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Improved Health-Related Quality of Life in a Phase 3 Islet Transplantation Trial in Type 1 Diabetes Complicated by Severe Hypoglycemia.
Foster, Eric D; Bridges, Nancy D; Feurer, Irene D; Eggerman, Thomas L; Hunsicker, Lawrence G; Alejandro, Rodolfo.
Afiliación
  • Foster ED; Clinical Trials Statistical and Data Management Center, Department of Biostatistics, University of Iowa, Iowa City, IA eric-foster@uiowa.edu.
  • Bridges ND; National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD.
  • Feurer ID; Departments of Surgery and Biostatistics, Vanderbilt University Medical Center, and Vanderbilt Transplant Center, Nashville, TN.
  • Eggerman TL; National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD.
  • Hunsicker LG; Clinical Trials Statistical and Data Management Center, Department of Biostatistics, University of Iowa, Iowa City, IA.
  • Alejandro R; Diabetes Research Institute, Miller School of Medicine, University of Miami, Miami, FL.
Diabetes Care ; 41(5): 1001-1008, 2018 05.
Article en En | MEDLINE | ID: mdl-29563196
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Calidad de Vida / Estado de Salud / Trasplante de Islotes Pancreáticos / Diabetes Mellitus Tipo 1 / Hipoglucemia Tipo de estudio: Clinical_trials / Guideline / Observational_studies / Prognostic_studies / Risk_factors_studies Aspecto: Determinantes_sociais_saude / Patient_preference Límite: Adult / Female / Humans / Male / Middle aged Idioma: En Revista: Diabetes Care Año: 2018 Tipo del documento: Article Pais de publicación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Calidad de Vida / Estado de Salud / Trasplante de Islotes Pancreáticos / Diabetes Mellitus Tipo 1 / Hipoglucemia Tipo de estudio: Clinical_trials / Guideline / Observational_studies / Prognostic_studies / Risk_factors_studies Aspecto: Determinantes_sociais_saude / Patient_preference Límite: Adult / Female / Humans / Male / Middle aged Idioma: En Revista: Diabetes Care Año: 2018 Tipo del documento: Article Pais de publicación: Estados Unidos