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A Glycemia Risk Index (GRI) of Hypoglycemia and Hyperglycemia for Continuous Glucose Monitoring Validated by Clinician Ratings

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Klonoff, David C., Wang, Jing, Rodbard, David, Kohn, Michael A., Li, Chengdong, Liepmann, Dorian, Kerr, David, Ahn, David, Peters, Anne L., Umpierrez, Guillermo E., Seley, Jane Jeffrie, Xu, Nicole Y., Nguyen, Kevin T., Simonson, Gregg, Agus, Michael S. D., Al-Sofiani, Mohammed E., Armaiz-Pena, Gustavo, Bailey, Timothy S., Basu, Ananda, Battelino, Tadej, Bekele, Sewagegn Yeshiwas, Benhamou, Pierre-Yves, Bequette, B. Wayne, Blevins, Thomas, Breton, Marc D., Castle, Jessica R., Chase, James Geoffrey, Chen, Kong Y., Choudhary, Pratik, Clements, Mark A., Close, Kelly L., Cook, Curtiss B., Danne, Thomas, Doyle, Francis J., Drincic, Angela, Dungan, Kathleen M., Edelman, Steven V., Ejskjaer, Niels, Espinoza, Juan C., Fleming, G. Alexander, Forlenza, Gregory P., Freckmann, Guido, Galindo, Rodolfo J., Gomez, Ana Maria, Gutow, Hanna A., Heinemann, Lutz, Hirsch, Irl B., Hoang, Thanh D., Hovorka, Roman, Jendle, Johan H., Ji, Linong, Joshi, Shashank R., Joubert, Michael, Koliwad, Suneil K., Lal, Rayhan A., Lansang, M. Cecilia, Lee, Wei-An (Andy), Leelarathna, Lalantha, Leiter, Lawrence A., Lind, Marcus, Litchman, Michelle L., Mader, Julia K., Mahoney, Katherine M., Mankovsky, Boris, Masharani, Umesh, Mathioudakis, Nestoras N., Mayorov, Alexander, Messler, Jordan, Miller, Joshua D., Mohan, Viswanathan, Nichols, James H., Nørgaard, Kirsten, O’Neal, David N., Pasquel, Francisco J., Philis-Tsimikas, Athena, Pieber, Thomas, Phillip, Moshe, Polonsky, William H., Pop-Busui, Rodica, Rayman, Gerry, Rhee, Eun-Jung, Russell, Steven J., Shah, Viral N., Sherr, Jennifer L., Sode, Koji, Spanakis, Elias K., Wake, Deborah J., Waki, Kayo, Wallia, Amisha, Weinberg, Melissa E., Wolpert, Howard, Wright, Eugene E., Zilbermint, Mihail, Kovatchev, Boris·2023·Journal of Diabetes Science and Technology

DOI 10.1177/19322968221085273PMC PMC10563532

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Abstract

Background: A composite metric for the quality of glycemia from continuous glucose monitor (CGM) tracings could be useful for assisting with basic clinical interpretation of CGM data. Methods: We assembled a data set of 14-day CGM tracings from 225 insulin-treated adults with diabetes. Using a balanced incomplete block design, 330 clinicians who were highly experienced with CGM analysis and interpretation ranked the CGM tracings from best to worst quality of glycemia. We used principal component analysis and multiple regressions to develop a model to predict the clinician ranking based on seven standard metrics in an Ambulatory Glucose Profile: very low–glucose and low-glucose hypoglycemia; very high–glucose and high-glucose hyperglycemia; time in range; mean glucose; and coefficient of variation. Results: The analysis showed that clinician rankings depend on two components, one related to hypoglycemia that gives more weight to very low-glucose than to low-glucose and the other related to hyperglycemia that likewise gives greater weight to very high-glucose than to high-glucose. These two components should be calculated and displayed separately, but they can also be combined into a single Glycemia Risk Index (GRI) that corresponds closely to the clinician rankings of the overall quality of glycemia (r = 0.95). The GRI can be displayed graphically on a GRI Grid with the hypoglycemia component on the horizontal axis and the hyperglycemia component on the vertical axis. Diagonal lines divide the graph into five zones (quintiles) corresponding to the best (0th to 20th percentile) to worst (81st to 100th percentile) overall quality of glycemia. The GRI Grid enables users to track sequential changes within an individual over time and compare groups of individuals. Conclusion: The GRI is a single-number summary of the quality of glycemia. Its hypoglycemia and hyperglycemia components provide actionable scores and a graphical display (the GRI Grid) that can be used by clinicians and researchers to determine the glycemic effects of prescribed and investigational treatments.

