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2. Process evaluation of Dulce Digital-Me: an adaptive mobile health (mHealth) intervention for underserved Hispanics with diabetes.

Author

Spierling Bagsic, Samantha, Savin, Kimberly, Soriano, Emily, San Diego, Emily, Orendain, Natalia, Clark, Taylor, Sandoval, Haley, Chichmarenko, Mariya, Perez-Ramirez, Perla, Farcas, Emilia, Gallo, Linda, Philis-Tsimikas, Athena, Fortmann, Addie, and Godino, Job

Subjects
Diabetes, Dulce Digital, RE-AIM, mHealth, Humans, Diabetes Mellitus, Type 2, Health Personnel, Telemedicine, Hispanic or Latino, Health Education
Abstract

Type 2 diabetes disproportionately impacts ethnic minorities and individuals from low socioeconomic status. Diabetes self-management education and support has been shown to improve clinical outcomes in these populations, and mobile health (mHealth) interventions can reduce barriers to access. Dulce Digital-Me (DD-Me) was developed to integrate adaptive mHealth technologies to enhance self-management and reduce disparities in the high-risk, underserved Hispanic population. The objective of the present study was to evaluate reach, adoption, and implementation of an mHealth diabetes self-management education and support intervention in this underrepresented population. The present analysis is a multimethod process evaluation using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. The study was effective in reaching a sample that was representative of the intended population; only modest but significant differences were observed in sex and age. The DD-Me health coach (HC) cited several important facilitators of intervention adoption, including outreach frequency and personalization, and the automated HC report. Implementation fidelity was high, with participants receiving >90% of intended interventions. Participants who received DD-Me with support from a HC were most engaged, suggesting utility and acceptability of integrating HCs with mHealth interventions. Perceptions of implementation among study participants were positive and consistent across study arms. This evaluation revealed the target population was successfully reached and engaged in the digital health interventions, which was implemented with high fidelity. Further studies should evaluate the efficacy and maintenance of the study following the RE-AIM model to determine whether this intervention warrants expansion to additional settings and populations.

Published
2023

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

Author

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 SD, 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, 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, and Kovatchev, Boris

Subjects
Biomedical and Clinical Sciences, Nutrition and Dietetics, Diabetes, Adult, Humans, Blood Glucose, Blood Glucose Self-Monitoring, Hypoglycemia, Hyperglycemia, Glucose, ambulatory glucose profile, composite metric, continuous glucose monitor, diabetes, glycemia risk index, hyperglycemia, hypoglycemia, time in range, Nutrition and dietetics
Abstract

BackgroundA 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.MethodsWe 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.ResultsThe 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.ConclusionThe 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.

Published
2023

4. Dulce Digital-Me: protocol for a randomized controlled trial of an adaptive mHealth intervention for underserved Hispanics with diabetes

Author

Philis-Tsimikas, Athena, Fortmann, Addie L, Godino, Job G, Schultz, James, Roesch, Scott C, Gilmer, Todd P, Farcas, Emilia, Sandoval, Haley, Savin, Kimberly L, Clark, Taylor, Chichmarenko, Mariya, Jones, Jennifer A, and Gallo, Linda C

Subjects
Health Services and Systems, Health Sciences, Diabetes, Clinical Trials and Supportive Activities, Patient Safety, Cost Effectiveness Research, Prevention, Comparative Effectiveness Research, Clinical Research, Networking and Information Technology R&D (NITRD), Behavioral and Social Science, Health Services, 7.1 Individual care needs, Management of diseases and conditions, Metabolic and endocrine, Good Health and Well Being, Adult, Diabetes Mellitus, Type 2, Glycated Hemoglobin, Hispanic or Latino, Humans, Randomized Controlled Trials as Topic, Telemedicine, Text Messaging, Digital, Hispanic, Latino, HbA1c, Health behavior, Cost-effectiveness, Cardiorespiratory Medicine and Haematology, Clinical Sciences, Cardiovascular System & Hematology, General & Internal Medicine, Clinical sciences, Epidemiology, Health services and systems
Abstract

BackgroundBy 2034, the number of US individuals with diabetes is predicted to increase from 23.7 to 44.1 million, and annual diabetes-related spending is expected to grow from $113 to $336 billion. Up to 55% of US Hispanics born in the year 2000 are expected to develop diabetes during their lifetime. Poor healthcare access and cultural barriers prevent optimal care, adherence, and clinical benefit, placing Hispanics at disproportionate risk for costly diabetes complications. Mobile technology is increasingly prevalent in all populations and can circumvent such barriers. Our group developed Dulce Digital, an educational text messaging program that improved glycemic control relative to usual care. Dulce Digital-Me (DD-Me) has been tailored to a participant's individual needs with a greater focus on health behavior change.MethodsThis is a three-arm, parallel group, randomized trial with equal allocation ratio enrolling Hispanic adults with low income and poorly managed type 2 diabetes (N = 414) from a San Diego County Federally Qualified Health Center. Participants are randomized to receive Dulce Digital, Dulce Digital-Me-Automated, or Dulce Digital-Me-Telephonic. The DD-Me groups include Dulce Digital components plus personalized goal-setting and feedback delivered via algorithm-driven automated text messaging (DD-Me-Automated) or by the care team health coach (DD-Me-Telephonic) over a 12-month follow-up period. The study will examine the comparative effectiveness of the three groups in improving diabetes clinical control [HbA1c, primary outcome; low-density lipoprotein cholesterol (LDL-C), and systolic blood pressure (SBP)] and patient-provider communication and patient adherence (i.e., medication, self-management tasks) over 12 months and will examine cost-effectiveness of the three interventions.DiscussionOur comparative evaluation of three mHealth approaches will elucidate how technology can be integrated most effectively and efficiently within primary care-based chronic care model approaches to reduce diabetes disparities in Hispanics and will assess two modes of personalized messaging delivery (i.e., automated messaging vs. telephonic by health coach) to inform cost and acceptability.Trial registrationNCT03130699-All items from the WHO Trial Registration data set are available in https://clinicaltrials.gov/ct2/show/study/NCT03130699 .

Published
2022

5. Improved treatment satisfaction with once-weekly insulin icodec compared with once-daily basal insulin in individuals with type 2 diabetes: An analysis of patient-reported outcomes and participant interviews from ONWARDS 2 and 5 and a physician survey from ONWARDS 1

Author

Polonsky, William, Benamar, Malik, Carstensen, Lisbeth, Davies, Melanie, Meller Donatsky, Anders, Franek, Edward, Kellerer, Monika, Philis-Tsimikas, Athena, and Goldenberg, Ronald

Published
2024
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7. Semaglutide and cardiovascular outcomes in patients with obesity and prevalent heart failure: a prespecified analysis of the SELECT trial

