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Assessing glycemia in diabetes using self-monitoring blood glucose and hemoglobin A1c.

CONTEXT: With the increasing prevalence of diabetes, successful management of blood glucose control is increasingly important. Current approaches to assessing glycemia include the use of self-monitoring of blood glucose (SMBG) and hemoglobin A1c (HbA1c). OBJECTIVES: To assess the evidence underlying the use of these 2 modalities, to evaluate confounders and sources of error in each test, to describe upcoming developments, and to reach evidence-based conclusions on their optimal use. DATA SOURCES, STUDY SELECTION, AND DATA EXTRACTION: Reports identified from MEDLINE searches (1976-2005) using relevant terms were selected for quality and relevance to the stated questions. Particular attention was paid to larger cohort studies, clinical trials, meta-analyses, and established recommendations. DATA SYNTHESIS: If used properly SMBG gives an acceptably accurate reflection of immediate plasma glucose levels. Study results vary, but in general, the evidence supports a positive effect of regular SMBG for improving glycemia, particularly in individuals treated with insulin. The best timing of SMBG and its frequency are controversial issues, but the clinical recommendation is for regular monitoring with frequency depending on the treatment and the instability of glycemia. In the relatively near term, SMBG could gradually be replaced by continuous glucose monitoring. HbA1c measures long-term glycemic control, reflecting a time-weighted mean over the previous 3 to 4 months. There are a number of physiologic and methodologic confounders that can affect HbA1c, but standardization of assays has been well established. The main value of HbA1c is its use as a predictor of diabetic complications and the proven effect of improved control of HbA1c on complication risk. A reasonable target value for HbA1c is less than 7%. A new method for measuring HbA1c may cause significant changes in the recommended levels, the numbers reported, and even the name of the test. CONCLUSION: Assessing glycemia in diabetes can be a challenge, but approaches are available that promote successful management of blood glucose and may thereby lead to a significant reduction in morbidity and mortality related to diabetes.

Blood Glucose Self-Monitoring↗

Prolonged exercise in adolescent boys with juvenile diabetes mellitus. Circulatory and metabolic responses in relation to perceived exertion.

Seven well-trained adolescent boys with juvenile diabetes mellitus were studied. They were non-ketotic and performed a 60 min exercise in the afternoon at an average intensity of 58% of maximal working capacity. Blood glucose, blood lactate, plasma levels of insulin, C-peptide and 3-hydroxybutyrate, oxygen uptake and respiratory quotient were determined. The perception of exertion was scored as rate of perceived exertion. Healthy athletes of the same age were controls. Blood glucose, monitored continuously, decreased successively after 10-15 min of exercise with a significant correlation to the pre-exercise glucose value. Blood glucose decreased during exercise to the same level or below that of controls. Despite hypoglycemia with values of 2-3 mmol/l, the exercise continued. Plasma insulin was unchanged. The 3-hydroxybutyrate level was significantly higher in the diabetics, increased somewhat during exercise and still more during the recovery period. The diabetic subjects had significantly higher systolic blood pressure and heart rate during exercise despite a relatively equal work intensity and lower absolute workload. The rate of perceived exertion increased normally during exercise without interference of decreasing blood glucose.

Adolescent↗

Exercise with and without an insulin pump among children and adolescents with type 1 diabetes mellitus.

