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Results for “continuous glucose monitoring”

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At least 217 records · Page 12Linked to original sources

PubMed2001

A novel method for continuous online glucose monitoring in humans: the comparative microdialysis technique.

The aim of this study was to prove the feasibility of continuous subcutaneous glucose monitoring in humans using the comparative microdialysis technique (CMT). The performance of the CMT was determined by comparing tissue glucose values with venous or capillary blood glucose values in healthy volunteers and type 1 diabetic subjects. The CMT is a microdialysis-based system for continuous online glucose monitoring in humans. This technique does not require calibration by the patient. Physiological saline with glucose (5.5 mM) is pumped in a stop-flow mode through a microdialysis probe inserted into the abdominal s.c. tissue. Tissue glucose concentration is calculated by comparing the dialysate and perfusate glucose concentrations. The time delay due to the measurement process is 9 min. We tested the CMT on six healthy volunteers and six type 1 diabetic patients for 24 h in our clinical setting. Comparisons were made to HemoCue analyzer (Angelholm, Sweden) capillary blood glucose measurements (healthy volunteers) and to venous blood glucose concentration determined with a Hitachi analyzer (diabetic patients). The mean absolute relative error of the CMT glucose values from the blood glucose values was 17.8+/-15.5% (n = 167) for the healthy volunteers and 11.0+/-10.8% (n = 425) for the diabetic patients. The mean difference was 0.42+/-1.06 mM (healthy volunteers) and -0.17+/-1.22 mM (diabetic patients). Error grid analysis for the values obtained in diabetic patients demonstrated that 99% of CMT glucose values were within clinically acceptable regions (regions A and B of the Clarke Error Grid). The study results show that the CMT is an accurate technique for continuous online glucose monitoring.

Adult↗

PubMed1998

Wearable microdialysis system for continuous in vivo monitoring of glucose.

We developed a new system to monitor glucose continuously in vivo. The miniaturised system is very easy to handle and was optimised to a resource-saving working modus. Sampling was performed by means of a biocompatible microdialysis needle probe inserted into the subcutaneous tissue. During glucose tolerance tests the results of our monitoring system were correlated with the glucose level of the venous blood stream. A comparison according to the procedure known as 'error grid analysis' provided an excellent correlation between the two completely independent analyses systems with the reference determination results. All values obtained with our systems were clinically correct or at least clinically acceptable.

Blood Glucose Self-Monitoring↗

PubMed2006

Continuous glucose monitoring-guided insulin adjustment in children and adolescents on near-physiological insulin regimens: a randomized controlled trial.

OBJECTIVE: This randomized controlled trial assesses the effect on glycemic control of continuous glucose monitoring system (CGMS)-guided insulin therapy adjustment in young people with type 1 diabetes on intensive diabetes treatment regimens with continuous subcutaneous insulin infusion (CSII) or glargine. RESEARCH DESIGN AND METHODS: Pediatric subjects were recruited if they had an HbA(1c) (A1C) <10% and had been on CSII or glargine for at least 3 months. Thirty-six subjects were randomized to insulin adjustment on the basis of 72 h of CGMS every 3 weeks or intermittent self-monitoring of blood glucose (SMBG) for 3 months. A1C and fructosamine were measured at baseline and 6 and 12 weeks. Follow-up A1C was measured at 6 months. Mean baseline A1C was 8.2% (n = 19) in the CGMS group and 7.9% (n = 17) in the control group. RESULTS: There was a significant improvement in A1C from baseline values in both groups, but there was no difference in the degree of improvement in A1C at 12 weeks between the CGMS (-0.4% [95% CI -0.7 to -0.1]) and the control group (-0.4% [-0.8 to 0.2]). In the CGMS group, improved A1C was at the cost of increased duration of hypoglycemia. CONCLUSIONS: CGMS is no more useful than intermittent fingerstick SMBG and frequent review in improving diabetes control in reasonably well-controlled patients on near-physiological insulin regimens when used in an outpatient clinic setting.