Author

Abe, Mitsunori, Abhaichand, Rajpal K, Abhayaratna, Walter P, Abhyankar, Atul, Abidin, Imran B Zainal, Abou Assi, Hiba, Accini Mendoza, Jose L, Adas, Mine, Agaiby, John M, Agarwal, Devendra K, Agha, Maher, Ahmed, Azazuddin, Ahtiainen, Petteri, Aigner, Elmar, Ajay, Naik, Ali, Norsiah, Al-Karadsheh, Amer, Allison, Roy, Allison, Dale C, Alpenidze, Diana, Altuntas, Yuksel, Al-Zoebi, Ayham, Ambuj, Roy, Amerena, John, Anderson, Robert J, Ando, Toshiaki, Andrews, Robert, Antonova, Elizaveta, Appel, Karl-Friedrich, Arantes, Flávia B, Araz, Mustafa, Arbel, Yaron, Arenas León, José L, Argyrakopoulou, Georgia, Ariani, Mehrdad, Arias Mendoza, Maria A, Arif, Ahmed A, Arneja, Jaspal, Aroda, Vanita R, Aronne, Louis J, Arstall, Margaret, Asamoah, Njaimeh, Asanin, Milika, Audish, Hanid, Avram, Rodica, Badat, Aysha, Badiu, Corin V, Bakdash, Wa'el, Bakiner, Okan S, Bandezi, Vuyokazi N, Bang, Liew H, Bansal, Sandeep, Baranyai, Marietta, Barbarash, Olga, Barber, Mark, Barnum, Otis, Barone Rochette, Gilles, Bashkin, Amir, Baum, Seth, Bays, Harold E, Bazzoni Ruiz, Alberto E, Beckowski, Maciej, Beerachee, Yaswin, Bellary, Srikanth, Belousova, Lidia, Berk, Martin, Bernstein, Marc, Berra, Cesare, Beshay, Isaac, Bhagwat, Ajit, Bhan, Arti, Biggs, William C, Billings, Liana, Bitar, Fahed, Block, Bradley, Bo, Simona, Bogdanski, Pawel, Bolshakova, Olga O, Boshchenko, Alla A, Bosworth, Hayden, Botero Lopez, Rodrigo, Bôttcher, Morten, Bourgeois, Ronald, Brautigam, Donald, Breton, Cristian F, Broadley, Andrew, Brockmyre, Andrew P, Brodie, Steven K, Bucci, Marco, Budincevic, Hrvoje, Budoff, Matthew J, Buffman, Barry, Buljubasic, Nediljka, Buranapin, Supawan, Burgess, Lesley, Burguera, Bartolomé, Buriakovska, Olena, Buscemi, Silvio, Busch, Robert, Buse, John B, Buynak, Robert, Byrne, Maria, Caceaune, Elena, Cadena Bonfanti, Alberto J, Calinescu, Cornell V, Call, Robert S, Canecki Varzic, Silvija, Cannon, Kevin, Capehorn, Matt, Cariou, Bertrand, Carr, Jeffrey, Carrillo-Jimenez, Rodolfo, Casas, Marcelo, Castro, Almudena, Celik, Ahmet, Cercato, Cintia, Cermak, Ondrej, Cha, James Y, Chacon, Carolina, Chaicha-Brom, Tira, Chandra, Sandeep, Chettibi, Mohamed, Chevts, Julia, Christopher, Johann, Chrustowski, Witold, Cif, Adriana, Clark, Rebecca, Clark, Wayne, Clifford, Piers, Coetzee, Kathleen, Cogni, Giulia, Colao, Anna Maria, Colquhoun, David M, Concha, Mauricio, Condit, Jonathan, Constance, Christian, Constantin, Ciprian, Constantinescu, Silviana, Corbett, Clive, Cornett, George M, Correia, Marcelo, Cortinovis, Fiorenzo, Cosma, Dana, Creely, Steven, Cross, David, Curtis, Brian, Czochra, Wojciech, Daboul, Nizar Y, Dagdelen, Selcuk, D'agostino, Ronald, Dang, Cuong, Datta, Sudip, Davuluri, Ashwini K, Dawood, Saleem Y, De Jong, Douwe M, De La Cuesta, Carmen, De Los Rios Ibarra, Manuel O, De Pablo, Carmen, De Pauw, Michel, Dela Llana, Alexander, Delibasic, Maja, Delic-Brkljacic, Diana, Demicheli, Thibaud, Denger, Ralf J, Desai, Devang, Desai, Piyush, Desouza, Cyrus V, Dicker, Dror, Djenic, Nemanja, Dobson, Simon, Doi, Masayuki, Doran, Jesse A, Dorman, Reinhart, Dotta, Francesco, Dukes, Carl E, Duronto, Ernesto, Durst, Ronen, Dvoryashina, Irina V, Ebrahim, Iftikhar O, Eggebrecht, Holger, Egstrup, Kenneth, Ekinci, Elif I, Eliasson, Björn, Eliasson, Ken, Enache, Georgiana, Enculescu, Dan, English, Patrick, Ermakova, Polina, Ershova, Olga, Ezaki, Hirotaka, Ezhov, Marat, Farias, Eduardo, Farias, Javier M, Farsky, Pedro S, Ferreira, Daniel, Filteau, Pierre, Finneran, Matthew P, Folkens, Eric M, Fonseca, Alberto G, Fonseca, Luisa, Fordan, Steven, Fourie, Nyda, França, Sara, Franco, Denise R, Franek, Edward, Friedman, Keith, Frittitta, Lucia, Froer, Michael, Fuckar, Krunoslav, Fujii, Kenshi, Fujita, Ryoko, Fukushima, Yasushi, Fulat, Mohamed, Fulwani, Mahesh, Gajos, Grzegorz, Galyavich, Albert, Gambill, Michael L, Gandotra, Dheeraj, Winston, Gandy, Jr., Garcia Hernandez, Pedro A, García Reza, Raymundo, Garg, Naveen, Garg, Sandeep, Garvey, William T, Garza, Juan C, Gatta-Cherifi, Blandine, Gelev, Valeri, Geller, Steven A, Geohas, Jeffrey G, Georgiev, Borislav, Ghazi, Adline, Gilbert, Matthew P, Gilinskaya, Olga, Gislason, Gunnar, Gogas Yavuz, Dilek, González Albarrán, Olga, Gordeev, Ivan G, Gorton, Sidney C, Goudev, Assen, Gretland Valderhaug, Tone, Groenemeijer, Bjorn, Gul, Ibrahim, Gullestad, Lars, Gurieva, Irina, Guseva, Galina N, Hagenow, Andreas, Haluzik, Martin, Halvorsen, Sigrun, Hammoudi, Naima, Hanaoka, Keiichi, Hancu, Nicolae, Hanusch, Ursula, Harris, Kathleen, Harris, Barry, Hartleib, Michael, Hartman, Aaron N, Hata, Yoshiki, Heimer, Brian, Herman, Lee, Herzog, William, Hewitt, Eric, Heymer, Peter, Hiremath, Shirish, Hjelmesaeth, Joeran, Høgalmen, Rasmus Geir, Høivik, Hans Olav, Holmer, Helene, Horoshko, Olha, Houser, Patricia M, Hove, Jens D, Hsieh, I-Chang, Hulot, Jean-Sébastien, Hussein, Zanariah, Ilashchuk, Tetiana, Ilveskoski, Erkki, Ipatko, Irina, Iranmanesh, Ali, Isawa, Tsuyoshi, Issa, Moises, Iteld, Bruce, Iwasawa, Takamasa, Jabbar, Danish, Jackson, Richard A, Jackson-Voyzey, Ewart, Jacob, Stephan, Jaffrani, Naseem A, Jardula, Michael F, Jastreboff, Ania, Jensen, Svend E, Jerkins, Terri, Jimenez-Ramos, Silvia A, Jitendra Pal Singh, Sawhney, Johnson, Wallace, Joyce, John M, Jozefowska, Malgorzata, Jugnundan, Prakash, Jungmair, Wolfgang, Jurowiecki, Jaroslaw, Kadokami, Toshiaki, Kahali, Dhiman, Kahrmann, Gerd, Kaiser, Sergio E, Kalmucki, Piotr, Kanadasi, Mehmet, Kandath, David, Kania, Grzegorz, Kannan, J, Kapp, Cornelia, Karczmarczyk, Agnieszka, Kartalis, Athanasios, Kaser, Susanne, Kasim, Sazzli Shahlan, Kastelic, Richard, Kato, Toshiaki, Katova, Tzvetana, Kaul, Upendra, Kautzky-Willer, Alexandra, Kawanishi, Masahiro, Kayikcioglu, Meral, Kazakova, Elena E, Keeling, Philip, Kempe, Hans-Peter, Kereiakes, Dean J, Kerneis, Mathieu, Keski-Opas, Tiina, Khadra, Suhail, Khaisheva, Larisa, Kharakhulakh, Marina, Khlevchuk, Tatiana, Khoo, Jeffrey, Kiatchoosakun, Songsak, Kinoshita, Noriyuki, Kinoshita, Masaharu, Kitamura, Ryoji, Kiyosue, Arihiro, Klavina, Irina, Klein, Eric J, Klimsa, Zdenek, Klonoff, David, Klug, Eric, Kobalava, Zhanna, Kodera, Satoshi, Koga, Tokushi, Kokkinos, Alexander, Koleckar, Pavel, Könyves, László, Koren, Michael J, Kormann, Adrian P, Kostner, Karam, Kreutzmann, Kristin, Krishinan, Saravanan, Krishnasamy, Sathya S, Krivosheeva, Inga, Kruljac, Ivan, Kubicki, Ted, Kuchar, Ladislav, Kujawiak, Monika, Kunishige, Hideyuki, Kurtinecz, Melinda, Kurtz Lisboa, Hugo R, Kushnir, Mykola, Kyyak, Yulian, Lace, Arija, Lakka, Timo, Lalic, Nebojsa, Lalic, Katarina, Lambadiari, Vaia, Lanaras, Leonidas, Lang, Chim, Langlois, Marie-France, Lash, Joseph, Latkovskis, Gustavs, Lau, David, Lazcano Soto, José Roberto, Le Roux, Carel, Ledesma, Gilbert N, Lee, Li Yuan, Lee, Thung-Lip, Lee, Kelvin, Lehrke, Michael, Leite, Silmara O, Leksycka, Agata, Lenzmeier, Thomas, Leonetti, Frida, Leonidova, Viktoriia, Lepor, Norman, Leung, Melissa, Levchenko, Olena, Levins, Peter, Levy, Louis J, Lewis, Matthew, Liberopoulos, Evangelos, Liberty, Idit, Lindholm, Carl-Johan, Lingvay, Ildiko, Linhart, Ales, Liu, Ming-En, Liu, Jenny, Lofton, Holly, Logemann, Timothy, Lombaard, Johannes J, Lombard, Landman, Lorraine, Richard, Lovell, Charles F, Ludvik, Bernhard, Lukaszewicz, Monika, Lupkovics, Géza, Lupovitch, Steven, Lupu, Sirona, Lynch, Mary, Lysak, Zoreslava, Lysenko, Tatyana A, Maeda, Hajime, Maeda, Itaru, Mæng, Michael, Mahajan, Ajay U, Maher, Vincent, Maia, Lilia N, Makotoko, Ellen M, Malavazos, Alexis, Malecha, Jan, Malicherova, Emilia, Manita, Mamoru, Mannucci, Edoardo, Mareev, Viacheslav, Marin, Liliana, Markova, Tatiana, Marso, Steven P, Martens, F.M.A.C., Martinez, Cuper, Martinez Cano, Carlos A, Martins, Cristina, Masmiquel Comas, Luis, Matsumoto, Takashi, Mcdonald, Kenneth, Mcgowan, Barbara, Mcgrew, Frank, Mclean, Barry K, Mcpherson, David D, Merino Torres, Juan Francisco, Meyers, Peter, Meyhöfer, Sebastian, Mezquita Raya, Pedro, Milanova, Maria, Milicic, Davor, Miller, Gary, Mills, Richard E, Mîndrescu, Nicoleta M, Mingrone, Geltrude, Minkova, Dotska A, Mirani, Marco, Miras, Alexander, Mistodie, Cristina V, Mitomo, Satoru, Mittal, Sanjay, Miyake, Taiji, Miyamoto, Naomasa, Molony, David, Monteiro, Pedro, Mooe, Thomas, Moosa, Naeem, Morales Portillo, Cristobal, Morales Villegas, Enrique C, Morawski, Emily J, Morbey, Claire, Morin, Robert P, Morisaki, Kuniaki, Morosanu, Magdalena, Mosenzon, Ofri, Mostovoy, Yuriy, Munir, Iqbal, Muratori, Fabrizio, Murray, Ryan, Murthy, Avinash, Myint, Min, Myshanych, Galyna, Nafornita, Valerica, Nagano, Takuya, Nair, Sunil, Nakhle, Samer N, Natsuaki, Masahiro, Nayak, Bindu M, Nibouche, Djamel Eddine, Nicholls, Stephen, Nicolau, José C, Nicolescu, Georgiana, Nierop, Peter, Niskanen, Leo, Ntaios, George, Nygård, Ottar Kjell, Oaks, Joshua B, Obrezan, Andrey, O'donnell, Philip, Oguri, Mitsutoshi, Oguzhan, Abdurrahman, Oh, Fumiki, Ohsugi, Mitsuru, Okada, Yoshio, Okayama, Hideki, Onaca, Adriana, Onaka, Haruhiko, Oneil, Patrick, Ong, Tiong Kiam, Ong, Stephen, Ono, Yasuhiro, Opsahl, Paul J, Ostrowska, Lucyna, Oviedo, Alejandra, Ozdogan, Oner, Ozpelit, Ebru, Pagkalos, Emmanouil, Pagotto, Uberto, Páll, Dénes, Pandey, Amritanshu- Shekhar, Parkhomenko, Oleksandr, Parvathareddy, Krishna Malakondareddy, Patel, Minesh B, Patsilinakos, Sotirios, Paul, Neil, Pedersen, Sue, Pereira, Isabel, Pereira, Edward Scott, Perez Terns, Paula, Perez-Vargas, Elba A, Pergaeva, Yulia, Perkelvald, Alexander, Peskov, Andrey B, Peter, Jonathan, Peters, Karina, Petit, Catherine, Petrov, Ivo, Philis-Tsimikas, Athena, Pietilä, Mikko, Pinto, Fausto, Piros, Annamária, Piyayotai, Dilok, Platonov, Dmitriy, Poirier, Paul, Pop, Lavinia, Popa, Bogdan, Pop-Busui, Rodica, Poremba, John, Porto, Alejandro, Postadzhiyan, Arman, Pothineni, Ramesh B, Potu, Ranganatha P, Powell, Talessa, Prafulla, Kerkar G, Prager, Rudolf, Prakova-Teneva, Zhulieta R, Pratley, Richard E, Price, Hermione, Pulka, Grazyna, Pullman, John, Punt, Zelda E, Purighalla, Raman S, Purnell, Peter, Qureshi, Mansoor, Rabasa-Lhoret, Remi, Raikhel, Marina A, Rancane, Gita, Randeva, Harpal, Rasouli, Neda, Reurean Pintilei, Delia V, Reyes, Ciro R, Rezgale, Inga, Rice, Eva, Riley, Thaddeus H, Risser, Joseph A, Ristic, Arsen, Rivas Fernández, Margarita, Robbins, David, Robitaille, Yves, Rodbard, Helena W, Rodriguez Plazas, Jaime A, Römer, T.J., Rosen, Glenn, Rosman, Dr Azhari, Rossi, Paulo, Rudenko, Leonid, Ruffin, Omari, Ruhani, Anwar Irawan, Runev, Nikolay, Ruyatkin, Dmitriy, Ruzic, Alen, Ryabov, Vyacheslav V, Rydén, Lars, Saggar, Suraj, Sakamoto, Tomohiro, Salter, Tim, Samal, Aditya K, Samoilova, Yulia, Sanabria, Hugo D, Sancak, Seda, Sangrigoli, Renee, Sansanayudh, Nakarin, Santini, Ferruccio, Saraiva, José F, Sardinov, Ruslan, Sargeant, William, Sari, Ramazan, Sathananthan, Airani, Sathyapalan, Thozhukat, Sato, Atsushi, Sauter, Joachim, Sbraccia, Paolo, Schaap, J., Schaum, Thomas, Schiele, François, Scott, John, Segal Lieberman, Gabriella, Segner, Alexander, Senior, Roxy, Sergeeva-Kondrachenko, Marina Y, Serota, Harvey, Serusclat, Pierre, Sethi, Rishi, Shah, Manoj K, Shah, Neerav, Shalaev, Sergey, Sharma, Raj, Sharma, Sumeet, Shaydyuk, Oksana, Shea, Heidi C, Shechter, Michael, Shehadeh, Naim, Shirazi, Mitra, Shlesinger, Yshay, Shneker, Ayham, Shutemova, Elena, Siasos, Gerasimos, Siddiqui, Imran A, Sidey, Jennifer, Sigal, Felix, Sime, Iveta, Singh, Narendra, Siraj, Elias, Sivalingam, Kanagaratnam, Skoczylas, Grzegorz, Smith, Stephen K, Smolenskaya, Olga, Snyder, Brian, Sofer, Yael, Sofley, C.W., Solano, Royce, Sonmez, Yusuf A, Sorokin, Maxim, Soto González, Alfonso, Sotolongo, Carlos, Soufer, Joseph, Soyluk Selcukbiricik, Ozlem, Spaic, Tamara, Spriggs, Douglas, Sreenan, Seamus, Stahl, Hans-Detlev, Stamatelopoulos, Kimon, Stanislavchuk, Mykola, Stankovic, Goran, Stasek, Josef, Steg, Gabriel, Steindorf, Joerg, Stephan, Dominique, Stewart, John, Still, Christopher, St-Maurice, Francois, Stogowska-Nikiciuk, Barbara, Stoker, Jeff, Stokic, Edita, Strzelecka, Anna, Sturm, Kerstin, Sueyoshi, Atsushi, Sugiura, Toshiyuki, Sultan, Senan, Suplotova, Lyudmila A, Suwanagool, Arisara, Suwanwalaikorn, Sompongse, Sveklina, Tatiana, Swanson, Neil, Swart, Henk, Swenson, Bradley P, Szyprowska, Ewa, Tait, Graeme, Takács, Róbert, Takeuchi, Yuzo, Tamirisa, Aparna, Tanaka, Hideki, Tatovic, Danijela, Tellier, Guy, Teragawa, Hiroki, Teterovska, Dace, Thomas, Nihal, Thuan, Jean-Francois, Tinahones, Francisco, Tisheva-Gospodinova, Snezhanka, Toarba, Cristina, Todoriuk, Liudmyla, Tokmakova, Mariya, Tonstad, Serena, Toplak, Hermann, Tran, Henry, Tripathy, Devjit, Trusau, Aliaksandr, Tsabedze, Nqoba, Tsougos, Elias, Tsoukas, George M, Tuccinardi, Dario, Tuna, Mazhar M, Turatti, Luiz A, Tziomalos, Konstantinos, Udommongkol, Chesda, Ueda, Osamu, Ukkola, Olavi, Unubol, Mustafa, Urbach, Dorothea, Urina Triana, Miguel A, Usdan, Lisa, Vaidya, Bijay, Vale, Noah, Vallieres, Gerald, Van Beek, Andre P, Van De Borne, Philippe, Van Der Walt, Eugene, Van Der Zwaan, C., Van Nieuwenhuizen, Elane, Van Zyl, Louis, Vanduynhoven, Philippe, Varghese, Kiron, Vasileva, Svetla P, Vassilev, Dobrin, Vathesatogkit, Prin, Velychko, Valentyna, Vercammen, Chris, Verges, Bruno, Verma, Subodh, Verwerft, Jan, Vesela, Alica, Veselovskaya, Nadezhda G, Vettor, Roberto, Veze, Irina, Vijan, Vinod, Vijayaraghavan, Ram, Villarino, Adriana, Vincent, Royce, Vinogradova, Oksana, Vishlitzky, Victor, Vlad, Adrian, Vladu, Ionela Mihaela, Vo, Anthony, Von Engelhardt, Charlotte, Von Münchhausen, Candy, Vorobyeva, Olga, Vossenberg, T., Vrolix, Mathias, Vukicevic, Marjana, Vyshnyvetskyy, Ivan, Wadvalla, Shahid, Wagner, Jan, Wakeling, John, Wallace, James, Wan Mohamed, Wan Mohd Izani, Wander, Gurpreet S, Ward, Kathleen, Warren, Mark L, Watanabe, Atsuyuki, Weber, Bruce, Weintraub, Howard, Weisnagel, John, Welker, James, Wendisch, Ulrich, Wenocur, Howard S, Wierum, Craig, Wilding, John, William, Maged, Wilson, Pete, Wilson, Jonathan P, Wong, Yuk-Ki, Wongcharoen, Wanwarang, Wozniak, Iwona, Wu, Chau-Chung, Wyatt, Nell, Wynne, Alan, Yamaguchi, Hiroshi, Yamasaki, Masahiro, Yazici, Dilek, Yeh, Hung-I, Yotov, Yoto, Yuan, Qingyang, Zacher, Jeffrey, Zagrebelnaya, Olga, Zaidman, Cesar J, Zalevskaya, Alsu, Zarich, Stuart, Zatelli, Maria Chiara, Zeller, Helga, Zhdanova, Elena A, Zornitzki, Taiba, Zrazhevskiy, Konstantin, Zykov, Mikhail, Lincoff, A Michael, Ryan, Donna H, Colhoun, Helen M, Deanfield, John E, Emerson, Scott S, Kahn, Steven E, Kushner, Robert F, Plutzky, Jorge, Brown-Frandsen, Kirstine, Hovingh, G Kees, Hardt-Lindberg, Soren, Tornøe, Christoffer W, Deanfield, John, Scirica, Benjamin M, Ryan, Donna, Kosiborod, Mikhail N, Hardt-Lindberg, Søren, Frenkel, Ofir, Weeke, Peter E, Rasmussen, Søren, Lang, Chim C, and Urina-Triana, Miguel

