Self-monitoring Of Blood Glucose Devices Research Articles

Noncontact optical device for measuring blood glucose in aqueous humor: a pilot clinical study investigating correlation with blood glucose levels.

Monitoring blood glucose levels is crucial for individuals with diabetes. Noninvasive methods for measuring serum glucose levels have been explored to aid in blood glucose control for diabetes management. We introduced a noncontact optical glucometer (NCGM) for measuring glucose levels in the aqueous humor of the human eye. We also investigated the correlation between glucose levels in the NCGM and the aqueous humor, blood samples, and self-monitoring blood glucose devices. The optical system used in this study measured both the near-infrared absorption and polarized rotatory distribution of glucose molecules in the human aqueous humor. This prospective study's outcomes were eye aqueous glucose level, preoperative blood glucose level, intraoperative blood glucose level, and NCGM reading of patients in a single center in Taiwan. The NCGM's measurements showed a strong correlation with blood glucose levels (intra-class correlation [ICC]: 0.95 to 0.98) and aqueous humor glucose levels (ICC: 0.76), indicating its ability to noninvasively measure blood glucose levels in human subjects. This NCGM may offer a convenient, pain-free, and rapid tool for measuring blood glucose levels in diabetic patients. The device could represent a significant advancement in noncontact hybrid optical glucose measurement systems.

Effects of Digitization of Self-Monitoring of Blood Glucose Records Using a Mobile App and the Cloud System on Outpatient Management of Diabetes: Single-Armed Prospective Study.

In recent years, technologies promoting the digitization of self-monitoring of blood glucose (SMBG) records including app-cloud cooperation systems have emerged. Studies combining these technological interventions with support from remote health care professionals have reported improvements in glycemic control. To assess the use of an app-cloud cooperation system linked with SMBG devices in clinical settings, we evaluated its effects on outpatient management of diabetes without remote health care professional support. In this multicenter, open-label, and single-armed prospective study, 48 patients with diabetes (including type 1 and type 2) at 3 hospitals in Japan treated with insulin or glucagon-like peptide 1 receptor agonists and performing SMBG used the app-cloud cooperation system for 24 weeks. The SMBG data were automatically uploaded to the cloud via the app. The patients could check their data, and their attending physicians reviewed the data through the cloud prior to the patients' regular visits. The primary outcome was changes in glycated hemoglobin (HbA1c) levels. Although HbA1c levels did not significantly change in all patients, the frequency of daily SMBG following applying the system was significantly increased before induction at 12 (0.60 per day, 95% CI 0.19-1.00; P=.002) and 24 weeks (0.43 per day, 95% CI 0.02-0.84; P=.04). In the subset of 21 patients whose antidiabetic medication had not been adjusted during the intervention period, a decrease in HbA1c level was observed at 12weeks (P=.02); however, this significant change disappeared at 24 weeks (P=.49). The Diabetes Treatment Satisfaction Questionnaire total score and "Q4: convenience" and "Q5: flexibility" scores significantly improved after using the system (all P<.05), and 72% (33/46) patients and 76% (35/46) physicians reported that the app-cloud cooperation system helped them adjust insulin doses. The digitization of SMBG records and sharing of the data by patients and attending physicians during face-to-face visits improved self-management in patients with diabetes. Japan Registry of Clinical Trials (jRCT) jRCTs042190057; https://jrct.niph.go.jp/en-latest-detail/jRCTs042190057.

Connection between glycemic variability obtained using the uniGluko system and the quality of life people with type 1 diabetes

Research has shown that glycemic variability increases the risk of the development of acute and chronic complications with diabetes. Accordingly, the assessment of glycemic variability is of great importance to determine the quality of life for people suffering from diabetes. Objective: To examine the connection between glycemic variability and the quality of life for people with type 1 diabetes who use self-monitoring blood glucose devices. Respondents and methods: 42 respondents participated in the research with an average age of 39.6, who are treated with intensified insulin therapy. For the purpose of glycemic variability assessment, an innovative uniGluko system is used, which enables the display of glycemia in a unique graphic interface in the form of numeric values within the last three months from which a glycemic variability index was calculated as well as a general information survey, a survey on the quality of life from the World Health Organization (WHOQOL – BREF) and a short questionnaire regarding illness perception (Brief – IPQ). Results: By usage of standard deviation as a glyemic variability measure, statistically significant results have been obtained and they demonstrate that lower glycemic variability is connected to better quality of life (rs=-0.4571; p=0.0023), higher satisfaction with health (rs=-0.3186; p=0.0398) and reduced impact of disease on emotional life (rs=0.4097; p=0.,0071). Lower glucose variability implies reduced impact of disease on everyday life (rs=0.3091; p=0.0464), reduced incidence of symptoms (rs=0.3441; p=0.0255), and patients’ sense that they have more control over disease (rs=-0.5185; p=0.0004). Conclusion: The glycemic variability has a negative impact on life quality and health of patients with diabetes type 1.

