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

Research output: Contribution to journalArticle

55 Citations (Scopus)

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

Original languageEnglish
Pages (from-to)2887-2894
Number of pages8
JournalDiabetes Care
Volume36
Issue number10
DOIs
Publication statusPublished - Oct 2013

Fingerprint

Blood Glucose Self-Monitoring
Type 2 Diabetes Mellitus
Patient Education
Italy
Blood Glucose
Fasting
Randomized Controlled Trials

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Advanced and Specialised Nursing

Cite this

Intensive structured self-monitoring of blood glucose and glycemic control in noninsulin-treated type 2 diabetes : The PRISMA randomized trial. / Bosi, Emanuele; Scavini, Marina; Ceriello, Antonio; Cucinotta, Domenico; Tiengo, Antonio; Marino, Raffaele; Bonizzoni, Erminio; Giorgino, Francesco.

In: Diabetes Care, Vol. 36, No. 10, 10.2013, p. 2887-2894.

Research output: Contribution to journalArticle

Bosi, Emanuele ; Scavini, Marina ; Ceriello, Antonio ; Cucinotta, Domenico ; Tiengo, Antonio ; Marino, Raffaele ; Bonizzoni, Erminio ; Giorgino, Francesco. / Intensive structured self-monitoring of blood glucose and glycemic control in noninsulin-treated type 2 diabetes : The PRISMA randomized trial. In: Diabetes Care. 2013 ; Vol. 36, No. 10. pp. 2887-2894.
@article{f334e2641beb4c96bc220c1fad8c13d2,
title = "Intensive structured self-monitoring of blood glucose and glycemic control in noninsulin-treated type 2 diabetes: The PRISMA randomized trial",
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",
author = "Emanuele Bosi and Marina Scavini and Antonio Ceriello and Domenico Cucinotta and Antonio Tiengo and Raffaele Marino and Erminio Bonizzoni and Francesco Giorgino",
year = "2013",
month = "10",
doi = "10.2337/dc13-0092",
language = "English",
volume = "36",
pages = "2887--2894",
journal = "Diabetes Care",
issn = "1935-5548",
publisher = "American Diabetes Association Inc.",
number = "10",

}

TY - JOUR

T1 - Intensive structured self-monitoring of blood glucose and glycemic control in noninsulin-treated type 2 diabetes

T2 - The PRISMA randomized trial

AU - Bosi, Emanuele

AU - Scavini, Marina

AU - Ceriello, Antonio

AU - Cucinotta, Domenico

AU - Tiengo, Antonio

AU - Marino, Raffaele

AU - Bonizzoni, Erminio

AU - Giorgino, Francesco

PY - 2013/10

Y1 - 2013/10

N2 - 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

AB - 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

UR - http://www.scopus.com/inward/record.url?scp=84889673528&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84889673528&partnerID=8YFLogxK

U2 - 10.2337/dc13-0092

DO - 10.2337/dc13-0092

M3 - Article

C2 - 23735724

AN - SCOPUS:84889673528

VL - 36

SP - 2887

EP - 2894

JO - Diabetes Care

JF - Diabetes Care

SN - 1935-5548

IS - 10

ER -