Published
2024
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10. Medical assistant health coaching (“MAC”) for type 2 diabetes in diverse primary care settings: A pragmatic, cluster-randomized controlled trial protocol

Author

Fortmann, Addie L, Philis-Tsimikas, Athena, Euyoque, Johanna A, Clark, Taylor L, Vital, Daniela G, Sandoval, Haley, Bravin, Julia I, Savin, Kimberly L, Jones, Jennifer A, Roesch, Scott, Gilmer, Todd, Bodenheimer, Thomas, Schultz, James, and Gallo, Linda C

Subjects
Health Services and Systems, Public Health, Health Sciences, Clinical Trials and Supportive Activities, Diabetes, Comparative Effectiveness Research, Prevention, Clinical Research, Behavioral and Social Science, Health Services, 7.1 Individual care needs, Management of diseases and conditions, Metabolic and endocrine, Generic health relevance, Good Health and Well Being, Adult, Allied Health Personnel, Diabetes Mellitus, Type 2, Ethnicity, Humans, Mentoring, Minority Groups, Primary Health Care, Randomized Controlled Trials as Topic, Self Care, Type 2 diabetes, Health coaching, Glycemic control, Pragmatic, Medical and Health Sciences, General Clinical Medicine, Biomedical and clinical sciences, Health sciences
Abstract

In the US, nearly 11% of adults were living with diagnosed diabetes in 2017, and significant type 2 diabetes (T2D) disparities are experienced by socioeconomically disadvantaged, racial/ethnic minority populations, including Hispanics. The standard 15-min primary care visit does not allow for the ongoing self-management support that is needed to meet the complex needs of individuals with diabetes. "Team-based" chronic care delivery is an alternative approach that supplements physician care with contact from allied health personnel in the primary care setting (e.g., medical assistants; MAs) who are specially trained to provide ongoing self-management support or "health coaching." While rigorous trials have shown MA health coaching to improve diabetes outcomes, less is known about if and how such a model can be integrated within real world, primary care clinic workflows. Medical Assistant Health Coaching for Type 2 Diabetes in Diverse Primary Care Settings - A Pragmatic, Cluster-Randomized Controlled Trial will address this gap. Specifically, this study compares MA health coaching versus usual care in improving diabetes clinical control among N = 600 at-risk adults with T2D, and is being conducted at four primary care clinics that are part of two health systems that serve large, ethnically/racially, and socioeconomically diverse populations in Southern California. Electronic medical records are used to identify eligible patients at both health systems, and to examine change in clinical control over one year in the overall sample. Changes in behavioral and psychosocial outcomes are being evaluated by telephone assessment in a subset (n = 300) of participants, and rigorous process and cost evaluations will assess potential for sustainability and scalability.

