356 results on '"A Philis-Tsimikas"'
Search Results
2. Process evaluation of Dulce Digital-Me: an adaptive mobile health (mHealth) intervention for underserved Hispanics with diabetes.
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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
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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.
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- 2023
3. 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 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
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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.
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- 2023
4. Dulce Digital-Me: protocol for a randomized controlled trial of an adaptive mHealth intervention for underserved Hispanics with diabetes
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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
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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 .
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- 2022
5. Semaglutide and cardiovascular outcomes in patients with obesity and prevalent heart failure: a prespecified analysis of the SELECT trial
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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
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- 2024
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6. 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
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Polonsky, William, Benamar, Malik, Carstensen, Lisbeth, Davies, Melanie, Meller Donatsky, Anders, Franek, Edward, Kellerer, Monika, Philis-Tsimikas, Athena, and Goldenberg, Ronald
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- 2024
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7. Addressing emotional distress to improve outcomes in adults with type 1 diabetes: Protocol for ACT1VATE randomized controlled trial
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Soriano, Emily C., Fortmann, Addie L., Guzman, Susan J., Sandoval, Haley, Spierling Bagsic, Samantha R., Bastian, Alessandra, Antrim, McKayla, Chichmarenko, Mariya, and Philis-Tsimikas, Athena
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- 2024
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8. Mi Puente (My Bridge) Care Transitions Program for Hispanic/Latino Adults with Multimorbidity: Results of a Randomized Controlled Trial
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Gallo, Linda C., Fortmann, Addie L., Clark, Taylor L., Roesch, Scott C., Bravin, Julia I., Spierling Bagsic, Samantha R., Sandoval, Haley, Savin, Kimberly L., Gilmer, Todd, Talavera, Gregory A., and Philis-Tsimikas, Athena
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- 2023
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9. Outcomes of the Dulce Digital-COVID Aware (DD-CA) discharge texting platform for US/Mexico border Hispanic individuals with diabetes
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Spierling Bagsic, Samantha R., Fortmann, Addie L., San Diego, Emily Rose N., Soriano, Emily C., Belasco, Rebekah, Sandoval, Haley, Bastian, Alessandra, Padilla Neely, Olivia M., Talavera, Laura, Leven, Eric, Evancha, Nicole, and Philis-Tsimikas, Athena
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- 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
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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
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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.
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- 2021
11. Switching to once-weekly insulin icodec versus once-daily insulin degludec in individuals with basal insulin-treated type 2 diabetes (ONWARDS 2): a phase 3a, randomised, open label, multicentre, treat-to-target trial
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Philis-Tsimikas, Athena, Asong, Marisse, Franek, Edward, Jia, Ting, Rosenstock, Julio, Stachlewska, Karolina, Watada, Hirotaka, and Kellerer, Monika
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- 2023
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12. Once‐weekly insulin efsitora alfa: Design and rationale for the QWINT phase 3 clinical development programme.
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Bergenstal, Richard M., Philis‐Tsimikas, Athena, Wysham, Carol, Carr, Molly C., Bue‐Valleskey, Juliana M., Botros, Fady T., Blevins, Thomas, and Rosenstock, Julio
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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]
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- 2024
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13. Dulce Digital-Me: protocol for a randomized controlled trial of an adaptive mHealth intervention for underserved Hispanics with diabetes
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Athena Philis-Tsimikas, Addie L. Fortmann, Job G. Godino, James Schultz, Scott C. Roesch, Todd P. Gilmer, Emilia Farcas, Haley Sandoval, Kimberly L. Savin, Taylor Clark, Mariya Chichmarenko, Jennifer A. Jones, and Linda C. Gallo
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Digital ,Diabetes ,Hispanic ,Latino ,HbA1c ,Health behavior ,Medicine (General) ,R5-920 - Abstract
Abstract Background By 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. Methods This 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. Discussion Our 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 registration NCT03130699-All items from the WHO Trial Registration data set are available in https://clinicaltrials.gov/ct2/show/study/NCT03130699 .
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- 2022
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14. Tirzepatide versus insulin glargine in type 2 diabetes and increased cardiovascular risk (SURPASS-4): a randomised, open-label, parallel-group, multicentre, phase 3 trial
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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
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- 2021
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15. REPLACE-BG: A Randomized Trial Comparing Continuous Glucose Monitoring With and Without Routine Blood Glucose Monitoring in Adults With Well-Controlled Type 1 Diabetes
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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
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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.
