Laboratory evaluation of the Glucocard blood glucose test meter.
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The Glucocard (Kyoto Daiichi Kagaku) blood glucose meter is designed for self-monitoring of blood glucose concentrations in capillary blood through use of an electrochemical test strip. Evaluated in this laboratory, the Glucocard had CVs of 4.6%, 6.6%, and 3.5% at blood glucose concentrations of 2.4, 4.1, and 18.9 mmol/L, respectively. The meter's response varied linearly with blood glucose concentration between 2.2 and 27.8 mmol/L. Hemolysis, urate, ascorbate, and acetaminophen interfered by > 5%. Different hematocrits, in the range 0.20-0.70, did not affect the measured glucose concentration. Comparison with glucose results measured in whole blood with a NOVA Stat Profile 5 instrument yielded the following: Glucocard = 0.898 NOVA--0.184 (r = 0.995). The main advantages of the Glucocard are its small sample volume (5 microL), wide linear range, and fully automated sample-handling steps, which reduce user-related variability. (+info)
Health behaviors and quality of care among Latinos with diabetes in managed care.
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OBJECTIVES: We evaluated whether ethnicity and language are associated with diabetes care for Latinos in managed care. METHODS: Using data from 4685 individuals in the Translating Research Into Action for Diabetes (TRIAD) Study, a multicenter study of diabetes care in managed care, we constructed multivariate regression models to compare health behaviors, processes of care, and intermediate outcomes for Whites and English- and Spanish-speaking Latinos. RESULTS: Latinos had lower rates of self-monitoring of blood glucose and worse glycemic control than did Whites, higher rates of foot self-care and dilated-eye examinations, and comparable rates of other processes and intermediate outcomes of care. CONCLUSIONS: Although self-management and quality of care are comparable for Latinos and Whites with diabetes, important ethnic disparities persist in the managed care settings studied. (+info)
The accuracy of the GlucoWatch G2 biographer in children with type 1 diabetes: results of the diabetes research in children network (DirecNet) accuracy study.
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The accuracy of the GlucoWatch G2 Biographer (GW2B; Cygnus, Inc., Redwood City, CA) was assessed in children and adolescents with type 1 diabetes mellitus (T1DM). During a 24-h clinical research center stay, 89 children and adolescents with T1DM (3.5-17.7 years old) wore 174 GW2Bs and had frequent serum glucose determinations during the day and night and during insulin-induced hypoglycemia and meal-induced hyperglycemia, resulting in 3672 GW2B-reference glucose pairs. The median relative absolute difference between the GW2B and reference glucose values was 16% (25th, 75th percentiles = 7%, 29%). The proposed International Organisation for Standardisation criteria were met for 60% of sensor values. Accuracy was better at higher serum glucose levels than low glucose levels. Accuracy degraded slightly as the sensor aged. Time of day, subject age, gender, or body mass index did not impact GW2B accuracy. There were no cases of serious skin reactions. Although the accuracy of this generation of sensor does not approach that of current home glucose meters, the majority of sensor glucose values are within 20% of the serum glucose. This level of accuracy may be sufficient for detecting trends and modifying diabetes management. Further longitudinal outpatient studies are needed to assess the utility of the GW2B as a management tool to improve glycemic control and decrease the incidence of severe hypoglycemia in children with diabetes. (+info)
White coat hyperglycaemia: disparity between diabetes clinic and home blood glucose concentrations.
