title: 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.
authors.affiliation: Diabetes Research Institute, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Marina
authors.initials: M
authors.lastname: Scavini
authors.forename: Emanuele
authors.initials: E
authors.lastname: Bosi
authors.forename: Antonio
authors.initials: A
authors.lastname: Ceriello
authors.forename: Francesco
authors.initials: F
authors.lastname: Giorgino
authors.forename: Massimo
authors.initials: M
authors.lastname: Porta
authors.forename: Antonio
authors.initials: A
authors.lastname: Tiengo
authors.forename: Giacomo
authors.initials: G
authors.lastname: Vespasiani
authors.forename: Davide
authors.initials: D
authors.lastname: Bottalico
authors.forename: Raffaele
authors.initials: R
authors.lastname: Marino
authors.forename: Christopher
authors.initials: C
authors.lastname: Parkin
authors.forename: Erminio
authors.initials: E
authors.lastname: Bonizzoni
authors.forename: Domenico
authors.initials: D
authors.lastname: Cucinotta
mesh_terms: D000328:Adult; D000368:Aged; D000465:Algorithms; D001786:Blood Glucose / Q000032:analysis*; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation / Q000379:methods / Q000592:standards; D003924:Diabetes Mellitus, Type 2 / Q000097:blood* / Q000188:drug therapy / Q000453:epidemiology; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage; D007558:Italy / Q000453:epidemiology; D008875:Middle Aged; D009819:Office Visits; D010353:Patient Education as Topic / Q000379:methods*
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; C517652:hemoglobin A1c protein, human