OBJECTIVE We 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 at risk target 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 was 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. © 2013 by the American Diabetes Association.
Intensive structured self-monitoring of blood glucose and glycemic control in noninsulin-treated type 2 diabetes: The PRISMA randomized trial / E., Bosi; M., Scavini; A., Ceriello; D., Cucinotta; A., Tiengo; R., Marino; E., Bonizzoni; F., Giorgino; Prisma Study R., Group Collaborators: Trevisan; A. R., Dodesini; A., Corsi; L., Sciangula; A., Ciucci; E. S., Olivo; L., Tonutti; C., Boscariol; M., Armellini; P., Pozzilli; A. R., Maurizi; S., Manfrini; N., Napoli; D., Tuccinardi; G., Ghirlanda; L., Gagliardi; L., Ranalli; D., Cucinotta; S., Zaccuri; L., Giorgianni; A., Tiengo; G., Guarnieri; P., Di Bartolo; F., Pellicano; P., Scolozzi; S., Leotta; L., Fontana; G., Tonolo; S., Cherchi; L., Canu; P., Foglini; R., Maricotti; E., Tortato; E., Bosi; C., Pianti; S., Madaschi; C., Tortul; R., Da Ros; R., Muraro; E., Ansaldi; S., Cacciola; M., Cignarelli; O., Lamacchia; M., Nizzoli; L., Buci; P., Calatola; G., Clemente; A., Caputo; F., Mollo; G., Friogato; A., Rampini; P., Morpurgo; G., Bonino; F., Giorgino; M. G., Vita; L., Laviola; A., Gnasso; C., Carallo; M., Calabria; G., Beltramello; A., Marangoni; A., Cattaneo; R., Guido; A., Massidda; G., Meloni; M. A., Bonomo; G., Pizzi; M., Camerini; V., Provenzano; L., Ferrara; F., Provenzano; A., Paccagnella; M., Sambataro; B., Almoto; Baroni, Marco Giorgio; E., Cossu; A., Zedde; A., Consoli; P., Di Fulvio; Dotta, Francesco; E., Guarino; G., Annuzzi; L., Bozzeto; G., Cicioni; M., Calabrese; S., Guizzotti; F., Cabasino; F., Farci; M., Ghiani; C., Tubili; M. R., Nardone; R., Candido; E., Tommasi; G., Jagodnik; M., Strazzabosco; C. A., Mesturino; F., Santeusanio; E., Torlone; S., Annone. - In: DIABETES CARE. - ISSN 0149-5992. - STAMPA. - 36:10(2013), pp. 2887-2894. [10.2337/dc13-0092]
Intensive structured self-monitoring of blood glucose and glycemic control in noninsulin-treated type 2 diabetes: The PRISMA randomized trial
BARONI, Marco Giorgio;DOTTA, Francesco;
2013
Abstract
OBJECTIVE We 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 at risk target 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 was 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. © 2013 by the American Diabetes Association.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