SAT-648 Flash Glucose Monitoring Helps Achieve Better Glycemic Control Than Conventional Self-Monitoring of Blood Glucose in Non-Insulin-Treated Type 2 Diabetes: A Randomized Controlled Trial

Background and aims: Flash glucose monitoring (FGM) is a novel system with which glucose levels are monitored and has been reported to improve glucose variability and glycemic control in type 1 and type 2 diabetes patients treated with insulin. The present study aimed to evaluate the effects of FGM and conventional self-monitoring of blood glucose (SMBG) on glycemic control in patients with non-insulin-treated type 2 diabetes. Reseach design and Methods: In this 24-week, multicenter, open-label, randomized (1:1), parallel group study, non-insulin-treated type 2 diabetic patients at 5 hospitals in Japan were randomly assigned to the FGM (n = 49) or SMBG (n = 51) groups and were provided FGM or SMBG devices for 12 weeks. The primary outcome was change in glycated hemoglobin (HbA1c) level. This trial is registered with UMIN-CTR (UMIN000026452). Results: Forty-eight participants in the FGM group and 45 in the SMBG group completed the study. The mean HbA1c levels were 7·83% (SD 0·25) in the FGM group and 7·84% (SD 0·27) in the SMBG group at baseline, and the values were reduced in both FGM (−0·43%; 95% confidence interval [CI], −0·57 to −0·28; p < 0·0001) and SMBG groups (−0·30%; 95% CI −0·48 to −0·13; p = 0·001) at 12 weeks. On the other hand, HbA1c was significantly decreased from baseline values in the FGM group, but not in the SMBG group at 24 weeks (FGM: −0·46%, 95% CI −0·59 to −0·32, p < 0·0001; SMBG: −0·17%, 95% CI −0·05 to 0·11, p = 0·124); a significant between-group difference was also observed (difference −0·29%, 95% CI −0·54 to −0·05; p = 0·022). Diabetes Treatment Satisfaction Questionnaire score was significantly improved, and the mean glucose levels, standard deviation of glucose, mean amplitude of glycemic excursions, and duration of hyperglycemia were significantly decreased in the FGM group compared with the SMBG group. Conclusions: Glycemic control was better with FGM than with SMBG after cessation of glucose monitoring in non-insulin-treated type 2 diabetic patients.

Comparing Self Monitoring Blood Glucose Devices and Laboratory Tests: Over 25 Years Experience&#x0D;

Self-monitoring blood glucose (SMBG) devices have been widely used in medical practice for decades. However, there are certain gaps between SMBG device readings and venous blood glucose levels. Here, 3,532 measurement data points were recorded over 25 years to compare SMBG device readings and venous blood glucose levels. The mean absolute difference (MAD) or the GAP was 10.9 mg/dL, and the mean absolute relative difference (MARD) was 8.3%. The absolute relative difference (ARD) (%) and absolute difference (AD or GAP) (mg/dL) coefficients of variation (CV) (%) of 100% indicate high variance between the capillary BG and venous true BG data. There was a slight skewing of MAD and MARD to the lower body mass index (BMI) side, the higher age side, and the female gender side. There were 41 data points that showed unacceptable gaps of over 50 mg/dL. Such large differences may cause incorrect medications or treatments. All healthcare providers should be aware of the gap between SMBG device readings and venous blood glucose levels.

