Citations 1
Patient-Reported Outcomes in a Randomized Trial of Closed-Loop Control: The Pivotal International Diabetes Closed-Loop Trial
Kudva, Yogish C. , Laffel, Lori M. , Brown, Sue A. , Raghinaru, Dan, Pinsker, Jordan E. , Ekhlaspour, Laya , Messer, Laurel H. , Kovatchev, Boris , Lum, John W. , Gonder‐Frederick, Linda , Anderson, Stacey M. , Emory, Emma, Voelmle, Mary, Conshafter, Katie, Morris, Kim, Mitchell, Harry, Calvo, Kayla, Wakeman, Christian, Breton, Marc D. , Ambler-Osborn, Louise, Flint, Emily, Kim, Kenny, Roethke, Lindsay, Church, Mei Mei , André, Camille , Piper, Molly, Lam, David W. , O’Malley, Grenye , Levister, Camilla, Ogyaadu, Selassie, Lovett, Jessica, Simha, Vinaya , Dadlani, Vikash, McCrady-Spitzer, Shelly , Reid, Corey, Forlenza, Gregory P. , Alonso, G. Todd, Slover, Robert H., Jost, Emily , Berget, Cari , Towers, Lindsey, Rossick-Solis, Alex, Buckingham, Bruce A. , Jacobson, Tali, Town, Marissa, Tabatabai, Ideen , Keller, Jordan, Salas, Evalina, Dassau, Eyal , Passman, Samantha, Campos, Tiffany, Kollman, Craig, Murphy, Carlos, Patibandla, Nandan, Borgman, Sarah, Arreaza-Rubín, Guillermo , Green, Neal, Reznik, Yves , Janicek, Robert, Gabrielson, Deanna, Belle, Steven H., Castle, Jessica R. , Legault, Laurent , Wysham, Carol , Eggerman, Thomas L., Messer, Laurel H , Lum, John , Forlenza, Gregory P , Kovatchev, Boris , Buckingham, Bruce , Levy, Carol J. , Beck, Roy W. , Oliveri, Mary Clancy , Isganaitis, Elvira , Kumari, Kanchan, Wadwa, R Paul , Doyle, Francis J. , Kollman, Craig , Renard, Eric , Cobelli, Claudio , Green, Jennifer Greif , Willi, Steven Matthew
Diabetes Technology & Therapeutics | June 11, 2021 | Volume: 23 | Issue: 10 | Pages: 673-683
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.