This week I got word about this study:
To assess the effectiveness of structured blood glucose testing in poorly controlled, noninsulin-treated type 2 diabetes.
RESEARCH DESIGN AND METHODS
This 12-month, prospective, cluster-randomized, multicenter study recruited 483 poorly controlled (A1C ≥7.5%), insulin-naïve type 2 diabetic subjects from 34 primary care practices in the U.S. Practices were randomized to an active control group (ACG) with enhanced usual care or a structured testing group (STG) with enhanced usual care and at least quarterly use of structured self-monitoring of blood glucose (SMBG). STG patients and physicians were trained to use a paper tool to collect/interpret 7-point glucose profiles over 3 consecutive days. The primary end point was A1C level measured at 12 months.
The 12-month intent-to-treat analysis (ACG, n = 227; STG, n = 256) showed significantly greater reductions in mean (SE) A1C in the STG compared with the ACG: −1.2% (0.09) vs. −0.9% (0.10); Δ = −0.3%; P = 0.04. Per protocol analysis (ACG, n = 161; STG, n = 130) showed even greater mean (SE) A1C reductions in the STG compared with the ACG: −1.3% (0.11) vs. −0.8% (0.11); Δ = −0.5%; P < 0.003. Significantly more STG patients received a treatment change recommendation at the month 1 visit compared with ACG patients, regardless of the patient’s initial baseline A1C level: 179 (75.5%) vs. 61 (28.0%); <0.0001. Both STG and ACG patients displayed significant (P < 0.0001) improvements in general well-being (GWB).
Appropriate use of structured SMBG significantly improves glycemic control and facilitates more timely/aggressive treatment changes in noninsulin-treated type 2 diabetes without decreasing GWB.
Self-monitoring of blood glucose (SMBG) is widely recognized as a core component of effective diabetic self-management (1–3). Although most evidence indicates that SMBG contributes to good glycemic control among type 1 (4,5) and type 2 diabetic (6,7) patients, it remains uncertain whether SMBG use is efficacious in insulin-naïve type 2 diabetic patients. Current evidence in this latter population is mixed, with some studies pointing to significant glycemic benefits resulting from SMBG use (8–10), while others have shown no significant benefits (11–13). Given the growing cost of current type 2 diabetic care, it is important to determine whether resources devoted to SMBG in the insulin-naïve population are justified and are effectively applied.
Inconsistent findings seen in studies of insulin-naïve type 2 diabetic patients may be due, in part, to differences in key design issues, such as subject selection criteria (e.g., whether or not patients had poor glycemic control at study entry), critical content differences in the actual SMBG intervention (e.g., whether physicians were privy to patient SMBG data), fidelity of treatment delivery (e.g., the same physicians cared for patients from multiple study groups), and/or intervention adherence (e.g., whether patients actually completed the SMBG study protocol as directed). A review of these issues was published previously (14). We developed a comprehensive, structured SMBG intervention package that addresses these design issues and encourages patients and physicians to work collaboratively to collect, interpret, and appropriately use structured SMBG data. Our study was designed to investigate the effect of this intervention on glycemic control in poorly controlled, insulin-naïve type 2 diabetic patients compared with enhanced usual care. Additionally, we assessed the effect of this intervention on SMBG frequency, timing and intensity of treatment modification, and general well-being (GWB).
In short, people with type 2 diabetes who are not on insulin (called “insulin-naïve” in the study -not a happy term, it seems to me) were scientifically proved to have an improved A1c after 12 months if they tested regularly (just over twice a day, on average) provided that they get physician feedback: what the numbers mean.
It may seem intuitive if you test as often or more often than this, but this tells me one thing we must know as PWD: data we can understand helps us make more informed decisions and this ultimately leads to an improvement in our diabetes management.
I received the information from Roche Diagnostics. In the study it clearly states:
“Funding for the study was provided by Roche Diagnostics, Indianapolis, Indiana. W.H.P., D.A.H., and C.G.P. have worked as consultants for Roche Diagnostics and Abbott Diabetes Care. L.F., C.H.S., and Z.J. have worked as consultants for Roche Diagnostics. B.P., M.S., and R.S.W. are employed by Roche Diagnostics. No other potential conflicts of interest relevant to this article were reported.”