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OBJECTIVES: To identify patients with discrepantly high clinic blood glucose concentrations compared with self reported values and to assess whether such patients have errors in self monitoring technique. To determine whether, in patients with good technique, the discrepancy is a transient phenomenon related to clinic attendance. DESIGN: Prospective study of diabetes clinic patients recruited over six months. SETTING: Outpatient diabetes clinic of a teaching hospital. SUBJECTS: 34 consecutive patients with non-insulin dependent diabetes who had had at least two consecutive clinic blood glucose concentrations more than 5 mmol/l higher than the mean self reported concentration. MAIN OUTCOME MEASURES: Assessment of monitoring technique; presence of cognitive or physical impairment; serum fructosamine concentration; home and clinic blood glucose concentrations. RESULTS: 15 of 34 patients had errors in monitoring technique, 12 of whom had cognitive or physical impairment. In the remaining 19, the mean (SD) blood glucose concentrations of capillary and venous samples taken at home (10.2 (0.6) and 12.2 (1.1) mmol/l respectively) were significantly lower than in those taken at the clinic (16.8 (1.6) mmol/l, p < 0.0002). The fructosamine concentration was significantly higher in patients with monitoring errors than those without (2.4 (0.4) v 1.8 (0.4) mmol/l, p < 0.0001). CONCLUSIONS: "White coat" hyperglycaemia was detected in about half the patients but errors in technique accounted for the rest of the discrepancies. Patients' ability should be assessed before teaching self monitoring and the technique checked regularly. (+info)
Self-monitoring of blood glucose significantly improves metabolic control in patients with type 2 diabetes mellitus: the Auto-Surveillance Intervention Active (ASIA) study.
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OBJECTIVE: Self monitoring of blood glucose (SMBG) in type 2 diabetes is a topic of current interest (imbalance between increased health-care costs and improvement in compliance with treatment and diet). An open label randomized prospective study was designed to compare changes in metabolic control over 6 months in patients managed with usual recommendations alone (conventional assessment group) or combined with SMBG. RESEARCH DESIGN AND METHODS: Patients not treated with insulin or previously self monitored, 40 to 75 years of age, with a diagnosis of type 2 diabetes > 1 year and standardized HbA(1c) level > =7.5 and< =11% were randomized to either a control group or SMBG group. They were followed up every 6 weeks over 24 weeks. Patients in the SMBG group were given the same device (Ascensia Esprit Discmeter, Bayer) and were required to perform at least 6 capillary assays a week (3 different days of the week, including weekend). Management of patients was standardized, including drugs, diet and physical activity. The primary efficacy criterion was change in HbA(1c) level in Intent To Treat (ITT) patients. Assays were performed at baseline, at 3 and 6 months using the calibrated DCA 2000(R) device (Bayer). RESULTS: Two hundred sixty five general practitioners randomized 988 patients (ITT Population), but 689 patients were evaluable for the primary criterion. At the endpoint, HbA(1c) was lower in the SMBG group (8.1 +/- 1.6%) than in the conventional treatment group (8.4 +/- 1.4%, P=0.012). The change in HbA(1c) levels between baseline and endpoint was classified into two classes: improvement if a change > 0.5% occurred, stability or worsening in case of a change< =0.5%; 57.1% of patients in the SMBG group vs 46.8% in the control group had an improvement in HbA(1c) level (P=0.007) after 3 months. A steady state was reached during the last 3 months. A multivariate logistic regression analysis was performed and identified factors predictive of improvement in HbA(1c) levels: HbA(1c) at baseline: odd ratio (OR)=1.749 (P<0.001), SMBG group (reference value: SMBG group): OR=0.665 (P=0.015), duration of diabetes: OR=0.953 (P=0.001) and BMI: OR=0.962 (P=0.039). CONCLUSIONS: This study is the first multicenter, controlled, prospective trial conducted on a large number of patients demonstrating that SMBG was statistically associated with a better quality of metabolic control than usual traditional recommendations alone in type 2 diabetes. (+info)
Improved metabolic control in diabetic adolescents using the continuous glucose monitoring system (CGMS).
