Self-monitoring Of Blood Glucose Measurements Research Articles

Hypoglycaemia in sulphonylurea-treated subjects with type 2 diabetes undergoing Ramadan fasting: a five-country observational study

Objectives:To determine the incidence of hypoglycaemia during Ramadan in Muslim subjects with type 2 diabetes treated with a sulphonylurea.Methods:In an observational study, eligible subjects were Muslims with type 2 diabetes (age ≥18 years) who were treated with glimepiride, gliclazide, or glibenclamide with or without metformin and who expressed their intention to fast during Ramadan in 2009. Subjects were recruited by clinicians in India, Malaysia, Israel, the United Arab Emirates (UAE), and Saudi Arabia. Each day during Ramadan, patients completed diary cards, which collected information regarding hypoglycaemic symptoms and complications, time from last meal and from last medication, self-monitored blood glucose measurements, and need for assistance. The overall incidence of symptomatic hypoglycaemia recorded during Ramadan was the primary endpoint of interest.Results:Of the enrolled subjects (N = 1397), 1378 returned their diary cards at study end and were included in the analysis. Overall, 89% of subjects who expressed their intention to fast prior to Ramadan reported that they observed the fast during Ramadan. A total of 271 subjects (19.7%) experienced one or more symptomatic hypoglycaemic events during Ramadan, with incidences of 25.6%, 16.8%, and 14.0% observed in subjects treated with glibenclamide, glimepiride, and gliclazide, respectively. By country, the highest incidence of hypoglycaemia was reported by subjects from Israel (40%) followed by those from Malaysia (24%), the UAE (18%), India (13%), and Saudi Arabia (10%). The overall incidence of severe hypoglycaemic events (i.e., events requiring medical or non-medical assistance) was 6.7%, with the highest incidence occurring in the glibenclamide group.Limitations:This was an observational study and as such subjects were not randomised to treatments. While baseline measures appeared comparable, it is possible that differences in measured and unmeasured patient characteristics (e.g., measures of glycaemic control) could partially explain these results. Lastly, no inferential testing was performed on the comparisons between sulphonylurea types and/or countries.Conclusions:In this five-country observational study, nearly 20% of sulphonylurea-treated Muslim subjects with type 2 diabetes experienced symptomatic hypoglycaemia while fasting during Ramadan, with variations across sulphonylureas and countries.

Real-time continuous glucose monitoring system for treatment of diabetes: a systematic review

This study reviews the effect of real-time continuous glucose monitoring systems in diabetes management. A systematic search was performed in PubMed/MEDLINE and EMBASE for randomized controlled trials comparing real-time continuous glucose monitoring systems with self-monitoring blood glucose or non-real-time continuous glucose monitoring systems. Nine randomized controlled trials were identified. Two studies used a device which is not on the market any more. In this review we focus on the other seven studies. Performing a meta-analysis was not possible because of extensive clinical heterogeneity. Six of seven studies showed some positive effect of real-time continuous glucose monitoring systems on HbA(1c) (HbA(1c) decrease 0.3-0.7% or 3-8 mmol/mol). In some studies, this effect only was shown in subgroups (compliant adult patients). However, the size of effect may be underestimated by better-than-average results in the control group, as self-monitoring blood glucose measurements are carried out more frequently than in usual clinical practice. Despite the goal of lowering HbA(1c) , no more severe hypoglycaemic episodes were seen, except in one study. In contrast, no positive effect was shown with the real-time continuous glucose monitoring system on hypoglycaemia, but randomized controlled trials were not designed or powered to investigate this issue. Time in different glucose strata was assessed only in some trials: two of them showed a significant but small increase in time in euglycaemia. Current evidence shows that the real-time continuous glucose monitoring system has a beneficial effect on glycaemic control in adult diabetes patients, without an increase in the incidence of hypoglycaemia. Studies in well-selected patient groups (pregnancy, history of severe hypoglycaemias, Type 2 diabetes) are lacking.

