HUMAN FACTORS STUDY: Handling of Blood Glucose Monitoring Test Strips with Use-by Period after First Opening

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HUMAN FACTORS STUDY: Handling of Blood Glucose Monitoring Test Strips with Use-by Period after First Opening Ilona Näger, Ulrike Mikles Spiegel Institut Mannheim (Version July 2015) Abstract This paper
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HUMAN FACTORS STUDY: Handling of Blood Glucose Monitoring Test Strips with Use-by Period after First Opening Ilona Näger, Ulrike Mikles Spiegel Institut Mannheim (Version July 2015) Abstract This paper focuses on the handling of test strips for blood glucose monitoring systems (BGM systems) that require the user to individually calculate the use-by period when they open a test strip container for the first time. A human factors study of 32 subjects with diabetes was conducted by the Spiegel Institut Mannheim to evaluate this process and to identify possible weak points. Results showed that none of the subjects calculated the use-by period when they opened the test strip container for the first time either during the test situation or at home. Few subjects (16%) were aware of the need to calculate the use-by period after first opening. Key Words: human factors study, diabetes mellitus, handling of test strips, use-by period after opening, use-by date, BGM systems, diabetes care products 1. Study Background In general, test strips for blood glucose monitoring systems (BGM systems) can be used for a prespecified period of time after manufacture. The end of this period, the use-by date, is printed on the packaging and on the test strip container. However, some BGM systems use test strips which also have a use-by period after opening, i.e. the test strips should be used only within a prespecified period of time after opening the test strip container for the first time. In these cases the use-by date printed on the test strip container and packaging is only valid as long as the test strip container has not been opened. The actual use-by period after opening usually differs from the use-by date printed on the test strip container and may shorten the time period (e.g. 3 months) during which the test strips have to be used. The use-by period after opening must be calculated by the user after opening the test strip container for the first time and is to be noted on the label of the test strip container. Figure 1 shows examples of the use-by date and use-by period on test strip containers. 1 Figure 1. Examples of Use-by Date and Use-by Period on Test Strip Containers A Accu-Chek Aviva test strip container (Roche Diabetes Care GmbH) B GluNEO TD 4230 Plus test strip container (Infopia Co., Ltd) Using expired test strips to test blood glucose can have an impact on the accuracy of the BGM systems 1. Resultant wrong or inaccurate results may lead to incorrect therapy decisions by patients or healthcare professionals. This poses a potential risk in particular for patients with diabetes who are treated with insulin, but may also have negative long-term effects, especially on achieving individual glycemic target goals 2,3. This human factors study was conducted by the Spiegel Institut Mannheim to provide insights into the handling of BGM systems in combination with test strips with a use-by period after first opening and to identify possible weak points in the process. The calculation and documentation of the use-by period after first opening by the user was of particular interest. 2. Methodology Recruitment Criteria To be eligible for the study, subjects had to have diabetes mellitus type 1 or type 2 and had to be users of a BGM system with test strips with a use-by period after first opening (e.g. 3, 6 or 9 months, depending on the system). Subjects also had to have used their BGM system for at least 3 months before taking part in the study. Every attempt was made to achieve equal numbers of men and women and an equal distribution to age groups (18-45, 46-65, 65) in the study. The required minimum age of subjects was 18 years. Test Procedure The test procedure consisted of a combination of participant observation and individual interviews. A structured computer-based questionnaire was designed specifically for the study. 2 First of all, the subjects performed the following two tasks by themselves: 1. Blood glucose test with the subject s own BGM system and test strips. 