Adolescent↗

PubMed2006

Accuracy of continuous subcutaneous glucose monitoring with the GlucoDay in type 1 diabetic patients treated by subcutaneous insulin infusion during exercise of low versus high intensity.

AIM: The GlucoDay allows continuous glucose monitoring by subcutaneous microdialysis in sedentary conditions. To validate it when glycaemia may undergo rapid and dramatic changes, we investigated its accuracy during two exercise sessions with markedly different glucose disposal rates. METHODS: Nine male diabetic patients, aged 32-61, treated by insulin pumps, first underwent a standard maximal exercise-test designed for determining the maximal oxygen consumption and the first ventilatory threshold (Vt1). Then two 30 min steady-state workloads at 15% below and 15% above the Vt1 were performed in random order with the GlucoDay, and measurement of CHO oxidation rates was made by indirect calorimetry. RESULTS: CHO oxidation during exercise at +15% Vt1 was higher (+943.5 mg/min, ie +45.5%, P<0.01) than during exercise at -15% Vt1 No hypoglycaemia occurred. Due to breakages of 39% of subcutaneous probes, eleven steady-state sessions in 7 subjects allowed to compare 141 paired glucose (sensor vs. venous) determinations. The Clarke error grid situates 92.9% of glucose values within the A zone and 6.4% within the B zone, while only one pair of values (0.7%) falls in the D zone. Venous glucose tended to decrease more rapidly than sensor glucose during exercise. Bland-Altman plots evidence for a few cases of underestimation of venous glucose at high intensity. CONCLUSIONS: This study showed satisfactory accuracy of the GlucoDay during exercise. A slight lag time in sensor values likely explains a few discrepancies that do not appear as clinically meaningful. Reduction of probe fragility and confirmed sensor accuracy in hypoglycaemia would further support applicability of GlucoDay at exercise.

Adult↗

PubMed2006

Results of a randomised controlled cross-over trial on the effect of continuous subcutaneous glucose monitoring (CGMS) on glycaemic control in children and adolescents with type 1 diabetes.

OBJECTIVE: To study the feasibility and the influence on glycaemic control of continuous glucose monitoring (CGMS) in young patients with type 1 diabetes. DESIGN AND METHODS: A double-blinded, cross-over study was performed in 30 children (median age 11.1 years [range: 2.3 - 16.3], diabetes duration 2.1 years [0.2 - 7.1]). Patients were randomised into an open (A) or blind study arm (B). Both groups performed standardised self-monitoring blood glucose (SMBG) and received CGMS at the beginning of the study, at 3 and 6 months, each. In the blinded arm, patients and investigator were concealed from CGMS data. After 3 months, open and blinded study arms crossed over. Average glucose values and area under the glucose curve (AUC) per 24 h, above 180 and below 60 mg/dl were calculated from CGMS. Haemoglobin A1c (HbA1c) was measured at each study point. RESULTS: Despite comparable clinical characteristics between the 15 patients of each arm, mean HbA1c was slightly lower in arm A than in B at baseline (7.8 +/- 1.2 % vs. 8.4 +/- 1.1 %, p = 0.148), at 3 months (7.8 +/- 1.1 % vs. 8.3 +/- 1.1 %, p = 0.233), and significantly lower at 6 months (7.6 +/- 1.1 % vs. 8.5 +/- 0.9 %, p = 0.026). However, no significant change of HbA1c occurred within each arm (A, p = 0.183 and B, p = 0.823), irrespectively whether CGMS data were blinded or not. Likewise, mean glucose and hyper- or hypoglycaemia values did not change significantly. CONCLUSIONS: In this setting, CGMS did not decisively influence glycaemic control of a total study cohort. More frequent use of CGMS at shorter intervals in single patients with hyper- or hypoglycaemic problems may be of greater value than SMBG.

Adolescent↗

PubMed2005

Interstitial glucose level is a significant predictor of energy intake in free-living women with healthy body weight.