BACKGROUND: The use of insulin pumps is becoming a popular technique for insulin delivery among patients with type 1 diabetes mellitus (T1DM), but there is no consensus regarding the guidelines for proper pump use during exercise. OBJECTIVE: To investigate the physiologic responses and risk of hypoglycemia among children and adolescents with T1DM when exercising with the pump on (PO) (50% of the basal rate) or pump off (PF). METHODS: Ten subjects with T1DM (6 female subjects and 4 male subjects), 10 to 19 years of age, performed prolonged exercise (40-45 minutes) on a cycle ergometer approximately 2 hours after a standard breakfast and an insulin (Lispro) bolus. Complex carbohydrates (20 g) were provided before and after the exercise. Each patient exercised once with PO and once with PF, in a randomized, crossover (single-blind) manner. During exercise and 45 minutes of recovery, subjects were monitored for cardiorespiratory, metabolic, and hormonal responses. Blood glucose concentrations were recorded for 24 hours after exercise, with a continuous glucose monitoring system, to document late hypoglycemic events. RESULTS: During exercise, blood glucose concentrations decreased by 59 +/- 58 mg/dL (mean +/- SD: 29 +/- 24%) with PF and by 74 +/- 51 mg/dL (35.5 +/- 18%) with PO (not significant). No significant differences were found in cortisol, growth hormone, or noradrenaline levels between PO and PF. There were no differences in cardiorespiratory parameters, blood lactate concentrations, or free fatty acids concentrations between pump modes. Hypoglycemic events during exercise were asymptomatic and occurred for 2 subjects with PO and 2 with PF. Nine subjects had late hypoglycemia after PO, compared with 6 after PF (not significant). CONCLUSIONS: We found no advantage for subjects with either PO or PF during exercise, and we noted that late hypoglycemia was more common than hypoglycemia during exercise. However, PO was associated with a trend of increased risk for late hypoglycemia. We recommend that the pump be removed or turned off during prolonged exercise and that blood glucose concentrations be monitored for several hours after exercise, regardless of the pump mode.

Adolescent↗

Diagnostic utility of fasting versus non-fasting blood glucose: contextualising testing strategies-a narrative review.

Diabetes mellitus is a chronic metabolic disorder characterised by impaired glucose homeostasis, resulting in persistent hyperglycaemia. Accurate and prompt diagnosis is essential for early intervention and prevention of long-term complications. Fasting blood glucose levels have traditionally been central to the diagnosis and monitoring of diabetes mellitus. However, growing evidence highlights the clinical relevance of non-fasting glucose measures, including postprandial glucose, random plasma glucose, and glycated haemoglobin (HbA1c) levels. Practical challenges, safety concerns, and evolving insights into glucose physiology have prompted renewed interest in flexible and context-driven approaches to glucose testing. This narrative review examines the physiological basis of fasting and non-fasting glucose regulation and critically evaluates their roles in diabetes screening, diagnosis, and monitoring. It also discusses the strengths and limitations of measuring fasting blood glucose, oral glucose tolerance, HbA1c, random plasma glucose, postprandial glucose, and continuous glucose monitoring. Special attention is given to pre-analytical and practical considerations, patient safety, and the ability of non-fasting measures to capture early metabolic dysfunction and real-world glycaemic exposure. This article reviews evidence supporting the prognostic value of postprandial hyperglycaemia and the expanding role of non-fasting monitoring tools. Non-fasting glucose testing offers substantial advantages in terms of accessibility, safety, and clinical relevance, and is well-suited for population screening and routine diabetes monitoring. Fasting glucose testing remains essential for specific diagnostic and research applications, particularly when strict metabolic standardisation is required. A context-driven framework that prioritises non-fasting approaches while reserving fasting tests for targeted indications provides a balanced and patient-centred strategy for contemporary diabetes care.

Diabetes screening↗

Closed-loop glycemic control with a wearable artificial endocrine pancreas. Variations in daily insulin requirements to glycemic response.

We succeeded in miniaturizing a needle-type glucose monitoring system with characteristics suitable for application in a wearable, closed-loop control system. A wearable artificial endocrine pancreas (12 X 15 X 6 cm, 400 g) consisting of a sensor, a microcomputer system that calculates insulin and glucagon infusion rates, and two roller pumps was developed. Continuous glucose monitoring by a glucose sensor inserted in the subcutaneous tissue of the forearm or abdomen of healthy and diabetic volunteers revealed that glucose concentrations in subcutaneous tissue were 10% lower than, but were highly correlated with, blood glucose concentrations in the range of 49-388 mg/dl. Glycemic control was established in diabetic patients by intravenously infusing insulin in response to measured glucose concentrations on a moment-to-moment basis for a period of several days. By comparing the glycemic control obtained in each patient treated with multiple insulin injections or open-loop subcutaneous insulin infusion, the superiority of feedback control with the system was clearly demonstrated. During continuous glycemic regulation, day-to-day variations of insulin requirements were recognized in both basal insulin infusion and postprandial insulin infusion rates in response to identical meals and exercise. These data suggest the feasibility of long-term glycemic control in diabetic subjects with a wearable artificial endocrine pancreas, and indicate that to overcome changes in individual metabolic characteristics on a moment-to-moment basis, a closed-loop glycemic control system may be essential for ambulatory diabetic patients.

