The combination of blood glucose monitoring and integrated diabetes management software in Bayer's Contour®USB meter offers advantages for both insulin-treated diabetes patients and health care professionals. It supports patients with effective self-management of diabetes and strengthens the doctor-patient-interaction. These are the conclusions drawn from a recent non-interventional study.(1) In the evaluation, more than 1,000 insulin-treated diabetes patients and more than 100 health care professionals assessed the usability of Bayer's Contour USB blood glucose monitoring device in everyday life over a period of four to six weeks. Prof. Dr Ulrich Schwedes, diabetologist and endocrinologist at the Diabetes Center Hamburg, Germany, presents the key findings of the study in a poster session at the Diabetes Technology Meeting in Bethesda, Maryland/USA, in November 2010.(2) "The usability of Contour USB was largely rated positively both by patients and diabetes advisors," summarizes Prof. Dr Schwedes. "About 97 percent of all participating people with diabetes stated that they plan to continue using the device after the study."
First non-interventional study of Contour USB and integrated software
This non-interventional study of Bayer's Contour USB, which is equipped with integrated Glucofacts® Deluxe diabetes management software and directly connects to computers via USB port. The objective was to explore "real-world usability" in blood glucose monitoring and diabetes management by healthcare providers and insulin-treated patients. Both groups were surveyed and asked to evaluate different features of Contour USB by standardized questionnaires. In addition, important parameters of routine diabetes self-management were evaluated.
Furthermore, a sub-analysis of documented laboratory parameters (postprandial and fasting blood glucose, and HbA1c) available for 237 patients was carried out. Comparing the initial values at baseline to those of the final examination four to six weeks later, it turned out that all three values had decreased. At the first visit, mean blood glucose was 133.8 mg/dl (fasting) and 181.2 mg/dl (postprandial). At the end of the evaluation, mean blood glucose levels were lower: 122.6 mg/dl (fasting) and 162.0 mg/dl (postprandial). Mean HbA1c was 7.8 percent at the start of the study and 7.4 percent at the end.
One in three participants had not practiced data management before
In total, 1,127 insulin-treated diabetic patients, who were selected by 129 diabetologists in private practices all over Germany, participated in the study. Approximately 80 percent have been diagnosed with type 1 diabetes and all of the participants were treated with insulin. Mean duration of diabetes was 13.5 years and all patients were experienced in daily blood glucose monitoring. "More than 80 percent of the test persons received intensive insulin therapy (ICT) with several injections per day," explains Prof. Dr Schwedes.
Nevertheless, one in three participants had not previously used any kind of diabetes management software. Of those tracking and documenting their data regularly, only approximately one in four patients used electronic diabetes management software to monitor and interpret individual values. This is despite the fact that electronic logbooks can assist patients effectively with gaining better gylcaemic control and optimizing treatment outcome. They offer a deeper understanding of recurrent patterns and trends and visualize how patient behavior affects blood sugar values in a way that is easier to comprehend. In addition, several studies have shown that computerized diabetes logbooks have marked advantages over hand-written diaries in terms of providing more accurate and reliable blood glucose values.(3,4,5)
Positive patients' evaluation of meter features
In the study, patients' judgment of features of the Contour USB was universally positive (excellent, very good, good). The most frequently mentioned and most popular features of the device stated in an unaided survey were:
Bayer's No Coding™ technology
- Memory size of up to 2,000 results
- Direct connectivity via USB port
- Diabetes management with integrated Glucofacts Deluxe software
The overall evaluation of Contour USB with regard to its usability was excellent, very good or good in 98.2 percent of patients. Managing diabetes with the integrated Glucofacts Deluxe diabetes management software was judged as excellent, very good or good in 97.3 percent of patients, even though the majority of the patients had no previous experience of logging their blood glucose values electronically. Almost all patients stated that they want to continue using the device.
High level of satisfaction with Contour USB among health care professionals
Assessment of the device by physicians and diabetic advisors was even more positive than the patients’ evaluations. 99.5 percent of doctors and diabetes consultants rated their level of satisfaction with the Contour USB meter as excellent, very good or good. They chose to recommend Contour USB primarily because it offers a simple and convenient diabetes management via PC (87.4 percent) and is easy to use (65.3 percent). Health care professionals especially appreciate that the meter may help to improve compliance and facilitates the identification of metabolic crises, which may lead to improved glucose control. In addition, it strengthens doctor-patient-interaction, since it provides a reliable data base for discussing therapeutic options and transferring knowledge into concrete action like the adjustment of meal planning, exercise or insulin dosing.