Frequency of SMBG correlates with HbA1c and acute complications in children and adolescents with type 1 diabetes

The aim of this study was to correlate the frequency of self-monitoring of blood glucose (SMBG) to the quality of metabolic control as measured by hemoglobin A1c (HbA1c), the frequency of hypoglycemia and ketoacidosis, and to see whether the associations between SMBG and these outcomes are influenced by the patient's age or treatment regime. We analyzed data from the DPV-Wiss-database of 26 723 children and adolescents aged 0-18 yr with type 1 diabetes recorded during 1995-2006. Variables evaluated were gender, age at visit, diabetes duration, therapy regime, insulin dose, body mass index-standard deviation scores (BMI-SDS), HbA1c, rate of hypoglycemia, and ketoacidosis. In the youngest age group of children under the age of 6 yr, the frequency of SMBG was the highest compared with that in children aged 6-12 yr or children aged > 12 yr: 6.0/d vs. 5.3/d vs. 4.4/d (p < 0.001). Frequency of SMBG differed significantly also in the different groups of treatment (p < 0.001), but only for the continuous subcutaneous insulin infusion (CSII) group the frequency was considerably higher: 5.3/d (CSII) vs. 4.7/d (multiple daily injections) vs. 4.6/d (conventional therapy). Adjusted for age, gender, diabetes duration, year of treatment, insulin regimen, insulin dose, BMI-SDS, and center difference, SMBG frequency was significantly associated with better metabolic control with a drop of HbA1c of 0.20% for one additional SMBG per day (p < 0.001). Increasing the SMBG frequency above 5/d did not result in further improvement of metabolic control. A higher frequency of SMBG measurements was related to better metabolic control. But only among adolescents aged > 12 yr, metabolic control (HbA1c) improved distinctively with two or more blood glucose measurements.

Assessment of glycemic lability and severity of hypoglycemia in Korean patients with type 1 diabetes

Few studies have focused on the quantification of glycemic lability and hypoglycemic events in Asian patients with type 1 diabetes; therefore, we conducted a study to assess glycemic lability and the severity of hypoglycemia in type 1 diabetic patients in Korea. A total of 124 type 1 diabetic patients were enrolled. Several glycemic lability indexes and hypoglycemic indexes were calculated using four-week self-monitoring of blood glucose (SMBG) data. Due to the dependence of the lability index (LI) on the frequency of glucose measurements, we generated a modified LI by dividing by the number of SMBG measurements per day for a given patient. The numbers of patients in our study with a composite hypoglycemic score ≥ 1,047 or LI ≥ 433 mmol/L(2)/h•week(-1), which was found in a previous study to indicate high risk of severe hypoglycemia or lability, were 0 (0%) and 44 (35%), respectively. Compared to previously reported hypoglycemia indexes, the low blood glucose index was lower in our study. However, the glycemic lability indexes were similar to those in previous studies, with the exception of the LI. The modified LI and the average daily risk range (ADRR) showed higher concordance with other glycemic lability indexes than did the LI or mean amplitude of glycemic excursions (MAGE). The results showed that the hypoglycemic indexes in this study population were lower than the results from Ryan et al. Furthermore, the ADRR or modified LI were better measures for high risk of severe lability than were the LI and MAGE.

Sensor-augmented pump therapy from the diagnosis of childhood type 1 diabetes: results of the Paediatric Onset Study (ONSET) after 12 months of treatment

The value of managing children with type 1 diabetes using a combination of insulin pump and continuous glucose monitoring starting from diagnosis for improving subsequent glycaemic control and preserving residual beta cell function was determined. A total of 160 children (aged 1-16 years, mean ± SD: 8.7 ± 4.4 years; 47.5% girls) were randomised to receive insulin pump treatment with continuous glucose monitoring or conventional self-monitoring blood glucose measurements. The primary outcome was the level of HbA(1c) after 12 months. Other analyses included fasting C-peptide, glycaemic variability, sensor usage, adverse events, children's health-related quality of life and parent's wellbeing. HbA(1c) was not significantly different between the two groups, but patients with regular sensor use had lower values (mean 7.1%, 95% CI 6.8-7.4%) compared with the combined group with no or low sensor usage (mean 7.6%, 95% CI 7.3-7.9%; p=0.032). At 12 months, glycaemic variability was lower in the sensor group (mean amplitude of glycaemic excursions 80.2 ± 26.2 vs 92.0 ± 33.7; p=0.037). Higher C-peptide concentrations were seen in sensor-treated 12- to 16-year-old patients (0.25 ± 0.12 nmol/l) compared with those treated with insulin pump alone (0.19 ± 0.07 nmol/l; p=0.033). Severe hypoglycaemia was reported only in the group without sensors (four episodes). Sensor-augmented pump therapy starting from the diagnosis of type 1 diabetes can be associated with less decline in fasting C-peptide particularly in older children, although regular sensor use is a prerequisite for improved glycaemic control. ISRCTN.org ISRCTN05450731 Medtronic International Trading Sàrl, Tolochenaz, Switzerland.