Adult↗

Poor glucose control in women with type 1 diabetes mellitus and 'safe' hemoglobin A1c values in the first trimester of pregnancy.

OBJECTIVE: To observe glycemic excursions, measured continuously over 24 h, in relation to hemoglobin A1c values in the first trimester of pregnancy of women with type 1 diabetes mellitus. METHODS: The MiniMed Continuous Glucose Monitoring System (CGMS) was used to obtain glucose values every 5 min during 24 h. Hemoglobin A1c was determined at the end of the continuous glucose recording and 6-12 weeks after the continuous glucose recording. RESULTS: Continuous glucose recordings were obtained in 13 women between 7 and 15 weeks of gestation. Nine patients had hemoglobin A1c levels of < or = 7.0% (< 1% above the upper limit of normal range) while up to 41.3% of the readings had values of < 3.9 mmol/l (70 mg/dl) and up to 52.8% of the readings had values of > 7.8 mmol/l (140 mg/dl). CONCLUSIONS: Hemoglobin A1c does not reflect the complexities of glycemic control in women with type 1 diabetes who are considered to have accomplished tight glycemic control in the first trimester of pregnancy.

Adult↗

Experience with the Biostator for diagnosis and assisted surgery of 21 insulinomas.

Surgical removal is the treatment of choice for insulinomas. Definitive biochemical diagnosis of organic hyperinsulinism has to be established before surgery. These tumors are sometimes undetected by preoperative imaging investigations and, in addition, surgical management may also be complicated by the absence of palpable tumors or the presence of multiple tumors. We report the value of the euglycemic clamp technique for diagnosis and surgical treatment in 21 patients with confirmed insulinomas. Data were compared with 12 controls, and nine patients were retested after surgery. During the euglycemic hyperinsulinic clamp, the mean C-peptide value was 3.6+/-2.2 ng/ml and it remained high (3.8+/-2.5 ng/ml), despite exogenous hyperinsulinemia (1762.7+/-233.2 microU/ml for the highest plateau). In contrast, the C-peptide concentration declined in 12 control patients (0.3+/-0.1 ng/ml, P < 0.001) and after successful surgery in nine retested patients (0.3+/-0.2 ng/ml, P < 0.01). During continuous glucose monitoring, successful removal of the insulin-secreting tumor was accompanied by an increase in plasma glucose concentrations and a loss of requirement for endogenous glucose within 36 min (range 28-43 min). The continuing requirement for glucose after the ablation of the tumor revealed the existence of additional and initially undetected tumors in four patients, among whom two had the multiple endocrine neoplasia type I (MEN I) syndrome. We conclude that the euglycemic hyperinsulinic clamp is a reliable and convenient diagnostic test for insulinoma, as it is both safe (no hypoglycemia) and relatively brief (3 x 90 min). Glucose monitoring and glucose clamping provide a reliable indicator of complete removal of insulin-hypersecreting tissue, especially in patients with occult or multiple tumors.

Adult↗

Type 2 diabetes, glycemic control, and continuous positive airway pressure in obstructive sleep apnea.