2. Blood glucose test with the subject s own BGM system, but with new test strips in their original packaging provided by the interviewer. Artificial blood was used for the blood glucose tests. The following aspects were monitored during the tasks: Is the use-by period after opening noted on the subjects test strip containers brought from home? Do subjects calculate the use-by period after opening when opening a new test strip container? Do subjects make a note of the use-by period after opening on the new test strip container (or somewhere else) if they calculate it? After performing the tasks, the subjects were asked various questions regarding their level of knowledge about the use-by period after first opening (e.g. general awareness of the use-by period after first opening, knowledge of consequences of using expired test strips, etc.). The tests and interviews were approximately 30 to 45 minutes in length and conducted as a studio test in a laboratory situation. Analysis Quantitative data was analyzed using descriptive statistics. Observational data was evaluated by qualitative content analysis. Difficulties performing the tasks were rated by the observer using various categories (no difficulties, minor difficulties, major difficulties). Video data was used for source data verification. 3. Results Sample The study was conducted between 18 vember and 2 December 2014 in the four German cities Düsseldorf, Frankfurt/Main, Mannheim and Munich. Thirty-two subjects participated in the study. Slightly more than half of the study population had type 1 diabetes (53%). Almost three quarters (72%) of the subjects were on insulin treatment. 41% of the subjects were female and 59% male. The subjects age ranged between 21 and 79 years with an average of 50 years, see Table 1. 3 Table 1. Study Population Diabetes type 53% (n=17) Type 1 Type 2 47% (n=15) Insulin treatment 72% (n=23) Female Gender 41% (n=13) 28% (n=9) Male 59% (n=19) Mean 65 Age 50 years 34% (n=11) 59% (n=19) 6% (n=2) Test Results The test results are shown in Table 2. ne of the subjects had calculated or documented the use-by period after opening on his/her own test strip container, which was brought to the study site for task 1. In addition, when the subjects used the new test strip container provided for task 2, none of them calculated or documented the use-by period after opening. Twenty seven (84%) of the 32 subjects were not aware of the existence of the use-by period after first opening. Even people with diabetes with significant experience in managing their disease emphasized a lack of awareness concerning the use-by period. Only 5 subjects (16%) were aware of or had already heard about the use-by period after first opening (both people with type 1 and people with type 2 diabetes). When asked why they did not calculate the use-by period after opening, the most frequent reason given by the 5 subjects was that all test strips are used up within a short period of time. In addition, the idea of calculating a use-by period after first opening was considered to be impractical in daily life. Table 2. Test Results Documentation of use-by period after opening on the personal test strip container Calculation of use-by period after opening at home Documentation of use-by period after first opening on new test strip container in test situation 4 Calculation of use-by period after opening in test situation Overall awareness of use-by period after first opening 16% (n=5) 84% (n=27) Even though some subjects mentioned the use-by date as being more important for orientation purposes than the use-by period after first opening, 5 subjects brought test strips from home that had expired. Four of the 5 subjects concerned were patients on insulin treatment. In general, there was confusion about the difference between the use-by period after first opening and the use-by date. 4. Conclusion The results of the human factors study show a consistent but also worrying picture regarding the level of knowledge about the use-by period after opening in the routine use of test strips by people with diabetes. It was demonstrated that many patients are unaware of the existence of a use-by period after opening a test strip container. The lack of awareness of the use-by period after first opening means that there is a risk that test strips may be used after expiry, especially as the system does not provide an expiry warning. Use of expired test strips may lead to false readings and miscalculation of insulin doses and ultimately to inappropriate treatment of diabetes, with a resultant potential risk of severe hypo- or hyperglycemia 1,2. Systems without the limitation of a use-by period after first opening and systems including warning features would appear to be safer alternatives for people with diabetes. 1 Schmid C, Haug C., Heinemann L, Freckmann G. System Accuracy of Blood Glucose Monitoring Systems: Impact of Use by Patients and Ambient Conditions. Diabetes Technology & Therapeutics. 2013;15(10): Freckmann G, Schmid C, Baumstark A, Pleus S, Link M, Haug C. System accuracy evaluation of 43 blood glucose monitoring systems for self-monitoring of blood glucose according to DIN EN ISO J Diabetes Sci Technol. 2012;6(5): Baumstark A, Pleus S, Schmidt C, Link M, Haug C, Freckmann G. Lot-to-Lot Variability of Test Strips and Accuracy Assessment of Systems for Self-Monitoring of Blood Glucose according to ISO J Diabetes Sci Technol. 2012;6(5):
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