Materiały źródłowe

• #1 Continuous Glucose Monitoring Sensors for Diabetes Management: A Review of Technologies and Applications

  https://www.e-dmj.org/journal/view.php?doi=10.4093/dmj.2019.0121

  By providing blood glucose (BG) concentration measurements in an almost continuous-time fashion for several consecutive days, wearable minimally-invasive continuous glucose monitoring (CGM) sensors are revolutionizing diabetes management, and are becoming an increasingly adopted technology especially for diabetic individuals requiring insulin administrations. […] The introduction of these minimally invasive needle CGM sensors in 1999 revolutionized, de facto, blood glucose (BG) concentration monitoring in diabetes and opened new exciting scenarios in the daily management of diabetes. […] CGM sensors deliver an almost continuous glucose trace providing BG readings every 1 to 5 minutes, mitigating the need of SMBG and greatly increasing the information on BG fluctuations and trend (which shows that CGM reveals hypoglycemic and hyperglycemic events not visible by SMBG).

• #2 Continuous Glucose Monitoring Sensors for Diabetes Management: A Review of Technologies and Applications

  https://e-dmj.org/DOIx.php?id=10.4093/dmj.2019.0121

  By providing blood glucose (BG) concentration measurements in an almost continuous-time fashion for several consecutive days, wearable minimally-invasive continuous glucose monitoring (CGM) sensors are revolutionizing diabetes management, and are becoming an increasingly adopted technology especially for diabetic individuals requiring insulin administrations. […] The introduction of these minimally invasive needle CGM sensors in 1999 revolutionized, de facto, blood glucose (BG) concentration monitoring in diabetes and opened new exciting scenarios in the daily management of diabetes. […] CGM sensors deliver an almost continuous glucose trace providing BG readings every 1 to 5 minutes, mitigating the need of SMBG and greatly increasing the information on BG fluctuations and trend (which shows that CGM reveals hypoglycemic and hyperglycemic events not visible by SMBG).

• #3 CG-DME-50 Automated Insulin Delivery Systems

  https://provider.healthybluemo.com/dam/medpolicies/healthybluemo/active/guidelines/gl_pw_e002723.html

  Automated insulin delivery systems combine an insulin pump and CGM, either as separate devices or as a device that incorporates both functions. […] Continuous interstitial glucose monitoring (CGM) device: A device applied to the skin that contains a sensor implanted into the skin to measure glucose concentrations in the interstitial fluid.

• #4 Advanced Technology (Continuous Glucose Monitoring and Advanced Hybrid Closed-Loop Systems) in Diabetes from the Perspective of Gender Differences

  https://www.mdpi.com/2673-4540/4/4/45

  Technologies and, in particular, CGM, have revolutionised diabetes management, as they have allowed a greater understanding of the disease and an improvement in treatment and outcomes. […] The use of the CGM allows increasing the TIR and reducing the CV (-3.09%) compared to the self-monitoring of glucose (SMBG) in adults and children with type 1 and 2 diabetes, as reported by a meta-analysis published in 2020. […] The growing awareness of gender differences accompanies a huge global change in the treatment of type 1 diabetes, especially thanks to new technologies such as continuous subcutaneous insulin infusion (CSII), CGM, AHCL. […] In people with type 1 diabetes, technologies facilitate the performance of physical activity and, above all, the management of hypoglycaemia. […] Various technologies have made it possible to improve the management of type 1 diabetes in pregnancy.

• #5 Continuous Glucose Monitoring Sensors for Diabetes Management: A Review of Technologies and Applications

  https://e-dmj.org/DOIx.php?id=10.4093/dmj.2019.0121

  CGM users represent only a small part of total diabetes population, CGM sensors proved to be effective in improving patient glucose control and enabling the possibility of designing new advanced technologies for diabetes management. […] The most recent CGM systems have achieved accuracies close to, or even within, the SMBG accuracy range, CGM systems improved also in terms of features and comfort for the patient. […] CGM systems are now accepted as standard tools for intensive glucose control in patients with type 1 diabetes mellitus (T1DM). […] The beneficial impact brought by the integration of a CGM system in diabetes management has been proven. […] The real-time availability of glucose concentration values as well as visual/acoustic hypoglycemic alerts allow users to act in order to mitigate, or even avoid, hypoglycemia.

