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Results for “continuous glucose monitoring”

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At least 325 records · Page 18Linked to original sources

PubMed2005

A two-center randomized controlled feasibility trial of insulin pump therapy in young children with diabetes.

OBJECTIVE: Our goals were to determine if continuous subcutaneous insulin infusion (CSII), compared with those continuing multiple daily injections (MDIs), can be safely used in young children, if those on CSII will have superior glycemic control, if subjects using CSII will have less hypoglycemia for their level of control, and if families using CSII will report an improved quality of life. RESEARCH DESIGN AND METHODS: We conducted a randomized 1-year feasibility trial comparing CSII with continuing MDIs in preschool children with a history of type 1 diabetes for at least 6 months' duration. Prospective outcomes included measures of overall glycemic control (HbA1c and continuous glucose monitoring system), the incidence of severe hypoglycemia and diabetic ketoacidosis, the percent of glucose values below 3.9 mmol/l, and the parents' report of quality of life. RESULTS: The 19 subjects' ages ranged from 1.7 to 6.1 (mean 3.6) years, duration of diabetes ranged from 0.6 to 2.6 (mean 1.4) years, and baseline HbA1c ranged from 6.7 to 9.6% (mean 7.9%). Seven subjects were male. Nine subjects were randomized to start CSII and 10 to continue on MDI. All baseline characteristics were well balanced. Overall metabolic control, diabetes quality of life, and the incidence of hypoglycemia were similar in the two groups. No subject had diabetic ketoacidosis, while one subject in each group had an episode of severe hypoglycemia. No CSII subject discontinued using the pump during or after the study. CONCLUSIONS: CSII can be a safe and effective method to deliver insulin in young children.

Blood Glucose↗

PubMed2006

Continuous glucose detection using boronic acid-substituted viologens in fluorescent hydrogels: linker effects and extension to fiber optics.

A fluorescent anionic dye and a viologen appended with boronic acids, which serve as glucose receptors, have been synthesized and immobilized into a poly(2-hydroxyethyl methacrylate) hydrogel for use as a continuous glucose monitor. The fluorescence of the dye is modulated by the quenching efficiency of the viologen-based receptor, which in turn is dependent on the glucose concentration. Two monomeric versions of the quencher/receptor unit were prepared and their performance within the hydrogel evaluated. By tethering the quencher/receptor to the hydrogel matrix using a single-point attachment, slightly improved glucose sensing was observed. The hydrogels were tested for their ability to continuously and reversibly detect glucose over the course of several hours. The tests were carried out using a cuvette-based system, as well as a fiber-optic-based configuration. Under physiological conditions (0.1 M phosphate buffer, pH 7.4, 37 degrees C), the fluorescent hydrogels display an excellent dynamic response to glucose concentrations within the biologically significant range (2.5-20 mM).

Biosensing Techniques↗

PubMed2004

Conventional measures underestimate glycaemia in cystic fibrosis patients.

AIMS: Diabetes mellitus is an increasingly important complication of cystic fibrosis (CF). The association with increased morbidity of cystic fibrosis-related diabetes (CFRD) has emphasized the need for accurate monitoring of glycaemia in all CF patients. The diagnosis has relied on conventional thresholds in an oral glucose tolerance test (OGTT) derived from epidemiological studies in non-CF subjects. However, it has not been established if these values are equivalent in CF and non-CF populations. METHODS: We compared glycaemia in 21 non-diabetic CF subjects with 21-age and BMI-matched non-CF controls using HbA(1c), OGTT and a subcutaneous continuous glucose monitoring system (CGMS) that measures interstitial glucose levels. RESULTS: All conventional measures of glycaemia were similar in the two groups: HbA(1c) mean CF vs. controls (5.5 vs. 5.3%P = 0.4), fasting glucose (4.8 vs. 4.7 mmol/l P = 0.7) and 2-h glucose (5.8 vs. 5.7 mmol/l P = 0.8). However, these conventional measures did not accurately reflect glycaemia 30-, 60- and 90-min. Glucose values and area under the curve in OGTT were all higher in CF subjects than controls (P = 0.01-0.0001). Mean CGMS value [5.9 (0.8) vs. 5.1 (0.5) mmol/l, P = 0.004], and the proportion of subjects with peak CGMS values > 11.1 mmol/l (33 vs. 5%P = 0.00001) were also higher in CF subjects than controls. These results remained significantly different when only subjects with normal glucose tolerance in the two groups were studied. CONCLUSIONS: We have shown that overall glycaemia, as shown by both the response during an OGTT and CGMS, is higher in CF subjects who have similar HbA(1c), fasting and 2-h glucose values. These results question whether it is appropriate to use the diagnostic thresholds and OGTT time points derived from the non-CF population for a diagnosis of diabetes in patients with cystic fibrosis.

