Citations 2
Endothelial Cell Loss 1 Year After Successful DMEK in the Diabetes Endothelial Keratoplasty Study
Lass, Jonathan H. , Lass, Jonathan H., Benetz, Beth Ann, Verdier, David D., Szczotka-Flynn, Loretta B., Bauza, Colleen E., Reed, Zachariah W., Greiner, Mark A., Mian, Shahzad I., Patel, Sanjay V., Pramanik, Sudeep, Price, Francis W., Soper, Mark C., Terry, Mark A., Titus, Michael S., Kollman, Craig, Beck, Roy W., Price, Marianne O., Group, Diabetes Endothelial Keratoplasty Study, Gang, Anjulie, Hall, Taylor, Lucas, Katelyn, Lynn, Ashlyn, Cole, Shawna, Phelps, Derek, Baratz, Keith H. , Hardtke, Elainey, Treichel, Emily J., Hood, Christopher , Nallasamy, Nambi , Verkade, Angela , Jones, Kristin, Shapiro, Jeremy N. , Leavy, Lisa, Sinkey, Chris, Tenkman, Lawrence R., Gordon, DJ, Ketcherside, Christopher, Fox, Jenni, Coonfield, Kristy, Vislisel, Jesse M., Sharma, Yogi, Young, Angela M. , Schoenberg, Evan, Kelly, Sharra, Huffman, James, Sears, Melinda, Stone, Merisa, Phillips, Paul, Maloney, Charlene, Jun, Albert S. , Maria, Christina, Boyce, Michelle, Kam, Yong, Crosser, Vicki, Chen, Jessica , Straiko, Michael D., Bauer, Alex, Croasdale, Christopher, Brown, Gayle Waldheim, Veldman, Peter B., Evans, Que, Majmudar, Parag A., Epstein, Rachel , Vaidya, Neal, Rosselson, Marie, Nykaza, Jim, Jurkunas, Ula V., Venkateswaran, Nandini, Cheung, Michael K., Ayres, Brandon D. , Haught, Drew Monteleone, Prasad, Elizabeth, Toti, G, Wier, Jim, Brandsdorfer, Ari, Pape, Denise, Hansen, Mark, Hardten, David R., Reeves, Sherman, Dreyer, Allison, Mack, Megan, Hamill, M. Bowes , Nguyen, Jessica, Koo, Ellen, Stanfield, Ryan, Greenwood, Michael, Ernst, L, Messer, Brooke, Risbrudt, Nick, Stofferahn, Seth, Saville, Alyson, Castaneda, Leslie, Torres, Nidia, Potts, Luke B. , Alexander, Jamie, Rinn, Jennifer, Bokosky, John, Cardenas, Ilina, Murphy, Doreen, Priebe, Kinsey, Sica, Chris, Buckman, Natalie, Ansin, Amy, Clover, Jameson , Pivoney, Charles, Vizzerra, Anthony, Elbanhawy, Lindsey, Mullins, Monica, Statz, Brianne, Fout, Elizabeth, Drury, Donna, Tavolazzi, Trisha, Lass, Jonathan, Lass, Jonathan, Szczotka-Flynn, Loretta, Richards, Leslie, Raghupathy, Sangeetha, Spruill, Rashad, Bauza, Colleen, Kollman, Craig, Garrett, Kaitlyn, Reed, Zachariah, Benetz, Beth Ann, Lê, Jimmy T. , Redford, Maryann , Arafah, Baha M. , Greiner, Mark, Johnson, Paula C, Keeler, D. K., Monnier, Vincent M. , Titus, Michael, Verdier, David, Soper, Mark, Velhuisen, Paul Van, Hawkins, Barbara S., Macsai, Marian S., Patel, Sanjay, Mian, Shahzad, Pramanik, Sudeep, Price, Francis, Terry, Mark, Sell, David, Gabrielson, Deanna, Barton, Glenn, Bear, Andrew, Das, Pravamaya, Dawson, Lauren, Dingess, Ryan, Madere, Mark, Sengupta, Pratim , Wadleigh, Garth, Greiner, Mark A. , Lass, Jonathan H., Benetz, Beth Ann, Verdier, David D., Szczotka-Flynn, Loretta B., Bauza, Colleen E., Reed, Zachariah W., Greiner, Mark A., Mian, Shahzad I., Patel, Sanjay V., Pramanik, Sudeep, Price, Francis W., Soper, Mark C., Terry, Mark A., Titus, Michael S., Kollman, Craig, Price, Marianne O., Group, Diabetes Endothelial Keratoplasty Study, Gang, Anjulie, Hall, Taylor, Lucas, Katelyn, Lynn, Ashlyn, Cole, Shawna, Phelps, Derek, Hood, Christopher, Sáles, Christopher S. , Sinkey, Chris, Gordon, DJ, Ketcherside, Christopher, Fox, Jenni, Young, Angela, Schoenberg, Evan, Kelly, Sharra, Huffman, James, Sears, Melinda, Stone, Merisa, Srikumaran, Divya S. , Daoud, Yassine J. , Eghrari, Allen Omid , Ali, Muhammad , Croasdale, Christopher, Brown, Gayle Waldheim, Epstein, Rachel H. , Vaidya, Neal, Jurkunas, Ula