24-h glycemia and not just the postprandial glucose values.

Adolescent↗

Hypoglycemia prevalence in prepubertal children with type 1 diabetes on standard insulin regimen: use of continuous glucose monitoring system.

OBJECTIVE: To determine hypoglycemia prevalence in prepubertal children on thrice (TID) and twice (BID) daily insulin regimens, using the Medtronic Minimed Continuous Glucose Monitoring System. RESEARCH DESIGN AND METHODS: Twenty-eight children aged <12 years (median 9.8, range 6.9-11.8) wore the sensor for three consecutive days and nights. Hypoglycemia was defined as glucose <60 mg/dl for >15 min. Data are expressed as the percentage of time period spent hypoglycemic. RESULTS: Hypoglycemia prevalence was 10.1% (mean 2.6 h. subject(-1) x day(-1)). Hypoglycemia was more common at night compared with daytime (18.81 vs. 4.4%, P < 0.001); 78 and 43% of subjects showed hypoglycemia on at least one night and two or more nights, respectively. Nocturnal episodes were prolonged (median 3.3 h) and asymptomatic (91% of episodes). Prevalence was greater between 0400 and 0730 h than between 2200 and 0400 h (25.5 vs. 15.4%, P < 0.001). On a TID compared with a BID regimen, nocturnal hypoglycemia prevalence was reduced, particularly between 0400-0730 h (22.9 vs. 27.4%, P = 0.005), whereas hypoglycemia the following morning (0730-1200 h) was greater (7.8 vs. 2.8%, P < 0.001). Nocturnal hypoglycemia risk was associated with decreasing age (by a factor of 0.6 for a year less in age), increased insulin dose (by 1.6 for an increase of 0.1 units. kg(-1) x day(-1)), insulin regimen (by 0.2 on a BID compared with a TID regimen), and increased weight standard deviation score (SDS) (by 2.7 for a one SDS rise). CONCLUSIONS: Use of standard insulin regimens results in high prevalence and large intraindividual variation in hypoglycemia, particularly at night. Independent risk factors for nocturnal hypoglycemia were younger age, greater daily insulin dose, insulin regimen, and increasing weight.

Blood Glucose Self-Monitoring↗

The beneficial effect of a diet with low glycaemic index on 24 h glucose profiles in healthy young people as assessed by continuous glucose monitoring.

Elevated postprandial glycaemia has been linked to CVD in a number of different epidemiological studies involving predominantly non-diabetic volunteers. The MiniMed continuous glucose monitor, which measures blood glucose every 5 min, over a 24 h period, was used to investigate changes in blood glucose readings before and after instigating a diet with low glycaemic index (GI) for 1 week in free-living healthy individuals. Nine healthy people (age 27 (SEM 1.3) years, BMI 23.7 (SEM 0.7) kg/m2, one male, eight females) completed the study. A reduction in GI (59.7 (SEM 2) v. 52.1 (SEM 2), P<0.01) occurred in all nine subjects while energy and other macronutrients remained constant. A significant reduction was also observed in fasting glucose at 06.00 hours (5.4 (SEM 0.2) v. 4.4 (SEM 0.3) mmol/l, P<0.001), mean glucose (5.6 (SEM 0.2) v. 5.1 (SEM 0.2) mmol/l, P=0.004), area under the 24 h glucose curve (8102 (SEM 243) v. 750 (SEM 235) mmol/l per min, P=0.004) and area under the overnight, 8 h glucose curve (2677 (SEM 92) v. 2223 (SEM 121) mmol/l per min, P=0.01). The present study provides important data on how a simple adjustment to the diet can improve glucose profiles that, if sustained in the long term, would be predicted from epidemiological studies to have a favourable influence on CVD.

Adult↗

Issues for the coming age of continuous glucose monitoring.