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OBJECTIVE: To determine the utility of the continuous glucose monitoring system (CGMS) as an outpatient procedure to improve management of diabetes in adolescents. RESEARCH DESIGN AND METHODS: Twelve adolescents (mean age: 16.2 +/- 3 years) with poorly controlled type 1 diabetes (HbA(1c) > 8%) were included in this trial. Mean HbA(1c) during the previous year was 10.1 +/- 1.2%. Insulin treatment consisted of 2 or 3 daily injections in 10 cases and CSII in 2. At the beginning of the study, HbA(1c) was determined and low blood glucose index (LBGI) was calculated. Continuous glucose monitoring was performed for three days. After downloading and analyzing data, results were discussed with the patient and insulin treatment was adjusted. Two months later testing was repeated and all parameters were reassessed. RESULTS: Initial CGMS profiles demonstrated glycemic excursions unrecognized by capillary measurements in all twelve patients. Glycemia before and after meals varied from<60 mg/dL to > 200 mg/dL in 2 patients (2 episodes). Postprandial hyperglycemia exceeded 200 mg/dL in 10 patients (24 episodes). Prolonged overnight hyperglycemia was observed in 5 patients (7 episodes), dawn phenomenon in 4 patients (6 episodes) and nighttime hypoglycemia in 4 patients (4 episodes). A day-to-day reproducibility of glycemic profiles was observed in 8 patients. Then insulin treatment was adjusted according to CGMS data. Changes involved dose levels in 3 patients, insulin type in 7, number of injections, i.e. 3 instead of 2, in 5 or change from insulin injection to CSII in 1. Reassessment two months later demonstrated a significant reduction of glycemic excursions in 8 patients. HbA(1c) (m +/- SD) decreased from 10.3 +/- 2.1% to 8.75 +/- 1.06% (p<0.05). LBGI increased from 1.7 +/- 0.9 to 2.4 +/- 1.4 but the difference was not significant. CONCLUSIONS: Use of CGMS in diabetic adolescent outpatients achieved a significant improvement in metabolic control not only by providing accurate data for adjustment of insulin treatment but also by promoting patient communication and motivation. (+info)
Technology failure analysis: understanding why a diabetes management tool developed for a Personal Digital Assistant (PDA) didn't work in a randomized controlled trial.
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Managing Type 1 Diabetes Mellitus is a challenging feat especially for young patients. It is a tedious and demanding disease which requires painful self-monitoring and injections multiple times per day. Many patients are unable to achieve good blood sugar control, in spite of strong evidence that good control leads to better outcomes. Many caregivers believe that more communication between caregivers and patients could lead to better control. This paper describes a tool that was developed to improve communication between caregivers and patients, its testing, how it failed to achieve its outcomes and recommendations for improvement. (+info)
Blood glucose self-monitoring in non-insulin-treated type 2 diabetes: a qualitative study of patients' perspectives.
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BACKGROUND: Self-monitoring of blood glucose is controversial in the management of type 2 diabetes. Some research suggests that self-monitoring improves glycaemic control, whereas other research is sceptical about its value for people with type 2 diabetes who are not on insulin. Although blood glucose meters are widely available and used by this group, patients' own views are absent from the debate. AIM: To explore the pros and cons of glucose monitoring from the patients' perspectives. DESIGN OF STUDY: Qualitative repeat-interview study. SETTING: Patients were recruited from 16 general practices and three hospital clinics within four local healthcare cooperatives in Lothian, Scotland. METHOD: Interview data from 40 patients diagnosed with type 2 diabetes within the previous 6 months were analysed using thematic analysis informed by grounded theory. We report findings from round 1 and round 2 interviews. RESULTS: Glucose monitoring can heighten patients' awareness of the impact of lifestyle; for example, dietary choices, on blood glucose levels. Glucose monitoring amplifies a sense of 'success' or 'failure' about self-management, often resulting in anxiety and self-blame if glucose readings remain consistently high. Moreover, monitoring can negatively effect patients' self-management when readings are counter-intuitive. CONCLUSION: Our analysis highlights the importance of understanding the meanings that newly diagnosed patients attach to glucose self-monitoring. To maximise the positive effects of self-monitoring, health professionals should ensure that patients understand the purpose of monitoring and should clarify with patients how readings should be interpreted. (+info)