Technical accuracy of ten self-monitoring blood glucose devices commonly used in Dhaka City of Bangladesh

Due to inadequate regulatory mechanisms, the accuracy of the self-monitoring blood glucose (SMBG) devices is not ensured leading to potentially serious clinical consequences in Bangladesh. The present study was undertaken to evaluate the technical accuracy of ten most commonly used SMBG devices marketed in Dhaka City of Bangladesh. Top ten SMBG devices sold in Dhaka City were studied on a group of 100 type 2 diabetes mellitus subjects. Blood glucose values estimated (at fasting and 2 h after breakfast) by SMBG devices, using a blinding technique, were compared with the corresponding laboratory values by enzymatic method using the Dimension RXLMax automated chemistry analyzer. Hematocrit was measured using the Sysmex XT 2000 hematology autoanalyzer. The mean absolute relative error (MARE, %) was used as an indicator of accuracy and precision together. A highly significant correlation was observed between the device and laboratory values. However, none of the devices showed an acceptable accuracy at 5–10% deviation from the corresponding laboratory values either at fasting or postprandial states. On pooling together data from two prandial states, even at 15% deviation limits, 70% of the devices failed to show accurate results. On calculation of MARE, 60% devices were found to be beyond 15% error limit at 95% accuracy level. Corresponding analysis with 90% accuracy level showed 30% beyond the limit. Blood glucose results from around 30% of the top ten SMBG devices sold in Dhaka City do not have even minimum level of technical accuracy, and many others are not optimum in their accuracy levels.

Evaluation of Linearity and Interference Effect on SMBG and POCT Devices, Showing Drastic High Values, Low Values, or Error Messages.

When a patient with diabetes measures blood glucose levels using a simple blood glucose meter, an error message or abnormal value may be displayed because of interfering substances, potentially leading to unnecessary medical treatment. Here, we tested 10 self-monitoring of blood glucose (SMBG) and point-of-care testing (POCT) devices to investigate under what conditions they fail to measure blood glucose levels or display abnormal values instead. We also evaluated the influence and linearity of several well-known interfering substances and hematocrit (Ht). Each adjusted sample was measured by each device twice and the values compared with the reference values. Linearity was favorable in all but one model. The impact of the interfering substances and Ht has been confirmed in many SMBG and POCT devices. In particular, some models showed significant pseudo-high or -low levels for samples that contained ascorbic acid, which is used widely in infusion solutions. Three devices showed error messages to avoid presenting a false value. Since pseudo-high levels may result in the excessive administration of insulin and lead to adverse events, this report serves as a critical reminder of the importance of device choice for specific indications. Three new devices have safety functions that prevent the showing of false values.

Perceptions of Dhaka City Retailers on User Choice of Self-Monitoring Blood Glucose Devices

Self-Monitoring Blood Glucose (SMBG) Devices are now thought to be an integral component in the prevention and management of diabetes mellitus which is increasingly becoming a major health and economic burden particularly in developing countries. The marketing of these Devices, however, are still not well regulated in most of the countries and this, in turn, may lead to more harm than good to the patients who are using these devices. Retailers are the most important contact points who create the interface among the Manufacturers, Professionals and Consumers for popularization of health related devices. In this study, the Users' Choice of SMBG Devices and its determinants, as reflected in the views of the Sales Persons (in a retail shop) in Dhaka City of Bangladesh, have been explored. Twenty Sales Persons from 20 Retail Shops, purposively selected from among major Dhaka City markets where these devices are commonly sold, were individually interviewed using a pretested Interviewer administered Questionnaire. The instrument consisted of six questions covering the Users' preference regarding quality vs cost and also regarding the guidance and motives for purchasing specific items. The results were analyzed by descriptive statistics. It was found that 90% of the consumers are dependent on the suggestions of the Sales Persons regarding the choice of devices. In 80% of the subjects the cost of the System was found to be the determining factor regarding the choice of a meter. Only among 20% subjects, quality played any role in the choice. In conclusion, the choice of specific SMBG devices in Dhaka City is overwhelmingly influenced by Retailers (who, in most cases are not even qualified Pharmacists or Pharmacy Assistants) and, except in few cases; Users are not concerned with quality. Price, particularly the price of the strip, is the dominant factor on Users' choice of SMBG Devices.&#x0D; Bangladesh J Med Biochem 2018; 11(1): 17-21

Changes in Self-Care Behavior (Summary of Diabetes Self-Care Activities Measure) Using Real-Time Blood Glucose Monitoring with the Free Style Libre