PURPOSE: This article reports the results of a symposium in which diabetes educators considered and discussed issues that are likely to arise when continuous glucose monitoring (CGM) becomes available and readily accessible. METHODS: Fifteen certified diabetes educators and 5 others with complementary expertise participated in a discussion based on their responses to 11 questions designed to elicit perspectives on issues related to CGM. Issues for discussion and debate include those related to patient acceptance and lifestyle, implications for professional practice and reimbursement, concerns about professional liability, use of CGM data by insurers and payers, and CGM data transfer. RESULTS: Educators offered varied and sometimes conflicting responses to CGM-related issues. CONCLUSIONS: Awareness of CGM-related issues will likely become an important part of diabetes professional development and perspectives in practice. Identifying and framing the issues before the new technologies become available allow diabetes educators to participate proactively in structuring the emerging policies, procedures, and standards of care.

Attitude of Health Personnel↗

Accuracy of the continuous glucose monitoring system in inpatient and outpatient conditions.

OBJECTIVE: To evaluate in inpatient and outpatient conditions, using only non-calibration data, the accuracy of the Continuous Glucose Monitoring System (CG-MS). RESEARCH DESIGN AND METHODS: Twelve, 21 and 20 type 1 diabetic patients participated in 3- day inhospital, 6-day ambulatory (i.e., 2 sensors worn consecutively) and 3-day ambulatory studies. Capillary glucose tests (7-8/day) served as comparisons. Pairs of data (excluding the 4 daily pairs used automatically by the CGMS for calibrations) were analyzed using correlation coefficient, error -grid analysis, and mean of absolute differences. RESULTS: Two third and half of the sensing days were qualified as "optimal", i.e., interpretable by the CGMS program in the inpatient and outpatient studies, respectively. Correlation coefficient was 0.92, 0.81 and 0.73 in the inpatient, 6 day outpatient and 3-day outpatient studies. 98%, 93% and 96% of the data fell in the A or B error-grid "clinically acceptable" zones. Mean absolute differences between sensor and glucometer values were 25 +/- 2, 34 +/- 5 and 32 +/- 5 mg/dl. CONCLUSION: CGMS may be used for assessment of glycemic trends, though accuracy is more in the range of glucometers than of laboratory tests. Inhospital utilisation improved accuracy and 6-day rather than 3-day sessions may be more appropriate to evaluate day to day reproducibility of glucose profile.

Automation↗

Components of an integrated microfluidic device for continuous glucose monitoring with responsive insulin delivery.

Miniaturized medical diagnostic and treatment devices are currently being developed. Microneedles and miniaturized microdialysis systems are particularly well suited to impact diabetes treatment for continuous glucose monitoring and feedback-controlled insulin delivery. Microneedles are an attractive advanced drug delivery system used to mechanically penetrate the skin and inject insulin intradermally where it is rapidly absorbed by the capillary bed into the bloodstream. The real advantage of microneedle-enhanced drug delivery lies in the fact that drug is actively injected into a patient so the dosage may be varied with time to allow complex drug delivery profiles. The delivery is independent of the drug composition and merely relies on the subsequent drug absorption into the bloodstream. A miniaturized microdialysis probe for continuous glucose sensing has also been designed. Microdialysis is based upon controlling the mass transfer rate of glucose diffusing across a semipermeable membrane into a dialysis fluid while excluding larger molecules such as proteins. Polymer microdialysis membranes are integrated with microfluidic systems. Because of the high surface area to fluid volume ratio of miniaturized fluid channels, faster recovery of glucose to increase glucose sensing frequency is expected. This work highlights recent advances made in the design and fabrication of microneedles to make them more biocompatible and more fracture resistant in order to effectively enter the biomedical market. In addition, the design of a miniaturized microdialysis system for increased glucose sampling frequency is presented. The sensing and infusion technologies may be combined into a miniaturized "artificial pancreas" for minimally invasive feedback-controlled insulin delivery.

Blood Glucose↗

Microdialysis-based 48-hour continuous glucose monitoring with GlucoDay: clinical performance and patients' acceptance.

