Standardized CGM visualization of data AGP 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.

Title:

International Consensus on Use of Continuous Glucose Monitoring

Running Title:

CGM Consensus

Authors:

Thomas Danne1; Revital Nimri2; Tadej Battelino3; Richard M. Bergenstal4; Kelly L. Close5;

J. Hans DeVries6; Satish Garg7; Lutz Heinemann8; Irl Hirsch9; Stephanie A. Amiel10; Roy

Beck11; Emanuele Bosi12; Bruce Buckingham13; Claudio Cobelli14; Eyal Dassau15; Francis J.

Doyle III15; Simon Heller16; Roman Hovorka17; Weiping Jia18; Tim Jones19; Olga

Kordonouri1; Boris Kovatchev20; Aaron Kowalski21; Lori Laffel22; David Maahs13; Helen R.

Murphy23; Kirsten Nørgaard24; Christopher G. Parkin25; Eric Renard26; Banshi Saboo27;

Mauro Scharf29; William V. Tamborlane29; Stuart A. Weinzimer29; Moshe Phillip2

Affiliations 1

Diabetes Centre for Children and Adolescents, AUF DER BULT, Kinder- und

Jugendkrankenhaus, Hannover, Germany; 2The Jesse Z and Sara Lea Shafer Institute for

Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children’s

Medical Center of Israel, Petah Tikva, and Sackler Faculty of Medicine, Tel-Aviv University,

Tel Aviv, Israel; 3Department of Pediatric Endocrinology, Diabetes and Metabolism,

University Medical Centre-University Children’s Hospital, and Faculty of Medicine,

University of Ljubljana, Slovenia; 4International Diabetes Center at Park Nicollet,

Minneapolis, MN, USA; 5Close Concerns, San Francisco, California, USA; 6Academic

Medical Center, University of Amsterdam, Amsterdam, The Netherlands; 7University of

Co GmbH, Düsseldorf, Germany; 9Department of Medicine, Division of Metabolism,

Endocrinology, & Nutrition, University of Washington School of Medicine, Seattle,

Washington, USA; 10Diabetes Research Group, King's College London, London, United

Kingdom; 11Jaeb Center for Health Research, Tampa, Florida, USA; 12Diabetes Research

Institute, University "Vita-Salute" San Raffaele, Milan, Italy; 13Stanford Medical Center,

Department of Pediatrics, Division of Endocrinology and Diabetes, Stanford, CA, USA; 14

Department of Information Engineering, University of Padova, Padova, Italy; 15John A.

Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge,

Massachusetts, USA; 16Academic Unit of Diabetes, Endocrinology and Metabolism,

University of Sheffield, Sheffield, United Kingdom; 17Wellcome Trust-MRC Institute of

Metabolic Science, and Department of Paediatrics, University of Cambridge, Cambridge,

United Kingdom; 18Department of Endocrinology & Metabolism, Shanghai Clinical Center

of Diabetes, Shanghai Diabetes Institute, Shanghai Key Laboratory of Diabetes Mellitus,

Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China; 19

Telethon Kids Institute and The School of Paediatrics and Child Health, The University of

Western Australia, and Department of Endocrinology and Diabetes, Princess Margaret

Hospital for Children, Perth, Australia; 20Center for Diabetes Technology, The University of

Virginia, Charlottesville, VA, USA; 21Juvenile Diabetes Research Foundation, New York,

New York, USA; 22Pediatric, Adolescent and Young Adult Section and Section on Clinical,

Behavioral and Outcomes Research, Joslin Diabetes Center, Harvard Medical School,

Boston, MA, USA; 23 Norwich Medical School, University of East Anglia, Norwich, United

Kingdom; 24Department of Endocrinology, Copenhagen University Hospital Hvidovre,

26

Montpellier University Hospital, Department of Endocrinology, Diabetes, Nutrition,

Montpellier, and Institute of Functional Genomics, University of Montpellier, Montpellier,

and INSERM Clinical Investigation Centre, Montpellier, France; 27DiaCare, Ahmedabad,

Gujarat, India; 28Centro de Diabetes Curitiba, Division of Pediatric Endocrinology os

Hospital Nossa Senhora Das Graças, Curitiba, Brazil; 29Department of Pediatrics, Yale

School of Medicine, New Haven, Connecticut, USA

Corresponding Author

Thomas Danne, MD, Diabetes Center for Children and Adolescents, Kinder- und

Jugendkrankenhaus AUF DER BULT, Janusz-Korczak-Allee 12, 30173 Hannover,

Germany, Phone: +49- 511-8115-3330, Fax: +49- 511-8115-993344, [email protected]

Word Count 4,836 Figures/Tables

1 Figure/1Table

Abbreviations

AACE, American Association of Clinical Endocrinologists; ACE, American College of

Endocrinology; ADA, American Diabetes Association; ADAG, A1C-Derived Average

Glucose; ADRR, Average Daily Risk Range; AGP, Ambulatory Glucose Profile; ATTD,

Advanced Technologies and Treatments for Diabetes Congress; AUCpp, area under the

curve of postprandial blood glucose; BG, blood glucose; BGM, blood glucose meters;

BMI, body mass index; CONGA, Continuous glucose monitoring, CGM; Continuous

Overlapping Net Glycemic Action; CSII, continuous subcutaneous insulin infusion; CV,

diabetic ketoacidosis; DSST, Digit Symbol Substitution Test; eAG, estimated Average

Glucose; EDIC, Epidemiology of Diabetes Interventions and Complications; GLP-1,

glucagon-like peptide-1; GRADE, glycemic risk assessment diabetes equation; GV

glycemic variability; HbA1c, glycated hemoglobin; HCL, Hybrid Closed-Loop; HGI,

High Glucose Index; HRR, Hourly risk range; IAH, impaired awareness of

hypoglycemia; IGP, incremental glucose peak; IMT, carotid intima-media thickness;

iCGM, intermittently-viewed CGM; IQR, interquartile range; ISF, interstitial fluid; ISO,

International Organization for Standardization; JDRF, Juvenile Diabetes Research

Foundation; LGI, Low Glucose Index; LGS, low glucose suspension; MAD, mean

absolute difference; MAG, Mean Absolute Glucose Change; MAGE, mean amplitude of

glucose excursions; MARD, mean absolute relative difference; MDI, multiple daily

insulin injections; MODD, mean of daily differences; OAD, oral antidiabetic drug;

PARD, precision absolute relative difference; RBCs, red blood cells; rtCGM, real-time

continuous glucose monitoring; SAP, sensor augmented pump therapy; SD, standard

deviation; SDS, Standard Deviation Score; SEG, surveillance error grid; SH, severe

hypoglycemia; SDBG, standard deviation of blood glucose; SMBG, self-monitoring of

blood glucose; T1D, type 1 diabetes; TIR, Time in Range; UKPDS, United Kingdom

(ABSTRACT)

Measurement of glycated hemoglobin (HbA1c) has been the traditional method for

assessing glycemic control. However, it does not reflect intra- and inter-day 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 continuous

glucose monitoring (iCGM), address many of the limitations inherent in HbA1c testing and

SMBG.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, and standardised advice about how best to use the new information

they provide, have yet to be established. In February 2017, the Advanced Technologies and

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