Improved Health-Related Quality of Life in a Phase 3 Islet Transplantation Trial in Type 1 Diabetes Complicated by Severe Hypoglycemia
Author:
Foster Eric D.1ORCID, Bridges Nancy D.2, Feurer Irene D.3, Eggerman Thomas L.4, Hunsicker Lawrence G.1, Alejandro Rodolfo5ORCID, Begley Beth, Cano Jose, Carpentier Sallie, Hutchinson Jennifer, Larsen Christian P., Moreno Johanna, Sears Marti, Turgeon Nicole A., Webster Dasia, Markmann James F., Al-saden Patrice, Chen Xioajuan, Hecyk Angela, Luo Xunrong, Molitch Mark, Monson Natalie, Stuart Elyse, Wallia Amisha, Wang Lingjia, Wang Shusen, Zhang Xiaomin, Czarniecki Christine W., Goldstein Julia S., Priore Allison, Robien Mark A., Schneider Elizabeth, Arreaza-Rubin Guillermo, Green Neal, Bigam David L., Campbell Patricia, Dinyari Parastoo, Kin Tatsuya, Kneteman Norman M., Lyon James, Malcolm Andrew, O’Gorman Doug, Onderka Chris, Owen Richard, Pawlick Rena, Richer Brad, Rosichuk Shawn, Sarman Donna, Schroeder Adam, Senior Peter A., Shapiro A. M. James, Toth Lana, Toth Vali, Zhai Wendy, Johnson Kristina, McElroy Joan, Posselt Andrew M., Ramos Marissa, Rojas Tara, Stock Peter G., Szot Gregory, Barbaro Barbara, Martellotto Joan, Oberholzer Jose, Qi Meirigeng, Wang Yong, Bayman Levent, Chaloner Kathryn, Clarke William R., Dillon Joseph S., Diltz Cynthia, Doelle Gregory C., Ecklund Dixie, Feddersen Deb, Jasperson Carol, Lafontant David-Erick, Neill-Hudson Tina, Nollen Deb, Qidwai Julie, Riss Holly, Schwieger Traci, Willits Jamie, Yankey Jon, Corrales Andrea Curry, Faradji Raquel, Froud Tatiana, Alvarez Gil Ana, Herrada Eva, Inverardi Luca, Kenyon Norma, Khan Aisha, Linetsky Elina, Peixoto Eduardo, Ricordi Camillo, Abdulla Muhamad H., Balamurugan A. N., Bellin Melena D., Brandenburg Mary, Harmon James V., Hering Bernhard J., Kandaswamy Raja, Loganathan Gopal, Mueller Kate, Papas Klearchos K., Pedersen Jayne, Wilhelm Joshua J., Witson Jean, Dalton-Bakes Cornelia, Fu Hongxing, Kamoun Malek, Kearns Jane, Li Yanjing, Liu Chengyang, Luning-Prak Eline, Luo Yanping, Markmann Eileen, Min Zaw, Naji Ali, Palanjian Maral, Rickels Michael R., Shlansky-Goldberg Richard, Vivek Kumar, Ziaie Amin Sam, Kaufman Dixon B., Korsgren Olle,
Affiliation:
1. Clinical Trials Statistical and Data Management Center, Department of Biostatistics, University of Iowa, Iowa City, IA 2. National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD 3. Departments of Surgery and Biostatistics, Vanderbilt University Medical Center, and Vanderbilt Transplant Center, Nashville, TN 4. National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD 5. Diabetes Research Institute, Miller School of Medicine, University of Miami, Miami, FL
Abstract
OBJECTIVE
Attaining glycemic targets without severe hypoglycemic events (SHEs) is a challenging treatment goal for patients with type 1 diabetes complicated by impaired awareness of hypoglycemia (IAH). The CIT Consortium Protocol 07 (CIT-07) trial showed islet transplantation to be an effective treatment for subjects with IAH and intractable SHEs. We evaluated health-related quality of life (HRQOL), functional health status, and health utility before and after pancreatic islet transplantation in CIT-07 trial participants.
RESEARCH DESIGN AND METHODS
Four surveys, the Diabetes Distress Scale (DDS), the Hypoglycemic Fear Survey (HFS), the Short Form 36 Health Survey (SF-36), and the EuroQoL 5 Dimensions (EQ-5D), were administered repeatedly before and after islet transplantation. Summary statistics and longitudinal modeling were used to describe changes in survey scores from baseline and to characterize change in relation to a minimally important difference (MID) threshold of half an SD.
RESULTS
Improvements in condition-specific HRQOL met the MID threshold. Reductions from baseline in the DDS total score and its four DDS subscales (all P ≤ 0.0013) and in the HFS total score and its two subscales (all P < 0.0001) were observed across all time points. Improvements were observed after both 1 and 2 years for the EQ-5D visual analog scale (both P < 0.0001).
CONCLUSIONS
In CIT-07, 87.5% of the subjects achieved the primary end point of freedom from SHE along with glycemic control (HbA1c <7% [<53 mmol/mol]) at 1 year post–initial islet transplantation. The same subjects reported consistent, statistically significant, and clinically meaningful improvements in condition-specific HRQOL as well as self-assessments of overall health.
Publisher
American Diabetes Association
Subject
Advanced and Specialized Nursing,Endocrinology, Diabetes and Metabolism,Internal Medicine
Cited by
89 articles.
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