BACKGROUND: Sleep-disordered breathing (SDB) is a prevalent condition associated with significant comorbidities, including hypertension, obesity, cardiovascular disease, and insulin resistance. It has been previously shown that the severity of insulin resistance is related to the severity of SDB. METHODS: Using a 72-hour continuous glucose monitoring system, we studied changes in interstitial glucose levels and measured hemoglobin A1c levels in 25 patients with type 2 diabetes mellitus before and after continuous positive airway pressure (CPAP) treatment for SDB. RESULTS: With a mean +/- SD CPAP treatment period of 83 +/- 50 days, the mean +/- SD 1-hour postprandial glucose values were significantly reduced for breakfast (191 +/- 68 mg/dL to 130 +/- 41 mg/dL [10.6 +/- 3.8 mmol/L to 7.2 +/- 2.3 mmol/L]), lunch (196 +/- 70 mg/dL to 138 +/- 49 mg/dL [10.9 +/- 3.9 mmol/L to 7.7 +/- 2.7 mmol/L]), and dinner (199 +/- 66 mg/dL to 137 +/- 48 mg/dL [11.0 +/- 3.7 mmol/L to 7.6 +/- 2.7 mmol/L]). In the 17 patients with a baseline hemoglobin A1c level greater than 7%, there was a significant reduction in hemoglobin A1c level (9.2% +/- 2.0% to 8.6% +/- 1.8%). Furthermore, in subjects who used CPAP for more than 4 h/d, the reduction in hemoglobin A1c level was significantly correlated with days of CPAP use. There was no such correlation in subjects who used CPAP for 4 h/d or less. CONCLUSIONS: These findings suggest that SDB is pathophysiologically related to impaired glucose homeostasis, and that CPAP can be an important therapeutic approach for diabetic patients with SDB.

Adult↗

Emerging technology in diabetes mellitus: glucose monitoring and new insulins.

Modern diabetes management requires intensive self-monitoring of blood glucose levels, often coupled with a multicomponent insulin program. Recent advances include alternate site blood glucose testing devices, which facilitate more frequent sampling by individuals with diabetes. Continuous glucose monitoring through interstitial fluid analysis is now available and appears to give a more representative picture of the glycemic variations typical for type 1 diabetes. Recombinant DNA technology has led to the development of new insulin analogs that provide more physiologic insulin delivery. Inhaled and oral insulin formulations may replace multiple injections in future insulin therapy regimens.

Blood Glucose Self-Monitoring↗

A novel approach to continuous glucose analysis utilizing glycemic variation.

BACKGROUND: Various methodologies have been proposed for analysis of continuous glucose measurements. These methods have mainly focused on the proportion of low or high glucose readings and have not attempted to analyze other dimensions of the data obtained. This study proposes an algorithm for analysis of continuous glucose data including a novel method of assessing glycemic variability. METHODS: Mean blood glucose and mean of daily differences (MODD) assessed the degree that the Continuous Glucose Monitoring System (CGMS, Medtronic MiniMed, Northridge, CA) trace was representative of the 3-month glycemic pattern. Percentages of times in low, normal, and high glucose ranges were used to assess marked glycemic excursion. Continuous overall net glycemic action (CONGA), a novel method developed by the authors, assessed intra-day glycemic variability. These methods were applied to 10 CGMS traces chosen randomly from those completed by children with type 1 diabetes from the Royal Children's Hospital, Melbourne, Victoria, Australia and 10 traces recorded by healthy volunteer controls. RESULTS: The healthy controls had lower values for mean blood glucose, MODD, and CONGA. Patients with diabetes had higher percentages of time spent in high and low glucose ranges. There was no overlap between the CONGA values for patients with diabetes and for controls, and the difference between controls and patients with diabetes increased markedly as the CONGA time period increased. CONCLUSIONS: We advocate an approach to the analysis of CGMS data based upon a hierarchy of relevant clinical questions alluding to the representative nature of the data, the amount of time spent in glycemic excursions, and the degree of glycemic variation. Integrated use of these algorithms distinguishes between various patterns of glycemic control in those with and without diabetes.

Adolescent↗

Portable device for continuous fractionated blood sampling and continuous ex vivo blood glucose monitoring.

