International Consensus on Use of Continuous Glucose Monitoring

Thomas Danne, Revital Nimri, Tadej Battelino, Richard M Bergenstal, Kelly L Close, J Hans DeVries, Satish Garg, Lutz Heinemann, Irl Hirsch, Stephanie A Amiel, Roy Beck, Emanuele Bosi, Bruce Buckingham, Claudio Cobelli, Eyal Dassau, Francis J Doyle 3rd, Simon Heller, Roman Hovorka, Weiping Jia, Tim Jones, Olga Kordonouri, Boris Kovatchev, Aaron Kowalski, Lori Laffel, David Maahs, Helen R Murphy, Kirsten Nørgaard, Christopher G Parkin, Eric Renard, Banshi Saboo, Mauro Scharf, William V Tamborlane, Stuart A Weinzimer, Moshe Phillip, Thomas Danne, Revital Nimri, Tadej Battelino, Richard M Bergenstal, Kelly L Close, J Hans DeVries, Satish Garg, Lutz Heinemann, Irl Hirsch, Stephanie A Amiel, Roy Beck, Emanuele Bosi, Bruce Buckingham, Claudio Cobelli, Eyal Dassau, Francis J Doyle 3rd, Simon Heller, Roman Hovorka, Weiping Jia, Tim Jones, Olga Kordonouri, Boris Kovatchev, Aaron Kowalski, Lori Laffel, David Maahs, Helen R Murphy, Kirsten Nørgaard, Christopher G Parkin, Eric Renard, Banshi Saboo, Mauro Scharf, William V Tamborlane, Stuart A Weinzimer, Moshe Phillip

Abstract

Measurement of glycated hemoglobin (HbA1c) has been the traditional method for assessing glycemic control. However, it does not reflect intra- and interday glycemic excursions that may lead to acute events (such as hypoglycemia) or postprandial hyperglycemia, which have been linked to both microvascular and macrovascular complications. Continuous glucose monitoring (CGM), either from real-time use (rtCGM) or intermittently viewed (iCGM), addresses many of the limitations inherent in HbA1c testing and self-monitoring of blood glucose. Although both provide the means to move beyond the HbA1c measurement as the sole marker of glycemic control, standardized metrics for analyzing CGM data are lacking. Moreover, clear criteria for matching people with diabetes to the most appropriate glucose monitoring methodologies, as well as standardized advice about how best to use the new information they provide, have yet to be established. In February 2017, the Advanced Technologies & Treatments for Diabetes (ATTD) Congress convened an international panel of physicians, researchers, and individuals with diabetes who are expert in CGM technologies to address these issues. This article summarizes the ATTD consensus recommendations and represents the current understanding of how CGM results can affect outcomes.

© 2017 by the American Diabetes Association.

Figures

Figure 1
Figure 1
The electronic AGP report visualizes the key CGM metrics: 1) mean glucose, 2) hypoglycemia: clinically significant/very low/immediate action required, 3) hypoglycemia: alert/low/monitor, 4) target range, 5) hyperglycemia: alert/elevated/monitor, 6) hyperglycemia: clinically significant/very elevated/immediate action required, 7) glycemic variability, 8) eA1C, 9) time blocks, 10) collection period, 11) percentage of expected readings, 12) hypoglycemia/hyperglycemia episodes, 13) area under the curve, 14) hypoglycemia/hyperglycemia risk, and 15) standardized rtCGM/iCGM visualization. AUC, area under the curve; Avg; average; IQR, interquartile range; MAGE, mean amplitude of glucose excursions; MODD, mean of daily differences.

