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New data supports the increasing importance of Self-Monitoring of Blood Glucose (SMBG) in Type 2 Patients To Be Presented at the 67th American Diabetes Association Annual Meeting

New analyses and re-evaluated data, based on the Retrolective Study Self-Monitoring of Blood Glucose and Outcome in People with Type 2 Diabetes (ROSSO)1, presented at the 67th American Diabetes Association (ADA) Scientific Session, support the increasing importance of SMBG in diabetes management, delivering more detailed benefits. The first analysis, by Kolb et al., suggests that the correlation between SMBG and a clinical outcome also applies to older patients. In type 2 diabetes patients diagnosed at over 65 years of age, SMBG was associated with better clinical outcome (all-cause mortality combined with severe non-fatal events, mostly myocardial infarction or stroke)2. The second analysis, by Martin et al., suggests that severe diabetic complications, such as myocardial infarction and stroke, occur later in the natural course of disease in type 2 diabetes patients practicing SMBG than in those who do not3. Also, SMBG in non-insulin treated type 2 diabetics is not only associated with a benefit for the individual, it is cost-effective as well. Finally, based on an earlier evaluation of the ROSSO data4 and a recent publication by Karter et al. on the influence of SMBG on outcomes5, Weber et al. came to the conclusion that a sufficient testing frequency of at least 1 to 2 times per day leads to improved glycemic control, CV risk reduction and resourceoutcome ratio6.

SMBG is an integral element of diabetes management
Prior to ROSSO, no study had evaluated the benefit of SMBG in terms of morbidity and mortality in type 2 diabetes, using “hard” endpoints as morbidity (myocardial infarction, stroke, foot amputation, blindness or renal failure requiring hemodialysis), and mortality (all deaths regardless of the cause of death).

In a total of 3,268 people with diabetes – 1,479 of whom practiced SMBG for at least one year, while 1,789 did not – ROSSO illustrated that morbidity as well as mortality were significantly lower in the SMBG group. During the follow-up period, 9% of the total study population (293 people) experienced a non-fatal endpoint, with a morbidity rate of 7.2% in the patient group practicing SMBG and of 10.4% in the group not practicing SMBG. The mortality rate was 2.7% in the patient group practicing SMBG and 4.6% in the group not practicing SMBG.

For the total study population, these data indicate that in the SMBG group, the morbidity risk was reduced by approximately one-third and the mortality risk by approximately one-half, thus reflecting a longer life expectancy and better quality of life for patients practicing SMBG than patients not practicing SMBG over the entire observation period.

An additional analysis of a subgroup of patients not treated with insulin was also performed. The result was that self-monitoring of blood glucose is also associated with reduced morbidity and mortality rates in non-insulin-treated people with diabetes. The study revealed that both the morbidity and mortality risks were reduced by approximately one-third. In other words, people with type 2 diabetes taking oral antidiabetics or using other forms of therapy also benefit from self-monitoring of blood glucose.

SMBG significantly increases life expectancy and quality of life
The findings from ROSSO, together with the further evidence presented at the ADA Scientific Session are also reflected in the recommendations of the current IDF global guidelines for Type 2 Diabetes. In the Standard Care section of the revised guidelines, the following has been integrated: “Self-monitoring of blood glucose (SMBG) should be available for all newly diagnosed people with type 2 diabetes as an integral part of self management education.”

ROSSO was supported by an unrestricted research grant from the Ministry of Science and Research of the State North Rhine-Westphalia, Düsseldorf, the Federal Ministry of Health, Bonn, Germany, and by Roche Diagnostics.

About Roche and the Roche Diagnostics Division
Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche is a world leader in diagnostics, the leading supplier of drugs for cancer and transplantation and a market leader in virology. In 2006 sales by the Pharmaceuticals Division totalled 33.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.7 billion Swiss francs. Roche employs roughly 75,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai Roche’s Diagnostics Division offers a uniquely broad product portfolio and supplies a wide array of innovative testing products and services to researchers, physicians, patients, hospitals and laboratories world-wide. For further information, please visit our websites www.roche.com, www.roche-diagnostics.us, www.accu-chek.com, and www.disetronic.com.

All trademarks used or mentioned in this release are protected by law.

For further information, please contact:
Doyia Turner
Corporate Communications, Roche Diagnostics
Doyia.turner@roche.com
317-521-7252

1“Self-Monitoring of blood glucose in type 2 diabetes and long-term outcome: an epidemiological cohort study” , Martin S et al., Diabetologia (2006) 49:271-278
2“Type 2 Diabetes Diagnosed Before or After 65 Years of Age: Different Diseases by Metabolic and Cardiovascular Parameters”, Kolb H et al., poster presented on behalf of ADA 2007, Chicago
3“Natural Course of Type 2 Diabetes Before a Macrovascular Event: Impact of SMBG”, Martin S et al., poster presented on behalf of ADA 2007, Chicago
4“Cost of type 2 diabetes in Germany over 8 years (the ROSSO study No.2)”, Weber C et al., Journal of Medical Economics (2006) 9: 45-53
5“Longitudinal Study of New and Prevalent Use of Self-Management of Blood Glucose”, Karter J et al., Diabetes Care (2006) 29: 1757-1763
6“Cost-effectiveness of SMBG in Function of the Testing Frequency in Patients with Type 2 Diabetes“, Weber C et al., poster presented on behalf of ADA 2007, Chicago

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