Performance of Blood Glucose Meters in the Low-Glucose Range: Current Evaluations Indicate That It Is Not Sufficient From a Clinical Point of View

Heinemann, Lutz; Zijlstra, Eric; Pleus, Stefan; Freckmann, Guido

doi:10.2337/dc15-0817

Cited by 48 publications

(5 citation statements)

References 3 publications

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“…More advanced forms of medical implants with integrated electronics enable closed‐loop health monitoring and advanced feedback therapy such as in situ active programmed stimulation in brain, cochlear or retinal prostheses, and nerve or cardiac stimulators . Advanced therapeutic functions such as targeted drug delivery are also achievable, for example, in drug‐eluting stents and insulin pumps …”

Section: Introductionmentioning

confidence: 99%

Bioresorbable Electronic Implants: History, Materials, Fabrication, Devices, and Clinical Applications

Doo

Kang

Lee

et al. 2019

Adv Healthcare Materials

102

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Medical implants, either passive implants for structural support or implantable devices with active electronics, have been widely used for the diagnosis and treatment of various diseases and clinical issues. These implants offer various functions, including mechanical support of biological structures in orthopedic and dental applications, continuous electrophysiological monitoring and feedback of electrical stimulation in neuronal and cardiac applications, and controlled drug delivery while maintaining arterial structure in drug‐eluting stents. Although these implants exhibit long‐term biocompatibility, surgery for their retrieval is often required, which imposes physical, biological, and economical burdens on the patients. Therefore, as an alternative to such secondary surgeries, bioresorbable implants that disappear after a certain period of time inside the body, including bioresorbable active electronics, have been highlighted recently. This review first discusses the historical background of medical implants and briefly define related terminology. Representative examples of non‐degradable medical implants for passive structural support and/or for diagnosis and therapy with active electronics are also provided. Then, recent progress in bioresorbable active implants composed of biosignal sensors, actuators for therapeutics, wireless power supply components, and their integrated systems are reviewed. Finally, clinical applications of these bioresorbable electronic implants are exemplified with brief conclusion and future outlook.

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Section: Introductionmentioning

confidence: 99%

Bioresorbable Electronic Implants: History, Materials, Fabrication, Devices, and Clinical Applications

Doo

Kang

Lee

et al. 2019

Adv Healthcare Materials

102

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“…Для пациентов с диабетом очень важно, чтобы глюкометр, используемый в среде активного отдыха, обладал высокой точностью измерения и соответствовал рекомендуемым стандартам (ISO 15197:2013). Система Контур Плюс Уан (Contour® Plus One), по данным исследований, продемонстрировала более высокую точность: полученные результаты превосходят требования к точности стандарта ISO 15197:2013 [5]. Результаты специального анализа системы Контур Плюс Уан показали, что 95% общих результатов были в пределах ±0,47 ммоль/л или ±8,5% от эталонных значений глюкозы YSI (YSI Life Sciences, Inc., Yellow Springs, OH) для полученной от субъекта исследования пациента с сахарным диабетом капиллярной крови из пальца, для образцов с концентрациями глюкозы < 5,55 ммоль/л и ≥ 5,55 ммоль/л соответственно.…”

Section: Introductionunclassified

“…При проведении анализа с использованием вероятностной методологии было показано, что система Контур Плюс Уан, использующая современные технологии при обработке информации, полученной от образца крови, поддерживает высокий уровень точности в широком диапазоне глюкозы крови, в т. ч. при низкой концентрации (рис. 2) [5,6].…”

Section: Introductionunclassified

“…Таким образом, система Контур Плюс Уан демонстрирует высокую точность при низкой концентрации глюкозы в крови, что важно для безопасного и эффективного управления диабетом [5]. Пользовательские параметры данного прибора и его способность к определению малых и пороговых значений гликемии получили положитель-ные отзывы от ведущих эндокринологов в рамках социальных программ для подростков с СД1 [7].…”

Section: Introductionunclassified

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Results of glycaemic control on exertion in children with type 1 diabetes mellitus in FOX children's recreational camp settings

