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

被引:48
作者
Kudva, Yogish C. [1 ]
Laffel, Lori M. [2 ,3 ]
Brown, Sue A. [4 ,5 ]
Raghinaru, Dan [6 ]
Pinsker, Jordan E. [7 ]
Ekhlaspour, Laya [8 ]
Levy, Carol J. [9 ]
Messer, Laurel H. [10 ]
Kovatchev, Boris P. [4 ]
Lum, John W. [6 ]
Beck, Roy W. [6 ]
Gonder-Frederick, Linda [4 ]
机构
[1] Mayo Clin, Div Endocrinol Diabet Metab & Nutr, Dept Internal Med, Rochester, MN USA
[2] Harvard Med Sch, Joslin Diabet Ctr, Res Div, Boston, MA 02115 USA
[3] Harvard Med Sch, Dept Pediat, Boston, MA 02115 USA
[4] Univ Virginia, Ctr Diabet Technol, Charlottesville, VA USA
[5] Univ Virginia, Dept Med, Div Endocrinol, Charlottesville, VA USA
[6] Jaeb Ctr Hlth Res, 15310 Amberly Dr,Suite 350, Tampa, FL 33647 USA
[7] Sansum Diabet Res Inst, Santa Barbara, CA USA
[8] Stanford Univ, Sch Med, Dept Pediat, Div Pediat Endocrinol & Diabet, Stanford, CA 94305 USA
[9] Icahn Sch Med Mt Sinai, Div Endocrinol, New York, NY 10029 USA
[10] Univ Colorado, Barbara Davis Ctr Diabet, Anschutz Med Campus, Aurora, CO USA
关键词
Patient-reported outcomes; Hypoglycemia fear; Diabetes distress; Hypoglycemia awareness; Usability; Adults; Adolescents; DISTRESS;
D O I
10.1089/dia.2021.0089
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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.
引用
收藏
页码:673 / 683
页数:11
相关论文
共 16 条
[1]  
Brooke J, 2013, J USABILITY STUD, V8, P29
[2]   Six-Month Randomized, Multicenter Trial of Closed-Loop Control in Type 1 Diabetes [J].
Brown, S. A. ;
Kovatchev, B. P. ;
Raghinaru, D. ;
Lum, J. W. ;
Buckingham, B. A. ;
Kudva, Y. C. ;
Laffel, L. M. ;
Levy, C. J. ;
Pinsker, J. E. ;
Wadwa, R. P. ;
Dassau, E. ;
Doyle, F. J., III ;
Anderson, S. M. ;
Church, M. M. ;
Dadlani, V ;
Ekhlaspour, L. ;
Forlenza, G. P. ;
Isganaitis, E. ;
Lam, D. W. ;
Kollman, C. ;
Beck, R. W. .
NEW ENGLAND JOURNAL OF MEDICINE, 2019, 381 (18) :1707-1717
[3]   REDUCED AWARENESS OF HYPOGLYCEMIA IN ADULTS WITH IDDM - A PROSPECTIVE-STUDY OF HYPOGLYCEMIC FREQUENCY AND ASSOCIATED SYMPTOMS [J].
CLARKE, WL ;
COX, DJ ;
GONDERFREDERICK, LA ;
JULIAN, D ;
SCHLUNDT, D ;
POLONSKY, W .
DIABETES CARE, 1995, 18 (04) :517-522
[4]   State of Type 1 Diabetes Management and Outcomes from the T1D Exchange in 2016-2018 [J].
Foster, Nicole C. ;
Beck, Roy W. ;
Miller, Kellee M. ;
Clements, Mark A. ;
Rickels, Michael R. ;
DiMeglio, Linda A. ;
Maahs, David M. ;
Tamborlane, William V. ;
Bergenstal, Richard ;
Smith, Elizabeth ;
Olson, Beth A. ;
Garg, Satish K. .
DIABETES TECHNOLOGY & THERAPEUTICS, 2019, 21 (02) :66-72
[5]  
Gonder-Frederick Linda, 2011, Diabetes Manag (Lond), V1, P627
[6]   Psychometric Properties of the Hypoglycemia Fear Survey-II for Adults With Type 1 Diabetes [J].
Gonder-Frederick, Linda A. ;
Schmidt, Karen M. ;
Vajda, Karen A. ;
Greear, Megan L. ;
Singh, Harsimran ;
Shepard, Jaclyn A. ;
Cox, Daniel J. .
DIABETES CARE, 2011, 34 (04) :801-806
[7]   Understanding the Areas and Correlates of Diabetes-Related Distress in Parents of Teens With Type 1 Diabetes [J].
Hessler, Danielle ;
Fisher, Lawrence ;
Polonsky, William ;
Johnson, Nicole .
JOURNAL OF PEDIATRIC PSYCHOLOGY, 2016, 41 (07) :750-758
[8]   One Year Clinical Experience of the First Commercial Hybrid Closed-Loop System [J].
Lal, Rayhan A. ;
Basina, Marina ;
Maahs, David M. ;
Hood, Korey ;
Buckingham, Bruce ;
Wilson, Darrell M. .
DIABETES CARE, 2019, 42 (12) :2190-2196
[9]   Real world hybrid closed-loop discontinuation: Predictors and perceptions of youth discontinuing the 670G system in the first 6 months [J].
Messer, Laurel H. ;
Berget, Cari ;
Vigers, Tim ;
Pyle, Laura ;
Geno, Cristy ;
Wadwa, R. Paul ;
Driscoll, Kimberly A. ;
Forlenza, Gregory P. .
PEDIATRIC DIABETES, 2020, 21 (02) :319-327
[10]   Why Expectations Will Determine the Future of Artificial Pancreas [J].
Messer, Laurel H. .
DIABETES TECHNOLOGY & THERAPEUTICS, 2018, 20 :65-68