The relative contribution of circulating glucose to meal-to-meal variability in energy intake is not known. In 8 free-living young (median age 26.5 y) women with healthy body weight (median BMI 22.2 kg/m(2)), we measured glucose in the interstitial space by an automated monitoring procedure (continuous glucose monitoring system, CGMS) for up to 3 consecutive days (mean 706 glucose readings per subject). We examined the association between interstitial glucose (which lags blood glucose by approximately 10 min), self-reported hunger, satiety, desire for a meal, and nutrient intakes. Participants reported consuming a typical Western diet (59% carbohydrate, 27% fat, 14% protein). Median (interquartile range) interstitial glucose was 5.2 mmol/L (4.7-5.8). Using repeated-measures techniques in univariate analyses, desire for a meal (r = 0.45, P < 0.0001), hunger (r = 0.37, P = 0.0002), satiety (r = -0.40, P < 0.0001), low interstitial absolute mean glucose up to 25 min before eating (r = -0.23, P = 0.02), and a large decline in glucose between 40 and 5 min before eating (r = -0.17, P = 0.08) were all associated with meal energy intake. In multivariate regression analyses, desire for a meal (P < 0.0001) and hunger (P = 0.02) were the strongest independent contributors to meal energy intake, whereas absolute mean glucose measured in the period 15 to 0 min before eating was marginally significant (P = 0.08). In conclusion, absolute glucose level is a significant predictor of energy intake in nonobese women. However, desire for a meal and hunger are quantitatively more important, emphasizing the importance of both glucose signals and nonglucose (internal or environmental) factors in within-subject variability in energy intake. In addition, the CGMS may have utility in understanding the role of circulating glucose in energy regulation in free-living subjects under a wide range of different nutritional conditions.

Adolescent↗

PubMedDate not supplied

Glucose-monitoring with continuous subcutaneous microdialysis in neonatal diabetes mellitus.

BACKGROUND: Neonatal diabetes mellitus can be extremely brittle. In this situation close glucose monitoring is essential for adequate insulin treatment. Continuous subcutaneous microdialysis is a promising approach for the babies to reduce the painful stress caused by diagnostic blood sampling. The goal of this study was to evaluate the feasibility of continuous subcutaneous microdialysis for glucose monitoring in a baby with neonatal diabetes and to assess the correlation between the blood and the subcutaneous glucose profile. PATIENT AND METHOD: During a period of seven days glucose monitoring was performed on a six month old infant with neonatal diabetes mellitus. In addition to frequent capillary blood glucose determinations, a continuous subcutaneous microdialysis device was used for the detection of the subcutaneous interstitial glucose concentration. RESULTS: Subcutaneous tissue glucose concentrations were measured in a wide range from 1.7 to 23.8 mM. Variations in the adipose tissue glucose concentration closely paralleled changes in the capillary blood glucose. Based on 104 reference pairs there was a high overall correlation (r = 0.89) between the subcutaneous interstitial tissue (X) and the blood (Y) glucose concentration (Y = 1.1 X + 0.29). However the glucose profiles demonstrated a considerable variation of the time lag, up to one hour, between blood and subcutaneous interstitial glucose concentration. CONCLUSIONS: Continuous subcutaneous microdialysis helps the glucose monitoring of infants with diabetes mellitus by providing additional informations about the rise and fall of the glucose concentration. Further studies should focus on how to get a tighter link between blood glucose and the subcutaneous interstitial glucose concentration in the area around the microdialysis probe. Thus monitoring the subcutaneous interstitial glucose concentration will become a reliable procedure for real-time glucose monitoring.

Blood Glucose↗

PubMed2004

The postprandial glucose profile in the diabetic pregnancy.