The relationship between self‐monitored blood glucose values and glycated haemoglobin in insulin‐treated patients with Type 2 diabetes

Self-monitoring of blood glucose (SMBG) is an important self-management tool for insulin-treated patients with Type 2 diabetes mellitus (T2DM). Its value in estimating glycaemic control in insulin-treated T2DM patients remains unclear. The relationship between glycated haemoglobin (HbA(1c)) and SMBG measures in T2DM patients treated with premixed insulin lispro mixtures or basal insulin glargine was examined. HbA(1c) and plasma equivalent glucose (PGe) data derived from SMBG profiles were pooled from five randomized clinical trials of patients with T2DM on one or more oral glucose-lowering medication +/- 0-2 insulin injections per day switching to insulin lispro mixtures (N = 317) or glargine (N = 306). Patients generated seven-point SMBG profiles three times in a 2-week period prior to each HbA(1c) measurement. Pearson's correlation coefficients (r) were calculated for PGe values and HbA(1c). Receiver-operating characteristic (ROC) curves determined the ability of sets of PGe to estimate HbA(1c) (< or > 7.0%). Mean +/- standard deviation age was 57.5 +/- 9.5 years, body mass index 31.3 +/- 5.6 kg/m(2), 52.5% were male and HbA(1c) overall was 7.4 +/- 1.0% at end-point. Among individual SMBG measures, r for HbA(1c) ranged from 0.34 to 0.49. For means of two or more PGe measures, r for HbA(1c) ranged from 0.51 to 0.59. Correlations were similar for either regimen. ROC curves were consistent with the correlation data. These data provide patients and clinicians information on the relationship between HbA(1c) and SMBG measurements in patients with T2DM, and support the value of frequent blood glucose measurements for assessing overall glycaemic control.

The Relationship between Self-Monitored Blood Glucose Values and Glycated haemoglobin in Insulin-treated Patients with Type 2 Diabetes

Diabet. Med. 27, 589–592 (2010) Abstract Aims Self-monitoring of blood glucose (SMBG) is an important self-management tool for insulin-treated patients with Type 2 diabetes mellitus (T2DM). Its value in estimating glycaemic control in insulin-treated T2DM patients remains unclear. The relationship between glycated haemoglobin (HbA1c) and SMBG measures in T2DM patients treated with premixed insulin lispro mixtures or basal insulin glargine was examined. Methods HbA1c and plasma equivalent glucose (PGe) data derived from SMBG profiles were pooled from five randomized clinical trials of patients with T2DM on one or more oral glucose-lowering medication ± 0–2 insulin injections per day switching to insulin lispro mixtures (N = 317) or glargine (N = 306). Patients generated seven-point SMBG profiles three times in a 2-week period prior to each HbA1c measurement. Pearson’s correlation coefficients (r) were calculated for PGe values and HbA1c. Receiver–operating characteristic (ROC) curves determined the ability of sets of PGe to estimate HbA1c (< or > 7.0%). Results Mean ± standard deviation age was 57.5 ± 9.5 years, body mass index 31.3 ± 5.6 kg/m2, 52.5% were male and HbA1c overall was 7.4 ± 1.0% at end-point. Among individual SMBG measures, r for HbA1c ranged from 0.34 to 0.49. For means of two or more PGe measures, r for HbA1c ranged from 0.51 to 0.59. Correlations were similar for either regimen. ROC curves were consistent with the correlation data. Conclusions These data provide patients and clinicians information on the relationship between HbA1c and SMBG measurements in patients with T2DM, and support the value of frequent blood glucose measurements for assessing overall glycaemic control.

