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      Reduced burden of diabetes and improved quality of life: Experiences from unrestricted day‐and‐night hybrid closed‐loop use in very young children with type 1 diabetes

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      1 , 2 , 1 , 1 , 3 , 4 , 1 , 3 , 4 , 4 , 5 , 5 , 6 , 6 , 6 , 7 , 8 , 9 , 9 , 10 , 1 , 1 , 3 , 11 , 11 , 11 , 8 , 12 , 7 , 3 , 6 , 13 , 5 , 4 , 1 , 3 , , on behalf of Kidsap Consortium
      Pediatric Diabetes
      John Wiley & Sons A/S
      artificial pancreas, closed‐loop insulin delivery, type 1 diabetes, very young children

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          Abstract

          Objective

          To evaluate the experiences of families with very young children aged 1 to 7 years (inclusive) with type 1 diabetes using day‐and‐night hybrid closed‐loop insulin delivery.

          Methods

          Parents/caregivers of 20 children aged 1 to 7 years with type 1 diabetes completed a closed‐loop experience survey following two 3‐week periods of unrestricted day‐and‐night hybrid closed‐loop insulin therapy using Cambridge FlorenceM system at home. Benefits, limitations, and improvements of closed‐loop technology were explored.

          Results

          Responders reported reduced burden of diabetes management, less time spent managing diabetes, and improved quality of sleep with closed‐loop. Ninety percent of the responders felt less worried about their child's glucose control using closed‐loop. Size of study devices, battery performance and connectivity issues were identified as areas for improvement. Parents/caregivers wished for more options to input information to the system such as temporary glucose targets.

          Conclusions

          Parents/caregivers of very young children reported important quality of life benefits associated with using closed‐loop, supporting adoption of this technology in this population.

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          Most cited references8

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          Closing the loop overnight at home setting: psychosocial impact for adolescents with type 1 diabetes and their parents

          Objective To explore the experiences of adolescents with type 1 diabetes mellitus (T1DM) and their parents taking part in an overnight closed loop study at home, using qualitative and quantitative research methods. Research design and methods Adolescents aged 12–18 years on insulin pump therapy were recruited to a pilot closed loop study in the home setting. Following training on the use of a study insulin pump and continuous glucose monitoring (CGM), participants were randomized to receive either real-time CGM combined with overnight closed loop or real-time CGM alone followed by the alternative treatment for an additional 21 days with a 2–3-week washout period in between study arms. Semistructured interviews were performed to explore participants’ perceptions of the impact of the closed loop technology. At study entry and again at the end of each 21-day crossover arm of the trial, participants completed the Diabetes Technology Questionnaire (DTQ) and Hypoglycemia Fear Survey (HFS; also completed by parents). Results 15 adolescents and 13 parents were interviewed. Key positive themes included reassurance/peace of mind, confidence, ‘time off’ from diabetes demands, safety, and improved diabetes control. Key negative themes included difficulties with calibration, alarms, and size of the devices. DTQ results reflected these findings. HFS scores were mixed. Conclusions Closed loop insulin delivery represents cutting-edge technology in the treatment of T1DM. Results indicate that the psychological and physical benefits of the closed loop system outweighed the practical challenges reported. Further research from longitudinal studies is required to determine the long-term psychosocial benefit of the closed loop technology.
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            Closing the Loop in Adults, Children and Adolescents With Suboptimally Controlled Type 1 Diabetes Under Free Living Conditions: A Psychosocial Substudy.

            The objective was to explore psychosocial experiences of closed loop technology for adults, children, and adolescents with type 1 diabetes and their parents taking part in two multicenter, free-living, randomized crossover home studies.
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              Psychosocial impacts of hybrid closed-loop systems in the management of diabetes: a review

              There is a pressing need for new treatment regimens that enable improved glycaemic control and reduced diabetes self-management burdens. Closed-loop, or artificial pancreas, systems represent one of the most promising avenues in this regard. Closed-loop systems connect wearable continuous glucose monitor (CGM) sensors to smartphone- or tablet-mounted algorithms that process and model CGM data to deliver precise and frequently updated doses of fast-acting insulin (and glucagon in dual-hormone systems) to users via wearable pumps. Recent studies have demonstrated that closed-loop systems offer significant benefit in terms of improved glycaemic control. However, less attention has been paid to the psychosocial impact on users of closed-loop systems. This article reviews recent research on psychosocial aspects of closed-loop usage in light of preceding research on user experience of currently available technologies such as insulin pumps and CGM sensors. The small, but growing body of research in this field reports generally positive user experience and a number of experienced benefits including: reassurance and reduced anxiety, improved sleep and confidence, and 'time off' from diabetes demands. However, these benefits are counterbalanced by important challenges, ranging from variable levels of trust to concerns about physical bulk, technical glitches and difficulties incorporating closed-loop systems into everyday life. Future research should explore psychosocial aspects of closed-loop usage in more diverse groups and with regard to clinicians, as well as users, to ensure that the clinical benefits of closed-loop systems are realized at scale in routine medical care.
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                Author and article information

