Automated Insulin Delivery (AID) Systems: Use and Efficacy in Children and Adults with Type 1 Diabetes and Other Forms of Diabetes in Europe in Early 2023.

Type 1 diabetes (T1D) patients' lifestyle and prognosis has remarkably changed over the years, especially after the introduction of insulin pumps, in particular advanced hybrid closed loop systems (AHCL). Emerging data in literature continuously confirm the improvement of glycemic control thanks to the technological evolution taking place in this disease. As stated in previous literature, T1D patients are seen to be more satisfied thanks to the use of these devices that ameliorate not only their health but their daily life routine as well. Limited findings regarding the use of new devices in different age groups and types of patients is their major limit. This review aims to highlight the main characteristics of each Automated Insulin Delivery (AID) system available for patients affected by Type 1 Diabetes Mellitus. Our main goal was to particularly focus on these systems' efficacy and use in different age groups and populations (i.e., children, pregnant women). Recent studies are emerging that demonstrate their efficacy and safety in younger patients and other forms of diabetes.

Hybrid Closed Loop Using a Do-It-Yourself Artificial Pancreas System in Adults With Type 1 Diabetes.

OBJECTIVE: There is increasing use of open-source artificial pancreas systems (APS) in the management of Type 1 diabetes. Our aim was to assess the safety and efficacy of the automated insulin delivery system AndroidAPS (AAPS), compared with stand-alone pump therapy in people with type 1 diabetes. The primary outcome was the difference in the percentage of time in range (TIR, 70-180 mg/dL). Secondary aims included mean sensor glucose value and percent continuous glucose monitor (CGM) time below range (TBR, <70 mg/dL). RESEARCH DESIGN AND METHODS: This open-label single-center randomized crossover study (ANZCTR, Australian New Zealand clinical trial registry, ANZCTR-ACTRN12620001191987) comprised 20 participants with type 1 diabetes on established pump therapy, assigned to either stand-alone insulin pump therapy or the open-source AAPS hybrid closed-loop system for four weeks, with crossover to the alternate arm for the following four weeks. The CGM outcome parameters were measured by seven-day CGM at baseline and the final week of each four-week study arm. RESULTS: Twenty participants were recruited (60% women), aged 45.8 ± 15.9 years, with mean diabetes duration of 23.9 ± 13.2 years, baseline glycated hemoglobin (HbA1c) 7.5% ± 0.5% (58 ± 6 mmol/mol) and mean TIR 62.3% ± 12.9%. The change in TIR from baseline for AAPS compared with stand-alone pump therapy was 18.6% (11.4-25.9), (P < .001), TIR 76.6% ± 11.7%, 58.0% ± 15.6%, for AAPS and stand-alone pump, respectively. Time glucose <54 mg/dL was not increased (mean = -2.0%, P = .191). No serious adverse events or episodes of severe hypoglycemia were recorded. CONCLUSIONS: This clinical trial of the open-source AAPS hybrid closed-loop system performed in an at-home setting demonstrated comparable safety to stand-alone pump therapy. The glycemic outcomes of AAPS were superior with improved TIR, and there was no significant difference in TBR compared with stand-alone pump therapy.

Use of automated insulin delivery systems in people with type 1 diabetes fasting during Ramadan: An observational study.

Fasting among people with type 1 diabetes imposes the risk of metabolic decompensation. Automated insulin dosing systems can allow better glycemic control without safety concerns. The utility in prolonged and repetitive fasting has not been studied. In this observational study, validated glycemic data were reviewed and analyzed from people with type 1 diabetes who observed fasting during Ramadan in 2019 and 2020 using automated insulin dosing systems. Six profiles met the inclusion criteria. The average age was 33.7 ± 4.8 years, diabetes duration was 23.5 ± 7.9 years, body mass index 23.6 ± 1.9 kg/m2 and glycated hemoglobin was 6.3 ± 0.2% (45 ± 5 mmol/mol). The average glucose during Ramadan was 7.0 ± 0.5 mmol/L (126 ± 9 mg/dL), coefficient of variation 28.5%, percentage of time in range 3.9-10 mmol/L (70-180 mg/dL) 88.8 ± 7.3% and percentage time <3.9 mmol/L (<70.0 mg/dL) 2.5 ± 1.3%. The number of fasting days was 27.3 ± 3.3, and the number of days where fasting was broken due diabetes was 1 ± 1.5/participant. No significant differences in glycemic outcomes were noted between Ramadan and non-Ramadan periods. In this first clinically validated study, automated insulin dosing systems showed a safe and effective management strategy to support prolonged and consecutive fasting in people with type 1 diabetes.

