Yogish C Kudva1, Lori M Laffel2, Sue A Brown3,4, Dan Raghinaru5, Jordan E Pinsker6, Laya Ekhlaspour7, Carol J Levy8, Laurel H Messer9, Boris P Kovatchev3, John W Lum5, Roy W Beck5, Linda Gonder-Frederick3. 1. Division of Endocrinology, Diabetes, Metabolism and Nutrition, Department of Internal Medicine, Mayo Clinic, Rochester, Minnesota, USA. 2. Research Division, Joslin Diabetes Center and Department of Pediatrics, Harvard Medical School, Boston, Massachusetts, USA. 3. University of Virginia Center for Diabetes Technology, Charlottesville, Virginia, USA. 4. Division of Endocrinology, Department of Medicine, University of Virginia, Charlottesville, Virginia, USA. 5. Jaeb Center for Health Research, Tampa, Florida, USA. 6. Sansum Diabetes Research Institute, Santa Barbara, California, USA. 7. Division of Pediatric Endocrinology and Diabetes, Department of Pediatrics, Stanford University School of Medicine, Stanford, California, USA. 8. Division of Endocrinology, Icahn School of Medicine at Mount Sinai, New York City, New York, USA. 9. Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora, Colorado, USA.
Abstract
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.
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.
Authors: Sue A Brown; Boris P Kovatchev; Dan Raghinaru; John W Lum; Bruce A Buckingham; Yogish C Kudva; Lori M Laffel; Carol J Levy; Jordan E Pinsker; R Paul Wadwa; Eyal Dassau; Francis J Doyle; Stacey M Anderson; Mei Mei Church; Vikash Dadlani; Laya Ekhlaspour; Gregory P Forlenza; Elvira Isganaitis; David W Lam; Craig Kollman; Roy W Beck Journal: N Engl J Med Date: 2019-10-16 Impact factor: 91.245
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