• #6 Advanced Technology (Continuous Glucose Monitoring and Advanced Hybrid Closed-Loop Systems) in Diabetes from the Perspective of Gender Differences

  https://www.mdpi.com/2673-4540/4/4/45

  An ever-growing body of evidence suggests that sex and gender influence the pathophysiology, incidence, prevalence, clinical manifestations, course, and response to therapy of diabetes. […] The turning point came in 2000 with the introduction of continuous glucose monitoring (CGM) and the first miniaturised insulin pumps (CSII) equipped with advanced functions; from the integration of the two devices, it was possible to create the SAP (Sensor Augmented Pump) system; from this moment on, the development of technologies has undergone an acceleration, up to the creation and appearance on the market of the first artificial pancreas system (Automatic Insulin Delivery—AID), closed-loop, and hybrid systems (HCL—Hybrid Closed Loop) a century after the discovery of insulin. […] The components of a closed-loop system are as follows: an insulin pump, a sensor that continuously detects the glucose values in the interstitial fluid and a control algorithm that automatically modulates the insulin infusion based on the glucose values detected by the sensor.

• #7 Closed-loop insulin delivery for treatment of type 1 diabetes | BMC Medicine | Full Text

  https://bmcmedicine.biomedcentral.com/articles/10.1186/1741-7015-9-120

  Automated systems modulating insulin delivery according to sensor glucose levels, independently of patient supervision, may be needed to fully exploit existing glucose-sensing and insulin-delivery technologies, and in particular to protect against nocturnal hypoglycemia and minimize the impact of noncompliant behaviors. […] Closed-loop insulin delivery, also referred to as the artificial pancreas, is an emerging therapeutic approach for people with type 1 diabetes. It is a medical device consisting of a linked continuous glucose monitor and an insulin pump. Wireless communication facilitates automated data transfer between components without the need for human intervention. […] The novelty of this approach resides in the real-time feedback between glucose levels and insulin delivery, similar to that presented by the -cell. Insulin delivery is modulated at intervals of 1 to 15 minutes, depending on interstitial glucose levels, in contrast to the pre-programmed insulin delivery that takes place during conventional insulin pump treatment.

• #8 Closed-Loop Insulin Delivery Systems: Past, Present, and Future Directions

  https://pmc.ncbi.nlm.nih.gov/articles/PMC9207329/

  Closed-loop (artificial pancreas) systems for automated insulin delivery have been likened to the holy grail of diabetes management. […] Continuous glucose monitoring systems (CGMS) are now minimally invasive and more accurate. […] These closed-loop systems also referred to as the artificial pancreas have been likened to the holy grail of diabetes management as they have the potential to improve glycemic outcomes and reduce disease burden. […] Hybrid closed-loop systems aim to minimize hypoglycemia and hyperglycemia and maintain glucose levels within a target range through the use of a computerized algorithm to adjust the basal rate of insulin and administer corrective bolus doses. […] Development of the first hybrid closed-loop systems began in parallel with LGS technology. […] A pivotal trial by Weinzimer et al. in 2008 was the first to show that a hybrid closed-loop system significantly improved overnight time spent in the normoglycemic range compared to conventional open-loop insulin delivery.

• #9 Continuous Glucose Monitoring Sensors for Diabetes Management: A Review of Technologies and Applications

  https://www.e-dmj.org/journal/view.php?doi=10.4093/dmj.2019.0121

  The purpose of this paper is to (1) provide an overview of the latest advances on CGM system development and glucose sensing technologies, (2) discuss about the current use of CGM sensor from patient affected by diabetes, and (3) review some recent advanced applications for diabetes treatment based on CGM. […] CGM systems are now accepted as standard tools for intensive glucose control in patients with type 1 diabetes mellitus (T1DM). […] Automatic CGM-based basal insulin suspension/attenuation represents the first step towards closed-loop systems, namely AP, in which a control algorithm automatically tune insulin pump injections based on CGM readings. […] Recently, a hybrid closed-loop system has entered the market, as in 2017 Medtronic launched the MiniMed 670G, i.e., the first commercially available hybrid closed-loop system.

