Accuracy of Home Glucose Monitoring Devices The Accuracy of Home Glucose Monitoring Devices during Hypo and Hyperglycaemia Self – monitoring of blood glucose at home is useful for the management of diabetes as it helps to monitor symptoms of hyper and hypoglycaemia (Diabetes UK). Testing of blood glucose also helps patients to adjust dosages of medication such as insulin and sulphonylureas, monitor the effects of exercise on blood glucose levels, and plan meals (Diabetes UK and Nipro Diagnostics, 2011). The FDA (US- Food and Drug Administration) (2014) refers to a trial in 1993 for control and complications of diabetes which stated “that good glucose control using home monitors led to fewer disease complicationsâ€. For these reasons blood glucose meters that aid self- monitoring most be accurate. Nipro Diagnostics (2011) in the “Accuracy Study of Blood Glucose Monitoring Systems†states that the “use of blood glucose meters and test strips are effective in controlling blood glucose valuesâ€. There are currently different brands of meters on the market ranging from expensive to less expensive. The accuracy of meters has been questioned by patients and consumer blog groups such as the†American Association of Retired Persons†and therefore the FDA and MHRA (UK-Medicines Healthcare Products and Regulatory Agency) monitor medical devices to ensure they work safely and provide accurate results. At a worldwide level the ISO (International Organization for Standardization) provide standards and regulations which manufactures must meet when producing self-monitoring glucose meters. All brands of glucose meters are subject to the ISO standards (Nipro Diagnostics, 2011) Incorrect blood glucose readings may occur with blood glucose meters due to software issues but may also occur due to operator errors, effects of oxidized uric acid and abnormal haematocrit levels (ADDE, 2013, Bode, 2007, and FDA, 2014). Inaccuracies due to operator error or short cuts, maybe due to poor technique, use of expired test strips, the use of un – calibrated meters, or meters calibrated with expired control solutions, unwashed hands before testing, applying too much or too little blood to the test strip, testing from sites damp with alcohol and from meters and testing strips not stored and handled according to manufacturer’s instructions (ADDE, 2013 Bode, 2007, and FDA, 2014). Oxidised uric acid may lead to falsely low glucose levels by the home glucose meter (Bode, 2007). Dehydration causes haematocrit levels to be elevated resulting in low glucose reading, whereas, high levels caused by anemia, for example, cause low levels of haematocrit resulting in high glucose readings (Bode, 2007). In 2013 the ISO updated the ISO 15197:2003 standards for the “self – testing glucose monitoring Systems†(ISO 15197:2013). The improved standards will enhance even greater accuracy for glucose meters for patient use (ISO, 2013). In 2013 a meeting of the Diabetes Technology Society researchers, presented evidence from studies done in the USA and Germany concerning accuracy of blood glucose meters using the ISO 15197:2003 standards (ADDE, 2013). The evidence presented showed that many meters did not meet the ISO standard that requires 95% of results to be within range of +/- 20% of the true value (ADDE, 2013). The new international standards ISO 15197:2013 require meters have increased accuracy especially with glucose reading over 4.2mmol/l, and 99% of all results to be within ±15% of true value (ISO, 2013). The FDA (2010) report as cited on Diabetesnet.com says that a potential inaccuracy with glucose meters between 1992 to 2009 were associated with 100 deaths and 12,672 injuries from 2004 to 2008. American Diabetes Association reported that up to 50% of home glucose meters did not meet the ±20% of the true values (Alto et al, 2002). The MHRA in April 2013 issued a Medical Device Alert (MDA/2013/022) about “Home Use Blood Glucose Metersâ€. These meters were recalled due to a software fault. At very high glucose concentration patients were given a “falsely low reading with One Touch Verio Pro and no results were recorded with One Touch Verio IQâ€. A recent alert (MDA/2014/009) was issued from the MHRA March 2014 about “FreeStyle Mini® and FreeStyle® blood glucose metersâ€. The meters were recalled