Clinical benefits confirmed
Among others, these findings for the perceived usability of Contour USB and its potential to optimize diabetes care are in line with the results of the Information-Motivation-Behavioral (IMB) Skills Analysis(6) conducted by Bayer Diabetes Care. Here, research revealed substantial information gaps, motivational obstacles and behavioral skills limitations that stand in the way of adherence to the self-monitoring of blood glucose values. Although international guidelines issued by organizations such as the International Diabetes Federation (IDF) or the European Association for the Study of Diabetes (EASD)(7) recommend SMBG for all types of diabetes treatment, not all patients self-test regularly or document their values properly over a longer period of time as defined by their diabetes advisors.
Studies have shown that routine tracking of individual values can help patients to better manage their blood sugar and may lead to a lower HbA1c level, which is important for diabetes management. In fact, even a one-percent reduction in results of HbA1c blood tests reduces the risk of developing microvascular diabetic complications (eye, kidney, and nerve disease) by 40 percent.(8) A study with diabetes management software from Bayer in 2007 confirmed that electronic data management also has a measurable benefit.(9) After just three months, software users had significantly reduced their HbA1c value by 0.58 percentile points and remained 0.41 percentile points lower than the baseline value after twelve months.
About Bayer HealthCare Diabetes Care
Bayer HealthCare, Diabetes Care as part of the Medical Care Division supports customers in 100 countries and stands in a long tradition of leading the way in diabetes care product innovation since the introduction of CLINITEST reagent tablets in 1941. The face of diabetes care was changed in 1969 when the first portable blood glucose meter and test strips were introduced. Certain features of Bayer's blood glucose monitors such as No Coding™ technology make diabetes management easier. Today, Bayer HealthCare Diabetes Care offers an unparalleled choice in diabetes management systems and comprehensive support including education, tools and resources designed to simplify life with diabetes.
Bayer HealthCare Diabetes Care global headquarters is located in Tarrytown, New York, in the United States and operates as part of Bayer HealthCare LLC, a member of the worldwide Bayer HealthCare group. The Headquarters for the region Europe-MERA is located in Basel as part of Bayer Consumer Care AG, in Basel.
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the health care and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Bayer Schering Pharma, Consumer Care and Medical Care divisions. Bayer HealthCare's aim is to discover and manufacture products that will improve human and animal health worldwide. Find more information at www.bayerhealthcare.com.
1. A non-interventional study (observational study) is defined as a study of one or more medicinal products, which have marketing authorization. For detailed conditions see: EU Directive 2001/20/EG article 2c.
2. Non-interventional Study to Investigate Suitability for Daily Use of Blood Glucose Meter Contour®USB in Routine Application in Insulin-treated Diabetic Patients. Poster presentation by U. Schwedes at DTS meeting, November 12, 2010, in Bethesda, Maryland, USA. SCH10134D.
3. B. Hirsch, Endocr Pract. 2004, 10, 67-76
4. R. S. Mazze et al, Am J Med 1884, 77, 211-217.
5. C. D. Williams et al, Diabetic Medicine, 1988, 5, 459-462.
6. W.A. Fisher et al, Understanding Self-Monitoring of Blood Glucose: An Information-Motiviation-Behavioral Skills Analysis, poster presentated at the American Diabetes Assiciation (ADA) Scientific Sessions, 25-29 June, 2010, Orlando, Florida/USA
7. For more information also see: "Consensus Statement - A European perspective" - O. Schnell et al, Diabetes, Stoffwechsel und Herz, 2009, 4, 285-289.
8. Centers for Disease Control and Prevention. National diabetes fact sheet: general information and national estimates on diabetes in the United States, 2003. www.cdc.gov/diabetes/pubs/pdf/ndfs_2003.pdf. Last accessed October 12, 2010.
9. M. Janssen et al, J Diabetes Sci Technol., 2007, 1, 47-53.