Adult↗

PubMed2004

Advances in diabetes for the millennium: insulin treatment and glucose monitoring.

Newer insulins and easier blood glucose monitoring have greatly improved the ability to obtain excellent control of blood glucose levels with less risk of hypoglycemia. In type 1 diabetes, insulin pump therapy remains the optimal approach with the most flexibility, especially with the ultra-fast-acting analogs lispro or aspart. Otherwise, once- or twice-daily dosing with the long-acting analog glargine provides excellent basal coverage, and lispro or aspart at meals provides bolus coverage, all in the attempt to mimic physiological insulin secretion. For type 2 diabetes, although oral agents continue to be a mainstay of therapy, it is clear that many patients require insulin to attain the goal A1c of < 6.5%. Once-daily glargine is now used more commonly after 1-2 oral agents have failed, and it typically takes the place of sulfonylureas. The future will likely have better systems for continuous glucose monitoring and novel therapies to control glucose through agents that affect gut hormones.

Blood Glucose Self-Monitoring↗

PubMed2005

Blood glucose changes and adjustments of diet and insulin doses in type 1 diabetic patients during scuba diving (for a change in French regulations).

OBJECTIVE: In France, diabetic subjects were not allowed to dive. The principal risk is hypoglycemia during immersion. However scuba diving is allowed in many countries. To follow blood glucose changes, food intake and insulin adjustments in type 1 diabetic patients when diving, and to propose specific guidelines for such patients willing to practice recreational scuba diving. METHODS: Fifteen well-controlled (mean HbA1c: 7.2%) type 1 diabetic patients without complications were volunteer to dive under strict medical monitoring. They dove 8 times in 4 days in autumn at a depth of 20 meters, in 12 degrees C to 16 degrees C water. A strict protocol based on blood glucose was implemented to prevent hypoglycaemia. RESULTS: No case of hypoglycemia was observed and no faintness was reported underwater. Mean blood glucose before diving was 200 mg/dl (11 mmol/l). There was a mean fall in blood glucose of 40 mg/dl (2.2 mmol/l) during dives, a mean decrease in daily insulin doses by 19.3% on the last day. Daily energy intake was 3,225 Kcal in average. A continuous glucose monitoring (CGMS) was performed in one patient and showed a rather stable glycemia during immersion but a decrease within the 8 hours after. CONCLUSION: When respecting a strict protocol to prevent hypoglycaemia, the risk of hypoglycaemia appears quite low. We recommend an ideal glycemic goal of 200-250 mg/dl (11-13.75 mmol/l) before immersion, a higher reduction of insulin doses (-30%) and taking carbohydrates on board in any case. The present data have recently led the French diving federation (FESSM) to allow type 1 diabetic patients to dive with some restrictive qualification requirements: dives within the "safety curve" (no decompression curve), in above 14 degrees C water, depth limited to the median space range (6 to 20 meters), plus mandatory guidance by a diving instructor.

Blood Glucose↗

PubMedDate not supplied

Continuous amperometric monitoring of subcutaneous oxygen in rabbit by telemetry.

