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SAN DIEGO -- Structured self-monitoring of blood glucose (SMBG) delivered by trained nurses to willing and informed patients was associated with early and sustained lowering of HbA1c among patients with non-insulin treated type 2 diabetes, researchers reported here.
In a randomized controlled trial of nearly 500 patients, the use of structured SMBG provided significant benefits in terms of glycemic control with a mean reduction of 0.9 percentage points (95% CI -1.18 to -0.62, P=<0.001) between the combined SMBG groups compared with the control group, reported David Owens, MD, of Swansea University in Wales, and colleagues.
"When we look at the SMBG groups, making decisions based on blood glucose results without any reference to HbA1c, we actually see quite significant results," Owens told MedPage Today at the American Diabetes Association meeting here. "Many of the studies in the past have tested self-monitoring of blood glucose, but making decisions based on the HbA1c. We wanted to have a clean study. We actually measured what really matters -- which is the blood glucose level. And in that context we were able to see a big, big difference compared to usual care which doesn't involve SMBG, and unfortunately does not include a lot of HbA1c measures either."
Andrea Dunaif, MD, of the Icahn School of Medicine at Mount Sinai, who wasn't involved with the study, said it "demonstrates that the use of SMBG significantly improved glycemic control in patients with type 2 diabetes not receiving insulin. It suggests that SMBG should be routinely added to the management of this group of patients."
The findings differ from those of another study presented at the meeting, which found that SMBG didn't contribute to improved glycemic control in patients with non-insulin treated type 2 diabetes. However, the researchers of that study noted that patients and clinicians should engage in dialogues to best determine whether or not SMBG fits their situation.
Owens and colleagues recruited 447 patients from 10 primary care sites and six secondary care sites in Wales and England. All participants had established (>1 year) type 2 diabetes, were not on insulin therapy, and had poor glycemic control (HbA1c ≥ 7.5% ≤ 13%). Nearly 60% were male, and the mean age was 61.7 years. The researchers also noted that 267 participants (60%) had diabetes for 5 years or more, with 85 (19%) having complications associated with the condition.
The researchers randomized the participants to one of three groups: a control group receiving usual diabetes care (n=151), structured SMBG with clinical review every 3 months (n=147), and a structured SMBG with additional monthly telecare support (n=143).
In both of the structured SMBG groups, participants and healthcare professionals were blinded to HbA1c, and glycemic management was based only on glucose results.
Since the study was conducted across multiple centers, the researchers enrolled nursing staff in standardized training, including an eHealth training program sponsored by the National Health Service (NHS). Nurses received an initial half-day training, followed by refresher training sessions for a "constant process" of learning.
Owens's group found that the mean HbA1c for all participants at randomization was 8.6%, and among the 323 participants who attended the final visit at 12 months, mean HbA1c levels were all significantly lower than at baseline: 8.3% (P<0.01), 7.4% (P<0.001), and 7.3% (P<0.001) for groups one, two, and three, respectively -- though the benefits were greater for those in the SMBG groups.
Owens noted that while there wasn't a large difference between the SMBG groups, there was evidence of the benefit of telemedicine.
"The big difference was when you implement blood glucose monitoring, if you are in constant communication -- as in monthly -- you will retain more people in that group," he said in an interview. "The message for us is that telemedicine in the early phase of blood glucose monitoring has a positive impact on maintaining people in the arena."
Looking forward, Owens called for future analyses to focus on secondary outcomes such as BMI, weight, and cholesterol, as well as compliance with the SMBG testing regimen.
"We want to look into who benefits, how they benefit, and why," he said during his presentation.
Dunaif also noted that further research is warranted, saying that "in particular, different SMBG regimens should be compared for their efficacy and cost in this large population of patients with type 2 diabetes not receiving insulin therapy."
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