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- 2017
16. Digital health tools to promote diabetes education and management of cardiovascular risk factors among under-resourced populations
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Tenes Paul, DO, Jordy Mehawej, MD, ScM, and Athena Philis-Tsimikas, MD
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Cultural sensitivity ,Diabetes management ,Latino ,Hispanic digital health ,Under-resourced populations ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 ,Medical technology ,R855-855.5 - Published
- 2021
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17. Medical Assistant Health Coaching for Type 2 Diabetes in Primary Care: Results From a Pragmatic Cluster Randomized Controlled Trial.
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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
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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: HbA
1c ≥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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18. My Bridge (Mi Puente), a care transitions intervention for Hispanics/Latinos with multimorbidity and behavioral health concerns: protocol for a randomized controlled trial
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Linda C. Gallo, Addie L. Fortmann, Julia I. Bravin, Taylor L. Clark, Kimberly L. Savin, Duvia Lara Ledesma, Johanna Euyoque, Haley Sandoval, Scott C. Roesch, Todd Gilmer, Gregory A. Talavera, and Athena Philis-Tsimikas
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Clinical trial ,Health behavior ,Hispanic Americans ,Mental health ,Multimorbidity ,Patient readmission ,Medicine (General) ,R5-920 - Abstract
Abstract Background Multimorbidity affects four of ten US adults and eight of ten adults ages 65 years and older, and frequently includes both cardiometabolic conditions and behavioral health concerns. Hispanics/Latinos (hereafter, Latinos) and other ethnic minorities are more vulnerable to these conditions, and face structural, social, and cultural barriers to obtaining quality physical and behavioral healthcare. We report the protocol for a randomized controlled trial that will compare Mi Puente (My Bridge), a cost-efficient care transitions intervention conducted by a specially trained Behavioral Health Nurse and Volunteer Community Mentor team, to usual care or best-practice discharge approaches, in reducing hospital utilization and improving patient reported outcomes in Latino adults with multiple cardiometabolic conditions and behavioral health concerns. The study will examine the degree to which Mi Puente produces superior reductions in hospital utilization at 30 and 180 days (primary aim) and better patient-reported outcomes (quality of life/physical health; barriers to healthcare; engagement with outpatient care; patient activation; resources for chronic disease management), and will examine the cost effectiveness of the Mi Puente intervention relative to usual care. Methods Participants are enrolled as inpatients at a South San Diego safety net hospital, using information from electronic medical records and in-person screenings. After providing written informed consent and completing self-report assessments, participants randomized to usual care receive best-practice discharge processes, which include educational materials, assistance with outpatient appointments, referrals to community-based providers, and other assistance (e.g., with billing, insurance) as required. Those randomized to Mi Puente receive usual-care materials and processes, along with inpatient visits and up to 4 weeks of follow-up phone calls from the intervention team to address their integrated physical-behavioral health needs and support the transition to outpatient care. Discussion The Mi Puente Behavioral Health Nurse and Volunteer Community Mentor team intervention is proposed as a cost-effective and culturally appropriate care transitions intervention for Latinos with multimorbidity and behavioral health concerns. If shown to be effective, close linkages with outpatient healthcare and community organizations will help maximize uptake, dissemination, and scaling of the Mi Puente intervention. Trial registration ClinicalTrials.gov: NCT02723019. Registered on 30 March 2016.
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- 2020
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19. 100 years on: the impact of the discovery of insulin on clinical outcomes
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John B Buse, Brian M Frier, and Athena Philis-Tsimikas
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Diseases of the endocrine glands. Clinical endocrinology ,RC648-665 - Abstract
Throughout history, up to the early part of the 20th century, diabetes has been a devastating disorder, particularly when diagnosed in childhood when it was usually fatal. Consequently, the successful pancreatic extraction of insulin in 1921 was a miraculous, life-changing advance. In this review, the truly transformative effect that insulin has had on the lives of people with type 1 diabetes and on those with type 2 diabetes who are also dependent on insulin is described, from the time of its first successful use to the present day. We have highlighted in turn how each of the many facets of improvements over the last century, from advancements in the properties of insulin and its formulations to the evolution of different methods of delivery, have led to continued improvement in clinical outcomes, through the use of illustrative stories from history and from our own clinical experiences. This review concludes with a brief look at the current challenges and where the next century of technological innovation in insulin therapy may take us.