The primary objective was to develop a telemetric oxygen sensor designed for implantation in subcutaneous tissue. In the sensor, the platinum indicating electrode was covered with polythene to retard oxygen entry and avoid interference. Given the potential for large indicating electrodes to deplete oxygen in vivo, some sensors were made with very small indicating electrodes. Sensors were tested in the anesthetized rabbit at various oxygen concentrations. Animals were studied 1 and 5 days after implementation. The sensor could detect changes in oxygen in vivo. Measurements were similar at 1 and 5 days and sensors with different sized electrodes yielded similar results. This telemetric implantable amperometric sensor can detect variations in tissue oxygenation and may have applications in cardiopulmonary physiology, continuous glucose monitoring and other related fields.

Animals↗

PubMed2003

Interactions between hypoglycemia and sleep architecture in children with type 1 diabetes mellitus.

OBJECTIVES: To assess the interactions between nocturnal hypoglycemia and sleep in children with type 1 diabetes mellitus (DM). STUDY DESIGN: Children with DM (n = 15) and 15 matched control children underwent full night polysomnographic recordings. Blood glucose levels were measured in the diabetic children by means of the MiniMed Continuous Glucose Monitoring System. Six of the diabetic children were also studied by peripheral arterial tonometry (an indirect indicator of sympathetic responses). RESULTS: Five children with DM (33%) had profound nocturnal hypoglycemia, which was associated with increased sleep efficiency, increased slow wave sleep, and increased Delta power in spectral analysis of the electroencephalogram. Hypoglycemic episodes were not associated with sympathetic activation. Rapid decline in glucose levels (>25 mg/dL/hour) but not the absolute degree of hypoglycemia were associated with awakenings from sleep. CONCLUSIONS: We conclude that sleep may inhibit sympathetic and arousal response to hypoglycemia. Rapid changes in glucose levels, independent of absolute glucose levels, may result in awakening from sleep. Continuous measurement of glucose levels during sleep may add important features in the treatment of children with DM.

Adolescent↗

PubMed2004

Direct detection of glucose by surface plasmon resonance with bacterial glucose/galactose-binding protein.

The monitoring and management of blood glucose levels are key components for maintaining the health of people with diabetes. Traditionally, glucose monitoring has been based on indirect detection using electrochemistry and enzymes such as glucose oxidase or glucose dehydrogenase. Here, we demonstrate direct detection of glucose using a surface plasmon resonance (SPR) biosensor. By site-specifically and covalently attaching a known receptor for glucose, the glucose/galactose-binding protein (GGBP), to the SPR surface, we were able to detect glucose binding and determine equilibrium binding constants. The site-specific coupling was accomplished by mutation of single amino acids on GGBP to cysteine and subsequent thiol conjugation. The resulting SPR surfaces had glucose-specific binding properties consistent with known properties of GGBP. Further modifications were introduced to weaken GGBP-binding affinity to more closely match physiologically relevant glucose concentrations (1-30 mM). One protein with a response close to this glucose range was identified, the GGBP triple mutant E149C, A213S, L238S with an equilibrium dissociation constant of 0.5mM. These results suggest that biosensors for direct glucose detection based on SPR or similar refractive detection methods, if miniaturized, have the potential for development as continuous glucose monitoring devices.

Amino Acid Substitution↗

PubMed2000

Microdialysis measurement of glucose in subcutaneous adipose tissue up to three weeks in type 1 diabetic patients.

