Assessing glycemia in diabetes using self-monitoring blood glucose and hemoglobin A1c.

CONTEXT With the increasing prevalence of diabetes, successful management of blood glucose control is increasingly important. Current approaches to assessing glycemia include the use of self-monitoring of blood glucose (SMBG) and hemoglobin A1c (HbA1c). OBJECTIVES To assess the evidence underlying the use of these 2 modalities, to evaluate confounders and sources of error in each test, to describe upcoming developments, and to reach evidence-based conclusions on their optimal use. DATA SOURCES, STUDY SELECTION, AND DATA EXTRACTION Reports identified from MEDLINE searches (1976-2005) using relevant terms were selected for quality and relevance to the stated questions. Particular attention was paid to larger cohort studies, clinical trials, meta-analyses, and established recommendations. DATA SYNTHESIS If used properly SMBG gives an acceptably accurate reflection of immediate plasma glucose levels. Study results vary, but in general, the evidence supports a positive effect of regular SMBG for improving glycemia, particularly in individuals treated with insulin. The best timing of SMBG and its frequency are controversial issues, but the clinical recommendation is for regular monitoring with frequency depending on the treatment and the instability of glycemia. In the relatively near term, SMBG could gradually be replaced by continuous glucose monitoring. HbA1c measures long-term glycemic control, reflecting a time-weighted mean over the previous 3 to 4 months. There are a number of physiologic and methodologic confounders that can affect HbA1c, but standardization of assays has been well established. The main value of HbA1c is its use as a predictor of diabetic complications and the proven effect of improved control of HbA1c on complication risk. A reasonable target value for HbA1c is less than 7%. A new method for measuring HbA1c may cause significant changes in the recommended levels, the numbers reported, and even the name of the test. CONCLUSION Assessing glycemia in diabetes can be a challenge, but approaches are available that promote successful management of blood glucose and may thereby lead to a significant reduction in morbidity and mortality related to diabetes.

[1]  N. Clark,et al.  Standards of Medical Care in Diabetes: Response to Power , 2006 .

[2]  B. Zinman,et al.  Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. , 2005, The New England journal of medicine.

[3]  S. Kaplan,et al.  Self‐monitoring of blood glucose in non‐insulin‐treated diabetic patients: a longitudinal evaluation of its impact on metabolic control , 2005, Diabetic medicine : a journal of the British Diabetic Association.

[4]  S. Kaplan,et al.  Self‐monitoring of blood glucose in non‐insulin‐treated diabetic patients: a longitudinal evaluation of its impact on metabolic control , 2005 .

[5]  N. Evans,et al.  Fluorescence-based glucose sensors. , 2005, Biosensors & bioelectronics.

[6]  L. Bouter,et al.  Self-monitoring of blood glucose in patients with type 2 diabetes who are not using insulin: a systematic review. , 2005, Diabetes care.

[7]  M. Davidson,et al.  Counterpoint: Self-monitoring of blood glucose in type 2 diabetic patients not receiving insulin: a waste of money. , 2005, Diabetes care.

[8]  R. Little,et al.  Effects of hemoglobin C and S traits on glycohemoglobin measurements by eleven methods. , 2005, Clinical chemistry.

[9]  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.

[10]  D. Sacks Global harmonization of hemoglobin A1c. , 2005, Clinical chemistry.

[11]  Bruce A Buckingham,et al.  Accuracy of the modified Continuous Glucose Monitoring System (CGMS) sensor in an outpatient setting: results from a diabetes research in children network (DirecNet) study. , 2005, Diabetes technology & therapeutics.

[12]  Kathryn Tan,et al.  Self-monitoring of blood glucose as part of a multi-component therapy among non-insulin requiring type 2 diabetes patients: a meta-analysis (1966–2004)* , 2005, Current medical research and opinion.

[13]  Claresa Levetan,et al.  Use of the Continuous Glucose Monitoring System to guide therapy in patients with insulin-treated diabetes: a randomized controlled trial. , 2004, Mayo Clinic proceedings.

[14]  M. Parchman,et al.  Association between self-monitoring of blood glucose and glycemic control in patients with type 2 diabetes mellitus. , 2004, American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists.