No studies have reported changes in self-care behavior, and it remains unclear whether Free Style Libre (Libre) differs from conventional blood glucose self-monitoring devices in this regard. Therefore, we instructed diabetes patients using conventional self-monitoring blood glucose (SMBG) devices to use the Libre and prospectively examined the effect of this new device on self-care behavior and patient treatment satisfaction. The subjects comprised 41 outpatients with diabetes who were using conventional SMBG devices. The subjects were randomly assigned to group A, which comprised patients using Libre for ≥2 weeks (n = 21), or group B, which comprised patients who continued using conventional SMBG devices (n = 20). All patients received 30 minutes of diet and exercise therapy instruction from a registered dietitian and nurse (or clinical laboratory technologists). The Summary of Diabetes Self-Care Activities measure (SDSCA) was administered at baseline, 1, 3, and 6 months. Changes in the SDSCA, glycated hemoglobin (HbA1c), glycated albumin (GA), and body weight from baseline to 1 month were analyzed (UMIN000029016). At baseline, the two groups did not differ significantly in terms of the HbA1c, GA, body weight, or 17 SDSCA items. At 1 month, the numbers of days involving eating five or more servings of fruits and vegetables were 5.0 (3.3, 6.8) in group A and 3.0 (1.0, 6.0) in group B, the numbers of days involving exercise for at least 30 minutes were 5.0 (2.0, 6.0) in group A and 2.0 (0, 3.0) in group B, and the number of days involving specific exercise were 3.0 (2.0, 6.0) in group A and 1.5 (0, 2.3) in group B; both of these values were significantly higher in group A than in group B (p = 0.033, 0.037 and 0.041, respectively). These results suggest that the use of the Libre may improve the self-care behaviors of diabetes patients regarding diet and exercise, compared with the use of conventional SMBG devices. Disclosure A. Kudara: None. T. Tosaki: Other Relationship; Self; Eli Lilly and Company, Takeda Development Center Asia, Pte. Ltd., MSD K.K., Mitsubishi Tanabe Pharma Corporation. S. Sato: None. A. Inagaki: None. M. Kondo: None. S. Tsunekawa: None. Y. Kato: Speaker's Bureau; Self; Merck Sharp &amp; Dohme Corp., Sanofi, Takeda Pharmaceutical Company, Eli Lilly Japan. H. Kamiya: Other Relationship; Self; MSD K.K., Ono Pharmaceutical Co., Ltd., Sanofi K.K., AstraZeneca, Astellas Pharma KK, Eli Lilly and Company, Novartis Pharma K.K., Dainippon Sumitomo Pharma Co., Ltd, Boehringer Ingelheim Pharmaceuticals, Inc., Takeda Pharmaceutical Co., Ltd, Ono Pharmaceutical Co., Ltd. J. Nakamura: Other Relationship; Self; Astellas Pharma US, Inc., AstraZeneca, Ono Pharmaceutical Co., Ltd., MSD K.K., Kyowa Hakko Kirin Co., Ltd., Kowa Pharmaceuticals America, Inc., Sanofi K.K., Taisho Pharmaceutical Co., Ltd., Takeda Development Center Asia, Pte. Ltd., Mitsubishi Tanabe Pharma Corporation, Eli Lilly and Company, Novartis Pharma K.K., Pfizer Inc..

Economic Value of Improved Accuracy for Self-Monitoring of Blood Glucose Devices for Type 1 and Type 2 Diabetes in England.

The objective was to model clinical and economic outcomes of self-monitoring blood glucose (SMBG) devices with varying error ranges and strip prices for type 1 and insulin-treated type 2 diabetes patients in England. We programmed a simulation model that included separate risk and complication estimates by type of diabetes and evidence from in silico modeling validated by the Food and Drug Administration. Changes in SMBG error were associated with changes in hemoglobin A1c (HbA1c) and separately, changes in hypoglycemia. Markov cohort simulation estimated clinical and economic outcomes. A SMBG device with 8.4% error and strip price of £0.30 (exceeding accuracy requirements by International Organization for Standardization [ISO] 15197:2013/EN ISO 15197:2015) was compared to a device with 15% error (accuracy meeting ISO 15197:2013/EN ISO 15197:2015) and price of £0.20. Outcomes were lifetime costs, quality-adjusted life years (QALYs) and incremental cost-effectiveness ratios (ICERs). With SMBG errors associated with changes in HbA1c only, the ICER was £3064 per QALY in type 1 diabetes and £264 668 per QALY in insulin-treated type 2 diabetes for an SMBG device with 8.4% versus 15% error. With SMBG errors associated with hypoglycemic events only, the device exceeding accuracy requirements was cost-saving and more effective in insulin-treated type 1 and type 2 diabetes. Investment in devices with higher strip prices but improved accuracy (less error) appears to be an efficient strategy for insulin-treated diabetes patients at high risk of severe hypoglycemia.