V. , Cheung, Michael, Prasad, Elizabeth, Toti, Gwen, Brandsdorfer, Ari, Pape, Denise, Hansen, Mark, Reeves, Sherman, Dreyer, Allison, Mack, Megan, Nguyen, Jessica, Greenwood, Michael, Messer, Brooke, Saville, Alyson, Omar, Ahmed F. , Castaneda, Leslie, Torres, Nidia, Rinn, Jennifer, Bokosky, John, Cardenas, Ilina, Murphy, Doreen, Priebe, Kinsey, Sica, Chris, Schmidt, Gregory A. , Lass, Jonathan, Lass, Jonathan, Price, Marianne O. , Szczotka-Flynn, Loretta, Richards, Leslie, Bauza, Colleen, Beck, Roy W. , Kollman, Craig, McCarthy, Chris, Garrett, Kaitlyn, Reed, Zachariah, Benetz, Beth Ann, Greiner, Mark, Johnson, Paula, Titus, Michael, Verdier, David, Soper, Mark, Aleppo, Grazia , Bateman-House, Alison , Tu, Elmer Yuchen , Patel, Sanjay, Mian, Shahzad, Pramanik, Sudeep, Price, Francis, Terry, Mark, Sell, David, Gabrielson, Deanna, Barton, Glenn, Bear, Andrew, Das, Pravamaya, Dingess, Ryan, Sengupta, Paromita
JAMA Ophthalmology | October 17, 2025 | Volume: 143 | Issue: 12 | Pages: 1053
10.1001/jamaophthalmol.2025.4261
Importance The effect of cornea donor diabetes on endothelial cell density (ECD) and morphometry after Descemet membrane endothelial keratoplasty (DMEK) is not known. Objective To determine whether endothelial cell loss (ECL) and morphometric changes 1 year after successful DMEK are related to cornea donor’s diabetes status. Design, Setting, and Participants This was a multicenter, double-masked, randomized clinical trial conducted from February 2022 to July 2024 at 28 US clinical sites (46 surgeons) and 13 eye banks. Included in the trial were the eyes of recipients (some of whom received tissue from donors without diabetes and others who received tissue from donors with diabetes) who underwent successful DMEK, primarily for Fuchs endothelial corneal dystrophy, and had at least 1 analyzable postoperative endothelial image. Intervention DMEK performed with a cornea from a donor without or with diabetes, assigned using a minimization procedure to achieve an approximate 2:1 distribution. Main Outcomes and Measures ECD, ECL, coefficient of variation in cell area (CV), and percentage of hexagonal cells (HEX) at 1 year from eye bank and postoperative specular central endothelial images. Results A total 1274 eyes of 982 recipients (mean [SD] age, 70 [8] years; 569 female [57.9%]; 816 [64.1%] with tissue from donors without diabetes and 458 [35.9%] with tissue from donors with diabetes) were included in the study. Preoperatively, mean (SD) central ECD in tissue from donors without diabetes and with diabetes were 2676 (290) cells/mm 2 and 2671 (286) cells/mm 2 , respectively. At 1 year, mean (SD) ECL was 28.3% (16.1%) and 28.0% (17.0%), in the donor groups without and with diabetes, respectively (adjusted mean difference = −0.4%; 95% CI, −2.3% to 1.4%), resulting in a mean (SD) 1-year ECD of 1927 (498) cells/mm 2 and 1920 (496) cells/mm 2 , respectively (adjusted mean difference = 10 cells/mm 2 ; 95% CI, −36 to 56; P = .95). No difference in ECD at 1 year associated with diabetes severity was noted ( P = .97). Mean (SD) CV did not differ at 1 year between the 2 groups of eyes (31.5% [4.1%] vs 31.4% [4.1%]; adjusted mean difference = −0.4%; 95% CI, −0.9% to 0.1%; P = .51), and mean (SD) HEX did not differ at 1 year between the 2 groups of eyes (57.7% [5.8%] vs 57.2% [5.8%]; adjusted mean difference = 0.1%, 95% CI, −0.8% to 0.9%; P = .33). Conclusions and Relevance This randomized clinical trial found that ECL and morphometry 1 year after DMEK were not affected by cornea donor diabetes status. With comparable 1-year graft success with tissue from donors with and without diabetes demonstrated in this trial, these findings support the use of corneas from donors with diabetes for endothelial keratoplasty procedures. Trial Registration ClinicalTrials.gov Identifier: NCT05134480
