Intensive Structured Self-Monitoring of Blood Glucose and Glycemic Control in Noninsulin-Treated Type 2 Diabetes

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.

[1]  Belgium.,et al.  Global guideline for type 2 diabetes. , 2014, Diabetes research and clinical practice.

[2]  R. Rubin,et al.  Structure and Correlates of Diabetes-Specific Locus of Control , 1994, Diabetes Care.

[3]  B P Kovatchev,et al.  Assessment of risk for severe hypoglycemia among adults with IDDM: validation of the low blood glucose index. , 1998, Diabetes care.

[4]  Stephan Martin,et al.  ROSSO-in-praxi: a self-monitoring of blood glucose-structured 12-week lifestyle intervention significantly improves glucometabolic control of patients with type 2 diabetes mellitus. , 2010, Diabetes Technology & Therapeutics.

[5]  Elizabeth Goyder,et al.  Impact of self monitoring of blood glucose in the management of patients with non-insulin treated diabetes: open parallel group randomised trial , 2007, BMJ : British Medical Journal.

[6]  L. Bouter,et al.  Self-monitoring of blood glucose in patients with type 2 diabetes mellitus who are not using insulin. , 2005, The Cochrane database of systematic reviews.

[7]  I. Shimomura,et al.  Efficacy of occasional self-monitoring of postprandial blood glucose levels in type 2 diabetic patients without insulin therapy. , 2010, Diabetes Research and Clinical Practice.

[8]  R. I. Harris,et al.  Statistical handling of drop-outs in longitudinal clinical trials. , 1993, Statistics in Medicine.

[9]  L. Welschen,et al.  Self-monitoring of blood glucose in patients with type 2 diabetes mellitus who are not using insulin. , 2012, The Cochrane database of systematic reviews.

[10]  A. Nicolucci,et al.  Four‐year impact of a continuous quality improvement effort implemented by a network of diabetes outpatient clinics: the AMD‐Annals initiative , 2010, Diabetic medicine : a journal of the British Diabetic Association.

[11]  D. Cucinotta,et al.  Prospective, randomized trial on intensive SMBG management added value in non-insulin-treated T2DM patients (PRISMA): a study to determine the effect of a structured SMBG intervention , 2011, Acta Diabetologica.

[12]  D. Hinnen,et al.  Results that matter: structured vs. unstructured self-monitoring of blood glucose in type 2 diabetes. , 2012, Diabetes research and clinical practice.

[13]  W. Ambrosius,et al.  Epidemiologic Relationships Between A1C and All-Cause Mortality During a Median 3.4-Year Follow-up of Glycemic Treatment in the ACCORD Trial , 2010, Diabetes Care.

[14]  M. Porta,et al.  A 5-year randomized controlled study of learning, problem solving ability, and quality of life modifications in people with type 2 diabetes managed by group care. , 2004, Diabetes care.

[15]  P. Cryer.  Management of Hyperglycemia in Type 2 Diabetes: A Consensus Algorithm for the Initiation and Adjustment of Therapy: A Consensus Statement From the American Diabetes Association and the European Association for the Study of Diabetes , 2007, Diabetes Care.

[16]  Darrell M. Wilson,et al.  Consensus Report of the Coalition for Clinical Research—Self-Monitoring of Blood Glucose , 2008, Journal of diabetes science and technology.

[17]  M. O'Kane,et al.  Efficacy of self monitoring of blood glucose in patients with newly diagnosed type 2 diabetes (ESMON study): randomised controlled trial , 2008, BMJ : British Medical Journal.

[18]  Christopher G Parkin,et al.  A structured self-monitoring of blood glucose approach in type 2 diabetes encourages more frequent, intensive, and effective physician interventions: results from the STeP study. , 2011, Diabetes technology & therapeutics.

[19]  A. Calle-Pascual,et al.  Benefits of self‐monitoring blood glucose in the management of new‐onset Type 2 diabetes mellitus: The St Carlos Study, a prospective randomized clinic‐based interventional study with parallel groups , 2010, Journal of diabetes.

[20]  M. Davidson,et al.  The effect of self monitoring of blood glucose concentrations on glycated hemoglobin levels in diabetic patients not taking insulin: a blinded, randomized trial. , 2005, The American journal of medicine.

[21]  Y. Jang,et al.  Standards of Medical Care in Diabetes-2010 by the American Diabetes Association: Prevention and Management of Cardiovascular Disease , 2010 .

[22]  P. Cryer.  Death during intensive glycemic therapy of diabetes: mechanisms and implications. , 2011, The American journal of medicine.

[23]  M. Trovati,et al.  Evaluation of a simple policy for pre- and post-prandial blood glucose self-monitoring in people with type 2 diabetes not on insulin. , 2010, Diabetes research and clinical practice.

[24]  W. Polonsky,et al.  Structured Self-Monitoring of Blood Glucose Significantly Reduces A1C Levels in Poorly Controlled, Noninsulin-Treated Type 2 Diabetes , 2011, Diabetes Care.

[25]  W. Polonsky,et al.  The impact of blood glucose monitoring on depression and distress in insulin-naïve patients with type 2 diabetes , 2011, Current medical research and opinion.

[26]  G. Sartore,et al.  ROSES: role of self‐monitoring of blood glucose and intensive education in patients with Type 2 diabetes not receiving insulin. A pilot randomized clinical trial , 2011, Diabetic medicine : a journal of the British Diabetic Association.

[27]  V. Basevi,et al.  Standards of Medical Care in Diabetes—2012 , 2011, Diabetes Care.

[28]  Daniel J Cox,et al.  Algorithmic evaluation of metabolic control and risk of severe hypoglycemia in type 1 and type 2 diabetes using self-monitoring blood glucose data. , 2003, Diabetes technology & therapeutics.

[29]  C. Viscoli,et al.  Lower Baseline Glycemia Reduces Apparent Oral Agent Glucose-Lowering Efficacy , 2006, Diabetes Care.

[30]  R. Holman,et al.  Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study , 2000, BMJ : British Medical Journal.

[31]  Daniel J Cox,et al.  Methods for quantifying self-monitoring blood glucose profiles exemplified by an examination of blood glucose patterns in patients with type 1 and type 2 diabetes. , 2002, Diabetes technology & therapeutics.

[32]  G. Nichols,et al.  Slow response to loss of glycemic control in type 2 diabetes mellitus. , 2003, The American journal of managed care.

[33]  Reliability and Validity of a Diabetes Quality-of-Life Measure for the Diabetes Control and Complications Trial (DCCT) , 1988, Diabetes Care.

[34]  G. Nijpels,et al.  Self-Monitoring of Blood Glucose in Noninsulin-Using Type 2 Diabetic Patients , 2012, Diabetes Care.

[35]  J. Wofford.  Clinical inertia. , 2002, Annals of internal medicine.

[36]  Martin Straume,et al.  Risk Analysis of Blood Glucose Data: A Quantitative Approach to Optimizing the Control of Insulin Dependent Diabetes , 2000 .

[37]  J. Lasalle,et al.  Tailoring treatment to the individual in type 2 diabetes practical guidance from the Global Partnership for Effective Diabetes Management , 2010, International journal of clinical practice.

[38]  M. Porta,et al.  The locus of control in patients with Type 1 and Type 2 diabetes managed by individual and group care , 2008, Diabetic medicine : a journal of the British Diabetic Association.