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Patient-Reported Outcomes in a Randomized Trial of Closed-Loop Control: The Pivotal International Diabetes Closed-Loop Trial

التفاصيل البيبلوغرافية
العنوان: Patient-Reported Outcomes in a Randomized Trial of Closed-Loop Control: The Pivotal International Diabetes Closed-Loop Trial
المؤلفون: Kudva, Yogish, Laffel, Lori, Brown, Sue, Raghinaru, Dan, Pinsker, Jordan, Ekhlaspour, Laya, Levy, Carol, Messer, Laurel, Kovatchev, Boris, Lum, John, Beck, Roy, Gonder-Frederick, Linda, Anderson, Stacey, Emory, Emma, Voelmle, Mary, Conshafter, Katie, Morris, Kim, Oliveri, Mary, Mitchell, Harry, Calvo, Kayla, Wakeman, Christian, Breton, Marc, Isganaitis, Elvira, Ambler-Osborn, Louise, Flint, Emily, Kim, Kenny, Roethke, Lindsay, Church, Mei, Andre, Camille, Piper, Molly, Lam, David, O'Malley, Grenye, Levister, Camilla, Ogyaadu, Selassie, Lovett, Jessica, Simha, Vinaya, Dadlani, Vikash, Mccrady-Spitzer, Shelly, Reid, Corey, Kumari, Kanchan, Wadwa, R. Paul, Forlenza, Greg, Alonso, G. Todd, Slover, Robert, Jost, Emily, Berget, Cari, Towers, Lindsey, Rossick-Solis, Alex, Buckingham, Bruce, Jacobson, Tali, Town, Marissa, Tabatabai, Ideen, Keller, Jordan, Salas, Evalina, Doyle, Francis, Dassau, Eyal, Passman, Samantha, Campos, Tiffany, Kollman, Craig, Murphy, Carlos, Patibandla, Nandan, Borgman, Sarah, Arreaza-Rubín, Guillermo, Green, Neal, Renard, Eric, Cobelli, Claudio, Reznik, Yves, Janicek, Robert, Gabrielson, Deanna, Belle, Steven, Castle, Jessica, Green, Jennifer, Legault, Laurent, Willi, Steven, Wysham, Carol, Eggerman, Thomas
المساهمون: Mayo Clinic Rochester, Joslin Diabetes Center, Harvard Medical School Boston (HMS), University of Virginia, Jaeb Center for Health Research, William Sansum Diabetes Center (SDRI), Stanford University, Icahn School of Medicine at Mount Sinai New York (MSSM), Barbara Davis Center for Childhood Diabetes (BDC), University of Colorado Anschutz Aurora, Centre Hospitalier Régional Universitaire Montpellier (CHRU Montpellier), Institut de Génomique Fonctionnelle (IGF), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS)
المصدر: ISSN: 1520-9156.
بيانات النشر: HAL CCSD
Mary Ann Liebert
سنة النشر: 2021
المجموعة: Université de Montpellier: HAL
مصطلحات موضوعية: Adolescents, Adults, Diabetes distress, Hypoglycemia awareness, Hypoglycemia fear, Patient-reported outcomes, Usability, MESH: Adolescent, MESH: Adult, MESH: Blood Glucose, MESH: Blood Glucose Self-Monitoring, MESH: Diabetes Mellitus, Type 1, MESH: Humans, MESH: Hypoglycemic Agents, MESH: Insulin, MESH: Insulin Infusion Systems, MESH: Patient Reported Outcome Measures, [SDV.MHEP.EM]Life Sciences [q-bio]/Human health and pathology/Endocrinology and metabolism
الوصف: International audience ; Background: Closed-loop control (CLC) has been shown to improve glucose time in range and other glucose metrics; however, randomized trials >3 months comparing CLC with sensor-augmented pump (SAP) therapy are limited. We recently reported glucose control outcomes from the 6-month international Diabetes Closed-Loop (iDCL) trial; we now report patient-reported outcomes (PROs) in this iDCL trial. Methods: Participants were randomized 2:1 to CLC (N = 112) versus SAP (N = 56) and completed questionnaires, including Hypoglycemia Fear Survey, Diabetes Distress Scale (DDS), Hypoglycemia Awareness, Hypoglycemia Confidence, Hyperglycemia Avoidance, and Positive Expectancies of CLC (INSPIRE) at baseline, 3, and 6 months. CLC participants also completed Diabetes Technology Expectations and Acceptance and System Usability Scale (SUS). Results: The Hypoglycemia Fear Survey Behavior subscale improved significantly after 6 months of CLC compared with SAP. DDS did not differ except for powerless subscale scores, which worsened at 3 months in SAP. Whereas Hypoglycemia Awareness and Hyperglycemia Avoidance did not differ between groups, CLC participants showed a tendency toward improved confidence in managing hypoglycemia. The INSPIRE questionnaire showed favorable scores in the CLC group for teens and parents, with a similar trend for adults. At baseline and 6 months, CLC participants had high positive expectations for the device with Diabetes Technology Acceptance and SUS showing high benefit and low burden scores. Conclusion: CLC improved some PROs compared with SAP. Participants reported high benefit and low burden with CLC. Clinical Trial Identifier: NCT03563313.
نوع الوثيقة: article in journal/newspaper
اللغة: English
العلاقة: info:eu-repo/semantics/altIdentifier/pmid/34115959; hal-03652114; https://hal.umontpellier.fr/hal-03652114Test; PUBMED: 34115959; PUBMEDCENTRAL: PMC8573794
DOI: 10.1089/dia.2021.0089
الإتاحة: https://doi.org/10.1089/dia.2021.0089Test
https://hal.umontpellier.fr/hal-03652114Test
رقم الانضمام: edsbas.87ED0150
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IllustrationInfo