Continuous Glucose Monitoring: Evidence and Consensus Statement for Clinical Use

Continuous glucose monitoring (CGM) is an essential tool for modern diabetes therapy. Randomized controlled studies have provided evidence that hemoglobin A1c (HbA1c) results can be improved in patients with type 1 diabetes with elevated baseline HbA1c when using CGM frequently enough and that the frequency and duration of hypoglycemic events can be reduced in patients with satisfactory baseline HbA1c. The CGM group within the Working Group Diabetes Technology (AGDT) of the German Diabetes Association (DDG) has defined evidence-based indications for the practical use of CGM in this consensus statement related to hypoglycemia (frequent, severe, or nocturnal) or hypoglycemia unawareness, insufficient metabolic control despite use of all possible therapeutic options and patient compliance, pregnancy associated with inadequate blood glucose results, and the need for more than 10 blood glucose measurements per day. Contraindications and defined preconditions for the successful use of CGM should be considered.

[1]  Darrell M. Wilson,et al.  The effect of continuous glucose monitoring in well-controlled type 1 diabetes , 2010 .

[2]  M. Phillip,et al.  Effect of Continuous Glucose Monitoring on Hypoglycemia in Type 1 Diabetes , 2011, Diabetes Care.

[3]  S. Greene,et al.  ABCD position statement on continuous glucose monitoring: use of glucose sensing in outpatient clinical diabetes care , 2010 .

[4]  Howard Wolpert,et al.  Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group. The effect of continuous glucose monitoring in well-controlled type 1 diabetes , 2009 .

[5]  Pa,et al.  Validation of measures of satisfaction with and impact of continuous and conventional glucose monitoring. , 2010, Diabetes technology & therapeutics.

[6]  T. Rönnemaa,et al.  Continuous glucose monitoring versus self-monitoring of blood glucose in the treatment of gestational diabetes mellitus. , 2007, Diabetes research and clinical practice.

[7]  Boris P Kovatchev,et al.  Graphical and numerical evaluation of continuous glucose sensing time lag. , 2009, Diabetes technology & therapeutics.

[8]  E. Renard,et al.  Real-time continuous glucose monitoring (CGM) integrated into the treatment of type 1 diabetes: consensus of experts from SFD, EVADIAC and SFE. , 2012, Diabetes & metabolism.

[9]  K. Dear,et al.  Continuous Glucose Monitoring–Guided Insulin Adjustment in Children and Adolescents on Near-Physiological Insulin Regimens , 2006, Diabetes Care.

[10]  H. Rodbard,et al.  American Association of Clinical Endocrinologists medical guidelines for clinical practice for the management of diabetes mellitus. , 2007, Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists.

[11]  Lutz Heinemann,et al.  Comparison of the Numerical and Clinical Accuracy of Four Continuous Glucose Monitors , 2008, Diabetes Care.

[12]  Boris Kovatchev,et al.  Evaluating the clinical accuracy of two continuous glucose sensors using continuous glucose-error grid analysis. , 2005, Diabetes care.

[13]  F. Ovalle,et al.  Continuous Glucose Monitoring and Intensive Treatment of Type 1 Diabetes , 2009 .

[14]  R. Potts,et al.  Physiological differences between interstitial glucose and blood glucose measured in human subjects. , 2003, Diabetes care.

[15]  Martin Holder,et al.  Prevention of hypoglycemia by using low glucose suspend function in sensor-augmented pump therapy. , 2011, Diabetes technology & therapeutics.

[16]  M. Knip,et al.  Sensor-augmented pump therapy from the diagnosis of childhood type 1 diabetes: results of the Paediatric Onset Study (ONSET) after 12 months of treatment , 2010, Diabetologia.

[17]  Santhisagar Vaddiraju,et al.  Technologies for Continuous Glucose Monitoring: Current Problems and Future Promises , 2010, Journal of diabetes science and technology.

[18]  R. Mazze,et al.  Evaluating the accuracy, reliability, and clinical applicability of continuous glucose monitoring (CGM): Is CGM ready for real time? , 2009, Diabetes technology & therapeutics.

[19]  Howard Wolpert,et al.  Clinical application of emerging sensor technologies in diabetes management: consensus guidelines for continuous glucose monitoring (CGM). , 2008, Diabetes technology & therapeutics.

[20]  Allan S. Brett.  Continuous Glucose Monitoring in Type 1 Diabetes , 2008 .

[21]  Christina Schmid,et al.  System Accuracy Evaluation of 43 Blood Glucose Monitoring Systems for Self-Monitoring of Blood Glucose according to DIN EN ISO 15197 , 2012, Journal of diabetes science and technology.

[22]  Howard Zisser,et al.  Improvement in glycemic excursions with a transcutaneous, real-time continuous glucose sensor: a randomized controlled trial. , 2006, Diabetes care.

[23]  C. Mathieu,et al.  Sensor‐augmented pump therapy lowers HbA1c in suboptimally controlled Type 1 diabetes; a randomized controlled trial , 2011, Diabetic medicine : a journal of the British Diabetic Association.

[24]  M. Lawson,et al.  Prevalence of nocturnal hypoglycemia in pediatric type 1 diabetes: a pilot study using continuous glucose monitoring. , 2011, The Journal of pediatrics.

[25]  S. Garg,et al.  Feasibility of 10-Day Use of a Continuous Glucose-Monitoring System in Adults With Type 1 Diabetes , 2009, Diabetes Care.