OBJECTIVE: A controversy exists regarding the time to monitor blood glucose in the diabetic pregnancy (60 or 120 minutes after meals). Using a novel approach that provides continuous measurement of blood glucose, we sought to determine postprandial glucose profile in the diabetic pregnancy. STUDY DESIGN: Subjects were connected to a continuous glucose monitoring system for 72 consecutive hours. A continuous glucose monitoring system measures the interstitial glucose levels in subcutaneous tissue every 5 minutes. Women were instructed to record the time of each meal during the study period. For each meal, the first 240 minutes were analyzed. RESULTS: Sixty-five women participated in the study: 26 women were treated by diet alone; 19 women received insulin therapy, and 20 women had type 1 diabetes mellitus. The time interval from meal to peak postprandial glucose levels was similar in all the evaluated types of diabetic pregnancies and in good and poor control insulin-treated patients with gestational diabetes mellitus (approximately 90 minutes). Failure to return to preprandial glucose values within a 3-hour observation period was identified in approximately 50% of the patients. A similar postprandial glucose peak time was obtained for breakfast, lunch, and dinner in all study groups. Postprandial hypoglycemia events were noted in approximately 10% of the meals and occurred about 160 minutes after mealtime. CONCLUSION: The time interval for postprandial glucose peak in diabetic pregnancies is approximately 90 minutes after meals throughout the day and is not affected by the level of glycemic control. This information should be considered in the treatment of diabetes mellitus in pregnancy.

Adult↗

PubMed1999

Subcutaneous glucose predicts plasma glucose independent of insulin: implications for continuous monitoring.

The present study investigated the relationship between blood and subcutaneous interstitial fluid (ISF) glucose by employing an amperometric glucose sensor specifically developed for 3-day continuous glucose monitoring. The apparent sensor sensitivity and ISF glucose equilibration delay were estimated on separate days during hyperglycemic clamps in four dogs in which insulin was either suppressed with somatostatin, allowed to change, or increased with an exogenous infusion. A 2-h sensor "settling-in" period was allowed before the clamps. During insulin deficiency, the sensor sensitivity and ISF glucose delay were 0.23 +/- 0.03 nA per mg/dl and 4.4 +/- 0. 8 min. Sensitivity was not affected by increases in endogenous (0.30 +/- 0.04 vs. 0.28 +/- 0.04 nA per mg/dl) or exogenous insulin (0.18 +/- 0.01 vs. 0.16 +/- 0.01 nA per mg/dl) nor was the delay (3.3 +/- 1.2 vs. 5.7 +/- 1.1 and 9.2 +/- 2.6 vs. 12.3 +/- 1.7 min; P > 0.05 for all). Sensor glucose accurately predicted plasma glucose without correcting for delays <10 min (r > 0.9 for all), whereas for longer delays a digital corrective filter was used (r = 0.91 with filter). We conclude that the relationship between blood and ISF glucose is not affected by insulin and that delays in ISF glucose equilibration can be corrected with digital filters.

Animals↗

PubMed1992

Microdialysis measurement of the absolute glucose concentration in subcutaneous adipose tissue allowing glucose monitoring in diabetic patients.

The possibility of continuously monitoring the absolute glucose concentration in subcutaneous adipose tissue, using microdialysis of the extracellular water space, was investigated in six Type 1 (insulin-dependent) diabetic patients. By using a large microdialysis probe (30 x 0.62 mm), and by perfusing with a low flow rate (0.5 microliters/min), complete recovery of glucose was attained in vitro. In the patients the dialysis probe was implanted subcutaneously, perfused by a wearable microinfusion pump, and dialysate samples were collected in 60-min fractions over 10 h. The absolute glucose concentration in the tissue dialysate was the same or almost the same as the blood glucose concentration (range 87-101% of the blood glucose value). The changes in blood glucose were closely paralleled by the variations in adipose tissue glucose (r = 0.93, p < 0.01), and the recovery of glucose in the microdialysate remained constant during the 10-h study period. In conclusion, it is possible, using microdialysis, to directly determine the absolute glucose concentration in subcutaneous adipose tissue. Hence, this technique may be used for continuous glucose monitoring in diabetic patients.

Adipose Tissue↗

PubMedDate not supplied

Making 'sense' of diabetes: using a continuous glucose sensor in clinical practice.