Published
2021

13. Tirzepatide versus insulin glargine in type 2 diabetes and increased cardiovascular risk (SURPASS-4): a randomised, open-label, parallel-group, multicentre, phase 3 trial

Author

Ahmann, Andrew J, Arora, Samir, Ball, Eric M, Calderon, Rafael B, Butuk, David J, Chaychi, Leila, Chen, Michael C, Curtis, Brian M, Chochinov, Ronald, Chow, Christopher, Cone, Clancy L, Connery, Lisa, Cortes-Maisonet, Gregorio A, de Souza, Jose, Dungan, Kathleen, Bradley, David, Frias, Juan P, Gabra, Nashwa, Gaudiani, Linda, Herandez-Vazquez, Luis, Hsia, Stanley H, Jardula, Michael R, Klein, Eric J, Kutner, Mark E, Loy, Juan, Miranda, Francisco G, Nunez, Lazaro D, Mujica-Baella, Miguel, Murray, Alexander V, Oliver, Michael J, Oritz-Carrasquillo, Ramon, Palal, Betsy, Parke, Michael T, Philis-Tsimikas, Athena, Purighalla, Raman S, Rosenstock, Julio, Sathananthan, Airani, Shelton, Courtney, Sivalingam, Kanagaratnam, Sorial, Ehab, Soufer, Joseph, Stacey, Helen L, Stonesifer, Larry D, Stringam, Stanley, Van, Joanna T, Vazquez-Tanus, Jose B, Reyes, Ramon, Welch, Michelle, Karimjee, Najmuddin, Martin, Earl E, Arif, Ahmed, Jennings, Timothy W, Fraser, Neil J, Bhargava, Anuj, Wynne, Alan G, Davidson, Evelyne, Billings, Liana, Barranco-Santana, Elizabeth A, Dever, Michael E, Walsh, Patrick, Cho, Austina, Chu, James W, Shubrook, Jay, Knouse, Albert B, Nadar, Venkatesh, Lewy-Alterbaum, Lorena, Lillestol, Michael J, Humiston, Daniel J, White, Alexander J, Mayfield, Ronald K, Bitar, Fahed G, Cereto, Fernando, de la Cuesta, Carmen, De Teresa Parreno, Luis, Jodar Gimeno, Esteban, Mezquita-Raya, Pedro, Morales Portillo, Cristobal J, Quesada Charneco, Miguel, Tinahones Madueno, Francisco J, Tofe Povedano, Santiago, Vazquez, Luis, Fajardo Montañana, Carmen, Soto Gonzalez, Alfonso, Mistodie, Cristina, Szilagyi, Iosif, Filimon, Adriana, Mindrescu, Nicoleta M, Pop, Lavinia, Pascu, Marlena, Negrisanu, Gabriela D, Ciomos, Daniela, Neacsu, Valentina, Thury-Burileanu, Amalia, Liberty, Idit, Stern, Naftali, Sofer, Yael, Sack, Jessica, Shimon, Ilan, Tirosh, Amir, Ishay, Avraham, Mosenzon Ninio, Ofri, Shehadeh, Naim, Wainstein, Julio, Darawsha, Mahmud, Skripova, Dasa, Pavleova, Eva, Donicova, Viera, Kubincova, Ludmila, Sosovec, Dalibor, Merciakova, Martina, El Boreky, Fadia, St-Amour, Eric, Yared, Zeina, Blouin, Francois, Ajala, Buki, Aggarwal, Naresh K, Bajaj, Harpreet, Tailor, Chetna, Egan, Alan, O'Mahony, John, St.Onge, Natasha, Conway, James R, Akerman Augusto, Gustavo, Borges, Joao L C, Gomes Cerqueira, Maria José A, Franco, Denise R, Franco Hirakawa, Tatiana, Souza, Filipe D, Hissa, Miguel N, Pechmann, Luciana M, Calil Salim, Camila P, Russo, Luis Augusto T, Siqueira, Joselita, Sassone, Sonia A, Glenny, Jorge A, Koretzky, Martín, Aizenberg, Diego, Steinacher, Andrea, Solis, Silvana E, Nardone, Lucrecia, Perez Manghi, Federico C, Orio, Silvia I, Gelersztein, Elizabeth, Fretes, José O, Calella, Pedro R F, Zaidman, Cesar J, Chertkoff, Alejandro, Salzberg, Susana, Majul, Claudio R, Nevarez, Luis A, Violante Ortiz, Rafael M, Banda Elizondo, Ramiro G, Arjona Villicaña, Ruy D, Gonzalez Galvez, Guillermo, Calvo, Cesar G, Koscianski, Andrzej, Rudzki, Henryk, Stankiewicz, Andrzej W, Sowinski, Dariusz, Krzyzagorska, Ewa, Jozefowska, Malgorzata, Matyjaszek-Matuszek, Beata, Franek, Edward, Skokowska, Ewa, Modzelewska, Anna, Szyprowska, Ewa, Simpson, Richard W, Gilfillan, Christopher, Colquhoun, David M, Davis, Timothy M, Morbey, Claire, McCarthy, Shannon E, Kaur, Kamal, Kemp, Laurence, Shea, Antony J, Khalimov, Yuriy Sh, Miroshnichenko, Olga A, Dvoryashina, Irina V, Karpova, Irina A, Kunitsyna, Marina A, Vorokhobina, Natalia V, Galstyan, Gagik R, Bondar, Irina A., Filippov, Evgeniy V, Ershova, Olga B, Ou, Horng-Yih, Tseng, Shih-Ting, Chen, Jung-Fu, Tien, Kai-Jen, Huang, Chien-Ning, Chen, Ching-Chu, Hwu, Chii-Min, Hsia, Te-Lin, Doupis, John, Pagkalos, Emmanouil, Mouslech, Zadalla, Bargiota, Alexandra, Kotsa, Kalliopi, Del Prato, Stefano, Kahn, Steven E, Pavo, Imre, Weerakkody, Govinda J, Yang, Zhengyu, Riesmeyer, Jeffrey S, Heine, Robert J, and Wiese, Russell J

Published
2021
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14. REPLACE-BG: A Randomized Trial Comparing Continuous Glucose Monitoring With and Without Routine Blood Glucose Monitoring in Adults With Well-Controlled Type 1 Diabetes

Author

Aleppo, Grazia, Ruedy, Katrina J, Riddlesworth, Tonya D, Kruger, Davida F, Peters, Anne L, Hirsch, Irl, Bergenstal, Richard M, Toschi, Elena, Ahmann, Andrew J, Shah, Viral N, Rickels, Michael R, Bode, Bruce W, Philis-Tsimikas, Athena, Pop-Busui, Rodica, Rodriguez, Henry, Eyth, Emily, Bhargava, Anuj, Kollman, Craig, and Beck, Roy W

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Diabetes, Pediatric, Prevention, Clinical Trials and Supportive Activities, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Metabolic and endocrine, Adult, Aged, Blood Glucose, Blood Glucose Self-Monitoring, Diabetes Mellitus, Type 1, Female, Glycated Hemoglobin, Humans, Insulin Infusion Systems, Male, Middle Aged, Socioeconomic Factors, Young Adult, REPLACE-BG Study Group, Medical and Health Sciences, Endocrinology & Metabolism, Biomedical and clinical sciences, Health sciences
Abstract

ObjectiveTo determine whether the use of continuous glucose monitoring (CGM) without confirmatory blood glucose monitoring (BGM) measurements is as safe and effective as using CGM adjunctive to BGM in adults with well-controlled type 1 diabetes (T1D).Research design and methodsA randomized noninferiority clinical trial was conducted at 14 sites in the T1D Exchange Clinic Network. Participants were ≥18 years of age (mean 44 ± 14 years), had T1D for ≥1 year (mean duration 24 ± 12 years), used an insulin pump, and had an HbA1c ≤9.0% (≤75 mmol/mL) (mean 7.0 ± 0.7% [53 ± 7.7 mmol/mol]); prestudy, 47% were CGM users. Participants were randomly assigned 2:1 to the CGM-only (n = 149) or CGM+BGM (n = 77) group. The primary outcome was time in range (70-180 mg/dL) over the 26-week trial, with a prespecified noninferiority limit of 7.5%.ResultsCGM use averaged 6.7 ± 0.5 and 6.8 ± 0.4 days/week in the CGM-only and CGM+BGM groups, respectively, over the 26-week trial. BGM tests per day (including the two required daily for CGM calibration) averaged 2.8 ± 0.9 and 5.4 ± 1.4 in the two groups, respectively (P < 0.001). Mean time in 70-180 mg/dL was 63 ± 13% at both baseline and 26 weeks in the CGM-only group and 65 ± 13% and 65 ± 11% in the CGM+BGM group (adjusted difference 0%; one-sided 95% CI -2%). No severe hypoglycemic events occurred in the CGM-only group, and one occurred in the CGM+BGM group.ConclusionsUse of CGM without regular use of confirmatory BGM is as safe and effective as using CGM with BGM in adults with well-controlled T1D at low risk for severe hypoglycemia.

