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Randomized Controlled Trial
. 2013 Oct;36(10):2887-94.
doi: 10.2337/dc13-0092. Epub 2013 Jun 4.

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

Emanuele Bosi  1 , Marina Scavini, Antonio Ceriello, Domenico Cucinotta, Antonio Tiengo, Raffaele Marino, Erminio Bonizzoni, Francesco Giorgino; PRISMA Study Group
Collaborators, Affiliations
Randomized Controlled Trial

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

Emanuele Bosi et al. Diabetes Care. 2013 Oct.

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.

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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%.
See this image and copyright information in PMC

Comment in

References

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