References

    1. Kato N, Cui J, Kato M. Structured self-monitoring of blood glucose reduces glycated hemoglobin in insulin-treated diabetes. J Diabetes Investig 2013;4:450–453
    1. Polonsky WH, Fisher L, Schikman CH, et al. . Structured self-monitoring of blood glucose significantly reduces A1C levels in poorly controlled, noninsulin-treated type 2 diabetes: results from the Structured Testing Program study. Diabetes Care 2011;34:262–26
    1. Franciosi M, Lucisano G, Pellegrini F, et al. .; ROSES Study Group . 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. Diabet Med 2011;28:789–796
    1. Kempf K, Kruse J, Martin S. ROSSO-in-praxi follow-up: long-term effects of self-monitoring of blood glucose on weight, hemoglobin A1c, and quality of life in patients with type 2 diabetes mellitus. Diabetes Technol Ther 2012;14:59–64
    1. Bolli GB. Hypoglycaemia unawareness. Diabetes Metab 1997;23(Suppl. 3):29–35
    1. Gold AE, MacLeod KM, Frier BM. Frequency of severe hypoglycemia in patients with type I diabetes with impaired awareness of hypoglycemia. Diabetes Care 1994;17:697–703
    1. American Diabetes Association Standards of Medical Care in Diabetes—2017. Diabetes Care 2017;40(Suppl. 1):S1–S135
    1. Orchard TJ, Nathan DM, Zinman B, et al. .; Writing Group for the DCCT/EDIC Research Group . Association between 7 years of intensive treatment of type 1 diabetes and long-term mortality. JAMA 2015;313:45–53
    1. Holman RR, Paul SK, Bethel MA, Matthews DR, Neil HAW. 10-year follow-up of intensive glucose control in type 2 diabetes. N Engl J Med 2008;359:1577–1589
    1. Garber AJ, Abrahamson MJ, Barzilay JI, et al. .; American Association of Clinical Endocrinologists (AACE); American College of Endocrinology (ACE) . Consensus statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the comprehensive type 2 diabetes management algorithm – 2016 Executive Summary. Endocr Pract 2016;22:84–113
    1. National Institute for Health and Care Excellence (NICE) Diabetes (type 1 and type 2) in children and young people: diagnosis and management, 2015. NICE guideline [NG18]. London, U.K., National Institute for Health and Care Excellence. Available from . Accessed 4 May 2017.
    1. National Institute of Diabetes and Digestive and Kidney Diseases Sickle cell trait & other hemoglobinopathies & diabetes (for providers) [Internet], 2014. Available from . Accessed 26 August 2017.
    1. Bry L, Chen PC, Sacks DB. Effects of hemoglobin variants and chemically modified derivatives on assays for glycohemoglobin. Clin Chem 2001;47:153–163
    1. Ford ES, Cowie CC, Li C, Handelsman Y, Bloomgarden ZT. Iron-deficiency anemia, non-iron-deficiency anemia and HbA1c among adults in the US. J Diabetes 2011;3:67–73
    1. Nielsen LR, Ekbom P, Damm P, et al. . HbA1c levels are significantly lower in early and late pregnancy. Diabetes Care 2004;27:1200–1201
    1. Bergenstal RM, Gal RL, Connor CG, et al. .; T1D Exchange Racial Differences Study Group . Racial differences in the relationship of glucose concentrations and hemoglobin A1c levels. Ann Intern Med 2017;167:95–102
    1. Shipman KE, Jawad M, Sullivan KM, Ford C, Gama R. Ethnic/racial determinants of glycemic markers in a UK sample. Acta Diabetol 2015;52:687–692
    1. Wolffenbuttel BHR, Herman WH, Gross JL, Dharmalingam M, Jiang HH, Hardin DS. Ethnic differences in glycemic markers in patients with type 2 diabetes. Diabetes Care 2013;36:2931–2936
    1. Herman WH. Are there clinical implications of racial differences in HbA1c? Yes, to not consider can do great harm! Diabetes Care 2016;39:1458–1461
    1. Beck RW, Connor CG, Mullen DM, Wesley DM, Bergenstal RM. The fallacy of average: how using HbA1c alone to assess glycemic control can be misleading. Diabetes Care 2017;40:994–999
    1. Fullerton B, Jeitler K, Seitz M, Horvath K, Berghold A, Siebenhofer A. Intensive glucose control versus conventional glucose control for type 1 diabetes mellitus. Cochrane Database Syst Rev 2014;14:CD009122
    1. Nathan DM, Genuth S, Lachin J, et al. .; Diabetes Control and Complications Trial Research Group . The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 1993;329:977–986