• #10 Closed-Loop Insulin Delivery Systems: Past, Present, and Future Directions

  https://pmc.ncbi.nlm.nih.gov/articles/PMC9207329/

  Further trials in adult and pediatric populations have demonstrated increased time in target and reduced hypoglycemia, mean glucose levels, and HbA1c in hybrid closed-loop systems. […] The pivotal trial establishing the efficacy of the MiniMed 670G system was published by Garg et al. in 2017. […] A prospective study by Lal et al. of real-world use of the MiniMed 670G over 12 months found significant correlation between time spent in Auto Mode (in which the hybrid closed-loop algorithm is activated) and HbA1c. […] The main challenge in fully closed-loop systems therefore is postprandial hyperglycemia, as there is no manually provided information about the timing and carbohydrate content of meals. […] Fully closed-loop systems can use the same types of algorithms as hybrid systems MPC, PID, or fuzzy logic although all fully closed-loop systems included in a 2017 meta-analysis used MPC-based algorithms.

• #11 JMIR Diabetes – Clinician Experiences With Hybrid Closed Loop Insulin Delivery Systems in Veterans With Type 1 Diabetes: Qualitative Study

  https://diabetes.jmir.org/2023/1/e45241/

  Hybrid closed loop (HCL) insulin pumps adjust insulin delivery based on input from a continuous glucose monitor. […] Several studies have reported many glycemic benefits to the use of HCL systems. […] These studies demonstrate that HCL systems increase time-in-range (TIR) up to 10% overall and 15% overnight compared to older insulin pump technology. […] Use of an HCL system for 6 months was associated with an approximately 1% decrease in time spent in clinically significant hypoglycemia. […] Overall, limited information about the factors that influence HCL pump clinical decision-making is available, especially among endocrinology clinicians. […] Findings suggest that clinicians believe HCL systems have significant glycemic benefits but are not appropriate for all patients, especially those with cognitive impairment.

• #12 Closed-loop insulin delivery for treatment of type 1 diabetes | BMC Medicine | Full Text

  https://bmcmedicine.biomedcentral.com/articles/10.1186/1741-7015-9-120

  The key component of the artificial pancreas is the control algorithm, which directs insulin delivery according to glucose levels while accounting for inherent measurement errors and kinetic delays. […] The MPC method is well suited to compensate for time delays associated with the subcutaneous route of insulin administration and interstitial glucose measurements. Other algorithms have been tested clinically, such as fuzzy logic, which is developed from qualitative approximations of clinical judgment by diabetes practitioners, a combination of MPC and PID algorithms for insulin and glucagon delivery, or a PID with insulin feedback. One of the objectives of the current research is to integrate existing control algorithms within increasingly sophisticated insulin pumps and continuous glucose monitors.

• #13

  https://link.springer.com/article/10.1007/s00125-021-05391-w

  A closed-loop system is a more sophisticated system, with a control algorithm adjusting insulin delivery (up and down) in response to real-time sensor glucose levels and other inputs, such as meal intake. […] Several different types of control algorithm have been developed, including model predictive control (MPC) algorithms, proportional integral derivative (PID) controllers and fuzzy logic control approaches. […] Clinical studies evaluating the safety and efficacy of hybrid closed-loop systems have evolved from small, highly supervised studies, undertaken overnight or over 24 h in research facilities, to larger randomised controlled trials of unrestricted home living use, conducted over 6 months or longer. […] Hybrid closed-loop systems have a favourable effect on HbA1c, with a reduction of 0.30.4% compared with control therapy in studies with a duration of more than 8 weeks per intervention.

• #14 CG-DME-50 Automated Insulin Delivery Systems

  https://www.anthem.com/dam/medpolicies/abcbs_va/active/guidelines/gl_pw_e002723.html

  Automated insulin delivery systems combine an insulin pump and CGM, either as separate devices or as a device that incorporates both functions. These devices may be called open-loop, hybrid closed-loop, or closed-loop. These terms refer to how the devices interact with each other, as well as how the individual interacts with them. […] Hybrid closed-loop devices eliminate the requirement of routine manual adjustment of pump administration rates, with the insulin pump and CGM devices working together to predict and calculate insulin dose requirements. […] Similar to open-loop devices, there have been multiple high quality studies demonstrating significant clinical outcomes benefit from the use of hybrid closed-loop devices. […] The body of evidence to-date for the iLet closed-loop automated insulin dosing system demonstrates significant improvements in HbA1c measures, as well as time in range and time below 180 mg/dL when compared to other methods of glucose control, including multiple daily injections, sensor-augmented pump therapy and use of hybrid closed-loop devices. […] Other closed-loop systems are under investigation, but have not yet received FDA approval or clearance.