[15]  C. Edwards International Textbook of Diabetes Mellitus , 2004 .

[16]  A. Wierzbicki,et al.  Biological variation in HbA1c predicts risk of retinopathy and nephropathy in type 1 diabetes. , 2004, Diabetes care.

[17]  Neil R. Powe,et al.  Meta-Analysis: Glycosylated Hemoglobin and Cardiovascular Disease in Diabetes Mellitus , 2004, Annals of Internal Medicine.

[18]  Janet B McGill,et al.  Circulating 1,5-anhydroglucitol levels in adult patients with diabetes reflect longitudinal changes of glycemia: a U.S. trial of the GlycoMark assay. , 2004, Diabetes care.

[19]  S. Majumdar,et al.  Lack of insurance coverage for testing supplies is associated with poorer glycemic control in patients with type 2 diabetes , 2004, Canadian Medical Association Journal.

[20]  A. Carter,et al.  A prospective, randomized, multicentered controlled trial to compare the annual glycemic and quality outcomes of patients with diabetes mellitus monitored with weekly fructosamine testing versus usual care. , 2004, Diabetes technology & therapeutics.

[21]  James D Dziura,et al.  Experience with the continuous glucose monitoring system in a medical intensive care unit. , 2004, Diabetes technology & therapeutics.

[22]  P. Damm,et al.  HbA1c levels are significantly lower in early and late pregnancy. , 2004, Diabetes care.

[23]  H. Lapinski,et al.  Self-monitoring of blood glucose in diabetic patients: from the least common denominator to the greatest common multiple. , 2004, Diabetes & metabolism.

[24]  M. Barton,et al.  Effects of health maintenance organization coverage of self-monitoring devices on diabetes self-care and glycemic control. , 2004, Archives of internal medicine.

[25]  C. Chia,et al.  Glucose sensors: toward closed loop insulin delivery. , 2004, Endocrinology and metabolism clinics of North America.

[26]  P Drouin,et al.  Self-monitoring of blood glucose significantly improves metabolic control in patients with type 2 diabetes mellitus: the Auto-Surveillance Intervention Active (ASIA) study. , 2003, Diabetes & metabolism.

[27]  C. Saudek,et al.  Is HbA(1c) affected by glycemic instability? , 2003, Diabetes care.

[28]  D. Hadden,et al.  Preprandial versus postprandial blood glucose monitoring in type 1 diabetic pregnancy: a randomized controlled clinical trial. , 2003, American journal of obstetrics and gynecology.

[29]  Arleen F. Brown,et al.  Out-of-pocket costs and diabetes preventive services: the Translating Research Into Action for Diabetes (TRIAD) study. , 2003, Diabetes care.

[30]  Hee-Seung Kim,et al.  Establishment of blood glucose monitoring system using the internet. , 2003, Diabetes care.

[31]  Dawn M. Bina,et al.  Clinical impact of prandial state, exercise, and site preparation on the equivalence of alternative-site blood glucose testing. , 2003, Diabetes care.

[32]  L. Phillips,et al.  Rapid A1c availability improves clinical decision-making in an urban primary care clinic. , 2003, Diabetes care.

[33]  Claude Colette,et al.  Contributions of fasting and postprandial plasma glucose increments to the overall diurnal hyperglycemia of type 2 diabetic patients: variations with increasing levels of HbA(1c). , 2003, Diabetes care.

[34]  R. Hanås Psychological impact of changing the scale of reported HbA(1c) results affects metabolic control. , 2002, Diabetes care.

[35]  G. Mertes,et al.  Meal-related structured self-monitoring of blood glucose: effect on diabetes control in non-insulin-treated type 2 diabetic patients. , 2002, Diabetes care.

[36]  Stefano Zucchini,et al.  The glucose area under the profiles obtained with continuous glucose monitoring system relationships with HbA(lc) in pediatric type 1 diabetic patients. , 2002, Diabetes care.

[37]  Ralph B D'Agostino,et al.  Fasting and postchallenge glycemia and cardiovascular disease risk: the Framingham Offspring Study. , 2002, Diabetes care.