because they may be “reporting incorrect low blood glucose reading†(MHRA). Alto et al (2002) in a study of 111 patients using 21 different brands of meters found that 84% were within the ±20% of the true value even though patients took short cuts. The study highlighted that patients were not always calibrating meters due to the price of strips and the use of expired control solutions (Alto et al, 2002). Overall, the blood glucose values obtained in this study were clinically useful (Alto et al, 2002). On the other hand, another study “The accuracy of home glucose meters in hypoglycemia†concluded that some meters were inaccurate in reporting hypoglycaemia (Aydoqdu et al, 2010). There is evidence that home glucose meters are associated with inaccuracies. These inaccuracies maybe due to software problems associated with the meters or due to the operator. The operator plays a very important role in the accuracy of home glucose monitoring. The operator should follow the manufacturer advice about use, technique, storage and calibration of meters to achieve optimum results. Diabetes UK (2014) and the FDA (2014) encourage patients to check accuracy of home glucose meters by comparing to results of blood processed in a laboratory (Collazo – Clavell, 2012). ISO has tightened requirements in 2013 for home glucose meters to ensure higher accuracy for all new meters. References Diabetes UK (2014)– “Blood Glucose Meter Guide†[Online]. Available at: http://www.diabetes.org.uk/ (Accessed 23 March 2014) FDA (2014) US Food and Drug Administration, ‘Medical Devices’, Blood Glucose Monitoring Devices’. [Online]. Available at: http://www.fda.gov/ (Accessed 23 March 2014) Nipro Diagnostics (2011) “Accuracy Study of Blood Glucose Monitoring Systems†http://www.niprodiagnostics.com/ (Accessed 23 March 2014) Bode, B.W, (2007) “The Accuracy and Interferences in Self-monitoring of Blood Glucoseâ€, Blood Glucose monitoring, US Endocrine Disease, pp. 46 -48. [Online]. Available at: http://www.touchendocrinology.com/ (Accessed 30 March 2014) MHRA (2013) ‘Medical Devices Alert’ Home use blood glucose meters: Lifescan OneTouch Verio Pro; Lifescan OneTouch Verio IQ (MDA/2013/022 [online]. Available at: http://www.mhra.gov.uk/ (Accessed 23 March 2014) MHRA(2014) ‘Medical Device Alert’ FreeStyle Mini® and FreeStyle® blood glucose monitoring systems manufactured by Abbott Diabetes Care (MDA/2014/009)[Online].Available at: http://www.mhra.gov.uk/ (Accessed 24 March 2014) ISO (2013) “More accurate self-testing results for diabetes patients with new ISO standard†[Online]. Available at: http://www.iso.org/ (Accessed 23 March 2014) AADE (2013) ‘American Association of Diabetes Educators’ Practice Advisory Blood Glucose Meter Accuracy [Online. Available at: http://www.diabeteseducator.org/ (Accessed 24 March 2014) Alto, W.A., Bryson, P, Kindig, J, Meyer, D, and Schneid. J (2002) ‘Assuring the Accuracy of Home Glucose Monitoring’, Journal of the American Board of Family Medicine 15(1). [Online]. Available at: http://www.medscape.com/ (Accessed 30 March 2014) Aydoqdu, A, Erbil, M.K, Kilic, S, Kutlin, M, Serdar, M, Sonmez, A, Tapan, S, Taslipinar, A, Uckaya, S, Yazici, M, Yilmaz, M.I, and Yilmaz, Z (2010) ‘The accuracy of home glucose meters in hypoglycemia’ Diabetes Technol Ther 12(8), pp. 619-26. PubMed. [Online]. Available at: http://www.ncbi.nlm.nih.gov/ (Accessed 30 March 2014) Collazo – Clavell, M (2012) ‘Diseases and Conditions’, Sometimes my blood glucose monitor seems to give incorrect readings. What can I do to make sure the measurement is accurate? Mayo Clinic [Online]. Available at: http://www.mayoclinic.org/ (Accessed 30 March 2014)
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12/16/2019 0 Comments Marketing Mix Halal chipsThe purpose of this paper is to presents the results of the comprehensive marketing analysis of the feasibility of introduction of Halal chips to Indonesian market. The study consists of the overview of the product (using certain elements of the Marketing Mix methodology) and the overview of the target market (a full macro environmental analysis, encompassing the scan of political, economic, social, and technological aspects of the chosen market), followed by a conclusion concerning the rationale behind the introduction of Halal chips in Indonesia.