BACKGROUND: Microdialysis of subcutaneous adipose tissue may provide an opportunity to monitor glucose continuously, when the device is connected to an extracorporal glucose sensor. We assessed whether our microdialysis probes are capable of measuring adipose tissue glucose over a prolonged period in Type 1 diabetic patients. Furthermore, the relationship between abdominal skinfold thickness and glucose recovery and the effect of spontaneous glucose excursions on its recovery were evaluated. METHODS: Microdialysis probes were pairwise inserted subcutaneously into the abdominal fat and remained in situ for 3 weeks in eight Type 1 diabetic patients. At days 1, 3, 4, 8, 11, 16, and 18 of probe retention, glucose, as measured by microdialysis, was compared to capillary blood glucose concentrations during a 4 h period. The recovery of glucose obtained by microdialysis was expressed as a percentage of the capillary blood glucose concentration. RESULTS: Eleven of the 16 inserted probes (69%) were evaluable during the complete study. Recovery of glucose was lower at day 1 and 3 (51+/-23% and 56+/-18%, respectively, mean+/-S.D.) compared to values found afterwards (67+/-19%, 72+/-13%, 76+/-14%, 71+/-16%, and 76+/-18%, for day 4, 8, 11, 16, and 18, respectively, for all P<0.05 vs. day 1 and 3). Skinfold thickness was inversely related to the overall 3 week glucose recovery (r=-0.76; P<0.03). Recovery was similar over a wide range of capillary blood glucose concentrations. CONCLUSIONS: Prolonged in vivo retention of microdialysis probes improves the recovery and lowers the variability of adipose tissue-sampled glucose in Type 1 diabetic patients. These findings show that microdialysis-based glucose measurements offer an opportunity for prolonged glucose monitoring.

Adipose Tissue↗

PubMed1997

A user-friendly method for calibrating a subcutaneous glucose sensor-based hypoglycaemic alarm.

A crucial step in developing a glucose monitoring system using a subcutaneous implanted glucose sensor is the transformation of the sensor signal (a current) into an estimation of a blood glucose concentration. We have developed an Electronic Control Unit (ECU) able to recognize, before and after a glucose load, that the sensor current presents a plateau, thus triggering an alarm asking for blood glucose determination. The system, fed with these results, subsequently transforms the current into an estimation of glucose concentration by linear extrapolation based on the sensor sensitivity and the background current computed from the two sets of current and glycaemia values (two-point calibration). In addition, the system is able to trigger an alarm when this estimation decreases below a threshold that can be set by the user. This system was evaluated in experiments performed in 12 normal rats. The quality of the calibration was assessed by comparing, by error grid analysis, the data displayed on the liquid-crystal display of the ECU to concomitant plasma glucose concentration determined at frequent intervals, 65 +/- 6 and 26 +/- 5% of the values were in zones A (good) and B (acceptable estimation) of the grid, respectively. The system was set to trigger an alarm when the estimation of glucose concentration decreased below 70 mg/dl. Following an insulin administration, the alarm was triggered when the system displayed a 64 +/- 2 mg/dl glucose concentration. The concomitant plasma glucose concentration was 59 +/- 5 mg/dl (NS). In conclusion, this work validates experimentally the new, user-friendly method for calibrating the glucose sensor integrated into the ECU, based on an automatic detection of plateaus. The quality of the sensor calibration performed with this procedure is compatible with the appropriate functioning of this continuous glucose monitoring system, which was demonstrated by its ability to detect mild hypoglycaemia following insulin injection.

Animals↗

PubMed2006

Activation of oxidative stress by acute glucose fluctuations compared with sustained chronic hyperglycemia in patients with type 2 diabetes.