Home blood glucose monitoring provides only a snapshot picture of prevailing glucose values. Continuous glucose monitoring allows identification of patterns of glucose levels for up to 72 h with details of excursions above and below target levels and thus may be a valuable adjunct tool in diabetes management. We have used the MiniMed Continuous Glucose Monitoring System (CGMS) in ten individuals and have uncovered a significant rate of hypoglycaemia that was previously undetected by conventional means. Preliminary evidence suggests that the novel technology may allow clinicians to 'personalise' intensive insulin therapy with improvement in glycaemic control.

Adult↗

PubMedDate not supplied

Human (recombinant DNA) and porcine NPH insulins are unequally effective in diabetic patients. A comparative study using continuous blood glucose monitoring.

The hypoglycemic activities of NPH biosynthetic human and pork insulins were compared in eight insulin-dependent diabetic patients using continuous blood glucose monitoring. After an overnight normalization of blood glucose levels, either human or pork NPH were injected subcutaneously in random order. Blood glucose was continuously recorded during 9.5 h while patients were consuming their usual diet. After NPH biosynthetic human insulin, blood glucose levels from the 2nd to the 9th h post-injection were lower as well as the glycemic nadir. The area under the curve was smaller after human than after pork insulin. But, in the last half-hour of the experiment, blood glucose was falling after pork insulin, while it was rising after human insulin. Under the conditions of this study, our results demonstrate that NPH biosynthetic human insulin may be more effective than NPH pork insulin, due to more rapid subcutaneous absorption but its duration is shorter than after porcine NPH insulin. These data may be of importance in the treatment of insulin-dependent diabetes mellitus.

Adolescent↗

PubMed2005

[The RECORD project. continuous blood glucose monitoring among high risk subjects for developing diabetes in Spanish primary health care].

OBJECTIVE: To evaluate the accuracy of continuous blood glucose monitoring (CBGM) in order to asses diagnostic procedures and predict glycaemic status in type 2 prediabetes. DESIGN: Observational, multicenter, cross-sectional (phase 1) plus longitudinal, cohort follow-up study (phase 2). SETTING: Five primary health-care centers. INTERVENTIONS: A total of 84 high-risk subjects will be included after a non-diabetic oral glucose tolerance test (OGTT). A first CBGM using a subcutaneous microdialysis glucose sensor technique in order to obtain a continuous profile will be carried out. Two different cohorts, subjects with normal OGTT (n = 42) and individuals with prediabetic hyperglycemia (n = 42) will be established. Diagnoses will be revised at 12 and 24 month follow-up by means of an OGTT together with a new monitoring. MAIN MEASUREMENT: Demographical, clinical (including metabolic syndrome items), basic, and advanced analyses (inflammation emergent markers, insulinemia, C-peptide). CBGM computerized analysis comparing fasting, preprandial, postprandial, nocturnal period, and area under the curve of continuous profile with regular diagnoses, taking into account temporary concordance. Relationship of CBGM parameters with normal glucose tolerance or diabetes incidence. Evaluation of day-to-day quality of life of CBGM users by means of an standardized Likert questionnaire. DISCUSSION: This study seeks to demonstrate the effectiveness and feasibility of CBGM, more physiological than OGTT and based on an underestimated random blood glucose diagnostic criterion. This innovative system may provide interesting scientific data in the field of type 2 prediabetes.

Blood Glucose↗

PubMedDate not supplied

Incidence of hypoglycemic episodes in diabetic patients under continuous subcutaneous insulin infusion and intensified conventional insulin treatment: assessment by means of semiambulatory 24-hour continuous blood glucose monitoring.