Incorporating Prior Information in Adaptive Model Predictive Control for Multivariable Artificial Pancreas Systems.

BACKGROUND: Adaptive model predictive control (MPC) algorithms that recursively update the glucose prediction model are shown to be promising in the development of fully automated multivariable artificial pancreas systems. However, the recursively updated glycemic prediction models do not explicitly consider prior knowledge in the identification of the model parameters. Prior information of the glycemic effects of meals and physical activity can improve model accuracy and yield better glycemic control algorithms. METHODS: A glucose prediction model based on regularized partial least squares (rPLS) method where the prior information is encoded as the regularization term is developed to provide accurate predictions of the future glucose concentrations. An adaptive MPC is developed that incorporates dynamic trajectories for the glucose setpoint and insulin dosing constraints based on the estimated plasma insulin concentration (PIC). The proposed adaptive MPC algorithm is robust to disturbances caused by unannounced meals and physical activities even in cases with missing glucose measurements. The effectiveness of the proposed adaptive MPC based on rPLS is investigated with in silico subjects of the multivariable glucose-insulin-physiological variables simulator (mGIPsim). RESULTS: The efficacy of the proposed adaptive MPC strategy in regulating the blood glucose concentration (BGC) of people with T1DM is assessed using the average percent time in range (TIR) for glucose, defined as 70 to 180 mg/dL inclusive, and the average percent time in hypoglycemia (<70 and >54 mg/dL) and level 2 hypoglycemia (≤54 mg/dL). The TIR for a cohort of 20 virtual subjects of mGIPsim is 81.9% ± 7.4% (with no hypoglycemia or severe hypoglycemia) for the proposed MPC compared with 73.9% ± 7.6% (0.2% ± 0.1% in hypoglycemia and 0.1% ± 0.1% in level 2 hypoglycemia) for an MPC based on a recursive autoregressive exogenous (ARX) model. CONCLUSIONS: The adaptive MPC algorithm that incorporates prior knowledge in the recursive updating of the glucose prediction model can contribute to the development of fully automated artificial pancreas systems that can mitigate meal and physical activity disturbances.

Prescribing unapproved medical devices? The case of DIY artificial pancreas systems.

In response to slow progress regarding technological innovations to manage type 1 diabetes, some patients have created unregulated do-it-yourself artificial pancreas systems (DIY APS). Yet both in the United Kingdom (UK) and internationally, there is an almost complete lack of specific guidance - legal, regulatory, or ethical - for clinicians caring for DIY APS users. Uncertainty regarding their professional obligations has led to them being cautious about discussing DIY APS with patients, let alone recommending or prescribing them. In this article, we argue that this approach threatens to undermine trust and transparency. Analysing the professional guidance from the UK regulator - the General Medical Council - we demonstrate that nothing within it ought to be interpreted as precluding clinicians from initiating discussions about DIY APS. Moreover, in some circumstances, it may require that clinicians do so. We also argue that the guidance does not preclude clinicians from prescribing such unapproved medical devices.

A real-world study of user characteristics, safety and efficacy of open-source closed-loop systems and Medtronic 670G.

We report a real-world evaluation of the first commercially approved automated insulin delivery (AID) system, MiniMed 670G (670G), and open source-automated insulin delivery (OS-AID) systems. This was undertaken as a retrospective observational study in adults with type 1 diabetes using AID systems for 6 months or longer in a publicly funded health service using clinically validated data. Sixty-eight adults (38 670G, 30 OS-AID systems) were included. OS-AID system users were younger, had a shorter diabetes duration and a higher education status. OS-AID systems displayed a significantly better change in HbA1c (median -0.9% [-0.4%, -1.1%] vs. -0.1% [IQR -0.7%, 0.2%], P = .004) and time in range 3.9-10 mmol/L (mean 78.5%, SD ± 12.0% vs. 68.2% ± 14.7%, P = .024) compared with 670G. Both systems showed minimal hypoglycaemia, with OS-AID systems revealing significantly improved secondary outcomes of mean glucose and percentage of time more than 10 mmol/L, with a higher percentage of time of less than 3 mmol/L. OS-AID system users displayed improved glycaemic outcomes with no clinical safety concerns compared with 670G, although higher weight-adjusted insulin dose and weight gain were noted. The study highlights key differences in OS-AID system user characteristics that are important for interpreting real-world findings from recent OS-AID system studies.

Looping with Do-It-Yourself Artificial Pancreas Systems During Ramadan Fasting in Type 1 Diabetes Mellitus: Perspectives of a User and a Physician.

