Structured Self-Monitoring of Blood Glucose Significantly Reduces A1C Levels in Poorly Controlled, Noninsulin-Treated Type 2 Diabetes Results from the Structured Testing Program study

OBJECTIVE-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-naive 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. RESULTS-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); Delta = -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); Delta = -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). CONCLUSIONS-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.