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Authors: Klonoff, D. C., Wang, J., Rodbard, D., Kohn, M. A., Li, C., Liepmann, D., Kerr, D., Ahn, D., Peters, A. L., Umpierrez, G. E., Seley, J. J., Xu, N. Y., Nguyen, K. T., Simonson, G., Agus, M. S. D., Al-Sofiani, M. E., Armaiz-Pena, G., Bailey, T. S., Basu, A., Battelino, T., Bekele, S. Y., Benhamou, P.-Y., Bequette, B. W., Blevins, T., Breton, M. D., Castle, J. R., Chase, J. G., Chen, K. Y., Choudhary, P., Clements, M. A., Close, K. L., Cook, C. B., Danne, T., Doyle, F. J., Drincic, A., Dungan, K. M., Edelman, S. V., Ejskjaer, N., Espinoza, J. C., Fleming, G. A., Forlenza, G. P., Freckmann, G., Galindo, R. J., Gomez, A. M., Gutow, H. A., Heinemann, L., Hirsch, I. B., Hoang, T. D., Hovorka, R., Jendle, J. H., Ji, L., Joshi, S. R., Joubert, M., Koliwad, S. K., Lal, R. A., Lansang, M. C., Lee, W.-A. (., Leelarathna, L., Leiter, L. A., Lind, M., Litchman, M. L., Mader, J. K., Mahoney, K. M., Mankovsky, B., Masharani, U., Mathioudakis, N. N., Mayorov, A., Messler, J., Miller, J. D., Mohan, V., Nichols, J. H., Nørgaard, K., O’Neal, D. N., Pasquel, F. J., Philis-Tsimikas, A., Pieber, T., Phillip, M., Polonsky, W. H., Pop-Busui, R., Rayman, G., Rhee, E.-J., Russell, S. J., Shah, V. N., Sherr, J. L., Sode, K., Spanakis, E. K., Wake, D. J., Waki, K., Wallia, A., Weinberg, M. E., Wolpert, H., Wright, E. E., Zilbermint, M., & Kovatchev, B.
Affiliations: San Mateo Medical Center (US)
Florida State University (US)
Biomedical Informatics Consultants LLC, Potomac, MD, USA
University of California, San Francisco (US)
University of California, Berkeley (US)
Sansum Diabetes Research Institute (US)
Hoag Memorial Hospital Presbyterian (US)
University of Southern California (US)
Emory University (US)
Weill Cornell Medicine (US)
Diabetes Technology Society (US)
International Diabetes Center, Minneapolis, MN, USA
Boston Children's Hospital (US)
King Saud University, Riyadh, Saudi Arabia
UT Health San Antonio, San Antonio, TX, USA
AMCR Institute (US)
University of Virginia (US)
University of Ljubljana (SI)
Addis Ababa University, Addis Ababa, Ethiopia
Centre Hospitalier Universitaire de Grenoble (FR)
Rensselaer Polytechnic Institute (US)
Texas Diabetes & Endocrinology (US)
Oregon Health & Science University (US)
University of Canterbury (NZ)
National Institute of Diabetes and Digestive and Kidney Diseases (US)
University of Leicester (GB)
Children's Mercy Hospital (US)
Close Concerns (United States) (US)
Mayo Clinic in Arizona (US)
Medizinische Hochschule Hannover (DE)
Harvard University (US)
University of Nebraska at Omaha (US)
The Ohio State University (US)
University of California San Diego (US)
Steno Diabetes Center North Denmark, Aalborg University Hospital, Aalborg, Denmark
Kinexum, Harpers Ferry, WV, USA
University of Colorado Health (US)
Institut für Diabetes-Technologie (Germany) (DE)
Pontificia Universidad Javeriana, Bogotá, Colombia
Science Consulting in Diabetes GmbH, Kaarst, Germany
University of Washington (US)
Walter Reed National Military Medical Center (US)
University of Cambridge (GB)
Örebro University (SE)
Peking University People's Hospital (CN)
Joshi Clinic, Mumbai, India
Caen University Hospital, Caen, France
Stanford University (US)
Cleveland Clinic (US)
Los Angeles County Department of Health Services (US)
University of Manchester (GB)
St. Michael's Hospital (CA)
University of Gothenburg (SE)
University of Utah (US)
Medical University of Graz (AT)
National Healthcare University of Ukraine, Kiev, Ukraine
Johns Hopkins University (US)
Endocrinology Research Center (RU)
Morton Plant Hospital (US)
Stony Brook University (US)
Madras Diabetes Research Foundation (IN)
Vanderbilt University Medical Center (US)
Steno Diabetes Center Copenhagen (DK)
University of Melbourne, Melbourne, VIC, Australia
Scripps Whittier Diabetes Institute, San Diego, CA, USA
Tel Aviv University (IL)
Behavioral Diabetes Institute, San Diego, CA, USA
University of Michigan, Ann Arbor, MI, USA
University of East Anglia (GB)
Kangbuk Samsung Hospital (KR)
Massachusetts General Hospital (US)
Yale University (US)
University of North Carolina at Chapel Hill (US)
University of Maryland, Baltimore (US)