Published
2017

15. Once‐weekly insulin efsitora alfa: Design and rationale for the QWINT phase 3 clinical development programme.

Author

Bergenstal, Richard M., Philis‐Tsimikas, Athena, Wysham, Carol, Carr, Molly C., Bue‐Valleskey, Juliana M., Botros, Fady T., Blevins, Thomas, and Rosenstock, Julio

Subjects
*INSULIN, *CONTINUOUS glucose monitoring, *TYPE 1 diabetes, *TYPE 2 diabetes, *PEOPLE with diabetes, *FASTING, *INSULIN therapy
Abstract

Aims: Insulin efsitora alfa (efsitora) is a once‐weekly basal insulin. This review describes the study design and rationale of the efsitora phase 3 Once Weekly (QW) Insulin Therapy (QWINT) clinical development programme, including the five trials, QWINT‐1 through QWINT‐5. Materials and Methods: The five trials included insulin‐naïve adults (QWINT‐1 and ‐2) with type 2 diabetes (T2D), adults with T2D previously treated with basal insulin (QWINT‐3 and ‐4), and QWINT‐5 in adults with type 1 diabetes. All five trials were designed as multicentre, randomized, controlled, open‐label, treat‐to‐target studies to investigate the efficacy and safety of efsitora versus active once‐daily basal insulin comparators (insulin glargine U100 or insulin degludec U100). The primary objective of each trial is to compare the change in HbA1c from baseline to week 26 or 52 between efsitora and the active comparator. The key secondary objectives include change in fasting glucose, insulin dose and continuous glucose monitoring variables, and patient‐reported outcome questionnaires. Conclusions: The QWINT development programme includes a racially and geographically diverse population to provide important information regarding the efficacy and safety of efsitora and its clinical management of people with diabetes. [ABSTRACT FROM AUTHOR]

Published
2024
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16. Medical Assistant Health Coaching for Type 2 Diabetes in Primary Care: Results From a Pragmatic Cluster Randomized Controlled Trial.

Author

Fortmann, Addie L., Soriano, Emily C., Gallo, Linda C., Clark, Taylor L., Spierling Bagsic, Samantha R., Sandoval, Haley, Jones, Jennifer A., Roesch, Scott, Gilmer, Todd, Schultz, James, Bodenheimer, Thomas, and Philis-Tsimikas, Athena

Subjects
TYPE 2 diabetes, HEALTH coaches, CLUSTER randomized controlled trials, MEDICAL assistants, PRIMARY care, SYSTOLIC blood pressure
Abstract

OBJECTIVE This cluster (clinic-level) randomized controlled trial (RCT) compared medical assistant (MA) health coaching (MAC) with usual care (UC) among at-risk adults with type 2 diabetes in two diverse real-world primary care environments: a federally qualified health center (FQHC; Neighborhood Healthcare) and a large nonprofit private insurance--based health system (Scripps Health). RESEARCH DESIGN AND METHODS A total of 600 adults with type 2 diabetes who met one or more of the following criteria in the last 90 days were enrolled: HbA1c ≥8% and/or LDL cholesterol ≥100 mg/dL and/or systolic blood pressure (SBP) ≥140 mmHg. Participants at MAC clinics received in-person and telephone self-management support from a specially trained MA health coach for 12 months. Electronic medical records were used to examine clinical outcomes in the overall sample. Behavioral and psychosocial outcomes were evaluated in a subsample (n = 300). RESULTS All clinical outcomes improved significantly over 1 year in the overall sample (P < 0.001). The reduction in HbA1c was significantly greater in the MAC versus UC group (unstandardized Binteraction = -0.06; P = 0.002). A significant time by group by site interaction also showed that MAC resulted in greater improvements in LDL cholesterol than UC at Neighborhood Healthcare relative to Scripps Health (Binteraction = -1.78 vs. 1.49; P < 0.05). No other statistically significant effects were observed. CONCLUSIONS This was the first large-scale pragmatic RCT supporting the real-world effectiveness of MAC for type 2 diabetes in U.S. primary care settings. Findings suggest that this team-based approach may be particularly effective in improving diabetes outcomes in FQHC settings. [ABSTRACT FROM AUTHOR]

Published
2024
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17. Continuous Glucose Monitoring-Based Metrics and Hypoglycemia Duration in Insulin-Experienced Individuals With Long-Standing Type 2 Diabetes Switched From a Daily Basal Insulin to Once-Weekly Insulin Icodec: Post Hoc Analysis of ONWARDS 2 and ONWARDS 4

Author

S. Bajaj, Harpreet, primary, Ásbjörnsdóttir, Björg, primary, Carstensen, Lisbeth, primary, Laugesen, Christian, primary, Mathieu, Chantal, primary, Philis-Tsimikas, Athena, primary, and Battelino, Tadej, primary

Published
2024
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19. Semaglutide and cardiovascular outcomes in patients with obesity and prevalent heart failure: a prespecified analysis of the SELECT trial

