Myocardial infarction and stroke in early years after diagnosis of type 2 diabetes: risk factors and relation to self-monitoring of blood glucose.

BACKGROUND: The natural course of macrovascular events in patients with type 2 diabetes was analyzed: what are the risk factors, and what is the relationship to the use of self-monitoring of blood glucose (SMBG)? METHODS: Data were retrieved from ROSSO-a German retrospective observational study-which followed 3,268 patients from diagnosis of type 2 diabetes for 6.5 +/- 1.6 years. We compared patients with or without a nonfatal macrovascular event (myocardial infarction or stroke) and patients using or not using SMBG. RESULTS: At baseline, worse glycemic control and higher body mass index were not risk factors for macrovascular events. Moreover, there was no association with classic risk factors like blood pressure or total cholesterol. Overall, there was a higher incidence of stroke than of myocardial infarction (0.78% vs. 0.51%). Myocardial infarction was positively associated with male sex, and stroke with age (P < 0.001 for each). Patients using SMBG compared to patients not using SMBG had fewer myocardial infarctions (2.0% vs. 4.0%, P = 0.002) and strokes (3.6% vs. 5.7%, P = 0.005), experienced a stroke later after diagnosis of type 2 diabetes (5.1 +/- 1.9 vs. 3.8 +/- 2.1 years, P < 0.001), and had a higher mean hemoglobin A1c in the years before a myocardial infarction (7.8 +/- 1.8% vs. 6.8 +/- 1.1%, P = 0.003) or a stroke (8.0 +/- 1.8% vs. 7.1 +/- 1.2%, P = 0.003). However, classic cardiovascular risk factors did not differ between patients using or not using SMBG. CONCLUSIONS: In patients with type 2 diabetes SMBG was associated with a lower event rate of myocardial infarction (-50%) and stroke (-37%), although at baseline the classic risk factors for macrovascular events were not different in both groups.

The effect of nurse-led diabetes self-management education on glycosylated hemoglobin and cardiovascular risk factors: a meta-analysis.

PURPOSE: The purpose of this meta-analysis was to determine the effect of nurse-led diabetes self-management education (DSME) on blood glucose control and cardiovascular risk factors. METHODS: The electronic databases PubMed and ISIS Knowledge were searched for relevant randomized controlled studies published between 1999 and 2009. Effect size was calculated for change in A1C, blood pressure, and lipid levels using both fixed- and random-effects models. Subgroup analyses were performed on patient age, gender, diabetes type, baseline A1C, length of follow-up, and study setting. RESULTS: A total of 34 randomized controlled trials with a combined cohort size of 5993 patients was identified. Mean patient age was 52.8 years, 47% were male, and mean A1C at baseline was 8.5%. Mean change in A1C was a reduction by -0.70% for nurse-led DSME versus -0.21% with usual care (UC). This corresponded to an effect size of 0.506, using a random-effects model for nurse-led DSME versus UC. Effect size was significantly associated with patient age older than 65 years and with duration of follow-up. Nurse-led DSME was also associated with improvements in cardiovascular risk factors, particularly among male patients, among those with good glycemic control, and in studies conducted in the United States. CONCLUSIONS: Nurse-led DSME is associated with improved glycemic control, demonstrating that programs are most effective among seniors and with follow-up periods of 1 to 6 months. Future programs tailored to the needs of patients younger than 65 years may improve the impact of DSME on blood glucose.

Impact of self-measurement of blood glucose on complications of type 2 diabetes: economic analysis from a Czech perspective.

OBJECTIVE: A growing body of evidence indicates that self-measurement of blood glucose (SMBG) also has beneficial effects in people with type 2 diabetes, irrespective of the type of therapy. The objective of this analysis was to determine the economic impact of SMBG by comparing the cost share of self-monitoring and the direct costs of diabetes-related complications in users and non-users. RESEARCH DESIGN AND METHODS: A matched-pair analysis based on the cohorts of a large retrospective study of patients with type 2 diabetes (ROSSO) was conducted. The average annual direct costs of diabetes monitoring, treatment-related services, complications and follow-up costs of the disease for SMBG users versus non-users were calculated from the perspective of the Czech statutory health insurance system. Univariate sensitivity analysis was performed to determine the main cost drivers. Limitations of this study are: (1) differences in medical facilities/practice between Germany and the Czech Republic, (2) causal relationship between SMBG and health outcomes is missing, (3) ROSSO underestimated the number of test strips used, (4) Czech cost data are scarce. RESULTS: In patients treated with oral antidiabetic drugs (OAD) only, total annual costs in Czech koruna (CZK) were CZK 16 476 for SMBG users and CZK 19 440 for non-users. In patients treated with OAD + insulin, total annual costs were CZK 32 590 and CZK 48 600, respectively. The main cost drivers were stroke and myocardial infarction in patients treated with OAD only, and stroke, dialysis and myocardial infarction in patients treated with OAD + insulin. CONCLUSION: Cost analysis indicated that SMBG provides a rapid return on initial investment. By increasing the number of patients using SMBG, the statutory health insurance system in the Czech Republic may save several million CZK annually.

System accuracy evaluation of 27 blood glucose monitoring systems according to DIN EN ISO 15197.