University of Edinburgh (GB)
The University of Tokyo (JP)
Northwestern University (US)
California Pacific Medical Center (US)
Boston Medical Center (US)
Charlotte AHEC, Charlotte, NC, USA
Corresponding author: Klonoff, David C.
ORCID: Klonoff, David C.
Wang, Jing
Rodbard, David
Kohn, Michael A.
Li, Chengdong
Liepmann, Dorian
Kerr, David
Ahn, David
Peters, Anne L.
Umpierrez, Guillermo E.
Seley, Jane Jeffrie
Xu, Nicole Y.
Nguyen, Kevin T.
Simonson, Gregg
Agus, Michael S. D.
Al-Sofiani, Mohammed E.
Armaiz-Pena, Gustavo
Bailey, Timothy S.
Basu, Ananda
Battelino, Tadej
Bekele, Sewagegn Yeshiwas
Benhamou, Pierre-Yves
Bequette, B. Wayne
Blevins, Thomas
Breton, Marc D.
Castle, Jessica R.
Chase, James Geoffrey
Chen, Kong Y.
Choudhary, Pratik
Clements, Mark A.
Close, Kelly L.
Cook, Curtiss B.
Danne, Thomas
Doyle, Francis J.
Drincic, Angela
Dungan, Kathleen M.
Edelman, Steven V.
Ejskjaer, Niels
Espinoza, Juan C.
Fleming, G. Alexander
Forlenza, Gregory P.
Freckmann, Guido
Galindo, Rodolfo J.
Gomez, Ana Maria
Gutow, Hanna A.
Heinemann, Lutz
Hirsch, Irl B.
Hoang, Thanh D.
Hovorka, Roman
Jendle, Johan H.
Ji, Linong
Joshi, Shashank R.
Joubert, Michael
Koliwad, Suneil K.
Lal, Rayhan A.
Lansang, M. Cecilia
Lee, Wei-An (Andy)
Leelarathna, Lalantha
Leiter, Lawrence A.
Lind, Marcus
Litchman, Michelle L.
Mader, Julia K.
Mahoney, Katherine M.
Mankovsky, Boris
Masharani, Umesh
Mathioudakis, Nestoras N.
Mayorov, Alexander
Messler, Jordan
Miller, Joshua D.
Mohan, Viswanathan
Nichols, James H.
Nørgaard, Kirsten
O’Neal, David N.
Pasquel, Francisco J.
Philis-Tsimikas, Athena
Pieber, Thomas
Phillip, Moshe
Polonsky, William H.
Pop-Busui, Rodica
Rayman, Gerry
Rhee, Eun-Jung
Russell, Steven J.
Shah, Viral N.
Sherr, Jennifer L.
Sode, Koji
Spanakis, Elias K.
Wake, Deborah J.
Waki, Kayo
Wallia, Amisha
Weinberg, Melissa E.
Wolpert, Howard
Wright, Eugene E.
Zilbermint, Mihail
Kovatchev, Boris
Venue: Journal of Diabetes Science and Technology
Publisher: SAGE Publications
Published: 2022-03-29
Volume: 17
Issue: 5
Pages: 1226-1242
ISSN: 1932-2968 (ISSN-L)
DOI: 10.1177/19322968221085273
PMC: PMC10563532
OpenAlex: W4221045506
Cited by: 295
References: 30
Citations by year: 2026: 58 · 2025: 81 · 2024: 90 · 2023: 50 · 2022: 14
FWCI: 43.55
Type: journal article
Language: en
Open access: green
www.ncbi.nlm.nih.gov
Licence: journals.sagepub.com/page/policies/text-and-data-mining-license (tdm)
Locations: Journal of Diabetes Science and Technology (publishedVersion)
PubMed Central (publishedVersion)
PubMed (publishedVersion)
Research at the University of Copenhagen (University of Copenhagen) (publishedVersion, other-oa)
eScholarship (California Digital Library) (submittedVersion)
Figshare (submittedVersion, cc-by)
VBN Forskningsportal (Aalborg Universitet) (submittedVersion)
Edinburgh Research Explorer (University of Edinburgh) (submittedVersion, cc-by)
Funders: U.S. Department of Veterans Affairs (I01 CX001825)
Amgen
Eli Lilly and Company
Pfizer
AstraZeneca
Sanofi
Insulet Corporation
MannKind Corporation
Dexcom
Horizon Therapeutics
Glenmark Pharmaceuticals
Novo Nordisk
Novo Nordisk Fonden (NNF17SA0031404-1)
Servier
Roche Diabetes Care
National Institutes of Health (UL1TR000130, 5r01dk051562-23, DK098722, NIH P30 DK098722, UL1TR001855, UL1TR001863)
U.S. Food and Drug Administration (P50FD006425)
University of California, San Francisco
Abbott Diabetes Care
National Institute of Diabetes and Digestive and Kidney Diseases (R01-DK-051562, P30DK098722, K23DK123384, P30DK020572, P30DK111024, P30DK045735, P30DK111022)
National Center for Advancing Translational Sciences
Topics: Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
Keywords: glycemia risk index, continuous glucose monitoring, hypoglycemia, hyperglycemia, time in range, ambulatory glucose profile, clinician ratings, insulin-treated diabetes
MeSH terms: Adult, Blood Glucose, Glucose, Humans, Hyperglycemia, Hypoglycemia, Blood Glucose Self-Monitoring

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A Glycemia Risk Index (GRI) of Hypoglycemia and Hyperglycemia for Continuous Glucose Monitoring Validated by Clinician Ratings

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