Bolotskaya,

Golubkina,

Frolova

2023

Medicinskij sovet

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ANO “Children’s Camp FOX CAMP (Lager’ Lisonok)” has been operating in Russia since 2019. Changes of observations in the Moscow region, Sochi, Kaliningrad region, Sochi, Gelendzhik, Chelyabinsk region, Altai. In the period from 2019 to 2022, 796 children and adolescents with type 1 diabetes mellitus (DM1) visited the shifts and active tours of the ANO “Children’s Camp FOKS CAMP (Lager’ Lisonok)”. The priority of children’s recreation is a focus on increased activity: marathons at various distances, football matches, basketball, alpine skiing and long hikes in the mountains, rafting. It is known that activity in patients with type 1 diabetes increases sharply by the level of blood increase, by a decrease in this indicator. In order, to prevent the development of hypoglycemia during heavy exercise, it is very important to quickly determine blood glucose using a glucometer and take the necessary measures to stop it. Thus, the presence of sufficient shifts is necessary to quickly and accurately carry out self-monitoring, sometimes in various and difficult conditions (on mountain trails, on a suspension bridge, when rafting on a mountain river, on the beach). This article presents the development of events on elevated blood levels in children and adolescents with DM1 in the conditions of the marathon, running at various distances in the conditions of the summer shift in the Moscow region of the children’s health camp ANO “Children’s Camp FOX CAMP (Lager’ Lisonok)”.

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“…[10][11][12] Even if the abovementioned requirements are met, it has been suggested that the ISO-allowed error margin of ±15 mg/dL in the hypoglycemic range may be too large, leading to a different interpretation of BG results in this critically important BG range. 13 Here, it is noteworthy that a recent trial comparing the safety and effectiveness of two insulin regimens had to be reorganized due to the suspicion that an FDA-cleared BGMS, that had been used in the study, was inaccurate and unsafe, especially in the hypoglycemic range. 14,15 Given the importance of BGMS accuracy and apparent issues with the current performance requirements, this article aims to examine the impact of various BGMS readings and their associated uncertainty in a clinical context.…”

Section: Introductionmentioning

confidence: 99%

Impact of Blood Glucose Monitoring System Accuracy on Clinical Decision Making for Diabetes Management

Eichenlaub

Pleus

Shaginian

et al. 2022

J Diabetes Sci Technol

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Background: The accuracy of blood glucose monitoring systems (BGMS) is crucial for the safe and effective management of diabetes mellitus. Despite standardization of accuracy assessment procedures and requirements, various studies have shown that the accuracy of BGMS on the market can vary considerably. This article therefore provides health care professionals and users with an intuitive illustration of the impact of BGMS accuracy on clinical decision making. Material and Methods: Several hypothetical patient scenarios based on blood glucose (BG) levels in the low, normal, and high BG range are devised. Using data from a recent BGMS accuracy study, a method for calculating the expected range of BG readings from four examined BGMS at the selected BG levels is introduced. Based on these ranges, it is illustrated how clinical decisions and subsequent outcomes of the hypothetical patients are affected by the expected inaccuracies of the BGMS. Results: The range of expected BGMS readings for the same true BG level can vary considerably between different BGMS. The discussion of hypothetical patient scenarios revealed that the use of some BGMS could be associated with an increased risk of adverse events such as failure to detect hypoglycemia, driving with an unsafe BG level, delay of treatment intervention in diabetes during pregnancy, or the failure to prevent diabetic ketoacidosis. Conclusions: This article can support both health care professionals and patients to understand the impact of BGMS accuracy in a relatable, clinical context. Furthermore, it is suggested that current accuracy requirements might be insufficient for the prevention of adverse clinical outcomes in certain circumstances.

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Performance of Blood Glucose Meters in the Low-Glucose Range: Current Evaluations Indicate That It Is Not Sufficient From a Clinical Point of View

Cited by 48 publications

References 3 publications

Bioresorbable Electronic Implants: History, Materials, Fabrication, Devices, and Clinical Applications

Bioresorbable Electronic Implants: History, Materials, Fabrication, Devices, and Clinical Applications

Results of glycaemic control on exertion in children with type 1 diabetes mellitus in FOX children's recreational camp settings

Impact of Blood Glucose Monitoring System Accuracy on Clinical Decision Making for Diabetes Management

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