Author

Deanfield, John, Verma, Subodh, Scirica, Benjamin M, Kahn, Steven E, Emerson, Scott S, Ryan, Donna, Lingvay, Ildiko, Colhoun, Helen M, Plutzky, Jorge, Kosiborod, Mikhail N, Hovingh, G Kees, Hardt-Lindberg, Søren, Frenkel, Ofir, Weeke, Peter E, Rasmussen, Søren, Goudev, Assen, Lang, Chim C, Urina-Triana, Miguel, Pietilä, Mikko, Lincoff, A Michael, Abe, Mitsunori, Abhaichand, Rajpal K, Abhayaratna, Walter P, Abhyankar, Atul, Abidin, Imran B Zainal, Abou Assi, Hiba, Accini Mendoza, Jose L, Adas, Mine, Agaiby, John M, Agarwal, Devendra K, Agha, Maher, Ahmed, Azazuddin, Ahtiainen, Petteri, Aigner, Elmar, Ajay, Naik, Ali, Norsiah, Al-Karadsheh, Amer, Allison, Roy, Allison, Dale C, Alpenidze, Diana, Altuntas, Yuksel, Al-Zoebi, Ayham, Ambuj, Roy, Amerena, John, Anderson, Robert J, Ando, Toshiaki, Andrews, Robert, Antonova, Elizaveta, Appel, Karl-Friedrich, Arantes, Flávia B, Araz, Mustafa, Arbel, Yaron, Arenas León, José L, Argyrakopoulou, Georgia, Ariani, Mehrdad, Arias Mendoza, Maria A, Arif, Ahmed A, Arneja, Jaspal, Aroda, Vanita R, Aronne, Louis J, Arstall, Margaret, Asamoah, Njaimeh, Asanin, Milika, Audish, Hanid, Avram, Rodica, Badat, Aysha, Badiu, Corin V, Bakdash, Wa'el, Bakiner, Okan S, Bandezi, Vuyokazi N, Bang, Liew H, Bansal, Sandeep, Baranyai, Marietta, Barbarash, Olga, Barber, Mark, Barnum, Otis, Barone Rochette, Gilles, Bashkin, Amir, Baum, Seth, Bays, Harold E, Bazzoni Ruiz, Alberto E, Beckowski, Maciej, Beerachee, Yaswin, Bellary, Srikanth, Belousova, Lidia, Berk, Martin, Bernstein, Marc, Berra, Cesare, Beshay, Isaac, Bhagwat, Ajit, Bhan, Arti, Biggs, William C, Billings, Liana, Bitar, Fahed, Block, Bradley, Bo, Simona, Bogdanski, Pawel, Bolshakova, Olga O, Boshchenko, Alla A, Bosworth, Hayden, Botero Lopez, Rodrigo, Bôttcher, Morten, Bourgeois, Ronald, Brautigam, Donald, Breton, Cristian F, Broadley, Andrew, Brockmyre, Andrew P, Brodie, Steven K, Bucci, Marco, Budincevic, Hrvoje, Budoff, Matthew J, Buffman, Barry, Buljubasic, Nediljka, Buranapin, Supawan, Burgess, Lesley, Burguera, Bartolomé, Buriakovska, Olena, Buscemi, Silvio, Busch, Robert, Buse, John B, Buynak, Robert, Byrne, Maria, Caceaune, Elena, Cadena Bonfanti, Alberto J, Calinescu, Cornell V, Call, Robert S, Canecki Varzic, Silvija, Cannon, Kevin, Capehorn, Matt, Cariou, Bertrand, Carr, Jeffrey, Carrillo-Jimenez, Rodolfo, Casas, Marcelo, Castro, Almudena, Celik, Ahmet, Cercato, Cintia, Cermak, Ondrej, Cha, James Y, Chacon, Carolina, Chaicha-Brom, Tira, Chandra, Sandeep, Chettibi, Mohamed, Chevts, Julia, Christopher, Johann, Chrustowski, Witold, Cif, Adriana, Clark, Rebecca, Clark, Wayne, Clifford, Piers, Coetzee, Kathleen, Cogni, Giulia, Colao, Anna Maria, Colquhoun, David M, Concha, Mauricio, Condit, Jonathan, Constance, Christian, Constantin, Ciprian, Constantinescu, Silviana, Corbett, Clive, Cornett, George M, Correia, Marcelo, Cortinovis, Fiorenzo, Cosma, Dana, Creely, Steven, Cross, David, Curtis, Brian, Czochra, Wojciech, Daboul, Nizar Y, Dagdelen, Selcuk, D'agostino, Ronald, Dang, Cuong, Datta, Sudip, Davuluri, Ashwini K, Dawood, Saleem Y, De Jong, Douwe M, De La Cuesta, Carmen, De Los Rios Ibarra, Manuel O, De Pablo, Carmen, De Pauw, Michel, Dela Llana, Alexander, Delibasic, Maja, Delic-Brkljacic, Diana, Demicheli, Thibaud, Denger, Ralf J, Desai, Devang, Desai, Piyush, Desouza, Cyrus V, Dicker, Dror, Djenic, Nemanja, Dobson, Simon, Doi, Masayuki, Doran, Jesse A, Dorman, Reinhart, Dotta, Francesco, Dukes, Carl E, Duronto, Ernesto, Durst, Ronen, Dvoryashina, Irina V, Ebrahim, Iftikhar O, Eggebrecht, Holger, Egstrup, Kenneth, Ekinci, Elif I, Eliasson, Björn, Eliasson, Ken, Enache, Georgiana, Enculescu, Dan, English, Patrick, Ermakova, Polina, Ershova, Olga, Ezaki, Hirotaka, Ezhov, Marat, Farias, Eduardo, Farias, Javier M, Farsky, Pedro S, Ferreira, Daniel, Filteau, Pierre, Finneran, Matthew P, Folkens, Eric M, Fonseca, Alberto G, Fonseca, Luisa, Fordan, Steven, Fourie, Nyda, França, Sara, Franco, Denise R, Franek, Edward, Friedman, Keith, Frittitta, Lucia, Froer, Michael, Fuckar, Krunoslav, Fujii, Kenshi, Fujita, Ryoko, Fukushima, Yasushi, Fulat, Mohamed, Fulwani, Mahesh, Gajos, Grzegorz, Galyavich, Albert, Gambill, Michael L, Gandotra, Dheeraj, Winston, Gandy, Garcia Hernandez, Pedro A, García Reza, Raymundo, Garg, Naveen, Garg, Sandeep, Garvey, William T, Garza, Juan C, Gatta-Cherifi, Blandine, Gelev, Valeri, Geller, Steven A, Geohas, Jeffrey G, Georgiev, Borislav, Ghazi, Adline, Gilbert, Matthew P, Gilinskaya, Olga, Gislason, Gunnar, Gogas Yavuz, Dilek, González Albarrán, Olga, Gordeev, Ivan G, Gorton, Sidney C, Goudev, Assen, Gretland Valderhaug, Tone, Groenemeijer, Bjorn, Gul, Ibrahim, Gullestad, Lars, Gurieva, Irina, Guseva, Galina N, Hagenow, Andreas, Haluzik, Martin, Halvorsen, Sigrun, Hammoudi, Naima, Hanaoka, Keiichi, Hancu, Nicolae, Hanusch, Ursula, Harris, Kathleen, Harris, Barry, Hartleib, Michael, Hartman, Aaron N, Hata, Yoshiki, Heimer, Brian, Herman, Lee, Herzog, William, Hewitt, Eric, Heymer, Peter, Hiremath, Shirish, Hjelmesaeth, Joeran, Høgalmen, Rasmus Geir, Høivik, Hans Olav, Holmer, Helene, Horoshko, Olha, Houser, Patricia M, Hove, Jens D, Hsieh, I-Chang, Hulot, Jean-Sébastien, Hussein, Zanariah, Ilashchuk, Tetiana, Ilveskoski, Erkki, Ipatko, Irina, Iranmanesh, Ali, Isawa, Tsuyoshi, Issa, Moises, Iteld, Bruce, Iwasawa, Takamasa, Jabbar, Danish, Jackson, Richard A, Jackson-Voyzey, Ewart, Jacob, Stephan, Jaffrani, Naseem A, Jardula, Michael F, Jastreboff, Ania, Jensen, Svend E, Jerkins, Terri, Jimenez-Ramos, Silvia A, Jitendra Pal Singh, Sawhney, Johnson, Wallace, Joyce, John M, Jozefowska, Malgorzata, Jugnundan, Prakash, Jungmair, Wolfgang, Jurowiecki, Jaroslaw, Kadokami, Toshiaki, Kahali, Dhiman, Kahrmann, Gerd, Kaiser, Sergio E, Kalmucki, Piotr, Kanadasi, Mehmet, Kandath, David, Kania, Grzegorz, Kannan, J, Kapp, Cornelia, Karczmarczyk, Agnieszka, Kartalis, Athanasios, Kaser, Susanne, Kasim, Sazzli Shahlan, Kastelic, Richard, Kato, Toshiaki, Katova, Tzvetana, Kaul, Upendra, 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Sangrigoli, Renee, Sansanayudh, Nakarin, Santini, Ferruccio, Saraiva, José F, Sardinov, Ruslan, Sargeant, William, Sari, Ramazan, Sathananthan, Airani, Sathyapalan, Thozhukat, Sato, Atsushi, Sauter, Joachim, Sbraccia, Paolo, Schaap, J., Schaum, Thomas, Schiele, François, Scott, John, Segal Lieberman, Gabriella, Segner, Alexander, Senior, Roxy, Sergeeva-Kondrachenko, Marina Y, Serota, Harvey, Serusclat, Pierre, Sethi, Rishi, Shah, Manoj K, Shah, Neerav, Shalaev, Sergey, Sharma, Raj, Sharma, Sumeet, Shaydyuk, Oksana, Shea, Heidi C, Shechter, Michael, Shehadeh, Naim, Shirazi, Mitra, Shlesinger, Yshay, Shneker, Ayham, Shutemova, Elena, Siasos, Gerasimos, Siddiqui, Imran A, Sidey, Jennifer, Sigal, Felix, Sime, Iveta, Singh, Narendra, Siraj, Elias, Sivalingam, Kanagaratnam, Skoczylas, Grzegorz, Smith, Stephen K, Smolenskaya, Olga, Snyder, Brian, Sofer, Yael, Sofley, C.W., Solano, Royce, Sonmez, Yusuf A, Sorokin, Maxim, Soto González, Alfonso, Sotolongo, Carlos, Soufer, Joseph, Soyluk 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Tsoukas, George M, Tuccinardi, Dario, Tuna, Mazhar M, Turatti, Luiz A, Tziomalos, Konstantinos, Udommongkol, Chesda, Ueda, Osamu, Ukkola, Olavi, Unubol, Mustafa, Urbach, Dorothea, Urina Triana, Miguel A, Usdan, Lisa, Vaidya, Bijay, Vale, Noah, Vallieres, Gerald, Van Beek, Andre P, Van De Borne, Philippe, Van Der Walt, Eugene, Van Der Zwaan, C., Van Nieuwenhuizen, Elane, Van Zyl, Louis, Vanduynhoven, Philippe, Varghese, Kiron, Vasileva, Svetla P, Vassilev, Dobrin, Vathesatogkit, Prin, Velychko, Valentyna, Vercammen, Chris, Verges, Bruno, Verma, Subodh, Verwerft, Jan, Vesela, Alica, Veselovskaya, Nadezhda G, Vettor, Roberto, Veze, Irina, Vijan, Vinod, Vijayaraghavan, Ram, Villarino, Adriana, Vincent, Royce, Vinogradova, Oksana, Vishlitzky, Victor, Vlad, Adrian, Vladu, Ionela Mihaela, Vo, Anthony, Von Engelhardt, Charlotte, Von Münchhausen, Candy, Vorobyeva, Olga, Vossenberg, T., Vrolix, Mathias, Vukicevic, Marjana, Vyshnyvetskyy, Ivan, Wadvalla, Shahid, Wagner, Jan, Wakeling, John, Wallace, James, Wan Mohamed, Wan Mohd Izani, Wander, Gurpreet S, Ward, Kathleen, Warren, Mark L, Watanabe, Atsuyuki, Weber, Bruce, Weintraub, Howard, Weisnagel, John, Welker, James, Wendisch, Ulrich, Wenocur, Howard S, Wierum, Craig, Wilding, John, William, Maged, Wilson, Pete, Wilson, Jonathan P, Wong, Yuk-Ki, Wongcharoen, Wanwarang, Wozniak, Iwona, Wu, Chau-Chung, Wyatt, Nell, Wynne, Alan, Yamaguchi, Hiroshi, Yamasaki, Masahiro, Yazici, Dilek, Yeh, Hung-I, Yotov, Yoto, Yuan, Qingyang, Zacher, Jeffrey, Zagrebelnaya, Olga, Zaidman, Cesar J, Zalevskaya, Alsu, Zarich, Stuart, Zatelli, Maria Chiara, Zeller, Helga, Zhdanova, Elena A, Zornitzki, Taiba, Zrazhevskiy, Konstantin, Zykov, Mikhail, Lincoff, A Michael, Ryan, Donna H, Colhoun, Helen M, Deanfield, John E, Emerson, Scott S, Kahn, Steven E, Kushner, Robert F, Plutzky, Jorge, Brown-Frandsen, Kirstine, Hovingh, G Kees, Hardt-Lindberg, Soren, and Tornøe, Christoffer W

Abstract

Semaglutide, a GLP-1 receptor agonist, reduces the risk of major adverse cardiovascular events (MACE) in people with overweight or obesity, but the effects of this drug on outcomes in patients with atherosclerotic cardiovascular disease and heart failure are unknown. We report a prespecified analysis of the effect of once-weekly subcutaneous semaglutide 2·4 mg on ischaemic and heart failure cardiovascular outcomes. We aimed to investigate if semaglutide was beneficial in patients with atherosclerotic cardiovascular disease with a history of heart failure compared with placebo; if there was a difference in outcome in patients designated as having heart failure with preserved ejection fraction compared with heart failure with reduced ejection fraction; and if the efficacy and safety of semaglutide in patients with heart failure was related to baseline characteristics or subtype of heart failure.

Published
2024
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20. Continuous Glucose Monitoring–Based Metrics and Hypoglycemia Duration in Insulin-Experienced Individuals With Long-standing Type 2 Diabetes Switched From a Daily Basal Insulin to Once-Weekly Insulin Icodec: Post Hoc Analysis of ONWARDS 2 and ONWARDS 4

Author

Bajaj, Harpreet S., Ásbjörnsdóttir, Björg, Carstensen, Lisbeth, Laugesen, Christian, Mathieu, Chantal, Philis-Tsimikas, Athena, and Battelino, Tadej

Subjects
TYPE 2 diabetes, CONTINUOUS glucose monitoring, HYPOGLYCEMIA, INSULIN derivatives, INSULIN
Abstract

OBJECTIVE: This post hoc analysis assessed continuous glucose monitoring (CGM)–based metrics and hypoglycemia duration with once-weekly insulin icodec versus once-daily basal insulin analogs in insulin-experienced individuals with long-standing type 2 diabetes from two 26-week phase 3a trials (ONWARDS 2 and ONWARDS 4). RESEARCH DESIGN AND METHODS: Time in range (TIR) (3.9–10.0 mmol/L), time above range (TAR) (>10.0 mmol/L), and time below range (TBR) (<3.9 mmol/L and <3.0 mmol/L) were assessed during three CGM time periods (switch [weeks 0–4], end of treatment [weeks 22–26], and follow-up [weeks 27–31]) for icodec versus comparators (ONWARDS 2, insulin degludec [basal regimen]; ONWARDS 4, insulin glargine U100 [basal-bolus regimen]) using double-blind CGM data. CGM-derived hypoglycemic episode duration (<3.9 mmol/L) was assessed. RESULTS: In both trials, there were no statistically significant differences in TIR, TAR, or TBR (<3.0 mmol/L) for icodec versus comparators across all time periods. In the end-of-treatment period, mean TIR was 63.1% (icodec) vs. 59.5% (degludec) in ONWARDS 2 and 66.9% (icodec) vs. 66.4% (glargine U100) in ONWARDS 4. Mean TBR <3.9 mmol/L and <3.0 mmol/L remained within recommended targets (<4% and <1%, respectively) across time periods and treatment arms. Hypoglycemic episode duration (<3.9 mmol/L) was comparable across time periods and treatment arms (median duration ≤40 min). CONCLUSIONS: In insulin-experienced participants with long-standing type 2 diabetes, CGM-based TIR, TAR, and CGM-derived hypoglycemia duration (<3.9 mmol/L) were comparable for icodec and once-daily basal insulin analogs during all time periods. TBR remained within recommended targets. [ABSTRACT FROM AUTHOR]