The objective of the study was to develop and evaluate a portable device for continuous fractionated blood sampling and continuous ex vivo monitoring of blood glucose. The inner lumen of a double lumen catheter (18 gauge x 45 mm) was placed in a peripheral vein and perfused with heparin solution (1.4 U min-1). The outer lumen was used to collect heparinized blood into 48 vacuum tubes at programmable sample volumes and time intervals (0.2-2 ml in 2.5-30 min). A sensor flow chamber with an internal volume of 1 mm3 incorporating a miniaturized thin-film amperometric glucose sensor was placed in the sampling line for continuous ex vivo blood glucose monitoring. Blood glucose and plasma insulin were measured during a frequently sampled intravenous glucose tolerance test (250 mg kg-1) and a subsequent oral glucose tolerance test (150 g) over 6 h in eight healthy volunteers (BMI 24.5 +/- 3.2 kg m-2). Additionally, in four experiments blood glucose was measured on-line using the glucose sensors. The overall correlation coefficients for whole blood glucose and plasma insulin between the manually drawn samples and the vacuum tubes were 0.73 and 0.87, respectively (p < 0.001). The miniaturized glucose sensor exhibited a linear measuring range of 25 mmol-1 glucose concentration and 95% response times of less than 30 s. Sensor readings and laboratory analyser results for the blood glucose measurement correlated between 0.93 and 0.98 (p < 0.001). In summary, continuous fractionated blood sampling and ex vivo blood glucose monitoring in ambulatory subjects is possible with a portable device.

Adult↗

Implantable glucose sensors for diabetes monitoring.

The development of glucose sensors for clinical use is driven by the aim of blood glucose normalization in diabetic patients, and the detection of blood glucose impairment in nondiabetic subjects submitted to critical conditions. Currently available devices for continuous glucose monitoring are either minimally invasive or partly implantable, and measure subcutaneous interstitial glucose using glucose-oxidase. The signal generated is calibrated against capillary blood glucose to provide estimated blood glucose values. The three certified glucose sensing systems for clinical use: GlucoWatch(R) biographer, CGMS(R) and GlucoDay(R) use different techniques for glucose recovery: reverse iontophoresis, direct subcutaneous implantation and microdialysis, respectively. These devices show sufficient accuracy to identify trends of blood glucose variations, but provide information either with significant delay (GlucoWatch(R)) or retrospectively after computerized analysis of "Holter-style" glucose recordings (CGMS(R), GlucoDay(R)). Only GlucoDay(R) can provide almost online data. Occasional use for short-term assessment of glucose control or educational purposes in diabetic subjects dominates the present clinical use of these devices. Because of the discrepancies between variations of blood and interstitial glucose levels, treatment adaptations from collected sensor data still need further assessment by capillary blood glucose measurements, while the limited biocompatibility of these systems allows only short-term recordings for a few days at most. Subcutaneous and intravenous, fully implantable, sensor models are currently under development and evaluated in clinical trials. Designed for long-term glucose sensing and permanent clinical use, these glucose sensors show promising early results in view of open-loop or closed-loop insulin delivery based upon a sensor signal.

Journal Article↗

Evaluation of CGMS during rapid blood glucose changes in patients with type 1 diabetes.

BACKGROUND: CGMS (Medtronic Minimed, Duesseldorf, Germany) allows continuous glucose monitoring. Recent studies with invasive monitoring techniques revealed discrepancies in blood glucose measurements obtained from different anatomical sites compared with those from the fingertip. The aim of this study was to investigate the CGMS and a device for alternative site testing (AST) during dynamic blood glucose changes and to compare these results with fingertip measurements. METHODS: Twelve patients with type 1 diabetes (seven women, five men; age, 33.3 +/- 8.7 years) received a 75-g oral glucose load. Insulin was applied intravenously (rapid glucose decline) or subcutaneously (moderate glucose decline) in a dosage between 3 to 18 units 2 h later in a randomized sequence on two different days. For continuous glucose measurements the CGMS standard sensor was inserted into the lower abdominal subcutis. Glucose measurements were obtained from the forearm using a minimally invasive technique (AST). CGMS and AST measurements were compared with glucose measurements obtained from the fingertip using a standard glucose oxidase method. RESULTS: No significant difference could be observed among all three methods during increasing glucose levels. Insulin-induced blood glucose decline resulted in a significant time lag in the time course of blood glucose measurements obtained by AST compared with those obtained from the fingertip (P < 0.05, respectively). No significant difference could be observed between CGMS and fingertip measurements. Error grid analysis revealed 100% during rapid glucose fall and 98.5% during modest glucose fall of CGMS measurements within the clinically acceptable zones A and B. CONCLUSIONS: Continuous glucose measurements using CGMS provide reliable glucose measurements even in the case of dynamic blood glucose changes.