    1. Miller KM, Beck RW, Bergenstal RM, et al. .; T1D Exchange Clinic Network . Evidence of a strong association between frequency of self-monitoring of blood glucose and hemoglobin A1c levels in T1D Exchange clinic registry participants. Diabetes Care 2013;36:2009–2014
    1. Bolinder J, Antuna R, Geelhoed-Duijvestijn P, Kröger J, Weitgasser R. Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, non-masked, randomised controlled trial. Lancet 2016;388:2254–2263
    1. Haak T, Hanaire H, Ajjan R, Hermanns N, Riveline JP, Rayman G. Flash glucose-sensing technology as a replacement for blood glucose monitoring for the management of insulin-treated type 2 diabetes: a multicenter, open-label randomized controlled trial. Diabetes Ther 2016;8:55–73
    1. Kropff J, Choudhary P, Neupane S, et al. . Accuracy and longevity of an implantable continuous glucose sensor in the PRECISE study: a 180-day, prospective, multicenter, pivotal trial. Diabetes Care 2017;40:63–68
    1. Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group Effectiveness of continuous glucose monitoring in a clinical care environment: evidence from the Juvenile Diabetes Research Foundation Continuous Glucose Monitoring (JDRF-CGM) trial. Diabetes Care 2010;33:17–22
    1. Hermanides J, Nørgaard K, Bruttomesso D, et al. . Sensor-augmented pump therapy lowers HbA1c in suboptimally controlled type 1 diabetes; a randomized controlled trial. Diabet Med 2011;28:1158–1167
    1. Battelino T, Conget I, Olsen B, et al. .; SWITCH Study Group . The use and efficacy of continuous glucose monitoring in type 1 diabetes treated with insulin pump therapy: a randomised controlled trial. Diabetologia 2012;55:3155–3162
    1. New JP, Ajjan R, Pfeiffer AF, Freckmann G. Continuous glucose monitoring in people with diabetes: the randomized controlled Glucose Level Awareness in Diabetes Study (GLADIS). Diabet Med 2015;32:609–617
    1. Wong JC, Foster NC, Maahs DM, et al. .; T1D Exchange Clinic Network . Real-time continuous glucose monitoring among participants in the T1D Exchange clinic registry. Diabetes Care 2014;37:2702–2709
    1. Riveline JP, Schaepelynck P, Chaillous L, et al. .; EVADIAC Sensor Study Group . Assessment of patient-led or physician-driven continuous glucose monitoring in patients with poorly controlled type 1 diabetes using basal-bolus insulin regimens: a 1-year multicenter study. Diabetes Care 2012;35:965–971
    1. Rachmiel M, Landau Z, Boaz M, et al. . The use of continuous glucose monitoring systems in a pediatric population with type 1 diabetes mellitus in real-life settings: the AWeSoMe Study Group experience. Acta Diabetol 2015;52:323–329
    1. Bergenstal RM, Klonoff DC, Garg SK, et al. .; ASPIRE In-Home Study Group . Threshold-based insulin-pump interruption for reduction of hypoglycemia. N Engl J Med 2013;369:224–232
    1. Weinstock RS, Xing D, Maahs DM, et al. .; T1D Exchange Clinic Network . Severe hypoglycemia and diabetic ketoacidosis in adults with type 1 diabetes: results from the T1D Exchange clinic registry. J Clin Endocrinol Metab 2013;98:3411–3419
    1. Pickup JC, Freeman SC, Sutton AJ. 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. BMJ 2011;343:d3805.
    1. Garg SK, Voelmle MK, Beatson CR, et al. . Use of continuous glucose monitoring in subjects with type 1 diabetes on multiple daily injections versus continuous subcutaneous insulin infusion therapy: a prospective 6-month study. Diabetes Care 2011;34:574–579
    1. Beck RW, Riddlesworth T, Ruedy K, et al. .; DIAMOND Study Group . Effect of continuous glucose monitoring on glycemic control in adults with type 1 diabetes using insulin injections: the DIAMOND randomized clinical trial. JAMA 2017;317:371–378
    1. Huang ES, O’Grady M, Basu A, et al. .; Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group . The cost-effectiveness of continuous glucose monitoring in type 1 diabetes. Diabetes Care 2010;33:1269–1274
