Trade News

Vienna, Sept. 30th, 2009

Preliminary study results show: New concept of Structured Testing can significantly help to improve diabetes therapy outcomes

The promising preliminary results of the Accu-Chek® 360° View Outcome study¹⁾ suggest: Structured Testing can enable people with type 2 diabetes and their healthcare professionals to get a better understanding of metabolic fluctuations, supports and encourages appropriate therapeutic intervention, and contributes to improved glycemic control. The 6-months interim analysis of the study reveals that patients in the intervention group showed not only an improved HbA1c but also significantly lowered average, pre- and postprandial as well as bedtime blood glucose levels.

Various studies have underlined that a structured diabetes self-management can help prevent the occurrence of secondary diseases and diabetes late complications²⁾. Nevertheless people with diabetes often find it hard to adhere to regular self-monitoring of blood glucose (SMBG), since they may not know how to interpret the results and therefore are not clear about how to respond effectively. Hence, it is essential to provide an approach that enhances greater utility and consequently promotes patient engagement. The new diabetes management concept of structured testing and the subsequent pattern analysis which is supported by Accu-Chek 360° View delivers such an approach. To investigate how beneficial the concept of a structured blood glucose testing and data evaluation can be, not only enhancing day-to-day diabetes management but also for improving medical outcomes, is the chief purpose of the Accu-Chek 360° View Outcome study.

522 patients with type 2 diabetes (non insulin-dependent) were enrolled in this multi-center, prospective and cluster-randomized study. (269 patients in the intervention group, 253 patients in the control group). Evaluations are performed at baseline and in month 1, 3, 6 and 9. The final analysis will be carried out in month 12. “This interim analysis of the Accu-Chek 360° View Outcome study suggests that people with poorly-controlled, type 2 diabetes can use blood glucose monitoring to improve their metabolic outcomes, as demonstrated by the significant reduction in HbA1c. With this new and easier-to-interpret link between blood glucose values and therapeutic intervention, it seems likely that patients will also be more motivated to take appropriate actions on the data obtained,” states Professor William H. Polonsky, Associate Clinical Professor, University of California, San Diego and Principal Investigator of the study group.

Lower HbA1c and postprandial glucose excursions

The 6-months results of the study suggest that the benefits of Structured Testing occur regardless of age, education or body mass index. Compared to the control group, the intervention group displayed a greater reduction in HbA1c D = - 0, 35% (adjusted means; p = 0.032). This effect was even more pronounced when patients adhered to the intervention protocol (D = - 0,43 % p= 0.03) . Furthermore, the intervention group achieved significantly better average, pre- and postprandial as well as bedtime blood glucose levels (p < 0.001). Intervention with the Accu-Chek 360° View tool was also associated with a significantly lower number of postprandial excursions above 50 mg/dl (p < 0.001). Importantly, the intervention was not associated with increase in depressed mood; indeed, it was linked to a significant decrease in diabetes-related emotional distress. The majority of patients in the intervention group (89%) reported receiving at least one recommendation for medication change compared to only 43% in the control group. In addition 81% of the study participants in the intervention group reported receiving at least one lifestyle change recommendation, such as nutrition or exercise, compared to only 48% of the control group. These results suggest that by following the new concept of Structured Testing, including organized data collection, visualization and focused intervention, not only can patient quality of life be enhanced but medical outcomes can also be significantly improved.

A holistic approach for a sustainable diabetes management

“We have started a lot of initiatives to support the healthcare professionals in optimally manage their patients condition. This comprises activities like the Accu-Chek 360° View Outcome study which examines the impact of new concepts for Structured Testing on therapeutic results,” says Burkhard G. Piper, President Roche Diabetes Care. The results of the Accu-Chek 360° View study underline the importance of this holistic approach Roche Diabetes Care takes to contribute to an efficient diabetes management. It is important for healthcare professionals and people with diabetes to work together and manage diabetes with a panoramic perspective. Instead of only focusing on the HbA1c value, blood glucose patterns as well as the individual person and lifestyle should also be taken into account.

About Accu-Chek 360°View

Accu-Chek 360° View is an easy-to-handle paper tool that offers a seven-point profile of blood glucose control. In three days it gives a more complete picture of the consequences of behavior. It shows how food portions affect blood glucose and energy levels. Discovering these patterns helps people with diabetes and their healthcare providers quickly to see if adjustments are needed. Obtaining such clear and graphic data so easily and quickly also assists in motivating people with diabetes to adhere to SMBG and achieve adequate glycemic control. Accu-Chek 360° View thus offers a better understanding of diabetes and helps to improve the quality of diabetes management.

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalized healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2008, Roche had over 80,000 employees worldwide and invested almost 9 billion Swiss francs in R&D. The Group posted sales of 45.6 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan.  For more information: www.roche.com.

About Roche Diabetes Care

Roche Diabetes Care is a pioneer in the development of blood glucose monitoring systems and a global leader for diabetes management systems and services. For more than 30 years, the Accu-Chek brand has been dedicated to enable people with diabetes to live life as normal and active as possible as well as to empower healthcare professionals manage their patients’ condition in an optimal way. Today, the Accu-Chek portfolio offers people with diabetes and healthcare professionals innovative products and impactful solutions for convenient, efficient and effective diabetes management spanning from blood glucose monitoring through information management to insulin delivery. The Accu-Chek brand encompasses blood glucose meters, insulin delivery systems, lancing devices, data management systems and education programs – leading to an improved medical outcome. For more information please visit www.accu-chek.com.

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1) Accu-Chek 360° View Outcome Study. Data on file.
2) Martin S, Schneider B, Heinemann L, Lodwig V, Kurth H-J, Kolb H et al. Self-monitoring of blood glucose in type 2 diabetes and long-term outcome: an epidemiological cohort study. Diabetologia. 2006;49(2):271-278.