The incidence and magnitude of hypoglycemia (i.e., blood glucose values less than 50 mg/dl) were assessed by continuous blood glucose monitoring over 24 h in 10 insulin-dependent diabetic (IDD) patients treated with continuous subcutaneous insulin infusion (CSII) and 9 IDD patients under intensified conventional treatment (ICT). A newly developed, battery-powered blood glucose monitor was employed. Patients were thus enabled to move freely in the hospital premises. Despite similar quality of previous blood glucose control (HbA1: 8.0 +/- 0.05% CSII versus 8.0 +/- 0.3% ICT, mean +/- SEM), the obtained profiles showed better regulation under CSII treatment (mean blood glucose [MBG], 99.6 +/- 10.0 versus 133.1 +/- 7.4 mg/dl; M-value, 12.3 +/- 3.5 versus 26.2 +/- 4.1; mean amplitude of glycemic excursion [MAGE], 71.9 +/- 8.7 versus 132.9 +/- 14.2 mg/dl; CSII versus ICT, mean +/- SEM). The incidence of blood glucose values less than 50 mg/dl was 9/10 patients (CSII) and 5/9 patients (ICT). In both groups, hypoglycemia was most frequent at noon and was related to elevated pre- and postprandial free insulin levels. Patients became aware of hypoglycemia only in 6/23 episodes (CSII) and 6/8 episodes (ICT). Our data indicate that CSII as well as ICT may result in postprandial hyperinsulinemia leading to frequent hypoglycemic episodes of variable length, reassessing the traditional experience of close correlation between aggressive insulin therapy and enhanced hypoglycemic risk.

Adolescent↗

PubMed2006

The relationship between 24-hour integrated glucose concentrations and % glycohemoglobin.

OBJECTIVE: Since glycohemoglobin values are widely used clinically as a surrogate for average glucose concentration over an extended period of time, we decided to determine the actual relationship between 24-hour integrated glucose values and percent total glycohemoglobin (%tGHb) in cohorts of people with and without diabetes. RESEARCH DESIGN AND METHODS: In 48 people without known diabetes with known stability of fasting glucose over a 1-year period of time, the calculated 24-hour integrated glucose concentration was compared with their %tGHb. In 15 normal young medical students, the glucose area response was determined from 46 venous blood samples obtained during a 24-hour period and compared with their %tGHb. In 18 people with type 2 diabetes, interstitial glucose concentrations were monitored using the Continuous Glucose Monitoring System (Medtronic MiniMed, Inc., Sylmar, Calif) for 3 days at 20-day intervals over 100 days. %tGHb was performed at 20-day intervals simultaneously. In 29 people with untreated type 2 diabetes, glucose area response was determined from 46 venous blood samples obtained during a 24-hour period and compared with their %tGHb after being on a standardized diet provided to the subjects for at least 5 weeks. The %tGHb and 24-hour profiles were stable. RESULTS: There was an excellent correlation between the mean 24-hour glucose concentration and the %tGHb among subjects with diabetes. The correlation was poor among subjects without diabetes. The relationship was curvilinear when plotted as a single group. Alternatively when data from subjects with or without diabetes were plotted separately, the slopes were identical but the y-intercepts were different. CONCLUSION: The relationship between the mean glucose concentration integrated over an extended period of time and the %tGHb is not linear. The reason for this nonlinearity remains to be determined. This non-linearity needs to be considered in the clinical interpretation of %tGHb (and probably HbA(1c)) in reference to glucose values.

Adult↗

PubMed2006

A novel wireless glucose sensor employing direct electron transfer principle based enzyme fuel cell.

In this paper we present a novel wireless glucose biosensing system employing direct electron transfer principle based enzyme fuel cell. Using the glucose dehydrogenase complex, which is composed of a catalytic subunit containing FAD, the cytochrome c subunit that harbors heme c as the electron transfer subunit, and chaperone-like subunit, a direct electron transfer-type glucose enzyme fuel cell was constructed. The enzyme glucose fuel cell generated electric power, and the open-circuit voltage showed glucose concentration dependence, which suggests potential applications for this glucose-sensing system. We constructed a miniaturized "all-in-one" glucose enzyme fuel cell, which represents a compartmentless fuel that is based on the direct electron transfer principle. This involved the combination of a wireless transmitter system and a simple and miniaturized continuous glucose monitoring system, which operated continuously for about 3 days with stable response. This is the first demonstration of an enzyme-based direct electron transfer-type enzyme fuel cell and fuel cell-type glucose sensor which can be utilized as a subcutaneously implantable system for continuous glucose monitoring.