Hybrid closed-loop automated insulin delivery systems have helped type 1 diabetes (T1D) users close the loop between glucose monitoring and insulin delivery, a very important step in efforts to simulate the glucose-responsive insulin secretory function of a healthy pancreas. Do-It-Yourself Artificial Pancreas Systems (DIY APS) are a form of hybrid closed-loop system that use open-source algorithms, which govern the delivery of insulin in response to interstitial glucose and other variables that are personalized to an individual. The flexibility and customization afforded by these systems make them amenable for use in different worldly circumstances, one of which is fasting during the annual occurrence of Ramadan for observant Muslims. Here, we present the views of a DIY APS user who was able to fast successfully on most days of Ramadan after adopting this system, and the overview of a physician on these systems, with a focus on fasting during Ramadan with T1D.

Looping with Do-It-Yourself Artificial Pancreas Systems During Ramadan Fasting in Type 1 Diabetes Mellitus: Perspectives of a User and a Physician.

Hybrid closed-loop automated insulin delivery systems have helped type 1 diabetes (T1D) users close the loop between glucose monitoring and insulin delivery, a very important step in efforts to simulate the glucose-responsive insulin secretory function of a healthy pancreas. Do-It-Yourself Artificial Pancreas Systems (DIY APS) are a form of hybrid closed-loop system that use open-source algorithms, which govern the delivery of insulin in response to interstitial glucose and other variables that are personalized to an individual. The flexibility and customization afforded by these systems make them amenable for use in different worldly circumstances, one of which is fasting during the annual occurrence of Ramadan for observant Muslims. Here, we present the views of a DIY APS user who was able to fast successfully on most days of Ramadan after adopting this system, and the overview of a physician on these systems, with a focus on fasting during Ramadan with T1D.

Do-It-Yourself (DIY) Artificial Pancreas Systems for Type 1 Diabetes: Perspectives of Two Adult Users, Parent of a User and Healthcare Professionals.

The artificial pancreas system or an automated insulin dosing system has been the 'holy grail' for patients with type 1 diabetes and their caregivers who have over the years wanted to 'close the loop' between monitoring of glucose and delivery of insulin. The launch of the Medtronic MiniMed 670G system in 2017 and the subsequent release of the Tandem t:slim with Control-IQ system, the DANA RS pump compatible-CamAPS FX app and the more recent announcement of the Medtronic MiniMed 780G system have come as answers to their prayers. However, in the time taken to develop and launch these commercial systems, creative and ebullient parents of young patients with type 1 diabetes, along with other patients, technologists and healthcare professionals have developed mathematical models as software solutions to determine insulin delivery that in conjunction with compatible hardware have helped 'close the loop'. Under an umbrella movement #WeAreNotWaiting, they have, as a community, refined and disseminated technologies that are open source and ubiquitously available as do-it-yourself (DIY) closed-loop systems or DIY artificial pancreas systems (APS). There are presently three systems-OpenAPS, AndroidAPS and Loop. We present perspectives of two patients, parent of a patient, and their healthcare providers; the users spanning an age spectrum most likely to use this technology-a child, an adolescent in transitional care and a 31-yr old adult patient, highlighting how looping has helped them self-manage diabetes within the routine of their lives and the challenges they faced.

Do-It-Yourself Artificial Pancreas Systems: A Review of the Emerging Evidence and Insights for Healthcare Professionals.

Application of artificial pancreas systems in type 1 diabetes (T1D) represents a change in approach to managing complex glucose and insulin dynamics using automated features with higher levels of safety, precision, and reliability than those afforded by manual adjustments. To date, limited commercial systems and more widely used open-source, hybrid closed loop, Do-It-Yourself Artificial Pancreas Systems (DIY APS) have been used in nontrial real-world management of T1D. The aims of this article are twofold. First, itsynthesizes the emerging literature on DIY APS and identifies a range of evidence including research, reviews, commentaries, and opinion pieces written by DIY APS users, healthcare professionals (HCPs), and researchers. It summarizes the emerging clinical evidence for DIY APS and provide insight into how the DIY APS movement began, has been disseminated throughout diabetes online communities, and is reshaping self-management of T1D in real-world settings. Second, the article provides commentaries that explore implications of DIY APS to healthcare practice. DIY APS are radically changing T1D management. Automating the process of frequently analyzing glucose readings and appropriately titrating insulin delivery is liberating people with T1D (PWD) from some of the demands of intensive management. Within this super-specialized area of T1D management, the expertise of DIY APS users has outstripped that of many HCPs. While educational, ethical, and legal constraints need to be resolved, HCPs still need to stay abreast of this rapidly developing area. Further research is needed to inform policy and practice relating to DIY APS. Meanwhile, HCPs continue to learn from PWD's real-world experiences of building and using DIY APS to improve metabolic and psychological outcomes.