The UVA/Padova Type 1 Diabetes Simulator Goes From Single Meal to Single Day.

A new version of the UVA/Padova Type 1 Diabetes (T1D) Simulator is presented which provides a more realistic testing scenario. The upgrades to the previous simulator, which was accepted by the Food and Drug Administration in 2013, are described. Intraday variability of insulin sensitivity (SI) has been modeled, based on clinical T1D data, accounting for both intra- and intersubject variability of daily SI. Thus, time-varying distributions of both subject's basal insulin infusion and insulin-to-carbohydrate ratio were calculated and made available to the user. A model of "dawn" phenomenon based on clinical T1D data has been also included. Moreover, the model of subcutaneous insulin delivery has been updated with a recently developed model of commercially available fast-acting insulin analogs. Models of both intradermal and inhaled insulin pharmacokinetics have been included. Finally, new models of error affecting continuous glucose monitoring and self-monitoring of blood glucose devices have been added. One hundred in silico adults, adolescent, and children have been generated according to the above modifications. The new simulator reproduces the intraday glucose variability observed in clinical data, also describing the nocturnal glucose increase, and the simulated insulin profiles reflect real life data. The new modifications introduced in the T1D simulator allow to extend its domain of validity from "single-meal" to "single-day" scenarios, thus enabling a more realistic framework for in silico testing of advanced diabetes technologies including glucose sensors, new insulin molecules and artificial pancreas.

Development of an Automatic Puncturing and Sampling System for a Self-Monitoring Blood Glucose Device.

Performing self-monitoring of blood glucose (SMBG) is a clinical challenge for elderly people with low dexterity. An all-in-one-type SMBG device that can simply and easily puncture and monitor would be useful for them. We developed an automatic skin-puncturing and blood-sampling (APS) system for introducing of an all-in-one-type SMBG device. The aims of this study were to determine if the developed APS system, which has automatic puncturing, squeezing, and application functions, could provide sufficient blood sample volumes for SMBG and to determine the factors associated with failure in the use of the system by adult volunteers. We investigated the success rate of obtaining a 0.8-μL sample volume using the APS system and determined the factors associated with failure in 140 adult volunteers. The participant characteristics, induration of puncturing sites, and states of finger grip conditions were evaluated as factors of a puncturing failure. The participant characteristics, skin hydration, states of finger grip, skin elasticity of the finger pad, and blood flow were evaluated as factors of a squeezing failure. The success rate was 61.9%. Puncturing failure was 21.6%, and squeezing failure was 16.5%. Automatic puncturing factors associated with failure were male sex, larger finger diameter, and thicker finger pad. The only squeezing failure factor was lower peripheral skin temperature. Improvement of the finger station groove shape to prevent ischemia and the squeezing angle would be useful developments of the all-in-one-type SMBG device for elderly people with decreased dexterity.

Type-1 Diabetes Patient Decision Simulator for In Silico Testing Safety and Effectiveness of Insulin Treatments.

Type-1 diabetes (T1D) treatment requires exogenous insulin administrations finely tuned based on glucose monitoring to avoid hyper/hypoglycemia. The safety and effectiveness of insulin treatments is commonly assessed in clinical trials, which are time demanding and expensive. These limitations can be overtaken by in silico clinical trials (ISCT) that require realistic patient and treatment models. The aim is to develop a T1D patient decision simulator usable to perform reliable ISCT. The T1D patient decision simulator was developed by connecting the UVA/Padova T1D model, which describes glucose, insulin, and glucagon kinetics, with modules describing glucose monitoring devices, like self-monitoring of blood glucose (SMBG) and continuous glucose monitoring (CGM), the patient's behavior in making treatment decisions, and insulin administration. The reliability of the simulator was assessed by comparing its predictions with data collected in 44 T1D subjects using the Dexcom G5 Mobile CGM sensor as an adjunct to the Bayer Contour Next USB SMBG device. Metrics like time spent in eu/hypo/hyperglycemia of simulated data well match those observed in subjects. In particular, mean time in euglycemia, mean time in hyperglycemia, and median time in hypoglycemia are 61.75% versus 63.60% (p-value = 0.4825), 33.38% versus 33.40% (p -value = 0.9950), and 3.17% versus 2.14% (p-value = 0.1134), respectively, in real versus simulated data. The proposed simulator can be used to perform credible ISCT in realistic insulin treatment scenarios. The T1D patient decision simulator can be used to reliably assess novel insulin treatments, e.g., based on use of CGM only, in a realistic multiple-day scenario.