Published
2024
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23. Real-Time Continuous Glucose Monitoring in the Hospital: A Real-World Experience

Author

Spierling Bagsic, Samantha R., primary, Fortmann, Addie L., additional, Belasco, Rebekah, additional, Bastian, Alessandra, additional, Lohnes, Suzanne, additional, Ritko, Anna, additional, Sandoval, Haley, additional, Chichmarenko, Mariya, additional, Soriano, Emily C., additional, Talavera, Laura, additional, and Philis-Tsimikas, Athena, additional

Published
2023
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24. Continuous glucose monitoring in insulin-experienced individuals with type 2 diabetes switched to once-weekly insulin icodec versus once-daily comparators in ONWARDS 2 and 4: post-hoc analysis

Author

Kellerer, Monika, additional, Bajaj, Harpreet Singh, additional, Ásbjörnsdóttir, Björg, additional, Lehrskov, Lars Lang, additional, Mathieu, Chantal, additional, Philis-Tsimikas, Athena, additional, Wang, Ni, additional, and Battelino, Tadej, additional

Published
2023
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25. A Glycemia Risk Index (GRI) of Hypoglycemia and Hyperglycemia for Continuous Glucose Monitoring Validated by Clinician Ratings.

Author

Li, Chengdong, Li, Chengdong, Liepmann, Dorian, Kerr, David, Ahn, David, Peters, Anne, Umpierrez, Guillermo, Seley, Jane, Xu, Nicole, Nguyen, Kevin, Simonson, Gregg, Agus, Michael, Al-Sofiani, Mohammed, Armaiz-Pena, Gustavo, Bailey, Timothy, Basu, Ananda, Battelino, Tadej, Bekele, Sewagegn, Benhamou, Pierre-Yves, Bequette, B, Blevins, Thomas, Breton, Marc, Castle, Jessica, Chase, James, Chen, Kong, Choudhary, Pratik, Clements, Mark, Close, Kelly, Cook, Curtiss, Danne, Thomas, Doyle, Francis, Drincic, Angela, Dungan, Kathleen, Edelman, Steven, Ejskjaer, Niels, Espinoza, Juan, Fleming, G, Forlenza, Gregory, Freckmann, Guido, Galindo, Rodolfo, Gomez, Ana, Gutow, Hanna, Heinemann, Lutz, Hirsch, Irl, Hoang, Thanh, Hovorka, Roman, Jendle, Johan, Ji, Linong, Joshi, Shashank, Joubert, Michael, Koliwad, Suneil, Lal, Rayhan, Lansang, M, Lee, Wei-An, Leelarathna, Lalantha, Leiter, Lawrence, Lind, Marcus, Litchman, Michelle, Mader, Julia, Mahoney, Katherine, Mankovsky, Boris, Masharani, Umesh, Mathioudakis, Nestoras, Mayorov, Alexander, Messler, Jordan, Miller, Joshua, Mohan, Viswanathan, Nichols, James, Nørgaard, Kirsten, ONeal, David, Pasquel, Francisco, Philis-Tsimikas, Athena, Pieber, Thomas, Phillip, Moshe, Polonsky, William, Pop-Busui, Rodica, Rayman, Gerry, Rhee, Eun-Jung, Russell, Steven, Shah, Viral, Sherr, Jennifer, Sode, Koji, Spanakis, Elias, Wake, Deborah, Waki, Kayo, Wallia, Amisha, Weinberg, Melissa, Wolpert, Howard, Wright, Eugene, Zilbermint, Mihail, Kovatchev, Boris, Klonoff, David, Wang, Jing, Rodbard, David, Kohn, Michael, Li, Chengdong, Li, Chengdong, Liepmann, Dorian, Kerr, David, Ahn, David, Peters, Anne, Umpierrez, Guillermo, Seley, Jane, Xu, Nicole, Nguyen, Kevin, Simonson, Gregg, Agus, Michael, Al-Sofiani, Mohammed, Armaiz-Pena, Gustavo, Bailey, Timothy, Basu, Ananda, Battelino, Tadej, Bekele, Sewagegn, Benhamou, Pierre-Yves, Bequette, B, Blevins, Thomas, Breton, Marc, Castle, Jessica, Chase, James, Chen, Kong, Choudhary, Pratik, Clements, Mark, Close, Kelly, Cook, Curtiss, Danne, Thomas, Doyle, Francis, Drincic, Angela, Dungan, Kathleen, Edelman, Steven, Ejskjaer, Niels, Espinoza, Juan, Fleming, G, Forlenza, Gregory, Freckmann, Guido, Galindo, Rodolfo, Gomez, Ana, Gutow, Hanna, Heinemann, Lutz, Hirsch, Irl, Hoang, Thanh, Hovorka, Roman, Jendle, Johan, Ji, Linong, Joshi, Shashank, Joubert, Michael, Koliwad, Suneil, Lal, Rayhan, Lansang, M, Lee, Wei-An, Leelarathna, Lalantha, Leiter, Lawrence, Lind, Marcus, Litchman, Michelle, Mader, Julia, Mahoney, Katherine, Mankovsky, Boris, Masharani, Umesh, Mathioudakis, Nestoras, Mayorov, Alexander, Messler, Jordan, Miller, Joshua, Mohan, Viswanathan, Nichols, James, Nørgaard, Kirsten, ONeal, David, Pasquel, Francisco, Philis-Tsimikas, Athena, Pieber, Thomas, Phillip, Moshe, Polonsky, William, Pop-Busui, Rodica, Rayman, Gerry, Rhee, Eun-Jung, Russell, Steven, Shah, Viral, Sherr, Jennifer, Sode, Koji, Spanakis, Elias, Wake, Deborah, Waki, Kayo, Wallia, Amisha, Weinberg, Melissa, Wolpert, Howard, Wright, Eugene, Zilbermint, Mihail, Kovatchev, Boris, Klonoff, David, Wang, Jing, Rodbard, David, and Kohn, Michael

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 clini

Published
2023

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

Author

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, 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, 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, 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, and Kovatchev, Boris

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 cl

Published
2023

27. Process evaluation of Dulce Digital-Me: an adaptive mobile health (mHealth) intervention for underserved Hispanics with diabetes.

Author

Bagsic, Samantha R Spierling, Savin, Kimberly L, Soriano, Emily C, Diego, Emily Rose N San, Orendain, Natalia, Clark, Taylor, Sandoval, Haley, Chichmarenko, Mariya, Perez-Ramirez, Perla, Farcas, Emilia, Godino, Job, Gallo, Linda C, Philis-Tsimikas, Athena, and Fortmann, Addie L

Abstract

Type 2 diabetes disproportionately impacts ethnic minorities and individuals from low socioeconomic status. Diabetes self-management education and support has been shown to improve clinical outcomes in these populations, and mobile health (mHealth) interventions can reduce barriers to access. Dulce Digital-Me (DD-Me) was developed to integrate adaptive mHealth technologies to enhance self-management and reduce disparities in the high-risk, underserved Hispanic population. The objective of the present study was to evaluate reach, adoption, and implementation of an mHealth diabetes self-management education and support intervention in this underrepresented population. The present analysis is a multimethod process evaluation using the Reach , Effectiveness, Adoption , Implementation, and Maintenance (RE-AIM) framework. The study was effective in reaching a sample that was representative of the intended population; only modest but significant differences were observed in sex and age. The DD-Me health coach (HC) cited several important facilitators of intervention adoption , including outreach frequency and personalization, and the automated HC report. Implementation fidelity was high, with participants receiving >90% of intended interventions. Participants who received DD-Me with support from a HC were most engaged, suggesting utility and acceptability of integrating HCs with mHealth interventions. Perceptions of implementation among study participants were positive and consistent across study arms. This evaluation revealed the target population was successfully reached and engaged in the digital health interventions, which was implemented with high fidelity. Further studies should evaluate the efficacy and maintenance of the study following the RE-AIM model to determine whether this intervention warrants expansion to additional settings and populations. [ABSTRACT FROM AUTHOR]

Published
2023
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29. Aminoguanidine Has Both Pro-oxidant and Antioxidant Activity Toward LDL

Author

Philis-Tsimikas, Athena, Parthasarathy, Sampath, Picard, Sylvie, Palinski, Wulf, and Witztum, Joseph L

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Clinical Sciences, Clinical Trials and Supportive Activities, Prevention, Nutrition, Clinical Research, Antioxidants, Apolipoproteins B, Dose-Response Relationship, Drug, Guanidines, Humans, Lipid Peroxides, Lipoproteins, LDL, Oxidation-Reduction, OXIDIZED LDL, ATHEROSCLEROSIS, DIABETES, AMINOGUANIDINE, Cardiorespiratory Medicine and Haematology, Cardiovascular System & Hematology, Cardiovascular medicine and haematology, Clinical sciences
Abstract

We previously demonstrated that aminoguanidine (AMGN) was able to prevent oxidative modification of LDL. Initially, we thought that this occurred solely because AMGN trapped reactive breakdown products of lipid peroxidation and prevented apoB modification, similar to AMGN's proposed ability to trap reactive glucose intermediates and prevent advanced glycosylation end-product formation. We now demonstrate that AMGN also displays dose-dependent pro-oxidant and antioxidant activity toward LDL. Moderate doses of AMGN (0.05 to 1.0 mmol/L) prevented lipid peroxidation in LDL exposed to copper. AMGN prevented the loss of polyunsaturated fatty acids and delayed or prevented conjugated-diene formation, both of which are sensitive indicators of lipid peroxidation. The same doses of AMGN also prevented apoB modification, a step distal to lipid peroxidation, as evidenced by the ability to (1) prevent fluorescence at 420 nm, (2) block enhanced electrophoretic mobility, and (3) prevent changes leading to enhanced macrophage uptake. Thus, AMGN inhibits LDL modification both by inhibiting lipid peroxidation as well as by trapping reactive breakdown products of lipid peroxidation. It was also demonstrated that for every LDL, there was also a very low dose of AMGN (about 0.01 mmol/L) that actually promoted lipid oxidation and subsequent protein modification. This activity of AMGN could be enhanced by increasing the content of lipid hydroperoxide in the LDL, eg, by aging or radioiodinating the LDL. Conversely, the pro-oxidant activity could be reduced by pretreatment of LDL with ebselen or vitamin E. We propose a mechanism by which AMGN effects pro-oxidant activity toward LDL at very low concentrations and antioxidant activity at higher concentrations and discuss the practical implications of these observations.

