Background: A composite metric for the quality of glycemia from continuous glucose monitor (CGM) tracings could be useful for assisting with basic clinical interpretation of CGM data. Methods: We assembled a data set of 14-day CGM tracings from 225 insulin-treated adults with diabetes. Using a balanced incomplete block design, 330 clinicians who were highly experienced with CGM analysis and interpretation ranked the CGM tracings from best to worst quality of glycemia. We used principal component analysis and multiple regressions to develop a model to predict the clinician ranking based on seven standard metrics in an Ambulatory Glucose Profile: very low–glucose and low-glucose hypoglycemia; very high–glucose and high-glucose hyperglycemia; time in range; mean glucose; and coefficient of variation. Results: The analysis showed that clinician rankings depend on two components, one related to hypoglycemia that gives more weight to very low-glucose than to low-glucose and the other related to hyperglycemia that likewise gives greater weight to very high-glucose than to high-glucose. These two components should be calculated and displayed separately, but they can also be combined into a single Glycemia Risk Index (GRI) that corresponds closely to the clinician rankings of the overall quality of glycemia (r = 0.95). The GRI can be displayed graphically on a GRI Grid with the hypoglycemia component on the horizontal axis and the hyperglycemia component on the vertical axis. Diagonal lines divide the graph into five zones (quintiles) corresponding to the best (0th to 20th percentile) to worst (81st to 100th percentile) overall quality of glycemia. The GRI Grid enables users to track sequential changes within an individual over time and compare groups of individuals. Conclusion: The GRI is a single-number summary of the quality of glycemia. Its hypoglycemia and hyperglycemia components provide actionable scores and a graphical display (the GRI Grid) that can be used by clinicians and researchers to determine the glycemic effects of prescribed and investigational treatments.
Physical exercise (PE) is a strong stimulant of glucose absorption by the skeletal muscles, a phenomenon that results from an increase in the rates of glucose release, transmembranal transport of glucose, and substrate flow at the intracellular level through glycolysis. 1 Although PE is an important tool for maintaining or improving cardiovascular fitness, most studies on the impact of PE on DM1 have not shown objective improvements on glycemic control. 2 It has been described that type 1 diabetic athletes show alterations in their metabolic control compared to sedentary type 1 diabetics.2 The fear of a hypoglycemic event underlies this finding because overcompensation generally occurs in terms of additional carbohydrate intake prior to exercise and excessive reductions to insulin dosages. 2 In fact, in a pediatric population, hypoglycemia during or after exercise is the most frequent specific cause of severe hypoglycemia, with most of the severe events occurring at night. 3It has been established that hypoglycemia associated with exercise is determined by an increase in glucose absorption, the inability of PE per se to decrease insulin levels, and the presence of autonomous diabetic neuropathy. 4 A history of hypoglycemia can deteriorate even further the adrenergic activity in response to hypoglycemia caused by exercise. Abstract Background: Although physical exercise (PE) is recommended for individuals with type 1 diabetes (DM1), participation in exercise is challenging because it increases the risk of severe hypoglycemia and the available therapeutic options to prevent it frequently result in hyperglycemia. There is no clear recommendation about the best timing for exercise. The aim of this study was to compare the risk of hypoglycemia after morning or afternoon exercise sessions up to 36 hours postworkout. Methods: This randomized crossover study enrolled subjects with DM1, older than 18 years of age, on sensor-augmented insulin pump (SAP) therapy. Participants underwent 2 moderate-intensity exercise sessions; 1 in the morning and 1 in the afternoon, separated by a 7 to 14 day wash-out period. Continuous glucose monitoring (CGM) data were collected 24 hours before, during and 36 hours after each session. Results: Thirty-five subjects (mean age 30.31 ± 12.66 years) participated in the study. The rate of hypoglycemia was significantly lower following morning versus afternoon exercise sessions (5.6 vs 10.7 events per patient, incidence rate ratio, 0.52; 95% CI, 0.43-0.63; P < .0001). Most hypoglycemic events occurred 15-24 hours after the session. On days following morning exercise sessions, there were 20% more CGM readings in near-euglycemic range (70-200 mg/dL) than on days prior to morning exercise (P = .003). Conclusions: Morning exercise confers a lower risk of late-onset hypoglycemia than afternoon exercise and improves metabolic control on the subsequent day.
BackgroundInpatient dysglycemia, including hyperglycemia, hypoglycemia, and increased glycemic variability, is associated with an increase in hospital-related complications and mortality. 1 Hyperglycemia in diabetic patients hospitalized in the general ward, surgical units, [2][3][4][5] or the intensive care unit 6 is associated with poor clinical outcomes, including longer hospital stay and higher deconditioning, sepsis, and mortality rates. Therefore, optimization of glycemic control in hospitalized patients has been proposed as a necessary and cost-effective strategy. 6 However, implementation of an intensive glucose management program increases the risk of hypoglycemia. Background: Continuous glucose monitoring (CGM) may improve the management of patients with type 2 diabetes hospitalized in the general ward by facilitating the detection of hyper-and hypoglycemic episodes. However, the lack of data on the accuracy and safety of CGM have limited its application.Methods: A prospective pilot study was conducted including 38 patients hospitalized in the general ward with a known diagnosis of type 2 diabetes mellitus (DM) and hyperglycemic individuals without a history of DM with a blood sugar of 140-400 mg on admission treated with a basal bolus insulin regimen. Inpatient glycemic control and the incidence of hypoglycemic episodes were compared between detection by CGM of interstitial fluid for up to 6 days and point-of-care (POC) capillary blood glucose monitoring performed pre-and postprandially, before bedtime and at 3 am.Results: No differences in average daily glucose levels were observed between CGM and POC (176.2 ± 33.9 vs 176.6 ± 33.7 mg/dl, P = .828). However, CGM detected a higher number of hypoglycemic episodes than POC (55 vs 12, P < .01). Glucose measurements were clinically valid, with 91.9% of patients falling within the Clarke error grid A and B zones. Conclusions:Our preliminary results indicate that the use of CGM in type 2 patients hospitalized in the general ward provides accurate estimation of blood sugar levels and is more effective than POC for the detection of hypoglycemic episodes and asymptomatic hypoglycemia.