CONTEXT: Glycemic disorders, one of the main risk factors for cardiovascular disease, are associated with activation of oxidative stress. OBJECTIVE: To assess the respective contributions of sustained chronic hyperglycemia and of acute glucose fluctuations to oxidative stress in type 2 diabetes. DESIGN, SETTING, AND PARTICIPANTS: Case-control study of 21 patients with type 2 diabetes (studied 2003-2005) compared with 21 age- and sex-matched controls (studied in 2001) in Montpellier, France. MAIN OUTCOME MEASURES: Oxidative stress, estimated from 24-hour urinary excretion rates of free 8-iso prostaglandin F2alpha (8-iso PGF2alpha). Assessment of glucose fluctuations was obtained from continuous glucose monitoring system data by calculating the mean amplitude of glycemic excursions (MAGE). Postprandial contribution to glycemic instability was assessed by determining the postprandial increment of glucose level above preprandial values (mean postprandial incremental area under the curve [AUCpp]). Long-term exposure to glucose was estimated from hemoglobin A1c, from fasting glucose levels, and from mean glucose concentrations over a 24-hour period. RESULTS: Mean (SD) urinary 8-iso PGF2alpha excretion rates were higher in the 21 patients with diabetes (482 [206] pg/mg of creatinine) compared with controls (275 [85] pg/mg of creatinine). In univariate analysis, only MAGE (r = 0.86; P<.001) and AUCpp (r = 0.55; P = .009) showed significant correlations with urinary 8-iso PGF2alpha excretion rates. Relationships between 8-iso PGF2alpha excretion rates and either MAGE or AUCpp remained significant after adjustment for the other markers of diabetic control in multiple linear regression analysis (multiple R2 = 0.72 for the model including MAGE and multiple R2 = 0.41 for the model including AUCpp). Standardized regression coefficients were 0.830 (P<.001) for MAGE and 0.700 (P = .003) for AUCpp. CONCLUSIONS: Glucose fluctuations during postprandial periods and, more generally, during glucose swings exhibited a more specific triggering effect on oxidative stress than chronic sustained hyperglycemia. The present data suggest that interventional trials in type 2 diabetes should target not only hemoglobin A1c and mean glucose concentrations but also acute glucose swings.

Aged↗

PubMedDate not supplied

Diabetes management in the new millennium using insulin pump therapy.

Current goals of therapy of type 1 and 2 diabetes are to achieve near normal glycemia, minimize the risk of severe hypoglycemia, limit excessive weight gain, improve quality of life and delay or prevent late vascular complications. As discussed in this review, insulin pump or continuous subcutaneous insulin infusion (CSII) therapy provides a treatment option that can dramatically aid in achieving all of these goals. In comparison to multiple daily injections (MDI), CSII uses only rapid-acting insulin, provides greater flexibility in timing of meals and snacks, has programmable basal rates to optimize overnight glycemic control, can reduce the risk of exercise-induced hypoglycemia, and enhances patients' ability to control their own diabetes. Most important, in adults and adolescents with type 1 diabetes, CSII has been shown to lower HbA(1c) levels, reduce the frequency of severe hypoglycemia and limit excessive weight gain versus MDI without increasing the risk of diabetic ketoacidosis. Similarly positive results are being seen with CSII in adults with type 2 diabetes. The effectiveness of CSII and improvements in pump technology have fueled a dramatic increase in the use of this therapy. Practical guidelines are presented for selection of patients, initiation of treatment, patient education, follow-up assessments and troubleshooting. The recent introduction of methods for continuous glucose monitoring provides a new means to optimize the basal and bolus capabilities of CSII and offers the hope of the development of a feedback-controlled artificial pancreas.

Adolescent↗

PubMedDate not supplied

The relationship of postprandial glucose to HbA1c.

The gold standard for the assessment of the overall glycemic control is the determination of HbA1c. There are, however, insufficient data to determine reliably the relative contribution of fasting and postprandial plasma glucose to HbA1c. Increasing evidence suggests that excessive excursions of postprandial glucose might be important for the development of micro- and macroangiopathic complications. With respect to the treatment options, one important question to be answered is whether premeal, postmeal or fasting plasma glucose, alone or in combination, will be necessary in adjusting the therapy to achieve optimal HbA1c levels while minimizing hypoglycemia. HbA1c is difficult to predict from fasting plasma glucose. There are indications that there is a shift in the relative contribution from postprandial glucose at good to fair HbA1c levels (<7.3% to <9.2%) to fasting plasma glucose at high HbA1c (>9.3%). There is also a better correlation of afternoon and evening plasma glucose with HbA1c than with prebreakfast and prelunch plasma glucose values. Since the definition on how to define postprandial glucose is still a matter of debate and since postprandial glucose depends on the premeal blood glucose level and, on the time of the meal, its size and composition and the therapeutic strategy, the data so far available are inconclusive and the best correlation of HbA1c is with the area under the glucose profiles. Continuous glucose monitoring under daily life conditions will be the key to definitely unravel the relationship among HbA1c and fasting, premeal, postprandial and postabsorptive plasma glucose.

