Intensive structured self-monitoring of blood glucose and glycemic control in noninsulin-treated type 2 diabetes: the PRISMA randomized trial

Emanuele Bosi, Marina Scavini, Antonio Ceriello, Domenico Cucinotta, Antonio Tiengo, Raffaele Marino, Erminio Bonizzoni, Francesco Giorgino, PRISMA Study Group, Roberto Trevisan, Alessandro Roberto Dodesini, Anna Corsi, Luigi Sciangula, Alessandra Ciucci, Emanuela Simona Olivo, Laura Tonutti, Clara Boscariol, Marina Armellini, Paolo Pozzilli, Anna Rita Maurizi, Silvia Manfrini, Nicola Napoli, Dario Tuccinardi, Giovanni Ghirlanda, Lucilla Gagliardi, Loredana Ranalli, Domenico Cucinotta, Simona Zaccuri, Letterio Giorgianni, Antonio Tiengo, Gabriella Guarnieri, Paolo Di Bartolo, Francesca Pellicano, Patrizia Scolozzi, Sergio Leotta, Lucia Fontana, Giancarlo Tonolo, Sara Cherchi, Lucia Canu, Paolo Foglini, Rossana Maricotti, Elena Tortato, Emanuele Bosi, Cecilia Pianti, Sara Madaschi, Carla Tortul, Roberto Da Ros, Raimonda Muraro, Egle Ansaldi, Serena Cacciola, Mauro Cignarelli, Olga Lamacchia, Maurizio Nizzoli, Lisa Buci, Pasqualino Calatola, Gennaro Clemente, Alessandra Caputo, Francesco Mollo, Gemma Friogato, Amatore Rampini, Paola Morpurgo, Giacomo Bonino, Francesco Giorgino, Maria Grazia Vita, Luigi Laviola, Agostino Gnasso, Claudio Carallo, Marilena Calabria, Giampietro Beltramello, Alberto Marangoni, Anna Cattaneo, Roberta Guido, Albino Massidda, Gisella Meloni, Matteo Andrea Bonomo, Gianluigi Pizzi, Mariangela Camerini, Vincenzo Provenzano, Lidia Ferrara, Francesca Provenzano, Agostino Paccagnella, Maria Sambataro, Barbara Almoto, Marco Giorgio Baroni, Efisio Cossu, Anita Zedde, Agostino Consoli, Patrizia Di Fulvio, Francesco Dotta, Elisa Guarino, Giovanni Annuzzi, Lutgarda Bozzeto, Giovanni Cicioni, Maria Calabrese, Sandra Guizzotti, Francesco Cabasino, Fernando Farci, Mariangela Ghiani, Caludio Tubili, Maria Rosaria Nardone, Riccardo Candido, Elisabetta Tommasi, Giuseppe Jagodnik, Marco Strazzabosco, Chiara Alberta Mesturino, Fausto Santeusanio, Elisabetta Torlone, Silvia Annone, Emanuele Bosi, Marina Scavini, Antonio Ceriello, Domenico Cucinotta, Antonio Tiengo, Raffaele Marino, Erminio Bonizzoni, Francesco Giorgino, PRISMA Study Group, Roberto Trevisan, Alessandro Roberto Dodesini, Anna Corsi, Luigi Sciangula, Alessandra Ciucci, Emanuela Simona Olivo, Laura Tonutti, Clara Boscariol, Marina Armellini, Paolo Pozzilli, Anna Rita Maurizi, Silvia Manfrini, Nicola Napoli, Dario Tuccinardi, Giovanni Ghirlanda, Lucilla Gagliardi, Loredana Ranalli, Domenico Cucinotta, Simona Zaccuri, Letterio Giorgianni, Antonio Tiengo, Gabriella Guarnieri, Paolo Di Bartolo, Francesca Pellicano, Patrizia Scolozzi, Sergio Leotta, Lucia Fontana, Giancarlo Tonolo, Sara Cherchi, Lucia Canu, Paolo Foglini, Rossana Maricotti, Elena Tortato, Emanuele Bosi, Cecilia Pianti, Sara Madaschi, Carla Tortul, Roberto Da Ros, Raimonda Muraro, Egle Ansaldi, Serena Cacciola, Mauro Cignarelli, Olga Lamacchia, Maurizio Nizzoli, Lisa Buci, Pasqualino Calatola, Gennaro Clemente, Alessandra Caputo, Francesco Mollo, Gemma Friogato, Amatore Rampini, Paola Morpurgo, Giacomo Bonino, Francesco Giorgino, Maria Grazia Vita, Luigi Laviola, Agostino Gnasso, Claudio Carallo, Marilena Calabria, Giampietro Beltramello, Alberto Marangoni, Anna Cattaneo, Roberta Guido, Albino Massidda, Gisella Meloni, Matteo Andrea Bonomo, Gianluigi Pizzi, Mariangela Camerini, Vincenzo Provenzano, Lidia Ferrara, Francesca Provenzano, Agostino Paccagnella, Maria Sambataro, Barbara Almoto, Marco Giorgio Baroni, Efisio Cossu, Anita Zedde, Agostino Consoli, Patrizia Di Fulvio, Francesco Dotta, Elisa Guarino, Giovanni Annuzzi, Lutgarda Bozzeto, Giovanni Cicioni, Maria Calabrese, Sandra Guizzotti, Francesco Cabasino, Fernando Farci, Mariangela Ghiani, Caludio Tubili, Maria Rosaria Nardone, Riccardo Candido, Elisabetta Tommasi, Giuseppe Jagodnik, Marco Strazzabosco, Chiara Alberta Mesturino, Fausto Santeusanio, Elisabetta Torlone, Silvia Annone

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 methods: The 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.

Results: Intent-to-treat analysis showed greater HbA1c reductions over 12 months in ISM (-0.39%) than in AC patients (-0.27%), with a between-group difference of -0.12% (95% CI, -0.210 to -0.024; P=0.013). In the per-protocol analysis, the between-group difference was -0.21% (-0.331 to -0.089; 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).

Conclusions: Use of structured SMBG improves glycemic control and provides guidance in prescribing diabetes medications in patients with relatively well-controlled noninsulin-treated type 2 diabetes.

Trial registration: ClinicalTrials.gov NCT00643474.

Figures

Figure 1
Figure 1
Flow of PRISMA study participants.
Figure 2
Figure 2
Least-square mean difference in HbA1c (%) during the study by treatment group in the ITT population (A) and PP population (B).
Figure 3
Figure 3
Proportion (95% CI) of participants who achieved clinically meaningful HbA1c reductions of >0.3, >0.4, or >0.5%.

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