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- 2021
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20. Semaglutide once weekly as add-on to SGLT-2 inhibitor therapy in type 2 diabetes (SUSTAIN 9): a randomised, placebo-controlled trial
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Zinman, Bernard, Bhosekar, Vaishali, Busch, Robert, Holst, Ingrid, Ludvik, Bernhard, Thielke, Desirée, Thrasher, James, Woo, Vincent, and Philis-Tsimikas, Athena
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- 2019
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21. Similar glycaemic control with less nocturnal hypoglycaemia in a 38-week trial comparing the IDegAsp co-formulation with insulin glargine U100 and insulin aspart in basal insulin-treated subjects with type 2 diabetes mellitus
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Philis-Tsimikas, A., Astamirova, K., Gupta, Y., Haggag, A., Roula, D., Bak, B.A., Fita, E.G., Nielsen, A.M., and Demir, T.
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- 2019
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22. 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
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Bajaj, Harpreet S., Ásbjörnsdóttir, Björg, Carstensen, Lisbeth, Laugesen, Christian, Mathieu, Chantal, Philis-Tsimikas, Athena, and Battelino, Tadej
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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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- View/download PDF
23. Efficacy and Safety of Fast-Acting Insulin Aspart in People with Type 1 Diabetes Using Carbohydrate Counting: A Post Hoc Analysis of Two Randomised Controlled Trials
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Rose, Ludger, Kadowaki, Takashi, Pieber, Thomas R., Buchholtz, Kristine, Ekelund, Magnus, Gorst-Rasmussen, Anders, and Philis-Tsimikas, Athena
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- 2019
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24. When insulin degludec enhances quality of life in patients with type 2 diabetes: a qualitative investigation
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James Weatherall, William H. Polonsky, Sally Lanar, Naomi Knoble, Jonas Håkan-Bloch, Elisabeth Constam, Athena Philis-Tsimikas, and Alexia Marrel
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Insulin degludec ,Type 2 diabetes ,Health-related quality of life ,Patient interviews ,Patient focus groups, qualitative research ,Computer applications to medicine. Medical informatics ,R858-859.7 - Abstract
Abstract Background Anecdotal reports suggest that insulin degludec (IDeg) may offer unique health-related quality of life (HRQoL) benefits. As the nature of these benefits remain unclear, this study utilized qualitative research methods to investigate and elucidate the experience of “feeling better” after initiating IDeg. Methods Twenty adults with type 2 diabetes (T2D) who reported “feeling better” on IDeg for > 3 months participated in 90-min interviews. One focus group and nine telephone interviews were conducted at two sites in the United States (US) and one focus group was conducted in Switzerland. Patients were ≥ 18 years of age, did not take mealtime insulin, and had switched to IDeg from another basal insulin. Discussions were audio-recorded, transcribed and translated (Swiss German). Utilizing grounded theory, transcripts were analyzed by sorting quotes into concepts using thematic analysis. Results Participants' mean age was 66 years and the average duration of T2D was 17.6 years. Mean duration of IDeg use was 1.45 years. Four major factors were identified as key contributors to patients’ sense of “feeling better”: 1) reduced sense of diabetes as burdensome and requiring excessive attention; 2) enhanced feelings of adaptability and freedom; 3) heightened sense of security, especially regarding concerns about hypoglycemia; and 4) greater sense of physical well-being (greater energy/less fatigue). Content saturation was achieved. Generally, patients from the US sites were more focused on medical results than Swiss patients, who were more likely to identify IDeg’s effect on overall HRQoL. A limitation of the study was that the population was primarily white, > 60 and otherwise healthy (no comorbid physical or mental condition). Conclusions A group of patients with T2D, who had switched to IDeg from another basal insulin, reported HRQoL benefits which were attributed to both diabetes-specific improvements (feeling less burdened by day-to-day diabetes demands) and non-specific gains (greater energy). The conclusions may have limited transferability due to the characteristics of the sample population and further research is needed.