BACKGROUND: This study was designed to assess clinical performance and patients' acceptance of the minimally invasive microdialysis-based continuous glucose monitoring system Gluco- Day() (Menarini Diagnostics, Florence, Italy) with a targeted monitoring time of 48 h. METHODS: An inpatient sample of 28 patients with diabetes was studied. The analysis of clinical performance was performed using mean absolute differences (MAD) (in percent), Pearson correlations, the Bland-Altman analysis, and Clarke Error Grid Analysis (EGA). GlucoDay glucose values were compared with laboratory standard blood glucose measurements (glucohexokinase assay). The patients' acceptance of the monitoring device was assessed via two self-report scales (pain during application and discomfort while wearing device). RESULTS: A mean (+/- SD) monitoring time of 45.7 +/- 3.3 h with a total of 484 paired readings could be achieved. A correlation of r (average) = 0.91 and a MAD of 19.9% indicated satisfactory to good clinical performance. Of the paired readings, 95.5% fell into the acceptable A and B zones of the EGA. Rather wide 95% limits of agreement were revealed in the Bland-Altman analysis. Whereas virtually no pain was experienced during sensor application, discomfort associated with wearing the device was rather high. All of the participants, however, stated that they would wear the device again. CONCLUSIONS: Satisfactory to good performance of the GlucoDay monitor was observed, indicating the device to be suitable for routine clinical use. In particular, however, the discomfort experienced during wearing requires further improvements in its usability.

Adult↗

Assessment of glycemic control after islet transplantation using the continuous glucose monitor in insulin-independent versus insulin-requiring type 1 diabetes subjects.

BACKGROUND: The aim of this study was to assess and compare glycemic control using the continuous glucose monitor (CGMS, Medtronic Minimed, Northridge, CA) in type 1 diabetes mellitus (T1DM) subjects who are insulin-independent versus those who require insulin after islet transplantation alone (ITA). METHODS: Glycemic control was assessed using 72-h CGMS in eight T1DM subjects who were insulin-independent after ITA (ITA-II), eight T1DM subjects who were C-peptide-positive but insulin-requiring after ITA (ITA-IR), and eight non-transplanted (NT) T1DM subjects. RESULTS: Standard deviation of glucose values was not significantly different between ITA-II and ITA-IR subjects (ITA-II, 1.2 +/- 0.1 mM; ITA-IR, 2.0 +/- 0.3 mM; P = 0.072). Both ITA groups were more stable than NT subjects (NT, 3.3 +/- 0.3 mM; P = 0.001 vs. ITA). Mean high glucose values were significantly lower in ITA subjects compared with NT subjects (ITA-II, 10.5 +/- 0.6 mM; ITA-IR, 13.0 +/- 1.0 mM; NT, 16.1 +/- 1.1 mM; P = 0.002). Mean average glucose values were not significantly different among all groups (ITA-I, 6.7 +/- 0.2 mM; ITA-IR, 7.8 +/- 0.3 mM; NT, 7.7 +/- 0.6 mM; P = 0.198). Mean low glucose values were significantly higher in both ITA groups compared with NT subjects (ITA-II, 4.5 +/- 0.2 mM; ITA-IR, 4.3 +/- 0.3 mM; NT, 3.0 +/- 0.2 mM; P = 0.003). Duration of hypoglycemic excursions (<3.0 mM) was markedly reduced in both ITA groups (ITA-II, 0%; ITA-IR, 2.4 +/- 0.2%; NT, 11.8 +/- 4.2%). Glycated hemoglobin was not significantly different between ITA groups (ITA-II, 6.4 +/- 0.2%; ITA-IR, 6.5 +/- 0.3%) and was significantly higher in NT subjects (8.3 +/- 0.2%; P < 0.001 vs. ITA). CONCLUSIONS: CGMS monitoring demonstrates that glycemic lability and hypoglycemia are significantly reduced in C-peptide-positive islet transplant recipients, whether or not supplementary, exogenous insulin is used, compared with non-transplanted T1DM subjects.

