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Randomized Controlled Trial
. 2011 Feb;34(2):262-7.
doi: 10.2337/dc10-1732.

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  1 , Lawrence Fisher, Charles H Schikman, Deborah A Hinnen, Christopher G Parkin, Zhihong Jelsovsky, Bettina Petersen, Matthias Schweitzer, Robin S Wagner
Affiliations
Randomized Controlled Trial

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 et al. Diabetes Care. 2011 Feb.

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.

Trial registration: ClinicalTrials.gov NCT00674986.

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Figures

Figure 1
Figure 1
Consort diagram.
Figure 2
Figure 2
A: ITT analysis: mean (± SE) A1C over 12 months (M) in patients with noninsulin-treated type 2 diabetes according to randomization group.B: PP analysis: mean (± SE) A1C over 12 months (M) in patients with noninsulin-treated type 2 diabetes, comparing ACG patients, adherent STG (STG/a) patients, and nonadherent STG (STG/na) patients.
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