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
- William H. Polonsky, PHD1,2,
- Lawrence Fisher, PHD3,
- Charles H. Schikman, MD4,
- Deborah A. Hinnen, ARNP5,
- Christopher G. Parkin, MS6,
- Zhihong Jelsovsky, MS7,
- Bettina Petersen, PHD8,
- Matthias Schweitzer, MD8 and
- Robin S. Wagner, DVM, PHD8
- 1University of California, San Diego, San Diego, California; the
- 2Behavioral Diabetes Institute, San Diego, California
- 3University of California, San Francisco, San Francisco, California
- 4North Shore University Health System, Skokie, Illinois
- 5Mid America Diabetes Associates, Wichita, Kansas
- 6Health Management Resources, Carmel, Indiana
- 7Biostat International, Tampa, Florida
- 8Roche Diagnostics, Indianapolis, Indiana
- Corresponding author: Christopher G. Parkin, .
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-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.
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); 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).
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.
- Received September 7, 2010.
- Accepted October 23, 2010.
- © 2011 by the American Diabetes Association.
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