Adult↗

The Continuous Glucose Monitoring System (CGMS) in type 1 diabetic children is the way to reduce hypoglycemic risk.

BACKGROUND: Diabetic children treated with intensive insulin therapy are showing a dangerous increase in severe hypoglycemic episodes. The Continuous Glucose Monitoring System (CGMS) allows glycemic profiles to be monitored over a 72-h period. The aim of the present study was to evaluate whether this system is sufficiently sensitive to detect asymptomatic hypoglycemia, and to determine if its periodic application would help to minimize the hypoglycemic risk in children with type 1 diabetes mellitus (T1DM). METHODS: Twenty-seven T1DM children (age range 6-13.1 years) were enrolled in the study. The sensor was inserted subcutaneously in each patient and the standard four or five registrations of capillary glycemia per day were performed. Eighteen patients continued in the study and the glucose sensor was again inserted after a 6-week interval. At the beginning and end of the study, fructosamine, glycosylated hemoglobin (HbA(1c)), median glycemia, number and duration of hypoglycemic events and insulin requirement were evaluated. RESULTS: A significantly higher number of asymptomatic hypoglycemic events was revealed by CGMS in comparison with the standard system (3.6 +/- 2.3 vs 0.7 +/- 0.9; p < 0.0001). In patients who continued in the study, insulin therapy adjustments reduced the incidence of hypoglycemic events (2.5 +/- 1.7 vs 3.9 +/- 2.2; p < 0.05). At the 6-week point, the fructosamine level was reduced (330 +/- 30 vs 349 +/- 24 micro mol/l; p < 0.05). CONCLUSIONS: The CGMS is a useful device not only for detecting unrecognized hypoglycemia, but also for modifying insulin therapy in order to reduce hypoglycemic events. The system appears to be useful in avoiding long exposure to hypoglycemia.

Adolescent↗

Efficacy of continuous glucose monitoring system to detect unrecognized hypoglycemia in children and adolescents with type 1 diabetes.

This retrospective study assessed 17 DM1 pediatric patients (15.76 +/- 4.5 years) submitted to 72 h continuous glucose monitoring system (CGMS) (Medtronic, CA). The aim of this study was to evaluate the accuracy of CGMS in children and adolescents with type 1 diabetes mellitus (DM1) and the efficacy of this method to detect unrecognized hypoglycemia in this population. It were analyzed capillary glycemia (CG) and CGMS sensors value; glycemic excursions; postprandial hyperglycemia; unrecognized hypoglycemia; complications and therapeutic management after CGMS. A1c levels were measured at the start and after 3 months of the study. Correlation coefficient during hypo, hyper, and normoglycemia and sensitivity/specificity was determined. The mean CG values were 213.8 +/- 63.4 mg/dl vs. 209.7 +/- 52.5 mg/dl by sensor, with statistical significance by Pearson's correlation (p < 0.001). There was no difference between CGMS and CG value in order to detect glycemic excursions (p = 0.32). The postprandial hyperglycemia and unrecognized hypoglycemia was detected in 66.7% and 56.2% of this patients, respectively. The correlation coefficient during hypoglycemia presented no statistical significance by Pearson's correlation (p = 0.29) vs. during hyperglycemia (p = 0.001). The CGMS sensor presented low sensitivity (63.3%) to detect hypoglycemia. This data showed important decreased level of A1c in this population 3 months after CGMS with statistical significance (p = 0.03). The CGMS showed to be a very safe method, well tolerated, with high accuracy in glycemic values and low complications rate. This results suggest that CGMS is a good method to identify postprandial hyperglycemia, to improve metabolic changes in therapeutics with significant impact in A1c of diabetic pediatric patients. This data confirmed the low sensitivity of CGMS to detect unrecognized hypoglycemia in pediatric DM1 patients.

Adolescent↗

Frequency and temporal profile of poststroke hyperglycemia using continuous glucose monitoring.

