Background: We evaluated how a structured patient/physician self-monitoring of blood glucose (SMBG) intervention influenced the timing, frequency, and effectiveness of primary care physicians' treatment changes with type 2 diabetes mellitus (T2DM) patients over 12 months.
Methods: The Structured Testing Program (STeP) study was a cluster-randomized, multicenter trial with 483 poorly controlled, insulin-naive T2DM subjects. Primary care practices were randomized to the Active Control Group (ACG) or the Structured Testing Group (STG), the latter of which included quarterly review of structured SMBG results. STG patients used a paper tool that graphs seven-point glucose profiles over 3 consecutive days; physicians received a treatment algorithm based on SMBG patterns. Impact of structured SMBG on physician treatment modification recommendations (TMRs) and glycemic outcomes was examined.
Results: More STG than ACG patients received a TMR at each study visit (P < 0.0001). Of patients who received at least one TMR, STG patients demonstrated a greater reduction in glycated hemoglobin A1c (HbA1c) than ACG patients (-1.2% vs. -0.8%, P < 0.03). Patients with a baseline HbA1c ≥8.5% who received a TMR at the Month 1 visit experienced greater reductions in HbA1c (P = 0.002) than patients without an initial TMR. More STG than ACG patients were started on incretins (P < 0.01) and on thiazolidinediones (P = 0.004). The number of visits with a TMR was unrelated to HbA1c change over time.
Conclusions: Patient-provided SMBG data contribute to glycemic improvement when blood glucose patterns are easy to detect, and well-trained physicians take timely action. Collaborative use of structured SMBG data leads to earlier, more frequent, and more effective TMRs for poorly controlled, non-insulin-treated T2DM subjects.