Comparison of Accuracy and Safety of the SEVEN and the Navigator Continuous Glucose Monitoring Systems

This study evaluated the accuracy and safety of two continuous glucose monitoring (CGM) systems, the SEVEN (DexCom, San Diego, CA) and the Navigator (Abbott Diabetes Care, Alameda, CA), with the YSI laboratory measurements of blood glucose (blood glucose meter manufactured by YSI, Yellow Springs, OH), when worn concurrently in adults with type 1 diabetes. Fourteen subjects with type 1 diabetes, 33 +/- 6 (mean +/- SD) years old, were enrolled in this study. All subjects wore both sensors concurrently over three consecutive 5-day CGM sessions (15-day wear). On Days 5, 10, and 15, subjects participated in an 8-h in-clinic session where measurements from the CGM systems were collected and compared with YSI measurements every 15 min. At the end of Day 5 and 10 in-clinic sessions, the sensors were removed, and new sensors were inserted for the following CGM session despite the SEVEN system's recommended use for up to 7 days. The mean absolute relative difference (ARD) for the two CGM devices versus YSI was not different: 16.8% and 16.1% for SEVEN and Navigator, respectively (P = 0.38). In the hypoglycemic region (YSI value <80 mg/dL), the mean ARD for SEVEN was lower than for Navigator (21.5% vs. 29.8%, respectively; P = 0.001). The data analyses were similar when compared with self-monitoring of blood glucose (SMBG) values. Thirteen additional Navigator replacement devices were issued compared to two for the SEVEN. A total of three versus 14 skin reactions were reported with the SEVEN and Navigator insertion area, respectively. Glucose measurements with the SEVEN and Navigator were found to be similar compared with YSI and SMBG measurements, with the exception of the hypoglycemic range where the SEVEN performed better. However, the Navigator caused more skin area reactions.

Minimizing hypoglycemia while maintaining glycemic control in diabetes.

In an accompanying Perspectives article, Cryer (1) identifies a number of different areas where therapeutic interventions have the potential to reduce hypoglycemia without compromising glycemic control. Some approaches provide well-defined clinical benefits, a few offer dramatic reductions in hypoglycemia but remain out of reach for most people, and others, although promising, have yet to be properly evaluated (Table 1). In this Perspectives article, I examine the evidence that underpins these interventions. It is beyond the scope of this article to review the data for each potential intervention in detail, but the reader is directed to the source where appropriate. The focus of this article is treatment of type 1 diabetes, as most of the specific potential therapies have been evaluated in this group, although included are comments in relation to recent trials of intensive therapy in type 2 diabetes. ### Education and skills training in self-management. Long before the benefits of tight glucose control had been established (2), the belief that insulin therapy should be designed to replace insulin “physiologically” had been advocated by a small number of enthusiastic clinicians. The advent of blood glucose monitoring in the late 1970s had a major impact, since background and meal-related insulin could be given separately and adjusted according to self-monitored blood glucose measurements. Participants were encouraged to eat freely, calculating their insulin dose according to their chosen amount of carbohydrate. Integrating these components was a complex task, probably beyond that of many physicians, let alone patients. If this was to be undertaken every day, then patients needed to acquire the skill of flexible insulin self-management and apply it successfully. The therapeutic education approach was pioneered by Assal et al. (3), and Berger and Muhlhauser (4) went on to develop a residential training course (Insulin Treatment and Training program [ITTP]) evaluating the intervention in a series of studies, including …

In silico simulation of long-term type 1 diabetes glycemic control treatment outcomes.

The goals of this study were to develop (1) a safe and effective protocol for the clinical control of type 1 diabetes using conventional self-monitoring blood glucose (SMBG) measurements and multiple daily injections with insulin analogues, and (2) an in silico simulation tool of type 1 diabetes to predict long-term glycemic control outcomes of clinical interventions. The virtual patient method was used to develop a simulation tool for type 1 diabetes using data from a type 1 diabetes patient cohort (n = 40). The tool was used to test the adaptive protocol (AC) and a conventional intensive insulin therapy (CC) against results from a representative control cohort. Optimal and suboptimal basal insulin replacements were evaluated as a function of SMBG frequency in conjunction with the (AC and CC) prandial control protocols. In long-term glycemic control, the AC protocol significantly decreased hemoglobin A1c in conditions of suboptimal basal insulin replacement for SMBG frequencies > or = 6/day, and reduced the occurrence of mild and severe hypoglycemia by 86-100% over controls, over all SMBG frequencies in conditions of optimal basal insulin. A simulation tool to predict long-term glycemic control outcomes from clinical interventions has been developed to test a novel, adaptive control protocol for type 1 diabetes. The protocol is effective and safe compared to conventional intensive insulin therapy and controls. As fear of hypoglycemia is a large psychological barrier to glycemic control, the AC protocol may represent the next evolution of intensive insulin therapy to deliver increased glycemic control with increased safety. Further clinical or experimental validation is needed to fully prove the concept.