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- 2018
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25. My Bridge (Mi Puente), a care transitions intervention for Hispanics/Latinos with multimorbidity and behavioral health concerns: protocol for a randomized controlled trial
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Gallo, Linda C., Fortmann, Addie L., Bravin, Julia I., Clark, Taylor L., Savin, Kimberly L., Ledesma, Duvia Lara, Euyoque, Johanna, Sandoval, Haley, Roesch, Scott C., Gilmer, Todd, Talavera, Gregory A., and Philis-Tsimikas, Athena
- Published
- 2020
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26. Process evaluation of Dulce Digital-Me: an adaptive mobile health (mHealth) intervention for underserved Hispanics with diabetes.
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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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27. Aminoguanidine Has Both Pro-oxidant and Antioxidant Activity Toward LDL
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Philis-Tsimikas, Athena, Parthasarathy, Sampath, Picard, Sylvie, Palinski, Wulf, and Witztum, Joseph L
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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.
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- 1995
28. Pilot Test of a Culturally Appropriate Diabetes Prevention Intervention for At-Risk Latina Women
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McCurley, Jessica L., Fortmann, Addie L., Gutierrez, Angela P., Gonzalez, Patricia, Euyoque, Johanna, Clark, Taylor, Preciado, Jessica, Ahmad, Aakif, Philis-Tsimikas, Athena, and Gallo, Linda C.
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- 2017
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29. When insulin degludec enhances quality of life in patients with type 2 diabetes: a qualitative investigation
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Weatherall, James, Polonsky, William H., Lanar, Sally, Knoble, Naomi, Håkan-Bloch, Jonas, Constam, Elisabeth, Philis-Tsimikas, Athena, and Marrel, Alexia
- Published
- 2018
- Full Text
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30. Initiating Basal Insulin Therapy in Type 2 Diabetes: Practical Steps to Optimize Glycemic Control
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Philis-Tsimikas, Athena
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- 2013
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31. Rationale and design of the phase 3a development programme (ONWARDS 1–6 trials) investigating once‐weekly insulin icodec in diabetes.
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Philis‐Tsimikas, Athena, Bajaj, Harpreet S., Begtrup, Kamilla, Cailleteau, Roman, Gowda, Amoolya, Lingvay, Ildiko, Mathieu, Chantal, Russell‐Jones, David, and Rosenstock, Julio
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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]
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- 2023
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32. IDF21-0140 Higher derived time in range with insulin degludec/insulin aspart vs insulin glargine U100 in Japanese adults with T2D
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Philis-Tsimikas, A., D'Cruz, J.M., De Block, C., Hachmann-Nielsen, E., Sivarathinasami, R., and Onishi, Y.
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- 2022
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33. Teen Peer Educators and Diabetes Knowledge of Low-Income Fifth Grade Students
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Coleman, Karen J., Clark, Andrea Yoder, Shordon, Maggie, Ocana, Leticia L., Walker, Chris, Araujo, Rachel A., Oratowski-Coleman, Jesica, and Philis-Tsimikas, Athena
- Published
- 2011
34. Digital health tools to promote diabetes education and management of cardiovascular risk factors among under-resourced populations
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Paul, Tenes, Mehawej, Jordy, and Philis-Tsimikas, Athena
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- 2021
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35. Tolerability, safety and adherence to treatment with insulin detemir injection in the treatment of type 2 diabetes
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Athena Philis-Tsimikas
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Medicine (General) ,R5-920 - Abstract
Athena Philis-TsimikasScripps Whittier Diabetes Institute, La Jolla, CA, USAAbstract: The progressive nature of type 2 diabetes poses challenges in the clinic: treatment must be continually reviewed and adjusted in response to the patient’s changing pathophysiology. Ultimately, insulin replacement therapy will be necessary as the physiological insulin response is compromised. The modern basal insulin analog insulin detemir has been the subject of several clinical trials and observational studies in type 2 diabetes. Compared with NPH insulin, insulin detemir offers an improved balance between achieving current glycemic targets with acceptable tolerability. Insulin detemir also has a unique weight-sparing effect which is associated with body mass index, and this may be a particular advantage to obese patients with type 2 diabetes. This review summarizes data from key clinical studies of insulin detemir, and also provides insights from observational studies.Keywords: type 2 diabetes mellitus, insulin detemir, modern analog, basal insulin
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- 2008
36. Dulce Mothers: an intervention to reduce diabetes and cardiovascular risk in Latinas after gestational diabetes
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Philis-Tsimikas, Athena, Fortmann, Addie L., Dharkar-Surber, Sapna, Euyoque, Johanna A., Ruiz, Monica, Schultz, James, and Gallo, Linda C.