Adult↗

Insulin pump therapy in childhood diabetes mellitus: guidelines for use.

The current goals for the therapy of children and adolescents with type 1 diabetes mellitus are to achieve near-normal glycemia, minimize the risk of severe hypoglycemia, limit excessive weight gain while achieving adequate growth, improve quality of life for both the patients and their families, and delay or prevent vascular complications. Insulin pump therapy provides a treatment option that can significantly aid in achieving all of these goals across all age ranges of pediatric patients. Continuous subcutaneous insulin infusion (CSII) pump therapy can provide greater flexibility in the timing of meals and snacks, has programmable basal rates to optimize overnight glycemic control, can reduce the risk of exercise-induced hypoglycemia, and enhances the ability of the patient and the family members to achieve acceptable diabetes control. In pediatric patients, CSII has been shown to reduce both glycosylated hemoglobin levels and the frequency of severe hypoglycemia without increasing the risk of diabetic ketoacidosis. The effectiveness of CSII, improvements in pump technology, and the availability of very rapid-acting insulin analogs have fueled a dramatic increase in the use of this therapy. This review presents practical guidelines for the selection of patients, initiation of treatment and patient education, as well as guidelines for use while exercising and at school. Keys to the success of CSII are to have a multidisciplinary team of clinicians who are expert in the care of children with diabetes, and patients and families who are able to carry out the tasks of intensive treatment, including self-monitoring of blood glucose levels, carbohydrate counting, and infusion pump management. Patients and parents need to be able to recognize and treat hypoglycemia, and prevent the development of ketoacidosis. School personnel need to be involved in the treatment plan and individual algorithms developed for periods of extra exercise and activity. The recent introduction of methods for continuous glucose monitoring provides a new means to optimize the basal and bolus capabilities of CSII and offers hope for the development of a feedback-controlled artificial pancreas.

Adolescent↗

Integral-based filtering of continuous glucose sensor measurements for glycaemic control in critical care.

Hyperglycaemia is prevalent in critical illness and increases the risk of further complications and mortality, while tight control can reduce mortality up to 43%. Adaptive control methods are capable of highly accurate, targeted blood glucose regulation using limited numbers of manual measurements due to patient discomfort and labour intensity. Therefore, the option to obtain greater data density using emerging continuous glucose sensing devices is attractive. However, the few such systems currently available can have errors in excess of 20-30%. In contrast, typical bedside testing kits have errors of approximately 7-10%. Despite greater measurement frequency larger errors significantly impact the resulting glucose and patient specific parameter estimates, and thus the control actions determined creating an important safety and performance issue. This paper models the impact of the continuous glucose monitoring system (CGMS, Medtronic, Northridge, CA) on model-based parameter identification and glucose prediction. An integral-based fitting and filtering method is developed to reduce the effect of these errors. A noise model is developed based on CGMS data reported in the literature, and is slightly conservative with a mean Clarke Error Grid (CEG) correlation of R=0.81 (range: 0.68-0.88) as compared to a reported value of R=0.82 in a critical care study. Using 17 virtual patient profiles developed from retrospective clinical data, this noise model was used to test the methods developed. Monte-Carlo simulation for each patient resulted in an average absolute 1-h glucose prediction error of 6.20% (range: 4.97-8.06%) with an average standard deviation per patient of 5.22% (range: 3.26-8.55%). Note that all the methods and results are generalizable to similar applications outside of critical care, such as less acute wards and eventually ambulatory individuals. Clinically, the results show one possible computational method for managing the larger errors encountered in emerging continuous blood glucose sensors, thus enabling their more effective use in clinical glucose regulation studies.

Adult↗

[Glycemic patterns and excursions in well-controlled patients with type 2 diabetes mellitus].

