Accuracy and User Performance of a New Blood Glucose Monitoring System

Introduction:Self-monitoring of blood glucose (BG) is important in diabetes management, allowing people with diabetes (PWD) to assess responses to diabetes therapy and to inform if they are attaining their glycemic targets. This study assessed the accuracy and user performance (UP) of a new blood glucose monitoring system (BGMS), CONTOUR®PLUS ELITE, according to International Organization for Standardization (ISO) 15197:2013 criteria and also more stringent criteria.Methods:In laboratory Study 1, capillary fingertip blood samples from 100 PWD were evaluated using the new BGMS. In clinical Study 2, 130 PWD had Yellow Springs Instrument (YSI) analyzer reference measurements against subject-obtained fingertip and palm blood, and trial staff-obtained venous blood. The new BGMS was tested with test strips from three different lots. A UP questionnaire assessed ease of use.Results:Study 1: 100% of combined accuracy results fulfilled ISO criteria (±15 mg/dL at BG <100 mg/dL; ±15% at BG ≥100 mg/dL); 99.8% fulfilled more stringent criteria (±10 mg/dL at BG <100 mg/dL; ±10% at BG ≥100 mg/dL). Error grid analysis showed that 100% of results were within zone A. Study 2: >98% of subject- and 100% of trial staff-obtained performance results met ISO criteria. Most subjects (>96%) found the BGMS easy to use.Conclusion:The new BGMS exceeded minimum ISO 15197:2013-specified standards for both accuracy and UP criteria, along with the more stringent accuracy criteria. These data show that this new BGMS can be a useful tool in managing glycemic control for PWD.     

Dietary Self-Monitoring,But Not Dietary Quality,Improves With Use of Smartphone App Technology in an 8-Week Weight Loss Trial

ObjectiveDietary self-monitoring is linked to improved weight loss success. Mobile technologies, such as smartphone applications (apps), might allow for improved dietary tracking adherence. The authors assessed the use of a popular smartphone app for dietary self-monitoring and weight loss by comparing it with traditional diet counseling and entry methods.MethodsDiet tracking and weight loss were compared across participants during an 8-week weight loss trial. Participants tracked intake using 1 of 3 methods: the mobile app “Lose It!”, the memo feature on a smartphone, or a traditional paper-and-pencil method.ResultsApp users (n = 19) recorded dietary data more consistently compared with the paper-and-pencil group (n = 15; P = .042) but not the memo group (n = 13). All groups lost weight over the course of the study (P = .001), and no difference in weight loss was noted between groups.Conclusions and ImplicationsSmartphone apps could represent a novel and feasible dietary self-monitoring method for individuals.     

The clinical usefulness of glycated albumin in patients with diabetes and chronic kidney disease: Progress and challenges

Prolonged hyperglycemia leads to a non-enzymatic glycation of proteins, and produces Amadori products, such as glycated albumin (GA) and glycated hemoglobin (HbA1c). The utility of HbA1c in the setting of chronic kidney disease (CKD) may be problematic since altered lifespan of red blood cells, use of iron and/or erythropoietin therapy, uremia and so on. Therefore, as an alternative marker, GA has been suggested as a more reliable and sensitive glycemic index in patients with CKD. In addition to the mean plasma glucose concentration, GA also reflects postprandial plasma glucose and glycemic excursion. Besides, with a half-life of approximately 2–3?weeks, GA may reflect the status of blood glucose more rapidly than HbA1c. GA is also an early precursor of advanced glycation end products (AGEs), which cause alterations in various cellular proteins and organelles. Thus, high GA levels may correlate with adverse outcomes of patients with CKD. In this review, the clinical usefulness of GA was discussed, including a comparison of GA with HbA1c, the utility and limitations of GA as a glycemic index, its potential role in pathogenesis of diabetic nephropathy and the correlations between GA levels and outcomes, specifically in patients with diabetes and CKD.     

The effect of an instant hand sanitizer on blood glucose monitoring results

Background

People with diabetes mellitus are instructed to clean their skin prior to self-monitoring of blood glucose to remove any dirt or food residue that might affect the reading. Alcohol-based hand sanitizers have become popular when soap and water are not available. The aim of this study was to determine whether a hand sanitizer is compatible with glucose meter testing and effective for the removal of exogenous glucose.

Methods

We enrolled 34 nonfasting subjects [14 male/20 female, mean ages 45 (standard deviation, 9.4)] years, 2 with diagnosed diabetes/32 without known diabetes]. Laboratory personnel prepared four separate fingers on one hand of each subject by (1) cleaning the second finger with soap and water and towel drying (i.e., control finger), (2) cleaning the third finger with an alcohol-based hand sanitizer, (3) coating the fourth finger with cola and allowing it to air dry, and (4) coating the fifth finger with cola and then cleaning it with the instant hand sanitizer after the cola had dried. Finger sticks were performed on each prepared finger and blood glucose was measured. Several in vitro studies were also performed to investigate the effectiveness of the hand sanitizer for removal of exogenous glucose.z

Results

Mean blood glucose values from fingers cleaned with instant hand sanitizer did not differ significantly from the control finger (p = .07 and .08, respectively) and resulted in 100% accurate results. Blood glucose data from the fourth (cola-coated) finger were substantially higher on average compared with the other finger conditions, but glucose data from the fifth finger (cola-coated then cleaned with hand sanitizer) was similar to the control finger. The data from in vitro experiments showed that the hand sanitizer did not adversely affect glucose meter results, but when an exogenous glucose interference was present, the effectiveness of the hand sanitizer on glucose bias (range: 6% to 212%) depended on the surface area and degree of dilution.