Blood Glucose↗

PubMedDate not supplied

Postprandial hyperglycaemia in type 2 diabetes: pathophysiological aspects, teleological notions and flags for clinical practice.

Type 2 diabetes subjects carry an excess risk for micro- and macrovascular disease and a higher cardiovascular morbidity and mortality rate. The beneficial impact of tight glycaemic control-evidenced by the integrated marker of fasting glucose and postprandial glucose values, the HbA1c-for the prevention of microvascular complications is definitely confirmed. Over the past few years, several studies have identified postprandial hyperglycaemia as a better predictor of cardiovascular or even of all-cause mortality, as well as an independent risk factor for atherosclerosis. The continuous glucose monitoring could offer a rationale means for the detection of postprandial hyperglycaemia and ultimately for its effective management. Advances in technology keep a promise for a reliable, convenient and closer to the idea of the artificial endocrine pancreas glucose sensor. Subcutaneous glucose levels charted by one of the new sensors were found to be well correlated with venous glucose measurements. Intervention for a healthy lifestyle is frequently hampered by patients' poor compliance. The availability of diverse antidiabetic agents provides options for targeting the glycaemic goal and a choice more fitted to the particularized pathophysiology of each individual subject. Drugs targeting postprandial glycaemia may prove to represent the 'sine qua non' for the 'return' of postprandial glucose values at a 'non-deleterious' threshold, either as monotherapy for the early stages of the disease or as combination therapy later in the progression of diabetes.

Blood Glucose↗

PubMed1986

In vivo hyperglycemic effect of (-)- and (+)-epinephrine in dogs.

(-)-Epinephrine is a major component in the regulation of the physiological homeostasis of glucose levels in the blood. (+)-Epinephrine, a synthetic stereoisomer, has been reported to have 10% of the in vitro adrenergic-lipolytic activity of (-)-epinephrine and only 7% in vitro competitive binding activity to fat cells. The in vivo hyperglycemic effects of the two stereoisomers were studied in 6 dogs using a continuous glucose monitor. The method allowed a direct comparison between the hyperglycemic effects of the two stereoisomers in each dog in the course of each test; therefore, the effect of individual variability of response was eliminated. Previous reports on the relative activity of the two stereoisomers were carried out only in vitro. The previous methods required interassay comparison. The present method is in vivo and uses intra-assay comparison. The hyperglycemic activity of (+)-epinephrine bitartrate was found to have 12.8% of the hyperglycemic activity of its natural (-)-stereoisomer.

Animals↗

PubMed2006

Forty-eight-hour first-trimester glucose profiles in women with type 1 diabetes mellitus: a report of three cases of congenital malformation.

OBJECTIVE: Despite modern methods of treatment and near-normal HbA(1c) levels, women with type 1 diabetes mellitus are still at risk of having an infant with a congenital malformation (CM). We hypothesised that HbA(1c) levels are too gross a measure of glycaemic control and used a continuous glucose monitoring system (CGMS) to determine the diurnal glucose profiles during the first trimester of pregnancy. We present three cases of infants with a CM. METHODS: Fifty-three women with type 1 diabetes used the CGMS for 48 h in the first trimester of pregnancy. Three of them gave birth to infants with a CM. HbA(1c) levels were determined at the time of the CGMS measurement and 6 to 8 weeks later. RESULTS: The HbA(1c) levels at the time of the CGMS measurement were 6.0, 6.5 and 7.8% (normal range 4.0-6.0%) in the three women. The 48-h diurnal glucose profiles of these women showed a large variability with frequent hyperglycaemic episodes. CONCLUSIONS: HbA(1c) levels are too gross a measure of glycaemic control to identify women at risk of giving birth to an infant with a CM. Even in women with normal or near-normal HbA(1c) levels, the diurnal glucose profiles reveal intermittent hyperglycaemic episodes that may cause the CM.

