Intensive Structured Self-Monitoring of Blood Glucose and Glycemic Control in Noninsulin-Treated Type 2 Diabetes
The PRISMA Randomized Trial
- Emanuele Bosi, MD1,2⇑,
- Marina Scavini, MD, PHD1,2,
- Antonio Ceriello, MD3,
- Domenico Cucinotta, MD4,
- Antonio Tiengo, MD5,
- Raffaele Marino, MD, MBA6,
- Erminio Bonizzoni, PHD7,
- Francesco Giorgino, MD, PHD8,
- on behalf of the PRISMA Study Group*
- 1Diabetes Research Institute, San Raffaele Hospital and Scientific Institute, Milan, Italy
- 2San Raffaele Vita-Salute University, Milan, Italy
- 3Institut d'Investigacions Biomèdiques August Pi Sunyer and Centro de Investigacion Biomedica en Red de Diabetes y Enfermedades Metabolicas Asociadis, Barcelona, Spain
- 4Department of Internal Medicine, Policlinico Universitario Gaetano Martino, Messina, Italy
- 5Department of Clinical and Experimental Medicine, Division of Metabolic Diseases, University of Padova, Padova, Italy
- 6Medical Affairs, Roche Diagnostics, Monza, Italy
- 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
- 8Department of Emergency and Organ Transplantation, Section of Internal Medicine, Endocrinology, Andrology, and Metabolic Diseases, University of Bari School of Medicine, Bari, Italy
- Corresponding author: Emanuele Bosi, , and Francesco Giorgino, .
Em.B. and M.S. contributed equally to this article.
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 on target for being at risk 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 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).
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.
↵* A complete list of the PRISMA Study Group Investigators can be found in the Supplementary Data online.
- Received January 13, 2013.
- Accepted March 28, 2013.
- © 2013 by the American Diabetes Association.
Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. See http://creativecommons.org/licenses/by-nc-nd/3.0/ for details.