Reduction of Blood Glucose Measurements to Calibrate Subcutaneous Glucose Sensors: A Bayesian Multiday Framework.

In most continuous glucose monitoring (CGM) devices used for diabetes management, the electrical signal measured by the sensor is transformed to glucose concentration by a calibration function whose parameters are estimated using self-monitoring of blood glucose (SMBG) samples. The calibration function is usually a linear model approximating the nonlinear relationship between electrical signal and glucose concentration in certain time intervals. Thus, CGM devices require frequent calibrations, usually twice a day. The aim here is to develop a new method able to reduce the frequency of calibrations. The algorithm is based on a multiple-day model of sensor time-variability with second-order statistical priors on its unknown parameters. In an online setting, these parameters are numerically determined by the Bayesian estimation exploiting SMBG sparsely collected by the patient. The method is assessed retrospectively on 108 CGM signals acquired for 7 days by the Dexcom G4 Platinum sensor, testing progressively less-calibration scenarios. Despite the reduction of calibration frequency (on average from 2/day to 0.25/day), the method shows a statistically significant accuracy improvement compared to manufacturer calibration, e.g., mean absolute relative difference when compared to a laboratory reference decreases from 12.83% to 11.62% (p-value of 0.006). The methodology maintains (sometimes improves) CGM sensor accuracy compared to that of the original manufacturer, while reducing the frequency of calibrations. Reducing the need of calibrations facilitates the adoption of CGM technology both in terms of ease of use and cost, an obvious prerequisite for its use as replacement of traditional SMBG devices.

PMD66 - Value of Improved Accuracy for Self-Monitoring of Blood Glucose Devices in Germany

PMD66 - Value of Improved Accuracy for Self-Monitoring of Blood Glucose Devices in Germany

Economic Value of Improved Accuracy for Self-Monitoring of Blood Glucose Devices for Type 1 Diabetes in Canada.

The objective was to simulate and compare clinical and economic outcomes of self-monitoring of blood glucose (SMBG) devices along error ranges and strip price. We programmed a type 1 diabetes natural history and treatment cost-effectiveness model. In phase 1, using past evidence from in silico modeling validated by the Food and Drug Administration, we associated changes in SMBG error to changes in hemoglobin A1c (HbA1c) and separately, changes in severe hypoglycemia requiring an inpatient stay. In phase 2, using Markov cohort simulation modeling, we estimated clinical and economic outcomes from the Canadian payer perspective. The primary comparison was a SMBG device with strip price $0.73 Canadian dollars (CAD) and 10% error (exceeding accuracy requirements by International Organization for Standardization (ISO) 15197:2013) versus a SMBG device with strip price $0.60 CAD and 15% error (accuracy meeting ISO 15197:2013). Outcomes for the average patient, were quality-adjusted life years (QALYs), incremental cost-effectiveness ratios (ICERs), and budget impact. Assuming benefits translate into HbA1c improvements only, the ICER with 10% error versus 15% was $11 500 CAD per QALY. Assuming the benefits translate into reduced severe hypoglycemia requiring an inpatient stay only, an SMBG device with 10% error dominated (ie, less costly, more effective) an SMBG device with 15% error. The 3-year budget impact findings ranged from $0.004 CAD per member per month for HbA1c improvements to cost-savings for severe hypoglycemia reductions. From efficiency (cost-effectiveness) and affordability (budget impact) payer perspectives, investing in devices with improved accuracy (less error) appears to be an efficient and affordable strategy.

Evaluation of two glucose meters and interference corrections for screening neonatal hypoglycemia.