Product: Halal chips Marketing Mix is one of the most effective tools to formulate a comprehensive marketing strategy. Marketing Mix is sometimes referred to as the ‘4 Ps’, which stands for product, place, price, and promotion. Sometimes this list is extended to ‘7 Ps’ to include people, process, and physical evidence; however, this paper will focus on the discussion of the traditional model. There are two basic marketing approaches to evaluating the product – Product Life Cycle and Three Levels of a Product. Product Life Cycle (PLC) model compares the existence of the product on the market with the biological life cycle: ‘After a period of development it is introduced or launched into the market; it gains more and more customers as it grows; eventually the market stabilizes and the product becomes mature; then after a period of time the product is overtaken by development and the introduction of superior competitors, it goes into decline and is eventually withdrawn’ (Marketing Teacher, 2006, The Product Life Cycle (PLC), para.2). Product Life Cycle is viewed as being comprised of four distinct stages such as introduction, growth, maturity and decline. At the Introduction stage, the pressure for immediate profit is less important than creating the first impression about the product. At the Growth stage, many competitors exist on the market, therefore companies tend to form strategic alliances, joint ventures, or merge. Profits are growing, and wide-scale advertising is the focus. At the Maturity stage, sales growth is stable, and the companies pay most attention to differentiating their offers and promoting the product through various media. At the Decline stage, the product is either radically transformed or withdrawn from the market. When introducing Halal chips to Indonesian market, it is of paramount importance to choose appropriate strategy at every stage of Product Life Cycle. Immediately after the introduction, it is necessary to develop a positive image of Halal chips. At the Growth stage, it is imperative to maintain a competitive advantage over competitors. At the moment, the competition is not intense, yet the situation may change if the introduction of Halal chips proves to be a success. At the Maturity and Decline stages, strategies like repackaging, differentiating (e.g. adding new flavors), and aggressive advertising will have to be applied. Another marketing model that can be applied to analyzing Halal chips is the Three Level Model. The Three Levels of a Product model argues that within each product it is possible to distinguish three different levels — the core product, the actual product, and the augmented product. The core product is the immediate benefit the customer receives from the ownership of a product. The actual product is the tangible, material thing. The augmented product encompasses the added value of the product, i.e. additional services that accompany the product. The examples can include ‘toll-free customer information, installation guides, delivery, warranty, and after-sale services’ (Lilien & Rangaswamy, 2006, p.234). In the case with Halal chips, the level of augmented product is virtually non-existent, therefore, the main focus should be on the levels of core product and actual product. The core product should be larger than the actual, tangible product. Through advertising and correct positioning, it is necessary to have the customer associate benefits from buying Halal chips not only with delicious taste and hunger satisfaction, but also with adherence to tradition or good times shared with friends while eating the chips. Pricing policy is another vital aspect of marketing the Halal chips. There are different pricing strategies, and the application of each strategy should rely on all other elements of the Marketing Mix. The basic pricing strategies include Premium Pricing, Penetration Pricing, Economy Pricing, Price Skimming, Psychological Pricing, Product Line Pricing, Optional Product Pricing, Captive Product Pricing, Product Bundle Pricing, Promotional Pricing, Geographical Pricing, and Value Pricing. In the case with Halal chips, Penetration Pricing can be used at the initial stages of the introduction of the product. This strategy implies that the price is artificially lowered with a view to establish the company on the market. When Halal chips are established on the Indonesian market, Price Skimming can be used. It is applied by companies that have a significant competitive advantage. Price Skimming can not be sustained for a long time as new competitors, lured by high revenues, enter the same segment of market. At the stages of Maturity and Decline, Economy Pricing might be the most feasible option. Economy Pricing means that it is a low price offered by a company that keeps marketing and manufacturing expenses at a minimum. Target Market: Indonesia Presently, Indonesia is a market that offers many lucrative opportunities for doing business in different spheres. However, it is necessary to assess all the possible risks involved, including political, economic, social, and environmental factors. Political Recently, Indonesia has been showing signs of enhanced political stability. The political climate of the country has become more favorable for further economic and social changes. In the framework of Reformasi movement following President Suharto’s resignation in 1998, greater democracy was introduced into Indonesian political life. However, problems include pervasive corruption, administrative obstacles to doing business, and the danger of radical Islamist ideology overtaking the political scene. Terrorism threat also remains high. Separatism is another risk factor: although a political settlement to an armed separatist conflict in Aceh was achieved in 2005, Indonesia a very diverse country where conflicts between different ethnic groups are hard to avoid. Economic Indonesia was badly hit by the Asian Financial Crisis of 1997, therefore the government increased its intervention in economic matter. Nevertheless, Indonesia has a functioning market economy. Furthermore, the government struggles to change the regulatory framework to attract more investment. Major problems include instable legal and judicial system, weak competition laws, and lack of internationally acceptable accounting and disclosure standards. Social Indonesia has a large population, which is supposed to increase in the years to come, given the present annual growth rate of 1.25%. Therefore, the number of potential consumers of Halal chips is doomed to increase, since chips and related snacks are popular among teenagers and youth. In terms of religious affiliations, 86% of Indonesians are Muslim. An interesting trend observed in Indonesia is the gradual Westernization of the society coupled with greater observance of religion and traditions. Therefore, there exists a degree of fascination with Western lifestyle (e.g. eating chips), yet there is also an avoidance of conflict between consumerist values and well-entrenched traditions (e.g. chips have to be Halal). Technological From the technological perspective, Indonesia is striving to meet all the international standards in this field. Indonesia has been noted for the rapid development of infrastructure and modernization of its production facilities. The development of Indonesian technological sphere may leave much to be desired, yet shows clear trends towards substantial improvement. Conclusion The entry of Halal chips into Indonesian market has high chances of being successful. Given the high percentage of young Muslim population, the target market is large and growing. However, the commercial success of such an entry depends greatly on the carefully chosen marketing and promotional strategy, pricing, and advertising. While there are some risks involved, mostly of political and economic nature, they can be offset by lucrative business opportunities Indonesian market offers. References Lilien, Gary L., & Arvind Rangaswamy. Marketing Engineering. Ottawa, Canada: Trafford Publishing, 2006. Marketing Teacher. ‘The Product Life Cycle (PLC).’ 2007. November 21, 2007. <http://marketingteacher.com/Lessons/lesson_plc.htm>     |