Real-time continuous glucose monitoring using Guardian ®RT: from research to clinical practice

The limited number of self-monitoring blood glucose measurements is an obstacle for good metabolic control in patients with type 1 diabetes. However, continuous glucose measurement with real-time data and alarms is a recent technology that promises to improve the efficacy of treatment in diabetic patients. Guardian ®RT uses a continuous telemetry display of real-time glucose values, and automatic alerts at preset hypo- and hyperglycaemic levels. Three calibrations a day are required, and the sensor must be changed every three days. The GuardControl study showed that, within three months, real-time continuous glucose monitoring with the Guardian ®RT led to significantly improved HbA 1c values in 162 poorly controlled patients (children and adults) with type 1 diabetes despite intensive insulin therapy. The continuous availability of glucose measurements permitted the patients to adjust their own insulin doses, food intake and physical activity and, thus, improve their glycaemic control. This report summarizes the available data on this tool and details how best to use this state-of-the-art modality in diabetic patients in clinical practice.

Approaches for Improving Glucose Monitor Measurements for Self-Monitoring of Blood Glucose: From Measurement Harmonization to External Quality Assessment Programs

Self-monitoring of blood glucose (SMBG) is an important component in diabetes management, helping patients to achieve and maintain normal blood glucose levels. The benefit of SMBG depends on the quality of the measurement performed. Therefore, it is important to know the factors affecting the measurements and to assure that the quality of SMBG measurements is at the highest achievable level possible. To accomplish this, all aspects of the measurement procedure need to be taken into consideration. Sources of variability can be related to the monitor itself, its calibration and use, including blood collection. Improving the variability caused by each source requires specifically designed and targeted efforts. Variability related to the monitor can be assessed in studies that minimize other sources of variability. Variability related to monitor calibration can be assessed and minimized through harmonization or standardization programs, while variability related to the use of the monitors can be addressed through patient-oriented assessment and training. The latter may follow procedures similar to external quality assessment (EQA) programs used in clinical laboratory medicine. However, to obtain an optimal impact on patient care, such programs need to have a wide reach and the social and cultural competency to work efficiently with all patients. The EQA approach or approaches that would provide the most benefit to the patient remain to be determined.

Long-Term Efficacy of Insulin Glargine After Switching from NPH Insulin as Intensive Replacement of Basal Insulin in Japanese Diabetes Mellitus. Comparison of Efficacy between Type 1 and Type 2 diabetes (JUN-LAN Study 1.2)

To assess and compare the efficacy and safety of insulin glargine as intensive replacement of basal insulin in Japanese patients with type 1 (n = 72) and type 2 (n = 46) diabetes, we switched their intensive insulin regimen from NPH plus regular or rapid-acting insulin to glargine plus bolus insulin, which included regular and rapid-acting insulin, and recorded changes in glycemic control and frequency of hypoglycemia for 18 months. The dose titration of basal and bolus insulin was based on home self-monitored blood glucose measurements and monthly HbA(1C). Mean HbA(1C) level was improved significantly at 3 months after switching to glargine plus bolus insulin regimen and these effects continued for 18 months in both type 1 and type 2 diabetes patients (HbA(1C) level: type 1: baseline 8.9 +/- 2.6%, 18 months 7.8 +/- 1.5% (p<0.05), type 2: baseline 8.2 +/- 2.6%, 18 months 7.7 +/- 1.5%. Body weight was slightly but significantly increased at 18 months only in type 2 diabetes. Total daily bolus insulin doses were not changed but basal insulin could be increased significantly after switching regimens in both types diabetes compared with baseline. The frequency of mild to moderate hypoglycemia (self-assisted episodes, blood glucose <70 mg/dl) was marginally lower with glargine but not significantly. Self-monitored fasting blood glucose level was significantly improved after switching in type 2 diabetes. Patients with the worst HbA(1C) level at baseline exhibited more than 10% improvement in HbA(1C) level after switching both type 1 and type 2 diabetes. The HbA(1C) levels of the effectively treated patients were comparable to those of ineffectively treated ones at 6 months and the same improvement was seen at 18 months. Our results suggested that insulin glargine is more effective than NPH insulin as intensive replacement of basal insulin, particularly in those Japanese patients with difficult glycemic control with NPH insulin, equally in both type 1 and type 2 diabetes.