                Contributors
                rh347@cam.ac.uk
                Journal
                Pediatr Diabetes
                Pediatr Diabetes
                10.1111/(ISSN)1399-5448
                PEDI
                Pediatric Diabetes
                John Wiley & Sons A/S (Former Munksgaard )
                1399-543X
                1399-5448
                13 June 2019
                September 2019
                : 20
                : 6 ( doiID: 10.1111/pedi.v20.6 )
                : 794-799
                Affiliations
                [ 1 ] Wellcome Trust‐MRC Institute of Metabolic Science University of Cambridge Cambridge UK
                [ 2 ] Department of Paediatric Endocrinology, Diabetes and Metabolic Diseases University Children's Hospital, University Medical Centre Ljubljana Slovenia
                [ 3 ] Department of Paediatrics University of Cambridge Cambridge UK
                [ 4 ] Department of Pediatrics and Adolescent Medicine Medical University of Vienna Vienna Austria
                [ 5 ] Department of Paediatric Diabetes Leeds Children's Hospital Leeds UK
                [ 6 ] Department of Pediatric Diabetes and Endocrinology Clinique Pédiatrique, Centre Hospitalier Luxembourg City Luxembourg
                [ 7 ] Division for Paediatric Diabetology University of Leipzig Leipzig Germany
                [ 8 ] Department of Pediatrics I Medical University of Innsbruck Innsbruck Austria
                [ 9 ] Department of Internal Medicine, Division of Endocrinology and Diabetology Medical University of Graz Graz Austria
                [ 10 ] Department of Nutrition & Dietetics Cambridge University Hospitals NHS Foundation Trust Cambridge UK
                [ 11 ] Jaeb Center for Health Research Tampa Florida
                [ 12 ] Department of Pediatrics and Adolescent Medicine Medical University of Graz Graz Austria
                [ 13 ] Department of Pediatrics Free University VUB Brussels Belgium
                Author notes
                [*] [* ] Correspondence

                Roman Hovorka, University of Cambridge Metabolic Research Laboratories and NIHR Cambridge Biomedical Research Centre, Wellcome Trust‐MRC Institute of Metabolic Science, Box 289, Addenbrooke's Hospital, Hills Road, Cambridge CB2 0QQ, UK.

                Email: rh347@ 123456cam.ac.uk

                [†]

                Gianluca Musolino and Klemen Dovc contributed equally to this manuscript.

                Author information
                https://orcid.org/0000-0002-4313-2834
                https://orcid.org/0000-0001-9201-2145
                https://orcid.org/0000-0001-6489-9068
                https://orcid.org/0000-0002-7644-4818
                https://orcid.org/0000-0001-6778-0062
                https://orcid.org/0000-0003-2121-5871
                https://orcid.org/0000-0001-5575-5222
                https://orcid.org/0000-0003-2901-461X
                Article
                PEDI12872
                10.1111/pedi.12872
                6771658
                31140654
                d613b5ec-d4a6-496c-8763-c775cf4c75c1
                © 2019 The Authors. Pediatric Diabetes published by John Wiley & Sons Ltd.

                This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

                History
                : 04 April 2019
                : 25 May 2019
                : 27 May 2019
                Page count
                Figures: 0, Tables: 1, Pages: 6, Words: 3713
                Funding
                Funded by: European Union's Horizon 2020 research
                Award ID: 731560
                Funded by: JDRF
                Award ID: 3‐SRA‐2016‐297‐M‐N
                Funded by: Jaeb Center for Health Research
                Award ID: 3‐SRA‐2016‐297‐M‐N
                Funded by: European Union's Horizon 2020 research and innovation programme
                Award ID: 731560
                Funded by: University of Cambridge
                Funded by: University Hospitals of Leicester, National Health Service Trust
                Funded by: Addenbrooke's Wellcome Trust Clinical Research Facility
                Funded by: Wellcome Trust Strategic Award
                Funded by: National Institute for Health Research Cambridge Biomedical Research Centre
                Categories
                Psychological Aspects of Diabetes
                Psychological Aspects of Diabetes
                Custom metadata
                2.0
                pedi12872
                September 2019
                Converter:WILEY_ML3GV2_TO_NLMPMC version:5.6.9 mode:remove_FC converted:01.10.2019

                artificial pancreas,closed‐loop insulin delivery,type 1 diabetes,very young children

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