Bailey, Timothy S
Mayo Clinic
AMCR Institute, Escondido, CA, USA.
Citations 2
A Glycemia Risk Index (GRI) of Hypoglycemia and Hyperglycemia for Continuous Glucose Monitoring Validated by Clinician Ratings
Klonoff, David C. , Wang, Jing , Rodbard, David , Kohn, Michael A. , Li, Chengdong , Liepmann, Dorian , Kerr, David , Ahn, David , Peters, Anne L. , Umpierrez, Guillermo E. , Xu, Nicole Y. , Nguyen, Kevin T. , Simonson, Gregg D. , Agus, Michael S. D. , Armaiz-Peña, Gustavo , Basu, Ananda , Battelino, Tadej , Yeshiwas, Sewagegn , Bequette, B. Wayne , Blevins, Thomas , Breton, Marc D. , Castle, Jessica R. , Close, Kelly L. , Drincic, Angela, Dungan, Kathleen , Ejskjær, Niels , Espinoza, Juan , Fleming, G. Alexander , Forlenza, Gregory P. , Freckmann, Guido , Galindo, Rodolfo J. , Gómez, Ana María , Gutow, Hanna A. , Hovorka, Roman , Ji, Linong , Joubert, Michaël , Koliwad, Suneil K. , Lal, Rayhan , Lansang, M. Cecilia , Lee, Wei-An , Leelarathna, Lalantha , Lind, Marcus , Mahoney, Katherine , Mankovsky, Boris , Masharani, Umesh , Mathioudakis, Nestoras , Mayorov, Alexander Yur'evich , Messler, Jordan , Mohan, Viswanathan , Nichols, James H. , O’Neal, David N. , Pasquel, Francisco J. , Philis‐Tsimikas, Athena , Phillip, Moshe , Rayman, Gerry , Russell, Steven J. , Spanakis, Elias K. , Waki, Kayo , Wallia, Amisha , Weinberg, Melissa E. , Wolpert, Howard , Zilbermint, Mihail , Kovatchev, Boris , 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 , Choudhary, Pratik , Clements, Mark A , Close, Kelly L , Cook, Curtiss B , Doyle, Francis J , Drincic, Angela , Dungan, Kathleen M , Edelman, Steven V , Ejskjaer, Niels , Espinoza, Juan , 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 , Kohn, Michael , Umpierrez, Guillermo E. , Peters, Anne L , Ahn, David T , Liepmann, Dorian , Bailey, Timothy S. , Chen, Kong Y. , Choudhary, Pratik , Cook, Curtiss B. , Danne, Thomas , Doyle, Francis J. , Heinemann, Lutz , Hirsch, Irl B. , Leiter, Lawrence A. , Mader, Julia K. , Pop‐Busui, Rodica , Shah, Viral N. , Sode, Koji , Wright, Eugene E.
Journal of Diabetes Science and Technology | March 29, 2022 | Volume: 17 | Issue: 5 | Pages: 1226-1242
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.
Evaluation of Extended Infusion Set Performance in Adults with Type 1 Diabetes: Infusion Set Survival Rate and Glycemic Outcomes from a Pivotal Trial
Brazg, Ron, Bhargava, Anuj , Thrasher, James, Latif, Kashif, Bode, Bruce W. , Bailey, Timothy S. , Horowitz, Barry , Cavale, Arvind R., Kudva, Yogish C. , Kaiserman, Kevin B. , Grunberger, George , Reed, John Chip, CHATTARAJ, SARNATH , ZHANG, GINA , Shin, John , Chen, Vivian , Lee, Scott W., Cordero, Toni L. , Rhinehart, Andrew S., Buckingham, Bruce A. , Bailey, Timothy S , Horowitz, Barry S , Kudva, Yogish C. , Cordero, Toni L , Vigersky, Robert A , Buckingham, Bruce , Garg, Satish K. , Reed, John H. Chip, Vigersky, Robert A.
Diabetes Technology & Therapeutics | March 9, 2022 | Volume: 24 | Issue: 8 | Pages: 535-543
Background: Standard insulin infusion sets (IISs) are to be replaced every 2 to 3 days to avoid complications and diabetic ketosis due to set failure. This pivotal trial evaluated the safety and performance of a new extended-wear infusion set (EIS) when used for 7 days by adults with type 1 diabetes (T1D). Methods: This single-arm, nonrandomized trial enrolled adults (18–80 years of age) with T1D, who used their own MiniMed™ 670G system with insulin lispro or insulin aspart and the EIS for up to 7 days, across 12 consecutive wears. Safety endpoints included incidence of serious adverse events (SAEs), serious adverse device effects (SADEs), unanticipated adverse device effects (UADEs), severe hypoglycemia (SevHypo), severe hyperglycemia (SevHyper), diabetic ketoacidosis (DKA), and skin infection. The EIS failure rate due to unexplained hyperglycemia (i.e., suspected occlusion), the overall EIS survival rate, glycemic control outcomes (i.e., A1C, mean sensor glucose and time spent in established glucose ranges), total daily insulin delivered, and satisfaction with the EIS were determined. Results: The intention to treat population ( n = 259, 48% men, 45.0 ± 14.1 years) wore a total of 3041 EIS devices. No SADE, UADE, or DKA events was reported. Overall rates of SAEs, SevHypo, SevHyper, and skin infection were 3.8, 2.5, 104.1, and 20.1 events per 100 participant-years. The rate of EIS failure due to unexplained hyperglycemia at the end of day 7 was 0.1% (95% confidence interval [CI]: 0.03–0.51) and 0.4% (95% CI: 0.16–1.00) for insulin lispro and aspart use, respectively. Overall EIS survival rate at the end of day 7 was 77.8% (95% CI: 76.2–79.3), glycemic control did not change, and participants reported greater satisfaction with the EIS compared with standard IISs worn before the study ( P < 0.001). Conclusions: This investigation demonstrates that the EIS, when worn for up to 7 days, was safe and rated with high satisfaction, without adversely affecting glycemic control in adults with T1D. Clinical Trial Registration number: NCT04113694 ( https://clinicaltrials.gov/ct2/show/NCT04113694 ).