OBJECTIVE: To evaluate the glycemic excursions in well-controlled (HbA1c<7%) patients with type 2 diabetes mellitus. METHODS: Thirty-two patients with type 2 diabetes whose HbA1c were<7% underwent CGMS (continuous glucose monitoring system). RESULTS: The highest blood glucose value was in 1.7 h after breakfast. The time duration for blood glucose levels of 7.8 mmol/L, 11.1 mmol/L and 13.9 mmol/L were 28%, 13% and 6%, respectively. The area above 7.8 mmol/L in blood glucose curve was significantly correlated with HbA1c levels. Asymptomatic hypoglycemia and continuous hyperglycemia (BS>13.9 mmol/L more than 2 hours) were also found in the study. CONCLUSION: The apparent hyperglycemia exists in well-controlled type 2 diabetic patients, and CGMS is useful in assessment of glycemia.

Adult↗

Relationship of fasting and hourly blood glucose levels to HbA1c values: safety, accuracy, and improvements in glucose profiles obtained using a 7-day continuous glucose sensor.

OBJECTIVE: In this study, we evaluated the safety and efficacy of 7-day transcutaneous, real-time, continuous glucose monitoring (CGM) in subjects with insulin-requiring diabetes. RESEARCH DESIGN AND METHODS: Eighty-six subjects were enrolled at five U.S. centers. Subjects wore a sensor inserted under the skin of the abdomen for 7 days during each of three consecutive periods. Data were blinded during period 1 and unblinded during periods 2 and 3. RESULTS: Of the 6,811 matched self-monitoring of blood glucose to sensor values prospectively analyzed, 97.2% fell in the Clarke error grid zones A and B, and median absolute relative difference was 11.4%. After unblinding, subjects reduced time spent at <55 mg/dl by 0.3 h/day, reduced time spent at >240 mg/dl by 1.5 h/day, and increased time in the target zone (81-140 mg/dl) by 1.4 h/day (P < 0.05 for all three comparisons). Improvements were seen in both types 1 and 2 diabetes and with use of both multiple daily injections and continuous subcutaneous insulin infusion. Modal day graphs were generated in six groups of subjects based on HbA1c (A1C) ( 10%). Mean glucose levels from midnight to 7:00 a.m. (fasting and dawn phenomenon periods) were only normal for subjects with A1C <or=6%. All other groups were hyperglycemic during this and all periods. Reductions in overall mean glucose were achieved for the four highest A1C groupings with unblinded device use. CONCLUSIONS: This is the first report of a real-time, transcutaneous glucose sensor that functioned for 7 days. The use of CGM in the unblinded phase resulted in improvements in target-range glycemia across all A1C values.

Blood Glucose↗

Relationship between glycosylated haemoglobin and mean plasma glucose concentration in cystic fibrosis.

BACKGROUND: HbA(1c) is recommended for monitoring glycaemic control in people with cystic fibrosis-related diabetes (CFRD). However the relationship between HbA(1c) and mean plasma glucose concentration (MPG) has not been established in CFRD, as in other forms of diabetes mellitus. METHODS: 20 people (13 male, 29.7+/-8.8 years, 10 CFRD) with cystic fibrosis (CF) underwent HbA(1c) measurement and 48 h continuous glucose monitoring for estimation of MPG. The relationship between HbA(1c) and MPG was established and compared to the reported relationship for type 1 diabetes. RESULTS: HbA(1c) was strongly correlated with MPG (R(2)=0.888, p<0.0001) in CF. The relationship of MPG to HbA(1c) was described by the equation MPG=(1.47xHbA(1c))-1.15, giving a 1.47 mmol L(-1) change in MPG per 1% change in HbA(1c). This equation predicts that MPG in people with CF and HbA(1c) <7.0% will be similar to MPG in people with type 1 diabetes who achieve the same HbA(1c) target. CONCLUSIONS: These results imply that HbA(1c)<7.0% will predict good blood glucose control in CF as in type 1 diabetes. However, although HbA(1c) predicts complications in type 1 diabetes, further studies are required to establish the relationship between HbA(1c) and diabetic complications in people with CFRD.

Adult↗