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- 2014
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37. Implementing Community-Based Diabetes Programs: The Scripps Whittier Diabetes Institute Experience
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Philis-Tsimikas, Athena and Gallo, Linda C.
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- 2014
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38. Improved Glycemia with Hybrid Closed-Loop (HCL) Versus Continuous Subcutaneous Insulin Infusion (CSII) Therapy: Results from a Randomized Controlled Trial.
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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.
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- 2023
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39. Insulin Degludec Once-Daily in Type 2 Diabetes: Simple or Step-Wise Titration (BEGIN: Once Simple Use)
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Philis-Tsimikas, Athena, Brod, Meryl, Niemeyer, Marcus, Ocampo Francisco, Ann Marie, and Rothman, Jeffrey
- Published
- 2013
- Full Text
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40. Community-created programs: can they be the basis of innovative transformations in our health care practice? implications from 15 years of testing, translating, and implementing community-based, culturally tailored diabetes management programs
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Philis-Tsimikas, Athena, Gilmer, Todd P., Schultz, James, Walker, Chris, Fortmann, Addie L., and Gallo, Linda C.
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Cholesterol ,Chronic diseases ,Diabetes ,Health care industry ,Health care industry ,Company business management ,Health ,American Diabetes Association -- Management - Abstract
Diabetes prevalence is predicted to rise dramatically during the next 20 years, and associated spending is expected to increase threefold. (1-3) Cultural barriers contribute to this burden by preventing optimal [...]
- Published
- 2012
41. Indicadores clinicos y apoyo para el manejo de la enfermedad, la depresion, el autocuidado en hispanos que padecen diabetes tipo 2 en el Condado de San Diego, Estados Unidos
- Author
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Fortmann, Addie L., Gallo, Linda C., Walker, Chris, and Philis-Tsimikas, Athena
- Published
- 2010
42. A comparison of adding liraglutide versus a single daily dose of insulin aspart to insulin degludec in subjects with type 2 diabetes (BEGIN: VICTOZA ADD-ON)
- Author
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Mathieu, C., Rodbard, H. W., Cariou, B., Handelsman, Y., Philis-Tsimikas, A., Ocampo Francisco, A. M., Rana, A., and Zinman, B.
- Published
- 2014
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43. A New Option for Glycemic Control: Insulin Degludec, a New-Generation Basal Insulin with an Ultralong Duration of Action
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Drab, Scott R. and Philis-Tsimikas, Athena
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- 2014
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44. Similar hypoglycemia duration with once-weekly icodec versus degludec or glargine U100 in insulin-treated T2D: a post hoc CGM analysis from ONWARDS 2 & 4.
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Kellerer, Monika, Bajaj, Harpreet Singh, Ásbjörnsdóttir, Björg, Carstensen, Lisbeth, Lehrskov, Lars Lang, Mathieu, Chantal, Philis-Tsimikas, Athena, and Battelino, Tadej
- Published
- 2024
- Full Text
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45. Comparison of insulin degludec with insulin glargine in insulin-naive subjects with Type 2 diabetes: a 2-year randomized, treat-to-target trial
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Rodbard, H. W., Cariou, B., Zinman, B., Handelsman, Y., Philis-Tsimikas, A., Skjth, T. V., Rana, A., and Mathieu, C.
- Published
- 2013
- Full Text
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46. Effect of insulin degludec versus sitagliptin in patients with type 2 diabetes uncontrolled on oral antidiabetic agents
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Philis-Tsimikas, A., Del Prato, S., Satman, I., Bhargava, A., Dharmalingam, M., Skjth, T. V., Rasmussen, S., and Garber, A. J.