    1. McQueen RB, Ellis SL, Campbell JD, Nair KV, Sullivan PW. Cost-effectiveness of continuous glucose monitoring and intensive insulin therapy for type 1 diabetes. Cost Eff Resour Alloc 2011;9:13.
    1. Roze S, Saunders R, Brandt AS, de Portu S, Papo NL, Jendle J. Health-economic analysis of real-time continuous glucose monitoring in people with type 1 diabetes. Diabet Med 2015;32:618–626
    1. Ly TT, Brnabic AJ, Eggleston A, et al. . A cost-effectiveness analysis of sensor-augmented insulin pump therapy and automated insulin suspension versus standard pump therapy for hypoglycemic unaware patients with type 1 diabetes. Value Health 2014;17:561–569
    1. Roze S, Smith-Palmer J, Valentine WJ, et al. . Long-term health economic benefits of sensor-augmented pump therapy vs continuous subcutaneous insulin infusion alone in type 1 diabetes: a U.K. perspective. J Med Econ 2016;19:236–242
    1. Roze S, Smith-Palmer J, Valentine W, et al. . Cost-effectiveness of sensor-augmented pump therapy with low glucose suspend versus standard insulin pump therapy in two different patient populations with type 1 diabetes in France. Diabetes Technol Ther 2016;18:75–84
    1. Beck RW, Riddlesworth TD, Ruedy K, et al. .; DIAMOND Study Group . Continuous glucose monitoring versus usual care in patients with type 2 diabetes receiving multiple daily insulin injections: a randomized trial. Ann Intern Med 2017;167:365–374
    1. Yoo HJ, An HG, Park SY, et al. . Use of a real time continuous glucose monitoring system as a motivational device for poorly controlled type 2 diabetes. Diabetes Res Clin Pract 2008;82:73–79
    1. Vigersky RA, Fonda SJ, Chellappa M, Walker MS, Ehrhardt NM. Short- and long-term effects of real-time continuous glucose monitoring in patients with type 2 diabetes. Diabetes Care 2012;35:32–38
    1. Carlson AL, Mullen DM, Bergenstal RM. Clinical use of continuous glucose monitoring in adults with type 2 diabetes. Diabetes Technol Ther 2017;19(Suppl. 2):S4–S11
    1. Obermaier K, Schmelzeisen-Redeker G, Schoemaker M, et al. . Performance evaluations of continuous glucose monitoring systems: precision absolute relative deviation is part of the assessment. J Diabetes Sci Technol 2013;7:824–832
    1. Kovatchev BP, Patek SD, Ortiz EA, Breton MD. Assessing sensor accuracy for non-adjunct use of continuous glucose monitoring. Diabetes Technol Ther 2015;17:177–186
    1. Cryer PE. The barrier of hypoglycemia in diabetes. Diabetes 2008;57:3169–3176
    1. Campbell MS, Schatz DA, Chen V, et al. .; T1D Exchange Clinic Network . A contrast between children and adolescents with excellent and poor control: the T1D Exchange clinic registry experience. Pediatr Diabetes 2014;15:110–117
    1. Lipska KJ, Warton EM, Huang ES, et al. . HbA1c and risk of severe hypoglycemia in type 2 diabetes: the Diabetes and Aging Study. Diabetes Care 2013;36:3535–3542
    1. Heller SR, Cryer PE. Reduced neuroendocrine and symptomatic responses to subsequent hypoglycemia after 1 episode of hypoglycemia in nondiabetic humans. Diabetes 1991;40:223–226
    1. Davis MR, Mellman M, Shamoon H. Further defects in counterregulatory responses induced by recurrent hypoglycemia in IDDM. Diabetes 1992;41:1335–1340
    1. Davis SN, Mann S, Galassetti P, et al. . Effects of differing durations of antecedent hypoglycemia on counterregulatory responses to subsequent hypoglycemia in normal humans. Diabetes 2000;49:1897–1903
    1. Öz G, Kumar A, Rao JP, et al. . Human brain glycogen metabolism during and after hypoglycemia. Diabetes 2009;58:1978–1985
    1. Kovatchev BP, Cox DJ, Gonder-Frederick LA, Young-Hyman D, Schlundt D, Clarke W. Assessment of risk for severe hypoglycemia among adults with IDDM: validation of the low blood glucose index. Diabetes Care 1998;21:1870–1875
    1. Fabris C, Patek SD, Breton MD. Are risk indices derived from CGM interchangeable with SMBG-based indices? J Diabetes Sci Technol 2015;10:50–59
    1. Temelkova-Kurktschiev TS, Koehler C, Henkel E, Leonhardt W, Fuecker K, Hanefeld M. Postchallenge plasma glucose and glycemic spikes are more strongly associated with atherosclerosis than fasting glucose or HbA1c level. Diabetes Care 2000;23:1830–1834