Improved Glycemic Control in Poorly Controlled Patients with Type 1 Diabetes Using Real-Time Continuous Glucose Monitoring

Intensive self-management with frequent self-monitoring of blood glucose (SMBG) is important in type 1 diabetes to achieve good metabolic control (1–3). Nevertheless, many patients still experience episodes of unrecognized hypo- and hyperglycemia (4). Novel technologies for continuous glucose monitoring (CGM) that provide information about glucose excursions are now available. Previous studies reported the benefits of retrospective evaluation of CGM data (5–11), but few assessed effects on glycemic control (5,12–14), and only one showed improvements compared with SMBG (14). We evaluated the effect of a new real-time glucose monitor on glycemic control in patients with poorly controlled type 1 diabetes. The device, Guardian RT (Medtronic MiniMed, Northridge, CA), allows users to see glucose readings and set hypo- and hyperglycemic alarms and provides trend information on changing glucose values. The study included 81 children (median age 14.4 years [range 8.0–18.9]) and 81 adults (age 39.1 years [19.0–59.5]) with stable type 1 diabetes. All had adhered to intensified insulin treatment (continuous subcutaneous insulin infusion, n = 78; multiple daily injection, n = 84) but had HbA1c (A1C) levels ≥8.1%. Informed consent was obtained from patients regularly attending the eight participating centers. Subjects were randomly assigned 1:1:1 for 3 months to Guardian RT continuously (arm 1) or biweekly for 3-day periods every 2 weeks (arm 2) or to continue conventional SMBG (control). Treatment adjustments made by physicians and patients were based on SMBG profiles in control subjects and on real-time glucose profiles in arms 1 and 2. Patients were instructed to perform confirmatory SMBG measurements before therapeutical interventions or corrective action if hypo- or hyperglycemic alarms or symptoms occurred. …

Results and Feasibility of an External Quality Assessment Scheme for Self-Monitoring of Blood Glucose

The analytical quality of self-monitoring of blood glucose (SMBG) is not satisfactory, and the need for standardized control routines for SMBG has been underscored. The objective of this study was to investigate whether an external quality assessment scheme (EQAS) designed for office laboratories could improve the quality of SMBG measurements. From October 2001 through March 2004, we conducted 6 glucose surveys for diabetes patients and coordinated them with an EQAS for office laboratories. Patients received 2 control samples by post twice a year. They measured each control sample in duplicate in accordance with written instructions, returned the results, and received an assessment of their analytical performance. Participants who got a poor evaluation were followed up by phone and were offered guidance. Participating in an EQA program over a period of 3 years decreased the percentage of poor results among diabetes patients significantly, from 11.2% to 1.9% in the first and last surveys, respectively. Between-participant CVs improved from 5.5% to 3.7% and were comparable to results from office laboratories. It was difficult to sort out factors contributing to quality improvement. Implementing a traditional EQAS among diabetes patients may improve the analytical quality of SMBG and could be convenient for motivated patients. Further evaluation of the clinical usefulness of implementing such a program is needed, however, and costs as well as limitations of current EQAS for glucose in general should be taken into account.

Evaluation of a new blood glucose monitoring system with auto-calibration for home and hospital bedside use

A new self-calibrating blood glucose monitoring system (BGMS) was evaluated in a series of clinical studies with both ambulatory subjects and with hospitalized patients. The new BGMS requires a 0.6 μL sample volume, provides results in 15 s, and uses a glucose dehydrogenase chemistry that is oxygen independent. In the first study, Ascensia ® Contour™ meters calibrated to whole blood were tested by health care professionals (HCP) and lay users at two clinical sites. Both HCPs and lay users obtained results that fulfilled the ISO 15197:2003 criteria that 95% of self-monitoring blood glucose (SMBG) measurements should fall within ±20% (for blood glucose (BG) concentrations ≥ 4.2 mmol/L or ±0.83 mmol/L for BG concentrations < 4.2 mmol/L) of the laboratory value. Lay users and HCPs obtained 97.2 and 96.7% of glucose results within ISO criteria, respectively. In a second study, HCPs assayed blood samples from patients at the hospital bedside using meters calibrated to give whole blood glucose and meters calibrated to give plasma glucose results. Overall, 94.7% of the measurements met the ISO 15197:2003 criteria. Most lay subjects rated the BGMS as either excellent or very good in a questionnaire, and were able to use it properly without training. These findings indicate that this new BGMS is a convenient and accurate instrument system suitable for both hospital bedside use by HCPs and for SMBG by people who routinely monitor their blood glucose.

