The artificial pancreas (closed-loop system) addresses the unmet clinical need for improved glucose control whilst reducing the burden of diabetes self-care in type 1 diabetes. Glucose-responsive ...insulin delivery above and below a preset insulin amount informed by sensor glucose readings differentiates closed-loop systems from conventional, threshold-suspend and predictive-suspend insulin pump therapy. Insulin requirements in type 1 diabetes can vary between one-third–threefold on a daily basis. Closed-loop systems accommodate these variations and mitigate the risk of hypoglycaemia associated with tight glucose control. In this review we focus on the progress being made in the development and evaluation of closed-loop systems in outpatient settings. Randomised transitional studies have shown feasibility and efficacy of closed-loop systems under supervision or remote monitoring. Closed-loop application during free-living, unsupervised conditions by children, adolescents and adults compared with sensor-augmented pumps have shown improved glucose outcomes, reduced hypoglycaemia and positive user acceptance. Innovative approaches to enhance closed-loop performance are discussed and we also present the outlook and strategies used to ease clinical adoption of closed-loop systems.
The daily complexities of insulin therapy and glucose variability in type 1 diabetes still pose significant challenges, despite advancements in modern insulin analogues. Minimising hypoglycaemia and ...optimising time spent within target glucose range are recommended to reduce the risk of diabetes‐related complications and distress. Access to structured education and adjuvant diabetes technologies, such as insulin pumps and glucose sensors, are recommended by National Institute for Health and Care Excellence (NICE) to enable people with type 1 diabetes achieve their glycaemic goals. One hundred years after the discovery of insulin, automated insulin dosing (AID, a.k.a. closed loop or artificial pancreas) systems are a reality with a number of systems available and being used in usual clinical practice. Evidence from randomised clinical trials and real‐world prospective studies support efficacy, effectiveness and safety of AID systems. Qualitative evaluations reveal treatment satisfaction and positive effects on quality of life. Current insulin‐only AID systems still require carbohydrate and activity announcement (hybrid closed loop) due to the inherent pharmacokinetic limitations of rapid‐acting insulin analogies. Ultra‐rapid acting insulin and adjunctive use of other therapies (e.g. glucagon, pramlitide) are being evaluated to achieve full closed loop. Open‐source AID (OS‐AID) systems have been developed by the diabetes community, driven by a desire for safety and to accelerate technological advancement. In addition to effectiveness and safety, real‐world prospective studies suggest that OS‐AID systems fulfil unmet needs of commercially approved systems. The development, ongoing challenges and expectations of AID are outlined in this review.
COVID-19: Impact of and on Diabetes Schofield, Jonathan; Leelarathna, Lalantha; Thabit, Hood
Diabetes therapy,
07/2020, Letnik:
11, Številka:
7
Journal Article
Odprti dostop
Diabetes has been identified as a pre-existing health condition linked with worse outcomes following coronavirus disease 2019 infection. Here we explore the association between hyperglycaemia and ...more severe illness, the impact of the pandemic on diabetes service delivery, and the resultant opportunities for innovation.
Parameters of physiological models of glucose-insulin regulation in type 1 diabetes have previously been estimated using data collected over short periods of time and lack the quantification of ...day-to-day variability. We developed a new hierarchical model to relate subcutaneous insulin delivery and carbohydrate intake to continuous glucose monitoring over 12 weeks while describing day-to-day variability. Sensor glucose data sampled every 10-min, insulin aspart delivery and meal intake were analyzed from eight adults with type 1 diabetes (male/female 5/3, age 39.9 ± 9.5 years, BMI 25.4 ± 4.4kg/m 2 , HbA1c 8.4 ± 0.6% ) who underwent a 12-week home study of closed-loop insulin delivery. A compartment model comprised of five linear differential equations; model parameters were estimated using the Markov chain Monte Carlo approach within a hierarchical Bayesian model framework. Physiologically, plausible a posteriori distributions of model parameters including insulin sensitivity, time-to-peak insulin action, time-to-peak gut absorption, and carbohydrate bioavailability, and good model fit were observed. Day-to-day variability of model parameters was estimated in the range of 38-79% for insulin sensitivity and 27-48% for time-to-peak of insulin action. In conclusion, a linear Bayesian hierarchical approach is feasible to describe a 12-week glucose-insulin relationship using conventional clinical data. The model may facilitate in silico testing to aid the development of closed-loop insulin delivery systems.
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.
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.
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.
Advances in diabetes technology have led to significant improvements in the quality of life and care received by individuals with diabetes. Despite this, achieving tight glycemic control through ...intensive insulin therapy and modern insulin regimens is challenging because of the barrier of hypoglycemia, the most feared complication of insulin therapy as reported by patients, caregivers, and physicians. This article outlines the individual components of the closed-loop system together with the existing clinical evidence. The artificial pancreas prototypes currently used in clinical studies are reviewed as well as obstacles and limitations facing the technology.
Physical exercise is an important component in the management of type 1 diabetes across the lifespan. Yet, acute exercise increases the risk of dysglycaemia, and the direction of glycaemic excursions ...depends, to some extent, on the intensity and duration of the type of exercise. Understandably, fear of hypoglycaemia is one of the strongest barriers to incorporating exercise into daily life. Risk of hypoglycaemia during and after exercise can be lowered when insulin-dose adjustments are made and/or additional carbohydrates are consumed. Glycaemic management during exercise has been made easier with continuous glucose monitoring (CGM) and intermittently scanned continuous glucose monitoring (isCGM) systems; however, because of the complexity of CGM and isCGM systems, both individuals with type 1 diabetes and their healthcare professionals may struggle with the interpretation of given information to maximise the technological potential for effective use around exercise (i.e. before, during and after). This position statement highlights the recent advancements in CGM and isCGM technology, with a focus on the evidence base for their efficacy to sense glucose around exercise and adaptations in the use of these emerging tools, and updates the guidance for exercise in adults, children and adolescents with type 1 diabetes.
Graphical abstract