[26]  M. Sculpher,et al.  Randomized controlled trial to assess the impact of continuous glucose monitoring on HbA1c in insulin‐treated diabetes (MITRE Study) , 2009, Diabetic medicine : a journal of the British Diabetic Association.

[27]  Ernest Alema-Mensah,et al.  Comparative Analysis of the Efficacy of Continuous Glucose Monitoring and Self-Monitoring of Blood Glucose in Type 1 Diabetes Mellitus , 2012, Journal of diabetes science and technology.

[28]  G. Steil,et al.  Subcutaneous glucose predicts plasma glucose independent of insulin: implications for continuous monitoring. , 1999, The American journal of physiology.

[29]  Pd redaction.  Summary of Revisions for the 2009 Clinical Practice Recommendations , 2009, Diabetes Care.

[30]  George Dailey,et al.  Effectiveness of sensor-augmented insulin-pump therapy in type 1 diabetes. , 2010, The New England journal of medicine.

[31]  R. Beck,et al.  Diabetes Research in Children Network: Availability of Protocol Data Sets , 2007, Journal of diabetes science and technology.

[32]  Roy Beck,et al.  Prolonged use of continuous glucose monitors in children with type 1 diabetes on continuous subcutaneous insulin infusion or intensive multiple‐daily injection therapy , 2009, Pediatric diabetes.

[33]  Christopher G. Parkin,et al.  Sensor-augmented insulin pump therapy: results of the first randomized treat-to-target study. , 2008, Diabetes technology & therapeutics.

[34]  The accuracy of the CGMS in children with type 1 diabetes: results of the diabetes research in children network (DirecNet) accuracy study. , 2003, Diabetes technology & therapeutics.

[35]  Sina Askari,et al.  Usage and Effectiveness of the Low Glucose Suspend Feature of the Medtronic Paradigm Veo Insulin Pump , 2011, Journal of diabetes science and technology.

[36]  F. Cameron,et al.  Preventing hypoglycemia using predictive alarm algorithms and insulin pump suspension. , 2009, Diabetes technology & therapeutics.

[37]  Alex J Sutton,et al.  Glycaemic control in type 1 diabetes during real time continuous glucose monitoring compared with self monitoring of blood glucose: meta-analysis of randomised controlled trials using individual patient data , 2011, BMJ : British Medical Journal.

[38]  B. Olsen,et al.  The use and efficacy of continuous glucose monitoring in type 1 diabetes treated with insulin pump therapy: a randomised controlled trial , 2012, Diabetologia.

[39]  S. Garg,et al.  Comparison of accuracy and safety of the SEVEN and the Navigator continuous glucose monitoring systems. , 2009, Diabetes technology & therapeutics.

[40]  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.

[41]  T. Jones,et al.  Glycaemic impact of patient-led use of sensor-guided pump therapy in type 1 diabetes: a randomised controlled trial , 2009, Diabetologia.

[42]  H. Guess,et al.  Continuous subcutaneous glucose monitoring in children with type 1 diabetes mellitus: a single‐blind, randomized, controlled trial , 2006, Pediatric diabetes.

[43]  David Kerr,et al.  Insulin Pump Therapy With Automated Insulin Suspension in Response to Hypoglycemia , 2011, Diabetes Care.

[44]  H. Murphy,et al.  Effectiveness of continuous glucose monitoring in pregnant women with diabetes: randomised clinical trial , 2008, BMJ : British Medical Journal.

[45]  Michael O'Grady,et al.  Continuous glucose monitoring and intensive treatment of type 1 diabetes. , 2008, The New England journal of medicine.

[46]  Lotty Hooft,et al.  Continuous glucose monitoring systems for type 1 diabetes mellitus. , 2012, The Cochrane database of systematic reviews.

[47]  O. Kordonouri,et al.  Reducing glycaemic variability in type 1 diabetes self-management with a continuous glucose monitoring system based on wired enzyme technology , 2009, Diabetologia.

[48]  J. Pickup.  Semi-closed-loop insulin delivery systems: early experience with low-glucose insulin suspend pumps. , 2011, Diabetes technology & therapeutics.

[49]  Howard C. Zisser,et al.  Reduction in hemoglobin A1C with real-time continuous glucose monitoring: results from a 12-week observational study. , 2007, Diabetes technology & therapeutics.

[50]  A. Patzak,et al.  Vascular Reactivity in Arterioles From Normal and Alloxan-Diabetic Mice , 2007, Diabetes.

[51]  Johnny Ludvigsson,et al.  Continuous subcutaneous glucose monitoring improved metabolic control in pediatric patients with type 1 diabetes: a controlled crossover study. , 2003, Pediatrics.

[52]  K. Jungheim,et al.  Glucose monitoring at the arm: risky delays of hypoglycemia and hyperglycemia detection. , 2002, Diabetes care.

[53]  B. Braun,et al.  Continuous glucose monitoring counseling improves physical activity behaviors of individuals with type 2 diabetes: A randomized clinical trial. , 2008, Diabetes research and clinical practice.

[54]  Roy Beck,et al.  Use of the DirecNet Applied Treatment Algorithm (DATA) for diabetes management with a real‐time continuous glucose monitor (the FreeStyle Navigator) , 2008, Pediatric diabetes.

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

[56]  David C Klonoff,et al.  Reduction in duration of hypoglycemia by automatic suspension of insulin delivery: the in-clinic ASPIRE study. , 2012, Diabetes technology & therapeutics.

[57]  Eric Renard,et al.  Incremental valúe of continuous glucose monitoring when starting pump therapy in patients with poorly controlled type 1 diabetes: the REALTREND Study , 2010 .