Comparison of glycaemic control over 1 year with pioglitazone or gliclazide in patients with Type 2 diabetes

To compare long-term (1 year) efficacy and safety of pioglitazone and gliclazide in patients with Type 2 diabetes. This was a double-blind, multicentre, comparative, parallel group trial in 283 patients with Type 2 diabetes, who were randomized to receive 1-year treatment with pioglitazone 30-45 mg/day or gliclazide 80-320 mg/day. Drug dose was titrated on the basis of self-monitored blood glucose (SMBG) measurements and HbA1c values. The 1-year changes in HbA1c, fasting blood glucose (FBG), insulin, HOMA-S (HOmeostatic Model Assessment) and SMBG were compared. In a subgroup of patients (n = 10), systemic glucose production and utilization were determined by a combination of isotopic (deuterated glucose) and clamp techniques. In both groups, there were similar decreases in HbA1c (pioglitazone: -0.79%; gliclazide: -0.79%) and FBG (pioglitazone: -1.0 mmol/l; gliclazide: -0.7 mmol/l), whereas the slope of the reduction of fasting blood glucose was different between groups (P = 0.004). Insulin levels as well as insulin resistance assessed using HOMA-S decreased significantly only after pioglitazone treatment (-11.94 pmol/l and -1.03, respectively, both P = 0.002 vs. baseline). A significantly greater reduction in systemic glucose production was observed in the pioglitazone group (-2.48 micromol/kg/min, P = 0.042) than in the gliclazide group (-1.02 micromol/kg/min). A few, mild adverse events occurred in both groups. A comparable decrease in HbA1c and FBG was observed with pioglitazone and gliclazide. However, with pioglitazone there was a continuous decrease in FBG over 1 year, whereas gliclazide failed to maintain a similar trend. This favourable effect of pioglitazone was due to its insulin-sensitizing effect and ability to decrease systemic glucose production.

Do HbA1c levels and the self-monitoring of blood glucose levels adequately reflect glycaemic control during pregnancy in women with type 1 diabetes mellitus?

Pregnancies of women with type 1 diabetes mellitus are associated with maternal and perinatal complications. These complication rates remain elevated despite achievement of the treatment goals described in the widely used guidelines of the American Diabetes Association (i.e. HbA(1)c level <or=7.0%). Against this background, we sought to answer two questions: (1) are HbA(1)c levels within 1% above normal appropriate in pregnant women with type 1 diabetes or should treatment be aimed at normal HbA(1)c levels; and (2) how many self-monitored blood glucose (SMBG) levels are needed per day to obtain an adequate image of glycaemic control in pregnant women with type 1 diabetes? We asked 43 pregnant women with type 1 diabetes to use the Continuous Glucose Monitoring System (CGMS) once in each trimester of pregnancy, while continuing their SMBG measurements. Glucose levels measured with the CGMS were compared between patients with HbA(1)c levels of 4.0-6.0%, 6.0-7.0% and >7.0%. Self-monitored glucose levels and those measured with CGMS were compared between patients with four or five, six to nine and ten or more SMBG determinations daily. In patients with HbA(1)c levels <or=6.0%, the glucose levels obtained by CGMS were significantly better than in patients with HbA(1)c levels >6.0%. In women with HbA(1)c levels 6.0-7.0% and >7.0%, these levels did not differ. The detection rate of hyper- and hypoglycaemic episodes was significantly higher in patients with ten or more SMBG determinations daily than in patients with fewer than ten. Treatment of diabetes in pregnant women should be aimed at achieving HbA(1)c levels within the normal range, i.e. <or=6.0%. A minimum of ten SMBG determinations daily is necessary to obtain adequate information of all daily glucose fluctuations.

