Structured Diabetes Management can Significantly Improve Overall Glycemic Control and Reduce HbA1c Values in Non-insulin Treated Type 2 Diabetes

MANNHEIM, Germany, Feb. 1, 2011 /PRNewswire/ -- An innovative diabetes management concept including structured self-monitoring of blood glucose (SMBG), data visualization, pattern analysis and derived therapy adjustments can significantly reduce HbA1c values, improve glycemic control and enhance patients' quality of life. These are the key findings of the 12-month data from the Structured Testing Protocol (STeP) Study, newly published in Diabetes Care.(1)

Self-monitoring of blood glucose (SMBG) is a well-established element of therapy management for people with type 1 or type 2 diabetes on insulin therapy.(2,3) However, there have been controversial views on the question of whether regular SMBG is similarly beneficial for non-insulin treated people with type 2 diabetes. (4,5,6,7) To gain new insights on this subject, the STeP Study was performed: A prospective, cluster-randomized, multi-center clinical trial, which examined the impact of structured SMBG upon glycemic control in 483 non-insulin treated people with type 2 diabetes who evidenced poor glycemic control (HbA1c greater than or equal to 7.5%) at baseline. The results provide new and significant evidence on its effectiveness.

The study design - usual diabetes care vs. structured diabetes management

Participants were recruited from various primary care practices across the eastern United States. Practices were randomly assigned to an active control group (ACG; n=227) or to a structured testing group (STG; n=256). Duration of the study was 12 months, and evaluations of clinical parameters were performed at baseline and during scheduled visits at months 1, 3, 6, 9 and 12. During the visits, healthcare professionals obtained relevant laboratory data, and all participants completed questionnaires relating to their quality of life. Patients in the ACG received enhanced usual care, complying with U.S. standard of care recommendations. STG patients received the same care, but their protocol was complemented by the SMBG-focused structured diabetes management concept. Patients in both groups received free BG monitors and strips.

Analysis of individual blood glucose profiles – key to effective structured diabetes management

The innovative concept is based on structured 7-point blood glucose profiles (fasting, preprandial and 2hour postprandial at each meal, and bedtime), collected and documented over 3 consecutive days prior to each scheduled quarterly healthcare professional visit. To document blood glucose values, meal sizes and energy levels, and to comment on their SMBG experiences, STG participants used the Accu-Chek® 360 Degree View 3-day profile tool. They discussed the obtained profiles with their caregivers at all medical visits. To familiarize them with the protocol, patients in the STG arm of the study received a standardized training in SMBG and pattern analysis, while their doctors were equally trained and equipped with an algorithm suggesting appropriate medication strategies.

Significantly reduced HbA1c values with use of structured diabetes management

Intent-to-treat (ITT) analysis showed significant improvements in mean HbA1c values for patients in both the ACG and STG. After 12 months, however, HbA1c values were significantly lower for STG patients than for ACG participants (-1.2% vs. -0.9%; delta= -0.3%, p=0.04). The per protocol analysis showed an even greater reduction in HbA1c (-1.3% vs. -0.8%; delta= 0.5%, p<0.003). Further evaluation of STG data also revealed significant reductions in glucose levels at all pre- and postprandial time points (p<0.001). More importantly, there was a significant drop from month 1 to month 12 in pre- to postprandial glucose excursions at all meals: breakfast (44 mg/dl to 35 mg/dl, p<0.005), lunch (25 mg/dl to 17 mg/dl, p<0.03) and dinner (34 mg/dl to 26 mg/dl, p<0.05). In addition, the mean amplitude of glucose excursions (MAGE) (p=0.0003) for the STG group indicated significant mean reductions in glycemic variability (month 1: 38.5 mg/dl vs. month 12: 34.3 mg/dl).

Meaningful test results for better therapy adjustments and glycemic control

The use of the structured and effective diabetes management concept with the individual pattern analysis, as applied in the STG arm of the study with the Accu-Chek 360 Degree View 3-day profile tool, can lead to substantially improved medical outcomes in poorly-controlled non-insulin treated people with type 2 diabetes, which are clinically meaningful. Since the STG protocol puts emphasis on when patients test and how healthcare professionals make clinically relevant use of this data supported by the Accu-Chek tools of Roche Diabetes Care, it may be appropriate to pay particular attention to increased SMBG quality and to how test results are used. Integrating structured SMBG into a collaborative program of care and hence the therapy routines of non-insulin treated people with type 2 diabetes can therefore lead to an improved doctor-patient interaction, supporting informed therapy adjustments and resulting in a better glycemic control.

For more information on the STeP study please visit:

Link Diabetes Care

Link Behavioral Diabetes Institute

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 personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2009, Roche had over 80'000 employees worldwide and invested almost 10 billion Swiss francs in R&D. The Group posted sales of 49.1 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 35 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.

For more information please contact

Roche Diabetes Care

Ute Volkmann

Roche Diagnostics GmbH

Roche Diabetes Care

Todd Siesky

Roche Diagnostics

Phone: +49 621 759 9561

Phone: +1 317 521 3966

E-Mail: ute.volkmann@roche.com

E-Mail: todd.siesky@roche.com



All trademarks used or mentioned in this release are legally protected.

(1) Polonsky WH, Fisher L, Shikman CH, Hinnen DA, Parkin GC, Jelsovsky Z et al. Structured SMBG significantly reduces HbA1c levels in poorly-controlled, non-insulin treated type 2 Diabetes: Results from the STeP Study [NCT00674986].Diabetes Care February 2011 34:262-267; doi:10.2337/dc10-1732.

(2) Diabetes Control and Complications Trial (DCCT) Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 1993; 329(14):977-986.

(3) Karter AJ, Ackerson LM, Darbinian JA, D'Agostino RB, Jr., Ferrara A, Liu J, Selby JV. Self-monitoring of blood glucose levels and glycemic control: the Northern California Kaiser Permanente Diabetes registry. Am J Med 2001; 111(1):1-9.

(4) Guerci B, Drouin P, Grange V, Bougneres P, Fontaine P, Kerlan V, Passa P, Thivole C, Vialettes B, Charbonnel B. Self-monitoring of blood glucose significantly improves metabolic control in patients with type 2 diabetes mellitus: the Auto-Surveillance Intervention Active (ASIA) study. Diabetes Metab 2003; 29(6):587-594.

(5) Barnett AH, Krentz AJ, Strojek K, Sieradzki J, Azizi F, Embong M, Imamoglu S, Perusicova J, Uliciansky V, Winkler G. The efficacy of self-monitoring of blood glucose in the management of patients with type 2 diabetes treated with a gliclazide modified release-based regimen. A multicentre, randomized, parallel-group, 6-month evaluation (DINAMIC 1 study). Diabetes Obes Metab 2008; 10(12):1239-1247.

(6) Farmer A, Wade A, Goyder E, Yudkin P, French D, Craven A, Holman R, Kinmonth AL, Neil A. Impact of self monitoring of blood glucose in the management of patients with non-insulin treated diabetes: open parallel group randomised trial. BMJ 2007; 335(7611):132.

(7) O'Kane MJ, Bunting B, Copeland M, Coates VE. Efficacy of self monitoring of blood glucose in patients with newly diagnosed type 2 diabetes (ESMON study): randomised controlled trial. BMJ 2008; 336(7654):1174-1177.

SOURCE Roche Diabetes Care



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