The value of episodic, intensive blood glucose monitoring in non-insulin treated persons with Type 2 Diabetes: design of the Structured Testing Program (STeP) study, a cluster-randomised, clinical trial

Authors: Polonsky, W., Fisher, L., Schikman, C., Hinnen, D., Parkin, C., Jelsovsky, Z., Amstutz, L., Schweitzer, M., Wagner, R.

Abstract

Background: 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.

Methods/design: 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.

Discussion: 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.

Source: https://pubmed.ncbi.nlm.nih.gov/20482765/

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BDI Monthly Events

March 12Case Consultation Meeting
March 12: BDI hosts the San Diego-wide, monthly case consultation meeting (for mental health professionals working in the field of diabetes). Contact us at [email protected] if you are in the greater San Diego area and would like further information about this program.
March 19-22International Conference
18th International Conference for ATTD (Advanced Technologies and Treatments for Diabetes) in Amsterdam, Dr. Polonsky (BDI President) has three presentations.
March 19Type 2 Presentation
On March 19, Dr. Polonski will present CGM is Wonderful, But… at the Roche-sponsored symposium, “Translating the Power of Prediction into Diabetes Management”, and Insulin Therapy Experience: Considering the Needs of People Living with Diabetes (with Professor Cukierman-Yaffe) at the Sanofi-sponsored symposium, Confidence and Simplicity in Diabetes Management”. https://attd.kenes.com/
March 20Type 2 Presentation
On March 20, Dr. Polonski will present Improved Patient- and Physician-Reported Outcomes with IGlarLixi When Switching From Premixed Insulin in People with Type 2 Diabetes: The Soli-Switch Study. https://cslide.ctimeetingtech.com/attd25/attendee/confcal/session/calendar/2025-03-20