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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: To assess the effectiveness of structured blood glucose testing in poorly controlled, noninsulin-treated type 2 diabetes.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.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); ? = -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); ? = -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).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.

SUBMITTER: Polonsky WH

PROVIDER: S-EPMC3024331 | biostudies-literature | 2011 Feb

REPOSITORIES: biostudies-literature

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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.

Polonsky William H WH Fisher Lawrence L Schikman Charles H CH Hinnen Deborah A DA Parkin Christopher G CG Jelsovsky Zhihong Z Petersen Bettina B Schweitzer Matthias M Wagner Robin S RS

Diabetes care 20110201 2

<h4>Objective</h4>To assess the effectiveness of structured blood glucose testing in poorly controlled, noninsulin-treated type 2 diabetes.<h4>Research design and methods</h4>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 enhanc ...[more]

PMID: 21270183

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Project description:The value and utility of self-monitoring of blood glucose (SMBG) in non-insulin treated T2DM has yet to be clearly determined. Findings from studies in this population have been inconsistent, due mainly to design differences and limitations, including the prescribed frequency and timing of SMBG, role of the patient and physician in responding to SMBG results, inclusion criteria that may contribute to untoward floor effects, subject compliance, and cross-arm contamination. We have designed an SMBG intervention study that attempts to address these issues.The Structured Testing Program (STeP) study is a 12-month, cluster-randomised, multi-centre clinical trial to evaluate whether poorly controlled (HbA1c >or= 7.5%), non-insulin treated T2DM patients will benefit from a comprehensive, integrated physician/patient intervention using structured SMBG in US primary care practices. Thirty-four practices will be recruited and randomly assigned to an active control group (ACG) that receives enhanced usual care or to an enhanced usual care group plus structured SMBG (STG). A total of 504 patients will be enrolled; eligible patients at each site will be randomly selected using a defined protocol. Anticipated attrition of 20% will yield a sample size of at least 204 per arm, which will provide a 90% power to detect a difference of at least 0.5% in change from baseline in HbA1c values, assuming a common standard deviation of 1.5%. Differences in timing and degree of treatment intensification, cost effectiveness, and changes in patient self-management behaviours, mood, and quality of life (QOL) over time will also be assessed. Analysis of change in HbA1c and other dependent variables over time will be performed using both intent-to-treat and per protocol analyses. Trial results will be available in 2010.The intervention and trial design builds upon previous research by emphasizing appropriate and collaborative use of SMBG by both patients and physicians. Utilization of per protocol and intent-to-treat analyses facilitates a comprehensive assessment of the intervention. Use of practice site cluster-randomisation reduces the potential for intervention contamination, and inclusion criteria (HbA1c >or= 7.5%) reduces the possibility of floor effects. Inclusion of multiple dependent variables allows us to assess the broader impact of the intervention, including changes in patient and physician attitudes and behaviours.Current Controlled Trials NCT00674986.

Project description:BACKGROUND:Patients' understanding of the hemoglobin A1c (HbA1c) has been linked to better diabetes care outcomes (glycemic control, self-care). This is concerning given low documented rates of HbA1c understanding. In this non-blinded, randomized trial, we compared two formats for communicating the HbA1c, selected based on input from people with diabetes, to standard presentation to assess their impact on participants' glycemic control and diabetes-related perceptions. METHODS:To design the tested formats, we interviewed 25 patients with diabetes and reviewed a range of possible formats, including color-based scales and graphs. The interviews were recorded, transcribed, and subjected to thematic analysis. Synthesizing interviewees' feedback, we selected two formats, one using a combination of words and colors (Words) and one using a color-coded graph (Graph), for further evaluation. We then randomized adults with poorly controlled diabetes to receive mailed information on their current diabetes control in one of three ways: 1) standard lab report (control), 2) Words format, or 3) Graph format. The primary outcome was HbA1c change at 6 months. Also examined were changes in participants' diabetes-related perceptions and choice of participation incentive. RESULTS:Of the 234 enrolled participants, 76.9% were Black, and their median baseline HbA1c was 9.1% (interquartile range 8.4-10.4). There were no between-arm differences in HbA1c change (-?1.04% [SD 2.2] Control vs. -0.59% [SD 2.0] Words vs. -0.54% [SD 2.1] Graph, p >?0.05 for all comparisons). Participants in the Words arm had an increase in the accuracy of their perceptions of diabetes seriousness (p =?0.04) and in the number of participants reporting a diabetes management goal (p =?0.01). CONCLUSIONS:The two patient-informed communication formats did not differentially impact glycemic control among adults with inadequately controlled diabetes. However, a significant proportion of participants in the Words arm had an increase in the accuracy of their perception of diabetes seriousness, a potential mediating factor in positive diabetes-related behavioral changes. With increasing use of patient-facing online portals, thoughtfully designed approaches for visually communicating essential, but poorly understood, information like the HbA1c to patients have the potential to facilitate interpretation and support self-management. CLINICAL TRIAL REGISTRATION:Prospectively registered as NCT01886170.

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Dataset Information

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.

Publications

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.

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