Adult↗

PubMed1982

Glucose control in mobile type 1 (insulin-dependent) diabetic patients by means of a semi-automatic feedback controlled insulin infusion system.

A portable insulin dosing device (Siemens) was used together with a programmable pocket calculator and a glucose analyzer for short-term adaptation of continuous intravenous insulin infusion to blood glucose alterations. A special algorithm was developed which utilizes a given blood glucose value and the glucose rate of change obtained from two to four consecutive samples as input variables. In contrast to current techniques of feedback-regulation, which require continuous glucose monitoring, intermittent blood sampling allows greater mobility of patients. With the semi-automatic feedback system, euglycaemic control was obtained for 12-h periods in ten Type 1 (insulin-dependent) diabetic patients (maximum value 9.50 mmol/l, minimum value 2.83 mmol/l). Severe hypoglycaemia occurred in no case and additional control by glucose infusion appeared to be unnecessary. Light exercise after termination of insulin dose for standard meals led to glycaemic excursions with a rapid decrease (mean 1.08 +/- 0.09 mmol/l), followed by a rebound (0.59 +/- 0.07 mmol/l) in each patient. The amplitude of these excursions decreased with increasing distance from the peak of the meal dose. Comparison of feedback-control alone with feedback by glucose plus preprogrammed dose (4 U/h) at the onset of the test meal revealed lower post-prandial glucose levels (post-prandial maximum +/- SEM: 6.49 +/- 0.18 versus 7.71 +/- 0.79 mmol/l) and a lower infusion rate of insulin for the combined regimen (mean post-prandial maximum +/- SEM: 8.4 +/- 1.2 versus 12.0 +/- 0 IU/h). The system is useful for programming of portable infusion devices and studies based on euglycaemic control in unrestrained patients.

Adult↗

PubMedDate not supplied

Clinical experience with an integrated continuous glucose sensor/insulin pump platform: a feasibility study.

The recent US Food and Drug Administration approval of an integrated real-time continuous glucose monitoring (CGM) system and insulin pump (Medtronic Mini-Med Paradigm REAL-Time System; Medtronic MiniMed, Inc., Northridge, Calif) is the most recent breakthrough paving the way toward the development of a closedloop insulin delivery system that could revolutionize diabetes care. An early prototype of the MiniMed Paradigm REAL-Time System--which provided both realtime CGM and insulin pump therapy but was not yet fully integrated--was tested in 20 volunteer subjects with type 1 diabetes who wore the device for up to 2 y. Subjects were instructed on the technical use of the device but were provided no additional support, aside from their usual diabetes care. Participation in the trial averaged 317 d (minimum, 88 d; maximum, 618 d). Five participants prematurely dropped out of the study (2 because of the inconvenience of carrying 2 devices). Data from all subjects were analyzed. Subjects reduced their A1C by a mean of 1.1% (standard deviation, 0.8). After 3 mo of device use, the number of participants who achieved A1C <7% increased by more than 3-fold. Individuals with baseline A1C >or= 7% had a 67% likelihood of achieving an A1C <7% by the first follow-up assessment. This observational study of combined CGM and insulin pump therapy suggests that this innovative device can help people achieve improved glycemic control. Given that only about one third of individuals with diabetes are achieving glycemic control targets, more effective methods to help patients avoid the devastating consequences of uncontrolled diabetes are desperately needed.

Adolescent↗