Published
1995

30. sj-docx-1-dst-10.1177_19322968221149041 – Supplemental material for Higher Derived Time in Range With IDegLira Versus Insulin Glargine U100 in People With Type 2 Diabetes

Author

Philis-Tsimikas, Athena, Aroda, Vanita R., De Block, Christophe, Billings, Liana K., Liebl, Andreas, Sivarathinasami, Ramsathish, D’Cruz, John M., and Lingvay, Ildiko

Subjects
111708 Health and Community Services, FOS: Clinical medicine, 111199 Nutrition and Dietetics not elsewhere classified, Medicine, FOS: Health sciences, 110306 Endocrinology
Abstract

Supplemental material, sj-docx-1-dst-10.1177_19322968221149041 for Higher Derived Time in Range With IDegLira Versus Insulin Glargine U100 in People With Type 2 Diabetes by Athena Philis-Tsimikas, Vanita R. Aroda, Christophe De Block, Liana K. Billings, Andreas Liebl, Ramsathish Sivarathinasami, John M. D’Cruz and Ildiko Lingvay in Journal of Diabetes Science and Technology

Published
2023
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35. 100-LB: Glycemic Control Using Recommended Settings in Youth and Adults with Type 1 Diabetes (T1D) —Minimed 780G System with the Calibration-Free Guardian 4 Sensor Results

Author

VIGERSKY, ROBERT A., primary, BODE, BRUCE W., additional, BRAZG, RONALD L., additional, BUCKINGHAM, BRUCE A., additional, CARLSON, ANDERS L., additional, KAISERMAN, KEVIN B., additional, KIPNES, MARK, additional, LILJENQUIST, DAVID R., additional, PHILIS-TSIMIKAS, ATHENA, additional, PIHOKER, CATHERINE, additional, POP-BUSUI, RODICA, additional, REED, JOHN, additional, SHERR, JENNIFER, additional, SHULMAN, DOROTHY I., additional, SLOVER, ROBERT H., additional, THRASHER, JAMES, additional, CHEN, XIAOXIAO, additional, LIU, MARGARET, additional, CORDERO, TONI L., additional, VELLA, MELISSA, additional, RHINEHART, ANDREW S., additional, and SHIN, JOHN, additional

Published
2022
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39. 582-P: Process Evaluation of Dulce Digital–Me: An Adaptive mHealth Intervention for Underserved Hispanics with Diabetes

Author

SPIERLING BAGSIC, SAMANTHA R., primary, SAVIN, KIMBERLY L., additional, SORIANO, EMILY, additional, SAN DIEGO, EMILY ROSE N., additional, ORENDAIN, NATALIA, additional, CLARK, TAYLOR, additional, SANDOVAL, HALEY, additional, CHICHMARENKO, MARIYA, additional, PEREZ-RAMIREZ, PERLA, additional, FARCAS, EMILIA, additional, GODINO, JOB G., additional, PHILIS-TSIMIKAS, ATHENA, additional, GALLO, LINDA, additional, and FORTMANN, ADDIE L., additional

Published
2022
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42. A Glycemia Risk Index (GRI) of Hypoglycemia and Hyperglycemia for Continuous Glucose Monitoring Validated by Clinician Ratings

Author

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

Published
2022
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43. sj-pdf-1-dst-10.1177_19322968221085273 – Supplemental material for A Glycemia Risk Index (GRI) of Hypoglycemia and Hyperglycemia for Continuous Glucose Monitoring Validated by Clinician Ratings

Author

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, and Kovatchev, Boris

Subjects
111708 Health and Community Services, FOS: Clinical medicine, 111199 Nutrition and Dietetics not elsewhere classified, Medicine, FOS: Health sciences, 110306 Endocrinology
Abstract

Supplemental material, sj-pdf-1-dst-10.1177_19322968221085273 for A Glycemia Risk Index (GRI) of Hypoglycemia and Hyperglycemia for Continuous Glucose Monitoring Validated by Clinician Ratings by David C. Klonoff, Jing Wang, David Rodbard, Michael A. Kohn, Chengdong Li, Dorian Liepmann, David Kerr, David Ahn, Anne L. Peters, Guillermo E. Umpierrez, Jane Jeffrie Seley, Nicole Y. Xu, Kevin T. Nguyen, Gregg Simonson, Michael S. D. Agus, Mohammed E. Al-Sofiani, Gustavo Armaiz-Pena, Timothy S. Bailey, Ananda Basu, Tadej Battelino, Sewagegn Yeshiwas Bekele, Pierre-Yves Benhamou, B. Wayne Bequette, Thomas Blevins, Marc D. Breton, Jessica R. Castle, James Geoffrey Chase, Kong Y. Chen, Pratik Choudhary, Mark A. Clements, Kelly L. Close, Curtiss B. Cook, Thomas Danne, Francis J. Doyle, Angela Drincic, Kathleen M. Dungan, Steven V. Edelman, Niels Ejskjaer, Juan C. Espinoza, G. Alexander Fleming, Gregory P. Forlenza, Guido Freckmann, Rodolfo J. Galindo, Ana Maria Gomez, Hanna A. Gutow, Lutz Heinemann, Irl B. Hirsch, Thanh D. Hoang, Roman Hovorka, Johan H. Jendle, Linong Ji, Shashank R. Joshi, Michael Joubert, Suneil K. Koliwad, Rayhan A. Lal, M. Cecilia Lansang, Wei-An (Andy) Lee, Lalantha Leelarathna, Lawrence A. Leiter, Marcus Lind, Michelle L. Litchman, Julia K. Mader, Katherine M. Mahoney, Boris Mankovsky, Umesh Masharani, Nestoras N. Mathioudakis, Alexander Mayorov, Jordan Messler, Joshua D. Miller, Viswanathan Mohan, James H. Nichols, Kirsten Nørgaard, David N. O’Neal, Francisco J. Pasquel, Athena Philis-Tsimikas, Thomas Pieber, Moshe Phillip, William H. Polonsky, Rodica Pop-Busui, Gerry Rayman, Eun-Jung Rhee, Steven J. Russell, Viral N. Shah, Jennifer L. Sherr, Koji Sode, Elias K. Spanakis, Deborah J. Wake, Kayo Waki, Amisha Wallia, Melissa E. Weinberg, Howard Wolpert, Eugene E. Wright, Mihail Zilbermint and Boris Kovatchev in Journal of Diabetes Science and Technology

Published
2022
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44. Innovations in insulin: insulin degludec U-100 and U-200

Author

Philis-Tsimikas, Athena

Subjects
Pharmacology -- Analysis, Insulin -- Innovations -- Dosage and administration, Pharmacokinetics -- Analysis, Type 1 diabetes -- Drug therapy, Health
Abstract

CLINICAL PHARMACOLOGY Insulin degludec (IDeg) is a long-acting basal human insulin analog produced using recombinant DNA technology. The insulin structure is modified at the B30 position to allow a di-hexamer [...]

Published
2016

48. Rationale and design of the phase 3a development programme (ONWARDS 1–6 trials) investigating once‐weekly insulin icodec in diabetes.

Author

Philis‐Tsimikas, Athena, Bajaj, Harpreet S., Begtrup, Kamilla, Cailleteau, Roman, Gowda, Amoolya, Lingvay, Ildiko, Mathieu, Chantal, Russell‐Jones, David, and Rosenstock, Julio

Subjects
*EXENATIDE, *INSULIN aspart, *INSULIN, *TYPE 1 diabetes, *GLYCEMIC control, *TYPE 2 diabetes, *PATIENT satisfaction
Abstract

Aim: To describe the phase 3a ONWARDS clinical development programme investigating insulin icodec (icodec), a once‐weekly basal insulin, including the design and rationale for each of the ONWARDS 1–6 trials. Materials and Methods: Six randomized controlled trials have been initiated in adults with type 2 diabetes (T2D) (insulin‐naive: ONWARDS 1, 3 and 5; previously insulin‐treated: ONWARDS 2 and 4) and type 1 diabetes (T1D) (ONWARDS 6). Each trial will investigate icodec use in a unique clinical scenario, with consideration of long‐term safety and varied comparator treatments (insulin glargine U100 or U300 or insulin degludec). ONWARDS 5 will incorporate real‐world elements and a digital dose titration solution to guide icodec dosing. The primary objective for each of the trials is to compare the change in HbA1c from baseline to week 26 or week 52 between icodec and comparator arms. Secondary objectives include investigating other glycaemic control and safety parameters, such as fasting glucose, time in glycaemic range and hypoglycaemia. Patient‐reported outcomes will assess treatment satisfaction. Conclusions: The ONWARDS 1–6 trials will evaluate the efficacy and safety of once‐weekly icodec compared with currently available daily basal insulin analogues in T2D and T1D. These trials will generate comprehensive evidence of icodec use in diverse populations across the spectrum of diabetes progression and treatment experience. [ABSTRACT FROM AUTHOR]

Published
2023
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49. Improved Glycemia with Hybrid Closed-Loop (HCL) Versus Continuous Subcutaneous Insulin Infusion (CSII) Therapy: Results from a Randomized Controlled Trial.

Author

Garg, Satish K., Grunberger, George, Weinstock, Ruth, Lawson, Margaret L., Hirsch, Irl B., DiMeglio, Linda A., Pop-Busui, Rodica, Philis-Tsimikas, Athena, Kipnes, Mark, Liljenquist, David R., Brazg, Ronald L., Kudva, Yogish C., Buckingham, Bruce A., McGill, Janet B., Carlson, Anders L., Criego, Amy B., Christiansen, Mark P., Kaiserman, Kevin B., Griffin, Kurt J., and Forlenza, Greg P.

Published
2023
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