Many neonatal intensive care and maternal units still use self-monitoring of blood glucose (SMBG) devices as a tool to aid diagnosis despite the introduction of point-of-care testing (POCT) devices, which are known to have higher accuracy. We evaluated the performance of two glucose meters, the StatStrip (Nova Biomedical), a POCT device, and the Medisafe Mini (Terumo), an SMBG device, to detect hypoglycemia in neonates. In addition, we evaluated the interference of hematocrit, acetaminophen and ascorbic acid. Whole blood samples were drawn from neonates who were at risk of hypoglycemia and analyzed with the StatStrip and Medisafe Mini. The results were further confirmed with blood gas analyzers ABL825 and BM6050. To evaluate the interference of hematocrit, acetaminophen and ascorbic acid, concentrated solutions of glucose and interfering substances were gravimetrically prepared and analyzed. Among the 222 blood samples analyzed, results from the StatStrip were more closely aligned to those of the ABL825 at all levels of glucose than the Medisafe Mini. StatStrip appears to be unaffected by hematocrit, ascorbic acid or acetaminophen. We recommend its use in neonates in hospital. Further studies are required to identify other interference effects.

Comprehensive approach to the management of diabetes: offering improved outcomes for diabetics and the healthcare system

SUMMARY The incidence of diabetes is increasing globally, resulting in an ever-increasing social and economic burden. Despite advances in treatment options, metabolic control often remains suboptimal, resulting in high levels of morbidity and mortality, and increased healthcare expenditure. Current guidelines advocate individualized treatment and a multidisciplinary approach to disease management. For these recommendations to be realized, a comprehensive system of care could be beneficial. In the proposed system, patients would be at the center of a multidisciplinary approach, being provided with the necessary tools, education and support to take responsibility for their condition. Drug delivery systems, treatment algorithms and self-monitoring blood glucose devices, as well as innovations in medication, may provide the tools needed for a patient-centered multidisciplinary integrated care system. Such an integrated approach needs to be economically sustainable and flexible so that it can be scaled up or d...

A New Test Strip Technology Platform for Self-Monitoring of Blood Glucose

In the management of diabetes, accuracy of devices used for self-monitoring of blood glucose (SMBG) is critical because SMBG results can affect patient diabetes-related health outcomes. A new blood glucose monitoring system (BGMS) platform has been developed that is based on the new CONTOUR® NEXT (CN) test strip. This BGMS platform uses a proprietary electron mediator and algorithm to minimize errors at different steps in the testing process, thus minimizing outliers and significantly improving accuracy from prior-generation blood glucose meter systems. As demonstrated by questionnaire results from clinical studies with the new BGMS platform, accuracy and ease of use are important considerations for people with diabetes and their health care professionals when selecting an SMBG device. This article provides an overview of laboratory studies and clinical trials in the hands of lay users involving the performance of the portfolio of blood glucose meters that uses the new test strip. Each BGMS in the platform, which includes the CONTOUR XT (CONTOUR NEXT EZ in the United States), CONTOUR NEXT LINK, CONTOUR NEXT USB, and CN systems, demonstrated advanced accuracy both in the laboratory and in the hands of subjects (people with diabetes) and trained health care professionals. All systems met and exceeded International Organization for Standardization accuracy criteria (both ISO 15197:2003 and ISO 15197:2013). Each system in the new BGMS platform delivers advanced accuracy, which is essential to people who utilize SMBG for improved management.

Spurious Elevation of Glucose Concentration during Administration of High Dose of Ascorbic Acid in a Patient with Type 2 Diabetes on Hemodialysis

We describe herein a case of life-threatening hypoglycemia due to spurious elevation of glucose concentration during the administration of ascorbic acid in a type 2 diabetic patient. A 31-year-old female was admitted for proliferative diabetic retinopathy treatment and prescribed high dose ascorbic acid. During hospitalization, she suddenly lost her consciousness and her glucose concentration was 291 mg/dL, measured using self-monitoring blood glucose (SMBG) device, while venous blood glucose concentration was 12 mg/dL. After intravenous injection of 50% glucose solution, the patient became alert. We reasoned that glucose measurement by SMBG device was interfered by ascorbic acid. Physicians should be aware of this interference; high dose ascorbic acid may cause spurious elevation of glucose concentration when measuring with SMBG devices.