Prospective, randomized trial on intensive SMBG management added value in non-insulin-treated T2DM patients (PRISMA): a study to determine the effect of a structured SMBG intervention

Abstract

Self-monitoring of blood glucose (SMBG) is a core component of diabetes management. However, the International Diabetes Federation recommends that SMBG be performed in a structured manner and that the data are accurately interpreted and used to take appropriate therapeutic actions. We designed a study to evaluate the impact of structured SMBG on glycemic control in non-insulin-treated type 2 diabetes (T2DM) patients. The Prospective, Randomized Trial on Intensive SMBG Management Added Value in Non-insulin-Treated T2DM Patients (PRISMA) is a 12-month, prospective, multicenter, open, parallel group, randomized, and controlled trial to evaluate the added value of an intensive, structured SMBG regimen in T2DM patients treated with oral agents and/or diet. One thousand patients (500 per arm) will be enrolled at 39 clinical sites in Italy. Eligible patients will be randomized to the intensive structured monitoring (ISM) group or the active control (AC) group, with a glycosylated hemoglobin (HbA1c) target of <7.0%. Intervention will comprise (1) structured SMBG (4-point daily glucose profiles on 3 days per week [ISM]; discretionary, unstructured SMBG [AC]); (2) comprehensive patient education (both groups); and (3) clinician's adjustment of diabetes medications using an algorithm targeting SMBG levels, HbA1c and hypoglycemia (ISM) or HbA1c and hypoglycemia (AC). The intervention and trial design build 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 assessment of the intervention. Inclusion of multiple dependent variables allows us to assess the broader impact of the intervention, including changes in patient and physician attitudes and behaviors.

Trial registration: ClinicalTrials.gov NCT00643474.

Figures

Fig. 1

Diagram of the PRISMA study protocol

Fig. 2

Data analysis system. The print-out of the Smart-Pix device is organized in four boxes: Box 1 shows mean, standard deviation, and number of glucose measurements during the previous 4 weeks, by point of the daily profile presented as a bar graph; Box 2 shows mean and number of glucose measurements during the previous 4 weeks before breakfast and lunch and mean and number of post-prandial glycemic excursion, each presented as a speed dial: the pointer in the green zone indicates desirable values, in the yellow zone values that requires attention, and in the red zone values that require corrective action; the number of hypoglycemic episodes is reported in a dot that changes color from green (no glucose value <70 mg/dl) to red when blood glucose values <70 mg/dl are measured; Box 3 shows the low blood glucose index (LBGI) and high blood glucose index (HBGI) [40] and the average daily risk range (ADRR) [49] calculated on the glucose values since the last visit and presented as a bar graph in green color if in the desired range, in red if outside the desired range; and Box 4 shows the suggested changes in diabetes medication according to the algorithm presented in Fig. 3

Fig. 3

Diabetes medication algorithm. The diabetes medication algorithm is based on guidelines by international and national scientific societies [American Diabetes Association (ADA), European Association for the Study of Diabetes (EASD), International Diabetes Federation (IDF), Società Italiana di Diabetologia (SID) and Associazione Medici Diabetologi (AMD)] [–39]