May 25, 2011

SMBG Can Reduce A1c's For Type 2 Diabetes Patients

Self-monitoring of blood glucose (SMBG) is a term quite well understood by many patients, but it is surprising to see researchers use it in the way this study did. And the report of the study by one of Big Pharma's own. This is a surprise and a pleasant one. Alan at loraldiabetes has been writing about the lack of respect and understanding SMBG has been receiving since at least 2006 and he has not missed much in the lack of understanding by researchers and the medical community.

So it is with respect that I need to report this study which I think for the first time does partially what Alan has been challenging researchers and patients to do. I think this study could have been taken many steps farther, but it is a start in the right direction, and for once it gives patients some insight into what may be accomplished as well as their physicians.

As it is reported by Roche, “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 and presented at an exclusive event on effective and structured diabetes management held in London in March”.

“SMBG is a well-established element of therapy management for people with type 1 or type 2 diabetes on insulin therapy. 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. To gain new insights on this subject, the STeP Study was performed: A prospective, cluster-randomised, multi-centre 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 ≥ 7.5%) at baseline. The results provide new and significant evidence on its effectiveness”.

The study was designed to analyze the differences between the usual diabetes care and structured diabetes management. Those in the active control group (ACG) and the structured testing group (STG) were in the study for 12 months and all received a baseline evaluation. Then they had scheduled visits at 1, 3, 6, 9, and 12 months. The difference between the two groups was the STG received the SMBG-focused structured diabetes management concept. Free BG monitors and test strips were given to both groups.

The STG used the 7 BG testing profiles (fasting, preprandial, and 2-hour postprandial at each meal, and bedtime) for the three days prior to scheduled healthcare visits. They were to document blood glucose values, meal sizes, plus energy levels, and comment on their SMBG experiences. The STG patients all used the the Roche 360 3-day profile tool and discussed the obtained profiles with their caregivers. The good part was both the patients and caregivers received standardized training in SMBG and pattern analysis. In addition the doctors were equipped with an algorithm suggesting appropriate medication strategies.

The study concluded with finding significant improvement in glycemic control and reduced HbA1c values in the non-insulin treated Type 2 diabetes patients in the STG using the SMBG diabetes management.

Read the article about the study here. You may read Alan's blogs Dec 2, 2006, July 1, 2007, Feb 16, 2010, and Mar 14, 2010. The full study can be read here.

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