[38]  R. McCarter,et al.  High and low hemoglobin glycation phenotypes in type 1 diabetes: a challenge for interpretation of glycemic control. , 2002, Journal of diabetes and its complications.

[39]  David M Nathan,et al.  Tests of Glycemia for the Diagnosis of Type 2 Diabetes Mellitus , 2002, Annals of Internal Medicine.

[40]  R. Little,et al.  Biological variation of glycohemoglobin. , 2002, Clinical chemistry.

[41]  John M Ellison,et al.  Rapid changes in postprandial blood glucose produce concentration differences at finger, forearm, and thigh sampling sites. , 2002, Diabetes care.

[42]  Matthew D. Davis,et al.  Effect of intensive therapy on the microvascular complications of type 1 diabetes mellitus. , 2002, JAMA.

[43]  D. Goldstein,et al.  Defining the relationship between plasma glucose and HbA(1c): analysis of glucose profiles and HbA(1c) in the Diabetes Control and Complications Trial. , 2002, Diabetes care.

[44]  R. Paroni,et al.  Approved IFCC Reference Method for the Measurement of HbA1c in Human Blood , 2002, Clinical chemistry and laboratory medicine.

[45]  R. Kronmal,et al.  Fasting and 2-hour postchallenge serum glucose measures and risk of incident cardiovascular events in the elderly: the Cardiovascular Health Study. , 2002, Archives of internal medicine.

[46]  S H Kaplan,et al.  The impact of blood glucose self-monitoring on metabolic control and quality of life in type 2 diabetic patients: an urgent need for better educational strategies. , 2001, Diabetes care.

[47]  Jennifer Y. Liu,et al.  Self-monitoring of blood glucose levels and glycemic control: the Northern California Kaiser Permanente Diabetes registry. , 2001, The American journal of medicine.

[48]  M. Harris,et al.  Frequency of blood glucose monitoring in relation to glycemic control in patients with type 2 diabetes. , 2001, Diabetes care.

[49]  J. Baker,et al.  Error detection and measurement in glucose monitors. , 2001, Clinica chimica acta; international journal of clinical chemistry.

[50]  L. Bry,et al.  Effects of hemoglobin variants and chemically modified derivatives on assays for glycohemoglobin. , 2001, Clinical chemistry.

[51]  Dawn M. Bina,et al.  Identifying Variables Associated With Inaccurate Self-Monitoring of Blood Glucose: Proposed Guidelines to Improve Accuracy , 2000, The Diabetes educator.

[52]  M. Gulliford,et al.  Self‐monitoring in Type 2 diabetes mellitus: a meta‐analysis , 2000, Diabetic medicine : a journal of the British Diabetic Association.

[53]  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.

[54]  K. Flegal,et al.  Use of GHb (HbA1c) in screening for undiagnosed diabetes in the U.S. population. , 2000, Diabetes care.

[55]  J. Chanard,et al.  Influence of in vivo Hemoglobin Carbamylation on HbA1c Measurements by Various Methods , 2000, Clinical chemistry and laboratory medicine.

[56]  D. Nathan,et al.  Immediate feedback of HbA1c levels improves glycemic control in type 1 and insulin-treated type 2 diabetic patients. , 1999, Diabetes care.

[57]  John J Mastrototaro,et al.  Subcutaneous glucose predicts plasma glucose independent of insulin: implications for continuous monitoring. , 1999, American journal of physiology. Endocrinology and metabolism.

[58]  Ö. Tarım,et al.  Effects of iron deficiency anemia on hemoglobin A1c in type 1 diabetes mellitus , 1999, Pediatrics international : official journal of the Japan Pediatric Society.

[59]  R. Holman,et al.  Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. , 1998 .

[60]  R. Holman,et al.  Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34) , 1998, The Lancet.

[61]  D. Goldstein,et al.  What is hemoglobin A1c? An analysis of glycated hemoglobins by electrospray ionization mass spectrometry. , 1998, Clinical chemistry.

[62]  P Wach,et al.  Validation of Home Blood Glucose Meters With Respect to Clinical and Analytical Approaches , 1998, Diabetes Care.