BACKGROUND: Blood glucose (BG) monitoring systems enable diabetes patients to effectively control and adjust their therapy. BG monitoring systems with a Conformité Européenne (CE) label should meet the standard DIN EN ISO 15197:2003: > or =95% of the BG results shall fall within +/-15 mg/dL of the reference method at BG concentrations <75 mg/dL and within +/-20% at BG concentrations > or =75 mg/dL. We intended to verify if BG monitoring systems with a CE label fulfill these minimum accuracy requirements. METHODS: We evaluated 27 BG monitoring systems from 18 manufacturers for system accuracy according to DIN EN ISO 15197:2003. Twenty-four systems were compared with the glucose oxidase reaction (YSI 2300 glucose analyzer [YSI Life Sciences, Yellow Springs, OH]) and three systems with the hexokinase reaction (Hitachi 917 [Roche Diagnostics GmbH, Mannheim, Germany]). Duplicate measurements of 100 blood samples with a defined distribution of BG concentrations from 20 mg/dL to 600 mg/dL from > or =100 subjects were included in the evaluation. RESULTS: Sixteen of the 27 BG monitoring systems fulfilled the minimum accuracy requirements of the standard, i.e., > or =95% of their results showed the minimum acceptable accuracy. Overall, the mean percentage of results showing the minimum acceptable accuracy was 95.2 +/- 5.2%, ranging from 80.0% to 100.0%. CONCLUSIONS: More than 40% of the evaluated BG monitoring systems did not fulfill the minimum accuracy requirements of DIN EN ISO 15197:2003. As inaccurate BG monitoring systems bear the risk of false treatment decisions by the diabetes patient and subsequent possible severe health injury, manufacturers should regularly and effectively check the quality of BG meters and BG test strips.

Comparison of lancing devices for self-monitoring of blood glucose regarding lancing pain.

BACKGROUND: Self-monitoring of blood glucose empowers diabetes patients to effectively control their blood glucose (BG) levels. A potential barrier to frequent BG controls is lancing pain, intrinsically linked to pricking the finger several times a day. In this study, we compared different state-of-the-art lancing devices from leading manufacturers regarding lancing pain, and we intended to identify lancing devices that are less painful. METHODS: First, 165 subjects compared 6 different BG monitoring systems-consisting of a lancing device and a BG meter-at home for 36 days and at least 3 BG tests per day. Second, the subjects directly compared 6 different lancing devices-independent from a BG meter-in a laboratory setting. The test results were collected in questionnaires, and lancing pain was rated on a numerical rating scale. RESULTS: One hundred fifty-seven subjects were included in the analysis. Accu-Chek BG monitoring systems were significantly (p < or = .006) preferred to competitor BG monitoring systems and were rated by >50% of the subjects as "less painful" than competitor BG monitoring systems. Accu-Chek lancing devices were significantly (p < .001) preferred to competitor lancing devices and were rated by >60% of the subjects as "less painful" than competitor lancing devices. CONCLUSIONS: We found significant differences in lancing pain between lancing devices. Diabetes patients clearly preferred lancing devices that cause less lancing pain. In order to improve patient compliance with respect to an adequate glycemic control, the medical staff should preferentially prescribe lancing devices that cause less lancing pain.

Prevention of diabetic ketoacidosis and self-monitoring of ketone bodies: an overview.

OBJECTIVE: Diabetic ketoacidosis (DKA) is associated with significant morbidity and mortality. Self-monitoring of ketone bodies by diabetes patients can be done using blood or urine. We compared the two self-monitoring methods and summarized recent developments in the epidemiology and management of DKA. METHODS: MEDLINE and EMBASE were searched for relevant publications addressing the epidemiology, management and prevention of DKA up to 2009. The current, relevant publications, along with the authors' clinical and professional experience, were used to synthesize this narrative review. FINDINGS: Despite considerable advances in diabetes therapy, key epidemiological figures related to DKA remained nearly unchanged during the last decades at a global level. Prevention of DKA - especially in sick day management - relies on intensive self-monitoring of blood glucose and subsequent, appropriate therapy adjustments. Self-monitoring of ketone bodies during hyperglycemia can provide important, complementary information on the metabolic state. Both methods for self-monitoring of ketone bodies at home are clinically reliable and there is no published evidence favoring one method with respect to DKA prevention. CONCLUSIONS: DKA is still a severe complication potentially arising during prolonged hyperglycemic episodes with possibly fatal consequences. Education of patients and their social environment to promote frequent testing - especially during sick days - and to lower their glucose levels, as well as to recognize the early symptoms of hyperglycemia and DKA is of paramount importance in preventing the development of severe DKA. Both methods for self-monitoring of ketone bodies are safe and clinically reliable.

Performance of a digital PCO2/SPO2 ear sensor.

OBJECTIVE: For determining the adequacy of ventilation, conventional pulse oximetry should be amended by PaCO2 (= arterial carbon dioxide partial pressure). This study investigates the precision of carbon dioxide measurements of the first digital ear-clip sensor providing continuous non-invasive monitoring of PaCO2, SpO2 (= functional arterial oxygen saturation as estimated with a pulse oximeter) and pulse rate and compares it to two conventional analog oximeters. METHODS: 30 hypoxemia episodes in 6 adult volunteers were investigated in a standardized protocol. EQUIPMENT: Masimo analog finger sensor, Nellcor analog ear sensor, SenTec digital ear sensor. RESULTS: The difference between PCO2 data (= PaCO2 estimated from the measured PcCO2 based on an algorithm by Severinghaus) (PcCO2 = cutaneous carbon dioxide pressure) and the PaCO2 is clinically unimportant. Therefore, we suggest, the two methods of estimating patient's carbon dioxide status can be used interchangeably. CONCLUSIONS: Combined digital SpO2/ PcCO2 ear sensors are very promising to allow for a fast and reliable monitoring of patient's oxygenation, hyper-/hypocapnia and ventilation with one single non-invasive probe. Optimal primary signal processing--amplification and digitalisation within the probe--allow for fast and reliable downstream signal processing algorithms. The resulting short SpO2 response times give the medical staff more time to take appropriate actions.