    1. Haffner SM. Do interventions to reduce coronary heart disease reduce the incidence of type 2 diabetes? A possible role for inflammatory factors. Circulation 2001;103:346–347
    1. Esposito K, Giugliano D, Nappo F, Marfella R; Campanian Postprandial Hyperglycemia Study Group . Regression of carotid atherosclerosis by control of postprandial hyperglycemia in type 2 diabetes mellitus. Circulation 2004;110:214–219
    1. Monnier L, Mas E, Ginet C, et al. . Activation of oxidative stress by acute glucose fluctuations compared with sustained chronic hyperglycemia in patients with type 2 diabetes. JAMA 2006;295:1681–1687
    1. Cox DJ, Kovatchev BP, Julian DM, et al. . Frequency of severe hypoglycemia in insulin-dependent diabetes mellitus can be predicted from self-monitoring blood glucose data. J Clin Endocrinol Metab 1994;79:1659–1662
    1. DeVries JH. Glucose variability: where it is important and how to measure it. Diabetes 2013;62:1405–1408
    1. Hirsch IB. Glycemic variability and diabetes complications: does it matter? Of course it does! Diabetes Care 2015;38:1610–1614
    1. Service FJ. Glucose variability. Diabetes 2013;62:1398–1404
    1. Bergenstal RM. Glycemic variability and diabetes complications: does it matter? Simply put, there are better glycemic markers! Diabetes Care 2015;38:1615–162
    1. Rodbard D. The challenges of measuring glycemic variability. J Diabetes Sci Technol 2012;6:712–715
    1. Kovatchev B, Cobelli C. Glucose variability: timing, risk analysis, and relationship to hypoglycemia in diabetes. Diabetes Care 2016;39:502–510
    1. Reichard P, Pihl M. Mortality and treatment side-effects during long-term intensified conventional insulin treatment in the Stockholm Diabetes Intervention Study. Diabetes 1994;43:313–317
    1. Kovatchev BP, Flacke F, Sieber J, Breton MD. Accuracy and robustness of dynamical tracking of average glycemia (A1c) to provide real-time estimation of hemoglobin A1c using routine self-monitored blood glucose data. Diabetes Technol Ther 2014;16:303–309
    1. Egi M, Bellomo R, Stachowski E, French CJ, Hart G. Variability of blood glucose concentration and short-term mortality in critically ill patients. Anesthesiology 2006;105:244–252
    1. Eslami S, Taherzadeh Z, Schultz MJ, Abu-Hanna A. Glucose variability measures and their effect on mortality: a systematic review. Intensive Care Med 2011;37:583–593
    1. Qu Y, Jacober SJ, Zhang Q, Wolka LL, DeVries JH. Rate of hypoglycemia in insulin-treated patients with type 2 diabetes can be predicted from glycemic variability data. Diabetes Technol Ther 2012;14:1008–1012
    1. El-Laboudi AH, Godsland IF, Johnston DG, Oliver NS. Measures of glycemic variability in type 1 diabetes and the effect of real-time continuous glucose monitoring. Diabetes Technol Ther 2016;18:806–812
    1. Monnier L, Colette C, Wojtusciszyn A, et al. . Toward defining the threshold between low and high glucose variability in diabetes. Diabetes Care 2017;40:832–838
    1. Rodbard D. Interpretation of continuous glucose monitoring data: glycemic variability and quality of glycemic control. Diabetes Technol Ther 2009;11(Suppl. 1):S55–S67
    1. International Diabetes Center AGP - Ambulatory Glucose Profile: AGP reports. Available from . Accessed 17 July 2017.
    1. Medtronic. New CareLink iPro Pattern Snapshot. Available from . Accessed 29 August 2017.
    1. Dexcom. Dexcom CLARITY Diabetes Management Software. Available from . Accessed 29 August 2017.
    1. Bergenstal RM, Ahmann AJ, Bailey T, et al. . Recommendations for standardizing glucose reporting and analysis to optimize clinical decision making in diabetes: the Ambulatory Glucose Profile (AGP). Diabetes Technol Ther 2013;15:198–211
    1. Xing D, Kollman C, Beck RW, et al. .; Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group . Optimal sampling intervals to assess long-term glycemic control using continuous glucose monitoring. Diabetes Technol Ther 2011;13:351–358

Source: PubMed

Sponsorer och medarbetare

Medicinska tillstånd

Läkemedelsinterventioner

3
Prenumerera