[63]  R. Holman,et al.  UKPDS 28: A Randomized Trial of Efficacy of Early Addition of Metformin in Sulfonylurea-Treated Type 2 Diabetes , 1998, Diabetes Care.

[64]  J. Rindone,et al.  Effect of home blood glucose monitoring on the management of patients with non-insulin dependent diabetes mellitus in the primary care setting. , 1997, The American journal of managed care.

[65]  F. Schellevis,et al.  The Efficacy of Self-Monitoring of Blood Glucose in NIDDM subjects: A criteria-based literature review , 1997, Diabetes Care.

[66]  J. Oki,et al.  Frequency and Impact of SMBG on Glycemic Control in Patients With NIDDM in an Urban Teaching Hospital Clinic , 1997, The Diabetes educator.

[67]  R. Hoffman,et al.  Relationship between home glucose testing and hemoglobin Alc in type II diabetes patients. , 1997, American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists.

[68]  Z. Trajanoski,et al.  Accuracy of home blood glucose meters during hypoglycemia , 1996, Diabetes Care.

[69]  M. Hanefeld,et al.  Risk factors for myocardial infarction and death in newly detected NIDDM: the Diabetes Intervention Study, 11-year follow-up , 1996, Diabetologia.

[70]  V Marks,et al.  Blood glucose: its measurement and clinical importance. , 1996, Clinica chimica acta; international journal of clinical chemistry.

[71]  J. Colwell Intensive Insulin Therapy in Type II Diabetes: Rationale and Collaborative Clinical Trial Results , 1996, Diabetes.

[72]  L. Jaber,et al.  Evaluation of a Pharmaceutical Care Model on Diabetes Management , 1996, The Annals of pharmacotherapy.

[73]  Influence of Intensive Diabetes Treatment on Quality-of-Life Outcomes in the Diabetes Control and Complications Trial , 1996, Diabetes Care.

[74]  H Lestradet,et al.  [The discovery of insulin]. , 1996, Bulletin de l'Academie nationale de medecine.

[75]  M. Morgan,et al.  Postprandial versus preprandial blood glucose monitoring in women with gestational diabetes mellitus requiring insulin therapy. , 1995, The New England journal of medicine.

[76]  Y. Yamasaki,et al.  1,5-Anhydro-D-glucitol Evaluates Daily Glycemic Excursions in Well-Controlled NIDDM , 1995, Diabetes Care.

[77]  Charles M Peterson,et al.  Tests of glycemia in diabetes. , 1995, Diabetes care.

[78]  E. Araki,et al.  Intensive insulin therapy prevents the progression of diabetic microvascular complications in Japanese patients with non-insulin-dependent diabetes mellitus: a randomized prospective 6-year study. , 1995, Diabetes research and clinical practice.

[79]  W. Cefalu,et al.  Glycohemoglobin measured by automated affinity HPLC correlates with both short-term and long-term antecedent glycemia. , 1994, Clinical chemistry.

[80]  D. Rogers,et al.  The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus , 1994 .

[81]  D. Muchmore,et al.  Self-monitoring of blood glucose in overweight type 2 diabetic patients , 1994, Acta Diabetologica.

[82]  A. Prochazka,et al.  Home blood glucose monitoring , 1993, Journal of General Internal Medicine.

[83]  S. Genuth,et al.  The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. , 1993, The New England journal of medicine.

[84]  K. Shima,et al.  The Response of GHb to Stepwise Plasma Glucose Change Over Time in Diabetic Patients , 1993, Diabetes Care.

[85]  D. Nathan,et al.  Implementation of capillary blood glucose monitoring in a teaching hospital and determination of program requirements to maintain quality testing. , 1992, The American journal of medicine.

[86]  J. Yudkin,et al.  Effect of Vitamin C on Glycosylation of Proteins , 1992, Diabetes.

[87]  K. Wiener The Effect of Haematocrit on Reagent Strip Tests for Glucose , 1991, Diabetic medicine : a journal of the British Diabetic Association.

[88]  G V Gill,et al.  Unexplained Deaths of Type 1 Diabetic Patients , 1991, Diabetic medicine : a journal of the British Diabetic Association.

