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. ClinicalTrials.gov (NCT00643474).

American Association Of Clinical Endocrinologists And American College Of Endocrinology 2016 Outpatient Glucose Monitoring Consensus Statement

“…Several recent trials of structured BGM included specific instructions on testing frequency and timing, interpreting and communicating these results, and integrating results into self-management plans. These studies have shown improved glycemic control in patients with T2DM who do not receive insulin therapy (8,9,97,98).…”

Self-Monitoring of Blood Glucose in Type 2 Diabetes: Recent Studies

“…The active control group received discretionary, unstructured SMBG, comprehensive patient education, and treatment adjustment according to HbA1c levels and hypoglycemia. 48 Publication of the PRISMA results is expected shortly, yielding further evidence regarding the effects of structured SMBG, including changes in patient and physician attitudes and behaviors. 48 …”

“…48 Publication of the PRISMA results is expected shortly, yielding further evidence regarding the effects of structured SMBG, including changes in patient and physician attitudes and behaviors. 48 …”

“…, controlled trial to evaluate the added value of an intensive, structured SMBG regimen in T2DM patients on oral treatment and/or diet. 48 The intervention group received structured SMBG (four-point daily glucose profiles 3 days per week), comprehensive patient education, and clinician's adjustment of medication based on an algorithm targeting SMBG levels, HbA1c, and hypoglycemia. The active control group received discretionary, unstructured SMBG, comprehensive patient education, and treatment adjustment according to HbA1c levels and hypoglycemia.…”

Effects of structured testing versus routine testing of blood glucose in diabetes self-management: A randomized controlled trial

“…Self-monitoring of seven-points on an SMBG device for 3 consecutive days once every three months in addition to daily tests resulted in better glycemic control compared to the active control group (Polonsky et al, 2011). Structured testing is a new method of less-frequent SMBG that guides glycemic management strategies and has the potential to improve problem-solving and decision-making skills for both patients and clinicians (Fisher et al, 2012;Scavini et al, 2013). Evidence suggests that less frequent SMBG can have favorable effects on glycemic control when both healthcare providers and patients appreciate the purpose of their SMBG measurements.…”