- Published
- 2013
- Full Text
- View/download PDF
47. Insulin Degludec Versus Insulin Glargine in Insulin-Naive Patients With Type 2 Diabetes: A 1-year, randomized, treat-to-target trial (BEGIN Once Long)
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Zinman, Bernard, Philis-Tsimikas, Athena, Cariou, Bertrand, Handelsman, Yehuda, Rodbard, Helena W., Johansen, Thue, Endahl, Lars, and Mathieu, Chantal
- Published
- 2012
- Full Text
- View/download PDF
48. Safety and Glycemic Outcomes During the MiniMed™ Advanced Hybrid Closed-Loop System Pivotal Trial in Adolescents and Adults with Type 1 Diabetes.
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Carlson, Anders L., Sherr, Jennifer L., Shulman, Dorothy I., Garg, Satish K., Pop-Busui, Rodica, Bode, Bruce W., Lilenquist, David R., Brazg, Ron L., Kaiserman, Kevin B., Kipnes, Mark S., Thrasher, James R., Reed, John H. Chip, Slover, Robert H., Philis-Tsimikas, Athena, Christiansen, Mark, Grosman, Benyamin, Roy, Anirban, Vella, Melissa, Jonkers, Richard A.M., and Chen, Xiaoxiao
- Published
- 2022
- Full Text
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49. Process evaluation of a medical assistant health coaching intervention for type 2 diabetes in diverse primary care settings.
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Clark, Taylor L, Fortmann, Addie L, Philis-Tsimikas, Athena, Bodenheimer, Thomas, Savin, Kimberly L, Sandoval, Haley, Bravin, Julia I, and Gallo, Linda C
- Abstract
Team-based models that use medical assistants (MAs) to provide self-management support for adults with type 2 diabetes (T2D) have not been pragmatically tested in diverse samples. This cluster-randomized controlled trial compares MA health coaching with usual care in adults with T2D and poor clinical control ("MAC Trial"). The purpose was to conduct a multi-method process evaluation of the MAC Trial using the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework. Reach was assessed by calculating the proportion of enrolled participants out of the eligible pool and examining representativeness of those enrolled. Key informant interviews documented adoption by MA Health Coaches. We examined implementation from the research and patient perspectives by evaluating protocol adherence and the Patient Perceptions of Chronic Illness Care (PACIC-SF) measure, respectively. Findings indicate that the MAC Trial was efficient and effective in reaching patients who were representative of the target population. The acceptance rate among those approached for health coaching was high (87%). Both MA Health Coaches reported high satisfaction with the program and high levels of confidence in their role. The intervention was well-implemented, as evidenced by the protocol adherence rate of 79%; however, statistically significant changes in PACIC-SF scores were not observed. Overall, if found to be effective in improving clinical and patient-reported outcomes, the MAC model holds potential for wider-scale implementation given its successful adoption and implementation and demonstrated ability to reach patients with poorly controlled T2D who are at-risk for diabetes complications in diverse primary care settings. [ABSTRACT FROM AUTHOR]
- Published
- 2022
- Full Text
- View/download PDF
50. Impact of kidney function on the safety and efficacy of insulin degludec versus insulin glargine U300 in people with type 2 diabetes: A post hoc analysis of the CONCLUDE trial.
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Pieber, Thomas R., Bajaj, Harpreet S., Heller, Simon R., Jia, Ting, Khunti, Kamlesh, Klonoff, David C., Ladelund, Steen, Leiter, Lawrence A., Wagner, Lily, and Philis‐Tsimikas, Athena
- Subjects
TYPE 2 diabetes ,INSULIN aspart ,KIDNEY physiology ,INSULIN ,TYPE 1 diabetes ,GLYCEMIC control - Abstract
Keywords: insulin analogues; insulin therapy; type 2 diabetes EN insulin analogues insulin therapy type 2 diabetes 332 336 5 01/11/22 20220201 NES 220201 PEER REVIEW The peer review history for this article is available at https://publons.com/publon/10.1111/dom.14564. Risk of hypoglycaemia with insulin degludec versus insulin glargine U300 in insulin-treated patients with type 2 diabetes: the randomised, head-to-head CONCLUDE trial. HbA1c levels and rates of hypoglycemia with insulin degludec U200 and insulin glargine U300 stratified by estimated renal function in people with type 2 diabetes: a post hoc analysis from the CONCLUDE trial. [Extracted from the article]
- Published
- 2022
- Full Text
- View/download PDF
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