Counterpoint: Self-Monitoring of Blood Glucose in Type 2 Diabetic Patients not Receiving Insulin

Most people would agree that treatment plans, especially those that have invasive components and/or are expensive, should result in improved clinical outcomes. Self-monitoring of blood glucose (SMBG), as part of a treatment plan, fulfills both of these criteria but does have the potential to improve outcomes by lowering glycemia and thereby decreasing diabetic retinopathy, nephropathy, and neuropathy. In insulin-requiring patients, A1C levels are inversely related to the frequency of SMBG measurements (1–7), attesting to the beneficial effect of this component of the treatment plan. However, simply measuring blood glucose is ineffective. In one study (8), increased frequency of SMBG resulted in lower A1C levels only in those who self-adjusted their insulin doses, not in the insulin-requiring patients who did not (strongly suggesting that acting on the values is necessary). What about type 2 diabetic patients not receiving insulin? A large number of studies have been carried out to answer this question, and the evidence is distinctly underwhelming. Randomized clinical trials are considered the best approach to evaluate these kinds of clinical questions, and six studies in which the patients were randomized have been published. In the earliest one, which included both insulin- and non–insulin-requring patients and lasted for 6 months (2), 68 non–insulin-requiring patients were randomized to SMBG, 72 to measuring urine glucose semiquantitatively (both groups being asked to do so twice every other day), and 68 to a control group. Compliance with requested SMBG testing was 50%. The baseline A1C levels were 7.8, 8.5, and 7.7%, respectively. The changes in A1C levels in each group at the end of the study were −0.4, −0.1, and −0.5%, respectively, which were not statistically significant. In a second study (9), 27 patients were randomized to SMBG and 27 to measuring urine glucose semiquantitatively, both before each meal every other day. …

Introductory Experience with the Continuous Glucose Monitoring System (CGMS®; Medtronic Minimed®) in Detecting Hyperglycemia by Comparing the Self-Monitoring of Blood Glucose (SMBG) in Non-Pregnant Women and in Pregnant Women with Impaired Glucose Tolerance and Gestational Diabetes

To assess the detection rate of hyperglycemia with a continuous glucose monitoring system compared to a self-monitoring blood glucose profile in non-pregnant, non-diabetic pregnant women, and patients with impaired glucose tolerance or gestational diabetes.. Eight non-pregnant (NP) and 56 pregnant women (17 dietary-treated gestational diabetics (GDM), 15 women with impaired glucose tolerance (IGT), and 24 non-diabetic pregnant women (NDP)) underwent a 72-hour measurement with the CGMS (Medtronic Minimed, Northridge, CA, USA). Self-monitored blood glucose measurements, performed 30 minutes before and 120 minutes after each meal, were compared to the duration of hyperglycemia monitored by the continuous glucose monitoring system. No clinically observable infection was found at the subcutaneous tissue where the electrode was placed. A statistically significant difference was found between the groups in body mass index, HbA1c, and in gestational age, but not in age or parity. Using the self-monitored blood glucose (SMBG), 88 % (7/8) of the NP and 54 % (13/24) of the NDP had no measurement above 6.7 mmol/l. However, 17 % (4/24) of the NDP and 40 % (6/15) of the IGT showed more than two measurements above 6.7 mmol/l compared to 24 % (4/17) of the dietary-treated GDM. The differences between these groups were not significant (p = 0.21). The mean durations (+/- SD) of hyperglycemia above 6.7 mmol/l/24 h were: NP 111 +/- 120 min, NDP 138 +/- 120 min, IGT 381.8 +/- 295 min, and GDM 190 +/- 155 min, p = 0.017; above 7.8 mmol/l/24 h NP 24 +/- 49 min, NDP 38 +/- 47 min, IGT 170.7 +/- 190 min, and GDM 64 +/- 88 min, p = 0.016; and above 8.9 mmol/l/24 h NP 9.3 +/- 25 min, NDP 7.5 +/- 14 min, IGT 59 +/- 77 min, and GDM 14 +/- 21 min, p = 0.026. There was no significant difference in the fetal outcome or rate of birth percentiles using the sensor data. The use of the sensor in pregnant women is unproblematic. a) The CGMS detected more frequent and longer durations of hyperglycemia in GDM compared to non-diabetic pregnant women than the SMBG. b) Women with an IGT exhibited higher glucose levels than patients with gestational diabetes. c) The clinical importance of these hyperglycemic intervals, e.g. with respect to the risk for macrosomia, must be assessed in larger trials.