Intensive Structured Self-Monitoring of Blood Glucose and Glycemic Control in Noninsulin-Treated Type 2 Diabetes: The PRISMA Randomized Trial. (Articolo in rivista)

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  • Intensive Structured Self-Monitoring of Blood Glucose and Glycemic Control in Noninsulin-Treated Type 2 Diabetes: The PRISMA Randomized Trial. (Articolo in rivista) (literal)
Anno
  • 2013-01-01T00:00:00+01:00 (literal)
Http://www.cnr.it/ontology/cnr/pubblicazioni.owl#doi
  • 10.2337/dc13-0092 (literal)
Alternative label
  • Bosi E, Scavini M, Ceriello A, Cucinotta D, Tiengo A, Marino R, Bonizzoni E, Giorgino F, Clemente G* (on behalf of the *PRISMA Study Group) (2013)
    Intensive Structured Self-Monitoring of Blood Glucose and Glycemic Control in Noninsulin-Treated Type 2 Diabetes: The PRISMA Randomized Trial.
    in Diabetes care; American Diabetes Association, Alexandria (Stati Uniti d'America)
    (literal)
Http://www.cnr.it/ontology/cnr/pubblicazioni.owl#autori
  • Bosi E, Scavini M, Ceriello A, Cucinotta D, Tiengo A, Marino R, Bonizzoni E, Giorgino F, Clemente G* (on behalf of the *PRISMA Study Group) (literal)
Rivista
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  • PubMed (literal)
  • ISI Web of Science (WOS) (literal)
Http://www.cnr.it/ontology/cnr/pubblicazioni.owl#affiliazioni
  • 1Diabetes Research Institute, San Raffaele Hospital and Scientific Institute, Milan, Italy; the 2San Raffaele Vita-Salute University, Milan, Italy; the 3Institut d'Investigacions Biomèdiques August Pi Sunyer and Centro de Investigacion Biomedica en Red de Diabetes y Enfermedades Metabolicas Asociadis, Barcelona, Spain; the 4Department of Internal Medicine, Policlinico Universitario Gaetano Martino, Messina, Italy; the 5Department of Clinical and Experimental Medicine, Division of Metabolic Diseases, University of Padova, Padova, Italy; the 6Medical Affairs, Roche Diagnostics, Monza, Italy; the 7Department of Occupational Health Clinica del Lavoro L. Devoto, Section of Medical Statistics and Biometry G.A. Maccacaro, School of Medicine, University of Milan, Milan, Italy; and the 8Department of Emergency and Organ Transplantation, Section of Internal Medicine, Endocrinology, Andrology, and Metabolic Diseases, University of Bari School of Medicine, Bari, Italy, IRPPS- CNR Penta di Fisciano (SA) (literal)
Titolo
  • Intensive Structured Self-Monitoring of Blood Glucose and Glycemic Control in Noninsulin-Treated Type 2 Diabetes: The PRISMA Randomized Trial. (literal)
Abstract
  • OBJECTIVEdWe aimed to evaluate the added value of intensive self-monitoring of blood glucose (SMBG), structured in timing and frequency, in noninsulin-treated patients with type 2 diabetes. RESEARCH DESIGN AND METHODSdThe 12-month, randomized, clinical trial enrolled 1,024 patients with noninsulin-treated type 2 diabetes (median baseline HbA1c, 7.3% [IQR, 6.9-7.8%]) at 39 diabetes clinics in Italy. After standardized education, 501 patients were randomized to intensive structured monitoring (ISM) with 4-point glycemic profiles (fasting, preprandial, 2-h postprandial, and postabsorptive measurements) performed 3 days/week; 523 patients were randomized to active control (AC) with 4-point glycemic profiles performed at baseline and at 6 and 12 months. Two primary end points were tested in hierarchical order: HbA1c change at 12 months and percentage of patients on target for being at risk for low and high blood glucose index. RESULTSdIntent-to-treat analysis showed greater HbA1c reductions over 12 months in ISM (20.39%) than in AC patients (20.27%), with a between-group difference of 20.12% (95% CI, 20.210 to 20.024; P = 0.013). In the per-protocol analysis, the between-group difference was 20.21% (20.331 to 20.089; P = 0.0007). More ISM than AC patients achieved clinically meaningful reductions in HbA1c (.0.3, .0.4, or .0.5%) at study end (P , 0.025). The proportion of patients reaching/maintaining the risk target at month 12 were similar in ISM (74.6%) and AC (70.1%) patients (P = 0.131). At visits 2, 3, and 4, diabetes medications were changed more often in ISM than in AC patients (P , 0.001). CONCLUSIONSdUse of structured SMBG improves glycemic control and provides guidance in prescribing diabetes medications in patients with relatively well-controlled noninsulintreated type 2 diabetes. (literal)
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