Closed-Loop Insulin Therapy Improves Glycemic Control in Adolescents and Young Adults: Outcomes from the International Diabetes Closed-Loop Trial
Isganaitis, Elvira , Raghinaru, Dan, Ambler-Osborn, Louise, Pinsker, Jordan E. , Buckingham, Bruce A. , Ekhlaspour, Laya , Kudva, Yogish C., Forlenza, Gregory P. , Beck, Roy W., Kollman, Craig, Lum, John W. , Brown, Sue A. , Laffel, Lori M. , Kovatchev, Boris, Anderson, Stacey, Emory, Emma, Voelmle, Mary, Conshafter, Katie, Morris, Kim, Gondor-Fredrick, Linda, Mitchell, Harry, Calvo, Kayla, Wakeman, Christian, Breton, Marc, Flint, Emily, Kim, Kenny, Roethke, Lindsay, Church, Mei Mei , André, Camille , Piper, Molly, Lam, David , O’Malley, Grenye , Levister, Camilla, Ogyaadu, Selassie, Lovett, Jessica, Simha, Vinaya , Dadlani, Vikash, McCrady-Spitzer, Shelly , Reid, Corey, Alonso, G. Todd, Slover, Robert H., Jost, Emily , Berget, Cari, Towers, Lindsey, Rossick-Solis, Alex, Jacobson, Tali, Town, Marissa, Tabatabai, Ideen , Keller, Jordan, Salas, Evalina, Dassau, Eyal , Passman, Samantha, Campos, Tiffany, Murphy, Carlos, Patibandla, Nandan, Borgman, Sarah, Arreaza-Rubín, Guillermo , Green, Neal, Laffel, Lori, Pinsker, Jordan, Doyle, Francis, Renard, Eric, Reznik, Yves , Lum, John, Janicek, Robert, Gabrielson, Deanna, Belle, Steven H., Castle, Jessica R. , Green, Jennifer , Legault, Laurent , Wysham, Carol , Eggerman, Thomas, Forlenza, Gregory P , Buckingham, Bruce , Wadwa, R Paul , Kudva, Yogish C. , Levy, Carol J. , Kollman, Craig , Kovatchev, Boris , Anderson, Stacey M. , Oliveri, Mary Clancy , Kumari, Kanchan , Messer, Laurel H , Jacobson, Tali, Doyle, Francis J. , Patibandla, Nandan, Laffel, Lori M. , Cobelli, Claudio , Beck, Roy W. , Willi, Steven Matthew
Diabetes Technology & Therapeutics | November 20, 2020 | Volume: 23 | Issue: 5 | Pages: 342-349
Objective: To assess the efficacy and safety of closed-loop control (CLC) insulin delivery system in adolescents and young adults with type 1 diabetes. Research Design and Methods: Prespecified subanalysis of outcomes in adolescents and young adults aged 14–24 years old with type 1 diabetes in a previously published 6-month multicenter randomized trial. Participants were randomly assigned 2:1 to CLC (Tandem Control-IQ) or sensor augmented pump (SAP, various pumps+Dexcom G6 CGM) and followed for 6 months. Results: Mean age of the 63 participants was 17 years, median type 1 diabetes duration was 7 years, and mean baseline HbA1c was 8.1%. All 63 completed the trial. Time in range (TIR) increased by 13% with CLC versus decreasing by 1% with SAP (adjusted treatment group difference = +13% [+3.1 h/day]; 95% confidence interval [CI] 9–16, P < 0.001), which largely reflected a reduction in time >180 mg/dL (adjusted difference −12% [−2.9 h/day], P < 0.001). Time <70 mg/dL decreased by 1.6% with CLC versus 0.3% with SAP (adjusted difference −0.7% [−10 min/day], 95% CI −1.0% to −0.2%, P = 0.002). CLC use averaged 89% of the time for 6 months. The mean adjusted difference in HbA1c after 6 months was 0.30% in CLC versus SAP (95% CI −0.67 to +0.08, P = 0.13). There was one diabetic ketoacidosis episode in the CLC group. Conclusions: CLC use for 6 months was substantial and associated with improved TIR and reduced hypoglycemia in adolescents and young adults with type 1 diabetes. Thus, CLC has the potential to improve glycemic outcomes in this challenging age group. The clinical trial was registered with ClinicalTrials.gov (NCT03563313).