[89]  D. Giugliano,et al.  Vitamin E Reduction of Protein Glycosylation in Diabetes: New Prospect for Prevention of Diabetic Complications? , 1991, Diabetes Care.

[90]  G. Rutten,et al.  Feasibility and effects of a diabetes type II protocol with blood glucose self-monitoring in general practice. , 1990, Family practice.

[91]  M Hørder,et al.  Effect of long-term monitoring of glycosylated hemoglobin levels in insulin-dependent diabetes mellitus. , 1990, The New England journal of medicine.

[92]  E. DeLong,et al.  Impact of Glucose Self-Monitoring on Non-lnsulin-Treated Patients With Type II Diabetes Mellitus: Randomized Controlled Trial Comparing Blood and Urine Testing , 1990, Diabetes Care.

[93]  K. Mann,et al.  Follow-up Intervention: Its Effect on Compliance Behavior to a Diabetes Regimen , 1990, The Diabetes educator.

[94]  G. Slama,et al.  Is glucose self-monitoring beneficial in non-insulin-treated diabetic patients? Results of a randomized comparative trial. , 1989, Diabete & metabolisme.

[95]  T. Wysocki Impact of blood glucose monitoring on diabetic control: Obstacles and interventions , 1989, Journal of Behavioral Medicine.

[96]  L. Epstein,et al.  Does self-monitoring of blood glucose levels improve dietary compliance for obese patients with type II diabetes? , 1986, The American journal of medicine.

[97]  P. Zimmet,et al.  Self‐monitoring of blood glucose levels in non‐insulin‐dependent diabetes mellitus , 1983, The Medical journal of Australia.

[98]  D. Nathan,et al.  Effect of aspirin on determinations of glycosylated hemoglobin. , 1983, Clinical chemistry.

[99]  K. Alberti,et al.  Safety of continuous subcutaneous insulin infusion: Metabolic deterioration and glycaemic autoregulation after deliberate cessation of infusion , 1982, Diabetologia.

[100]  P. Sönksen,et al.  HOME MONITORING OF BLOOD-GLUCOSE Method for Improving Diabetic Control , 1978, The Lancet.

[101]  R. Tattersall,et al.  SELF-MONITORING OF BLOOD-GLUCOSE Improvement of Diabetic Control , 1978, The Lancet.

[102]  A. Cerami,et al.  Correlation of glucose regulation and hemoglobin AIc in diabetes mellitus. , 1976, The New England journal of medicine.

[103]  P. Gallop,et al.  The biosynthesis of human hemoglobin A1c. Slow glycosylation of hemoglobin in vivo. , 1976, The Journal of clinical investigation.

[104]  O. Blumenfeld,et al.  Studies of an unusual hemoglobin in patients with diabetes mellitus. , 1969, Biochemical and biophysical research communications.

[105]  S. Genuth,et al.  Biological variation in HbA1c predicts risk of retinopathy and nephropathy in type 1 diabetes: response to McCarter et al. , 2005, Diabetes care.

[106]  Cas Weykamp,et al.  IFCC reference system for measurement of hemoglobin A1c in human blood and the national standardization schemes in the United States, Japan, and Sweden: a method-comparison study. , 2004, Clinical chemistry.

[107]  John M. Lachin,et al.  Sustained effect of intensive treatment of type 1 diabetes mellitus on development and progression of diabetic nephropathy: the Epidemiology of Diabetes Interventions and Complications (EDIC) study. , 2003, JAMA.

[108]  Ilya Fine,et al.  Glucose correlation with light scattering patterns--a novel method for non-invasive glucose measurements. , 2003, Diabetes technology & therapeutics.

[109]  G J Kost,et al.  Effects of drugs on glucose measurements with handheld glucose meters and a portable glucose analyzer. , 2000, American journal of clinical pathology.

[110]  G M Steil,et al.  Can interstitial glucose assessment replace blood glucose measurements? , 2000, Diabetes technology & therapeutics.

[111]  W. Newman,et al.  Impact of glucose self-monitoring on glycohemoglobin values in a veteran population. , 1990, Archives of internal medicine.