Animals↗

PubMed2002

Spurious reporting of nocturnal hypoglycemia by CGMS in patients with tightly controlled type 1 diabetes.

OBJECTIVE: The Medtronic MiniMed Continuous Glucose Monitoring System (CGMS) is designed to continuously monitor interstitial fluid glucose levels within a range of 40-400 mg/dl. It is considered an important tool for overnight glucose monitoring. The goal of this study was to determine the accuracy of this system in individuals with tightly controlled diabetes. RESEARCH DESIGN AND METHODS: Seven adolescents and young adults with HbA(1c) levels 6.6 +/- 0.6% (range 5.7-7.1) were admitted to the Clinical Research Center. Simultaneous glucose measurements obtained by glucose analyzer, Accu-Check Advantage meter, and CGMS were compared. The analyzer levels were considered the standard. RESULTS: The CGMS results were lower than analyzer readings in 74% of simultaneous pairs of tests performed during the 24-h period; the average correlation was 0.76. There was a trend for the poorest correlation to occur in patients with the narrowest range in daily glucose levels. When the lowest CGMS reading of the night was compared with the simultaneous analyzer reading, the CGMS level was lower in all cases by an average of 38 +/- 15%. In six of seven patients, the discrepancy was believed to be clinically significant; in at least four patients, overnight glucose levels reported by CGMS were falsely low, in a range that might have resulted in inappropriate reduction of overnight insulin dose. CONCLUSIONS: CGMS reports of asymptomatic nighttime hypoglycemia may be spurious and should be interpreted with caution in patients with tightly controlled diabetes.

Adolescent↗

PubMed2006

Continuous subcutaneous glucose monitoring in children with type 1 diabetes mellitus: a single-blind, randomized, controlled trial.

BACKGROUND: Tight glycemic control delays the long-term complications of type 1 diabetes mellitus (T1DM) but increases the risk for hypoglycemia. The continuous glucose-monitoring system (CGMS) provides blood glucose (BG) readings every 5 min, and its accuracy and reliability has been established in adults. However, there are limited data on its efficacy and safety in children. The purpose of this study was to determine if CGMS use improves metabolic control in children with T1DM. METHODS: Twenty-seven children (12 male) with T1DM participated in this single-blind, randomized, controlled trial. Participants (age: 11.4 +/- 3.7 (mean +/- SD) yr, range: 7-17 yr) were randomized to an intervention group (n = 18) or a control group (n = 9). Both groups wore the CGMS for 72-h periods at 0, 2, and 4 months. Adjustments in therapy for the intervention group were based on both CGMS and self-monitoring of BG (SMBG) data, while only SMBG data were used for the control group. Hemoglobin A1c (HbA1c) was determined at 0, 2, 4, and 6 months. The change in HbA1c from 0 to 6 months (HbA1c(Delta1-4)) and mean daily area under the CGMS curve for glucose <70 mg/dL area under the curve (AUC(<70)) were compared between groups. RESULTS: At study entry, HbA1c levels were similar in the intervention and control groups (8.4 +/- 0.98 and 8.8 +/- 0.86%, respectively; p = 0.12) but were significantly lower in the intervention group compared with the control group at study completion (7.8 +/- 0.88 and 8.6 +/- 0.95%, respectively; p = 0.02). The decrease in HbA1c of 0.61 +/- 0.68% in the intervention group was statistically significant (p = 0.03), whereas the decrease in HbA1c of 0.28 +/- 0.78% in the control group was not. Nonetheless, the differences in HbA1c(Delta1-4) between groups did not reach statistical significance (p = 0.13). There was no statistically significant difference in AUC(<70) between study groups (p = 0.18). CONCLUSION: CGMS use may improve metabolic control in children with T1DM without increasing the risk for hypoglycemia.

Adolescent↗