Conclusions

In our study, use of an instant hand sanitizer was compatible with the results of a blood glucose monitor and did not affect finger stick blood glucose results. However, depending on surface area, hand sanitizers may not be adequate for cleaning the skin prior to glucose meter testing.     

Utilizing information technologies for lifelong monitoring in diabetes patients

Background

Information and communication technologies have long been acknowledged to support information sharing along the whole chain of care, from the clinic to the homes of patients and their relatives. Thus they are increasingly being considered for improving the delivery of health care services also in light of clinical and technological achievements that propose new treatments requiring a tighter interaction among patients and physicians.

Methods

The multiagent paradigm has been utilized within an architecture for delivering telemedicine services to chronic outpatients at their domiciles and enforcing cooperation among patients, caregivers, and different members of the health care staff. The architecture sees each communication device such as a palmtop, smart phone, or personal digital assistant as a separate agent upon which different services are deployed, including telemetry, reminders, notifications, and alarms. Decoupling services from agents account for a highly configurable environment applicable to almost any context that can be customized as needed.

Results

The architecture has been used for designing and implementing a prototypical software infrastructure, called LifePhone, that runs on several communication devices. A basic set of services has been devised with which we were able to configure two different applications that address long-term and short-term monitoring scenarios for diabetes patients. The long-term scenario encompasses telemetry and reminder services for patients undergoing peritoneal dialysis, which is a treatment for chronic renal failure, a diabetes complication. The short-term scenario incorporates telemetry and remote alarms and is applicable for training patients to use an artificial pancreas.

Conclusions

Our experiments proved that an infrastructure such as LifePhone can be used successfully for bridging the interaction gap that exists among all the components of a health care delivery process, improving the quality of service and possibly reducing the overall costs of health care. Furthermore, the modularity of services allows for more complex scenarios encompassing data analysis or even involving actors at multiple institutions in order to better support the overall health care organization.     

Individuals Achieve More Accurate Results with Meters That Are Codeless and Employ Dynamic Electrochemistry

Background

Studies have shown that controlling blood glucose can reduce the onset and progression of the long-term microvascular and neuropathic complications associated with the chronic course of diabetes mellitus. Improved glycemic control can be achieved by frequent testing combined with changes in medication, exercise, and diet. Technological advancements have enabled improvements in analytical accuracy of meters, and this paper explores two such parameters to which that accuracy can be attributed.

Methods

Four blood glucose monitoring systems (with or without dynamic electrochemistry algorithms, codeless or requiring coding prior to testing) were evaluated and compared with respect to their accuracy.

Results

Altogether, 108 blood glucose values were obtained for each system from 54 study participants and compared with the reference values. The analysis depicted in the International Organization for Standardization table format indicates that the devices with dynamic electrochemistry and the codeless feature had the highest proportion of acceptable results overall (System A, 101/103). Results were significant when compared at the 10% bias level with meters that were codeless and utilized static electrochemistry (p = .017) or systems that had static electrochemistry but needed coding (p = .008).

Conclusions

Analytical performance of these blood glucose meters differed significantly depending on their technologic features. Meters that utilized dynamic electrochemistry and did not require coding were more accurate than meters that used static electrochemistry or required coding.     

Evolution of Data Management Tools for Managing Self-Monitoring of Blood Glucose Results: A Survey of iPhone Applications

Background

Studies have indicated that sharing of self-monitoring of blood glucose (SMBG) data and subsequent feedback from the health care provider (HCP) can help achieve glycemic goals such as a reduction in glycated hemoglobin. Electronic SMBG data management and sharing tools for the PC and smartphones may help in reducing the effort to manage SMBG data.

Methods

We reviewed software and top-ranking applications (Apps) for the iPhone platform to document the variety of useful features. Additionally, in an attempt to assess metrics such as task analysis and user friendliness of diabetes Apps, we observed and surveyed patients with diabetes as they recorded and relayed sample SMBG results to their hypothetical HCP using three Apps.

Results

Observation and survey demonstrated that the WaveSense Diabetes Manager allowed the participants to complete preselected SMBG data entry and relay tasks faster than other Apps. The survey revealed patient behavior patterns that would be useful in future App development.

Conclusion

Being able to record, analyze, seamlessly share, and obtain feedback on the SMBG data using an iPhone/iTouch App might potentially benefit patients. Trends in SMBG data management and the possibility of having interoperability of blood glucose monitors and smartphones may open up new avenues of diabetes management for the technologically savvy patient.