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      Closed-loop for type 1 diabetes – an introduction and appraisal for the generalist

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          Abstract

          Background

          Rapid progress over the past decade has been made with the development of the ‘Artificial Pancreas’, also known as the closed-loop system, which emulates the feedback glucose-responsive functionality of the pancreatic beta cell. The recent FDA approval of the first hybrid closed-loop system makes the Artificial Pancreas a realistic therapeutic option for people with type 1 diabetes. In anticipation of its advent into clinical care, we provide a primer and appraisal of this novel therapeutic approach in type 1 diabetes for healthcare professionals and non-specialists in the field.

          Discussion

          Randomised clinical studies in outpatient and home settings have shown improved glycaemic outcomes, reduced risk of hypoglycaemia and positive user attitudes. User input and interaction with existing closed-loop systems, however, are still required. Therefore, management of user expectations, as well as training and support by healthcare providers are key to ensure optimal uptake, satisfaction and acceptance of the technology. An overview of closed-loop technology and its clinical implications are discussed, complemented by our extensive hands-on experience with closed-loop system use during free daily living.

          Conclusions

          The introduction of the artificial pancreas into clinical practice represents a milestone towards the goal of improving the care of people with type 1 diabetes. There remains a need to understand the impact of user interaction with the technology, and its implication on current diabetes management and care.

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          Most cited references 26

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          Continuous glucose monitoring and intensive treatment of type 1 diabetes.

          The value of continuous glucose monitoring in the management of type 1 diabetes mellitus has not been determined. In a multicenter clinical trial, we randomly assigned 322 adults and children who were already receiving intensive therapy for type 1 diabetes to a group with continuous glucose monitoring or to a control group performing home monitoring with a blood glucose meter. All the patients were stratified into three groups according to age and had a glycated hemoglobin level of 7.0 to 10.0%. The primary outcome was the change in the glycated hemoglobin level at 26 weeks. The changes in glycated hemoglobin levels in the two study groups varied markedly according to age group (P=0.003), with a significant difference among patients 25 years of age or older that favored the continuous-monitoring group (mean difference in change, -0.53%; 95% confidence interval [CI], -0.71 to -0.35; P<0.001). The between-group difference was not significant among those who were 15 to 24 years of age (mean difference, 0.08; 95% CI, -0.17 to 0.33; P=0.52) or among those who were 8 to 14 years of age (mean difference, -0.13; 95% CI, -0.38 to 0.11; P=0.29). Secondary glycated hemoglobin outcomes were better in the continuous-monitoring group than in the control group among the oldest and youngest patients but not among those who were 15 to 24 years of age. The use of continuous glucose monitoring averaged 6.0 or more days per week for 83% of patients 25 years of age or older, 30% of those 15 to 24 years of age, and 50% of those 8 to 14 years of age. The rate of severe hypoglycemia was low and did not differ between the two study groups; however, the trial was not powered to detect such a difference. Continuous glucose monitoring can be associated with improved glycemic control in adults with type 1 diabetes. Further work is needed to identify barriers to effectiveness of continuous monitoring in children and adolescents. (ClinicalTrials.gov number, NCT00406133.) 2008 Massachusetts Medical Society
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            Threshold-based insulin-pump interruption for reduction of hypoglycemia.

            The threshold-suspend feature of sensor-augmented insulin pumps is designed to minimize the risk of hypoglycemia by interrupting insulin delivery at a preset sensor glucose value. We evaluated sensor-augmented insulin-pump therapy with and without the threshold-suspend feature in patients with nocturnal hypoglycemia.
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              Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, non-masked, randomised controlled trial.

              Tight control of blood glucose in type 1 diabetes delays onset of macrovascular and microvascular diabetic complications; however, glucose levels need to be closely monitored to prevent hypoglycaemia. We aimed to assess whether a factory-calibrated, sensor-based, flash glucose-monitoring system compared with self-monitored glucose testing reduced exposure to hypoglycaemia in patients with type 1 diabetes.
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                Author and article information

                Contributors
                +44 1223 762 862 , rh347@cam.ac.uk
                Journal
                BMC Med
                BMC Med
                BMC Medicine
                BioMed Central (London )
                1741-7015
                23 January 2017
                23 January 2017
                2017
                : 15
                Affiliations
                [1 ]ISNI 0000 0004 0369 9638, GRID grid.470900.a, 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
                [2 ]ISNI 0000 0004 0383 8386, GRID grid.24029.3d, Department of Diabetes & Endocrinology, , Cambridge University Hospitals NHS Foundation Trust, ; Cambridge, UK
                [3 ]Department of Diabetes, Endocrinology, Clinical Nutrition & Metabolism, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
                [4 ]ISNI 0000000121885934, GRID grid.5335.0, Department of Paediatrics, , University of Cambridge, ; Cambridge, UK
                Article
                794
                10.1186/s12916-017-0794-8
                5260117
                28114938
                © The Author(s). 2017

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/100008871, JDRF;
                Funded by: National Institute for Health Research Cambridge Biomedical Research Centre
                Funded by: FundRef http://dx.doi.org/10.13039/100004440, Wellcome Trust;
                Award ID: 100574/Z/12/Z
                Funded by: FundRef http://dx.doi.org/10.13039/501100001711, Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung;
                Award ID: P1BEP3_165297
                Award Recipient :
                Funded by: FundRef http://dx.doi.org/10.13039/100010676, H2020 Societal Challenges;
                Award ID: H2020-SC1-731560
                Award Recipient :
                Funded by: FundRef http://dx.doi.org/10.13039/100000062, National Institute of Diabetes and Digestive and Kidney Diseases;
                Award ID: DP3DK112176
                Award ID: 1UC4DK108520-01
                Award Recipient :
                Categories
                Opinion
                Custom metadata
                © The Author(s) 2017

                Medicine

                glucose control, type 1 diabetes, artificial pancreas, closed-loop

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