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
Abstract
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.
Footnotes
Clinical trial reg. no. NCT00674986, clinicaltrials.gov.
See accompanying editorial, p. 527.
- Received September 7, 2010.
- Accepted October 23, 2010.
- © 2011 by the American Diabetes Association.
Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. See http://creativecommons.org/licenses/by-nc-nd/3.0/ for details.