Katharine D Barnard1, Manu V Venkat2, Kelly Close3, Lutz Heinemann4, Jill Weissberg-Benchell5, Korey K Hood6, Thomas Kubiak7, Aaron J Kowalski8, Lori Laffel9. 1. Human Development and Health Academic Unit, Faculty of Medicine, University of Southampton, Southampton, UK katharine.barnard1@virginmedia.com. 2. Close Concerns, San Francisco, CA, USA. 3. The diaTribe Foundation, San Francisco, CA, USA. 4. Science & Co, Dusseldorf, Germany. 5. Northwestern University Feinberg School of Medicine, Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago, IL, USA. 6. Pediatrics, Psychiatry and Behavioural Sciences, Stanford University School of Medicine, San Francisco, CA, USA. 7. Health Psychology, Johannes Gutenberg University, Mainz, Germany. 8. Juvenile Diabetes Research Foundation Ltd, New York, NY, USA. 9. Joslin Diabetes Center, Harvard Medical School, Boston, MA, USA.
Abstract
BACKGROUND: Diabetes technology is a cornerstone of diabetes management in the 21st century, with advances in available devices over recent years playing a central role in the way that health care has progressed. Psychosocial interventions have been shown to have a positive impact on glycemic control, reduce psychological distress and reduce costs of health care. Addressing and improving psychosocial outcomes that complement biomedical improvements and looking to the future are crucial to enhance patient acceptance of artificial pancreas (AP) systems. METHODS: To achieve closer collaboration and comparability across different AP research trials, a working group was established. RESULTS: Existing measures fail to adequately capture the extent to which human and psychological factors play a role in the uptake and efficient use of AP systems. Understanding these factors will ultimately lead to the most benefit for users. Reliable measures of the psychosocial impact of AP systems for users is crucial to ensure that (1) regulatory authorities are able to robustly consider these aspects as part of their approval process, (2) government and private payers are able to factor these aspects into their decisions regarding reimbursement, and (3) persons with diabetes maximize benefits in terms of both glycemic control and quality of life to minimize the burden of diabetes in everyday life. CONCLUSIONS: This working group will serve as a platform to foster exchange, identify research needs, and guide and initiate collaborative research laying the groundwork for optimal utilization of diabetes technology in clinical diabetes care. A close collaboration among all key stakeholders is crucial to ensure that devices are designed, trialed, approved, and provided with minimal user burden and maximum beneficial effect.
BACKGROUND:Diabetes technology is a cornerstone of diabetes management in the 21st century, with advances in available devices over recent years playing a central role in the way that health care has progressed. Psychosocial interventions have been shown to have a positive impact on glycemic control, reduce psychological distress and reduce costs of health care. Addressing and improving psychosocial outcomes that complement biomedical improvements and looking to the future are crucial to enhance patient acceptance of artificial pancreas (AP) systems. METHODS: To achieve closer collaboration and comparability across different AP research trials, a working group was established. RESULTS: Existing measures fail to adequately capture the extent to which human and psychological factors play a role in the uptake and efficient use of AP systems. Understanding these factors will ultimately lead to the most benefit for users. Reliable measures of the psychosocial impact of AP systems for users is crucial to ensure that (1) regulatory authorities are able to robustly consider these aspects as part of their approval process, (2) government and private payers are able to factor these aspects into their decisions regarding reimbursement, and (3) persons with diabetes maximize benefits in terms of both glycemic control and quality of life to minimize the burden of diabetes in everyday life. CONCLUSIONS: This working group will serve as a platform to foster exchange, identify research needs, and guide and initiate collaborative research laying the groundwork for optimal utilization of diabetes technology in clinical diabetes care. A close collaboration among all key stakeholders is crucial to ensure that devices are designed, trialed, approved, and provided with minimal user burden and maximum beneficial effect.
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