Continuous Glucose Monitoring and Risk of Hypoglycemia

International Consensus on Use of Continuous Glucose Monitoring

  1. Thomas Danne1⇑,
  2. Revital Nimri2,
  3. Tadej Battelino3,
  4. Richard M. Bergenstal4,
  5. Kelly L. Close5,
  6. J. Hans DeVries6,
  7. Satish Garg7,
  8. Lutz Heinemann8,
  9. Irl Hirsch9,
  10. Stephanie A. Amiel10,
  11. Roy Beck11,
  12. Emanuele Bosi12,
  13. Bruce Buckingham13,
  14. Claudio Cobelli14,
  15. Eyal Dassau15,
  16. Francis J. Doyle III15,
  17. Simon Heller16,
  18. Roman Hovorka17,
  19. Weiping Jia18,
  20. Tim Jones19,
  21. Olga Kordonouri1,
  22. Boris Kovatchev20,
  23. Aaron Kowalski21,
  24. Lori Laffel22,
  25. David Maahs13,
  26. Helen R. Murphy23,
  27. Kirsten Nørgaard24,
  28. Christopher G. Parkin25,
  29. Eric Renard26,
  30. Banshi Saboo27,
  31. Mauro Scharf28,
  32. William V. Tamborlane29,
  33. Stuart A. Weinzimer29 and
  34. Moshe Phillip2
  1. 1Diabetes Centre for Children and Adolescents, Children’s and Youth Hospital “Auf Der Bult,” Hannover, Germany
  2. 2The Myrtle and Henry Hirsch National Center for Childhood Diabetes, The Jesse and Sara Lea Shafer Institute of Endocrinology and Diabetes, Schneider Children’s Medical Center of Israel, Petah Tikva, Israel
  3. 3Department of Pediatric Endocrinology, Diabetes and Metabolic Diseases, University Children’s Hospital, Ljubljana University Medical Centre, and Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia
  4. 4International Diabetes Center at Park Nicollet, Minneapolis, MN
  5. 5Close Concerns, San Francisco, CA
  6. 6Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands
  7. 7University of Colorado Denver and Barbara Davis Center for Diabetes, Aurora, CO
  8. 8Science & Co, Düsseldorf, Germany
  9. 9Division of Metabolism, Endocrinology, and Nutrition, Department of Medicine, University of Washington School of Medicine, Seattle, WA
  10. 10Diabetes Research Group, King's College London, London, U.K.
  11. 11Jaeb Center for Health Research, Tampa, FL
  12. 12Diabetes Research Institute, University “Vita-Salute” San Raffaele, Milan, Italy
  13. 13Division of Endocrinology and Diabetes, Department of Pediatrics, Stanford University Medical Center, Stanford, CA
  14. 14Department of Information Engineering, University of Padova, Padova, Italy
  15. 15John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge, MA
  16. 16Academic Unit of Diabetes, Endocrinology & Metabolism, The University of Sheffield, Sheffield, U.K.
  17. 17Wellcome Trust-MRC Institute of Metabolic Science and Department of Paediatrics, University of Cambridge, Cambridge, U.K.
  18. 18Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai Diabetes Institute, Shanghai Key Laboratory of Diabetes Mellitus, Shanghai Clinical Center of Diabetes, Shanghai, China
  19. 19Telethon Kids Institute and School of Paediatrics and Child Health, The University of Western Australia, and Department of Endocrinology and Diabetes, Princess Margaret Hospital for Children, Perth, Australia
  20. 20Center for Diabetes Technology, University of Virginia School of Medicine, Charlottesville, VA
  21. 21JDRF, New York, NY
  22. 22Pediatric, Adolescent and Young Adult Section and Section on Clinical, Behavioral and Outcomes Research, Joslin Diabetes Center, Harvard Medical School, Boston, MA
  23. 23Norwich Medical School, University of East Anglia, Norwich, U.K.
  24. 24Department of Endocrinology, Copenhagen University Hospital Hvidovre, Hvidovre, Denmark
  25. 25CGParkin Communications, Boulder City, NV
  26. 26Department of Endocrinology, Diabetes, and Nutrition, Montpellier University Hospital, and Institute of Functional Genomics, University of Montpellier, and INSERM Clinical Investigation Centre, Montpellier, France
  27. 27DiaCare, Ahmedabad, Gujarat, India
  28. 28Centro de Diabetes Curitiba and Division of Pediatric Endocrinology, Hospital Nossa Senhora das Graças, Curitiba, Brazil
  29. 29Department of Pediatrics, Yale School of Medicine, New Haven, CT
  1. Corresponding author: Thomas Danne, danne{at}hka.de.
Diabetes Care 2017 Dec; 40(12): 1631-1640. https://doi.org/10.2337/dc17-1600

Article Figures & Tables

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.

Tables

  • Table 1

    Key metrics for CGM data analysis and reporting

    CGM metricMeasuresATTD consensus
    1Mean glucose√ (calculated)
    Severe hypoglycemia*Clinical diagnosis: event requiring assistance (level 3)
    Percentage of time in hypoglycemic ranges, mg/dL (mmol/L)
    2 Clinically significant/very low/immediate action required<54 (<3.0) (level 2)
    3 Alert/low/monitor<70–54 (<3.9–3.0) (level 1)
    Percentage of time in target range, mg/dL (mmol/L)
    4 Default70–180 (3.9–10.0)
     Secondary70–140 (3.9–7.8)
    Percentage of time in hyperglycemic ranges, mg/dL (mmol/L)
    5 Alert/elevated/monitor>180 (>10) (level 1)
    6 Clinically significant/very elevated/immediate action required>250 (>13.9) (level 2)
    Diabetic ketoacidosis*Clinical diagnosis: ketones, acidosis, and usually hyperglycemia (level 3)
    Glycemic variability
    7 Primary glycemic variabilityCV
      StableCV <36%,
      UnstableCV ≥36%
     Secondary glycemic variabilitySD
    8eA1C√ (calculated)
    9Three time blocks: sleep, wake, 24 h12:00 a.m.–6:00 a.m., 6:00 a.m.–12:00 a.m., 12 a.m.–12:00 a.m.
    Recommended data sufficiency
    10 Collection period (minimum no. of weeks)2
    11 Percentage of expected CGM readings (minimum percentage)70–80 (10 of 14 days)
    12Episodes of hypoglycemia/hyperglycemia (minimum no. of minutes) (with beginning and end of episode defined)15 min
    13Area under the curve√ (calculated)
    14Risk of hypoglycemia and hyperglycemiaLBGI/HBGI recommended
    15Standardized CGM visualization of dataAGP recommended

    • ↵* Severe hypoglycemia (level 3) and diabetic ketoacidosis (level 3) are not key CGM metrics per se. However, these conditions are included in the table because they are important clinical categories that must be assessed and documented.

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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, 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
Diabetes Care Dec 2017, 40 (12) 1631-1640; DOI: 10.2337/dc17-1600
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