Summary Risk of death and risk of recurrence in 108 potentially curable non-small-cell lung cancer patients were analysed with respect to TNM stage, histological type and carcinoembryonic antigen (CEA), CA125 antigen and squamous cell carcinoma antigen (SCC) levels in serum and cytosol. CA125 and CEA levels were closely related to outcome figures. Multivariate analyses indicated that TNM stage and histological type had the best predictive power, but serum and cytosolic CA125 and serum CEA contained additional, independent prognostic information. Predictive information drawn from serum and cytosolic levels proved mutually complementary. We conclude that CA125 and CEA complement TNM classification and histological type for the purpose of quantifying risk of death or recurrence.Keywords: carcinoembryonic antigen; CA125; squamous cell carcinoma antigen; lung cancer; prognostic factor; survivalThe tumour -node-metastasis (TNM) classification system is the cornerstone for planning therapy options in patients with non-small-cell lung cancer (NSCLC) (Bains, 1991). Such staging of tumour spread is the best available prognostic factor. However, its predictive power is limited. Differences may be seen between expected and actual outcome after curative resection among patients within the same TNM category of risk. Efforts are under way to confirm the possibility that long-term results or response to treatment may be partially based on biological characteristics inherent in tumour cells (Carney, 1991). Methods for the description of biological tumour aggressiveness are rapidly expanding (Carney, 1991;Lee and Hong, 1992).Owing to their low sensitivity and specificity, tumour markers have, until now, played a less important role in the diagnosis and management of NSCLC than has been the case with most other common cancers (Bergman et al., 1993;Strauss and Skarin, 1994;Jarvisalo et al., 1993 (Gail et al., 1984;Sanchez et al., 1994), guiding follow-up after surgical treatment (Diez et al., 1995) and monitoring response to chemotherapy in advanced disease (Shinkai et al., 1986;Spiridonis et al., 1995). CA125 was initially described as an ovarian cancer-associated antigen, and has recently been assayed in NSCLC. In a previous study we reported that serum levels of CA 125 provide independent information on survival and tumour relapse in patients undergoing curative surgical treatment for NSCLC (Diez et al., 1994a Analysis of tumour marker expression in NSCLC tumour tissue has not been reported as frequently. In a previous study we observed that cytosolic concentration of CEA, SCC and CA125 is a particular and distinctive characteristic of each histological type, something which could aid pathological classification (Picardo et al., 1994). In addition, high CEA plus high CA125 content allows for identification of the large-cell carcinoma histological subtype (Picardo et al., 1994). In our opinion, this kind of study could lead to a better understanding of the relationship between tumour marker and the biological features of the neop...
Background Inflammation is an important risk for mortality in dialysis patients. Extracellular fluid volume (ECFv) expansion, a condition commonly seen in peritoneal dialysis (PD) patients, may be associated with inflammation. However, published support for this relationship is scarce. Objectives To quantify the proportion of patients on PD with inflammation and to analyze the role of ECFv expansion and the factors related to these conditions. Design A prospective, multicenter cross-sectional study in six hospitals with a PD program. Patients and Methods Adult patients on PD were studied. Clinical data, body composition, and sodium and fluid intake were recorded. Biochemical analysis, C-reactive protein (CRP), and peritoneal and urinary fluid and sodium removal were also measured. Results CRP values positive (≥ 3.0 mg/L) for inflammation were found in 147 (80.3%) and negative in 36 patients. Patients with positive CRP had higher ECFv/total body water (TBW) ratio (women 47.69 ± 0.69 vs 47.36 ± 0.65, men 43.15 ± 1.14 vs 42.84 ± 0.65; p < 0.05), higher serum glucose (125.09 ± 81.90 vs 103.28 ± 43.30 mg/dL, p < 0.03), and lower serum albumin (2.86 ± 0.54 vs 3.17 ± 0.38 g/dL, p < 0.001) levels. They also had lower ultrafiltration (1003 ± 645 vs 1323 ± 413 mL/day, p < 0.005) and total fluid removal (1260 ± 648 vs 1648 ± 496 mL/day, p < 0.001), and less peritoneal (15.59 ± 162.14 vs 78.11 ± 110.70 mEq/day, p < 0.01) and total sodium removal (42.06 ± 142.49 vs 118.60 ± 69.73 mEq/day, p < 0.001). In the multivariate analysis, only ECFv/TBW was significantly ( p < 0.04) and independently associated with inflammation. ECFv/TBW was correlated with fluid removal ( r = 0.16, p < 0.03) and renal sodium removal ( r = 0.2, p < 0.01). Conclusion The data suggest that ECFv expansion may have a significant role as an inflammatory stimulus. The results disclose a relationship between the two variables, ECFv expansion and inflammation, identified as independent risk factors for mortality in PD patients.
These results represent the first patient-reported dataset on hypoglycemia in the participating countries and confirm that hypoglycemia is under-reported and more widespread than previously believed. Although the incidence of hypoglycemia was variable among patients on different treatment regimens, there were substantial impacts on both productivity and healthcare utilization following an episode of hypoglycemia. This trial is registered at clinicaltrials.gov: NCT02306681.
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