OBJECTIVE: Poststroke hyperglycemia (PSH) is common and has adverse effects on outcome. In this observational study, we aimed to describe the frequency and temporal profile of PSH using a continuous glucose monitoring system (CGMS) in patients with and without diabetes. RESEARCH DESIGN AND METHODS: Fifty-nine patients with acute hemispheric ischemic stroke were prospectively studied with the CGMS, regardless of medication, admission plasma glucose value, and diabetes status. The CGMS records interstitial glucose every 5 min for 72 h. RESULTS: On admission, 36% of patients had preexisting diabetes. At the earliest analyzed time point of 8 h from stroke onset, 50% of nondiabetic subjects and 100% of diabetic patients were hyperglycemic (> or =7 mmol/l). This early-phase hyperglycemia was followed by a decrease in glucose 14-16 h poststroke when only 11% of nondiabetic and 27% of diabetic patients were hyperglycemic. A late hyperglycemic phase 48-88 h poststroke was observed in 27% of nondiabetic and 78% of diabetic patients. Thirty-four percent of nondiabetic and 86% of diabetic patients were hyperglycemic for at least a quarter of the monitoring period. Multivariate regression analysis demonstrated that diabetes, insular cortical ischemia, and increasing age independently predicted higher glucose values. CONCLUSIONS: Poststroke hyperglycemia is common and prolonged despite treatment based on current guidelines. There are early and late hyperglycemic phases in nondiabetic as well as diabetic patients. Treatment protocols with frequent glucose measurement and intensive glucose-lowering therapy for a minimum of 72 h poststroke need to be evaluated.

Aged↗

Reduction of blood glucose variability in type 1 diabetic patients treated by pancreatic islet transplantation: interest of continuous glucose monitoring.

OBJECTIVE: To compare the glycemic profiles of patients with type 1 diabetes treated with either an implantable insulin pump or pancreas or islet transplantation by the means of the continuous glucose monitoring system (CGMS; Minimed, Sylmar, CA). RESEARCH DESIGN AND METHODS: The CGMS enabled recording of subcutaneous glucose concentrations (range 2.2-22 mmol/l) over 72 h (288 measurements per day). Over 3 days, 26 patients with type 1 diabetes were connected to a CGMS: 10 patients were treated with intraperitoneal insulin infusion through an implantable pump (IPII), 9 patients were treated with simultaneous pancreas-kidney transplantation (SPK), and 7 patients were treated with pancreatic islet transplantation after kidney grafting (IAK). All SPK patients and four IAK patients were insulin independent, whereas three IAK patients had partial graft function and reduced exogenous insulin needs. Glucose control was evaluated by the mean glucose concentration, glucose variability, and the number and duration of hypoglycemic events (<3.3 mmol/l) over 3 days. RESULTS: The mean glucose concentration and the glucose variability in SPK and IAK patients were significantly lower than those observed in patients treated with IPII: 5.38 +/- 1.12 and 5.83 +/- 0.81 vs. 7.81 +/- 1.55 mmol/l (P < 0.001) and 1.40 +/- 0.42 and 1.32 +/- 0.53 vs. 3.47 +/- 1.66 mmol/l (P < 0.001), respectively. Furthermore, the mean glucose concentration and the glucose variability were comparable between SPK and IAK patients. Over 3 days, no hypoglycemic events were observed in SPK patients and insulin-independent IAK patients. A total of 4.12 +/- 1.66 hypoglycemic events were detected in the IPII patient group, whereas only 0.66 +/- 0.57 events were observed in IAK patients with partial graft function (P < 0.001). The duration of the hypoglycemic events was significantly longer in IPII patients as compared with IAK patients: 64 +/- 33 vs. 30 +/- 15 min for the day period and 130 +/- 62 vs. 30 +/- 27 min for the night period (P < 0.001). CONCLUSIONS: Use of subcutaneous CGMS confirms that islet transplantation can be as efficient as pancreas transplantation in restoring good metabolic control and reducing blood glucose variability. Metabolic improvement due to use of an implantable insulin pump requires insulin delivery by a closed loop.

Adult↗