• #15 CG-DME-50 Automated Insulin Delivery Systems

  https://provider.healthybluemo.com/dam/medpolicies/healthybluemo/active/guidelines/gl_pw_e002723.html

  Hybrid closed-loop systems can increase, decrease, or stop insulin delivery automatically beyond pre-set infusion rates in response glucose concentration measurements from a paired CGM device. […] Similar to open-loop devices, there have been multiple high quality studies demonstrating significant clinical outcomes benefit from the use of hybrid closed-loop devices. […] The body of evidence to-date for the iLet closed-loop automated insulin dosing system demonstrates significant improvements in HbA1c measures, as well as time in range and time below 180 mg/dL when compared to other methods of glucose control, including multiple daily injections, sensor-augmented pump therapy and use of hybrid closed-loop devices. […] Other closed-loop systems are under investigation, but have not yet received FDA approval or clearance.

• #16

  https://link.springer.com/article/10.1007/s00125-016-4022-4

  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. […] Closed-loop systems accommodate these variations and mitigate the risk of hypoglycaemia associated with tight glucose control. […] Continuous glucose monitoring, insulin pump and control algorithms constitute backbone technologies of the closed-loop systems. […] The present generation of continuous glucose monitoring devices provide a minimally invasive method to measure real-time interstitial fluid glucose levels. […] Continuous glucose monitoring adherence: Lessons from a clinical trial to predict outpatient behavior. […] The hybrid closed-loop approach relies on manual administration of prandial bolus to partially mitigate absorption delay of subcutaneous, rapid-acting insulin.

• #17 Type 1 Diabetes: Hybrid Closed-Loop and Open-Loop…

  https://www.dzd-ev.de/en/press/press-releases/press-releases-2025/type-1-diabetes-hybrid-closed-loop-and-open-loop-systems/index.html

  People with type 1 diabetes require continuous insulin treatment and must regularly measure their glucose levels. With open-loop therapies, insulin administration is manually controlled, while hybrid closed-loop systems automatically regulate insulin delivery. A study with the involvement of the German Center for Diabetes Research showed that hybrid closed-loop systems offer improved long-term blood sugar values (HbA1c levels) and a lower risk of hypoglycemic coma, but lead to a higher rate of diabetic ketoacidosis. […] Until now, the effect of insulin delivery in hybrid closed-loop systems on the risk of acute diabetes complications in people with type 1 diabetes has been unclear. Researchers have therefore now investigated whether the rates of severe low blood sugar levels (hypoglycemia) and diabetic ketoacidosis are lower with hybrid closed-loop insulin therapy compared with sensor-augmented (open-loop) pump therapy.

• #18 Type 1 Diabetes: Hybrid Closed-Loop and Open-Loop…

  https://www.dzd-ev.de/en/press/press-releases/press-releases-2025/type-1-diabetes-hybrid-closed-loop-and-open-loop-systems/index.html

  The results: People using hybrid closed-loop therapy had a significantly lower rate of hypoglycemic coma (0.62 per 100 patient-years) than those using open-loop therapy (0.91 per 100 patient-years). Furthermore, patients in the hybrid closed-loop group had a significantly lower HbA1c level (7.34% versus 7.50%). They had a higher percentage of time in the target glucose range of 3.9 to 10.0 mmol/L (64% versus 52% of the time). Their glycemic variability was also lower (coefficient of variation of 35.4% versus 38.3%). […] However, individuals using a hybrid closed-loop system had a higher rate of ketoacidosis (1.74 events per 100 patient-years) than those using open-loop therapy (0.96 per 100 patient-years). The rate of ketoacidosis was particularly high in people with an HbA1c level of 8.5% or higher in the closed-loop therapy group (5.25 per 100 patient-years). […] Due to the higher risk of ketoacidosis, it is important to provide patients with targeted information and, in case of potential metabolic decompensation, to closely monitor ketone bodies in the blood or urine in order to prevent such adverse events, emphasize the authors of the study.

• #19 Artificial pancreas: The journey continues – Mayo Clinic

  https://www.mayoclinic.org/medical-professionals/endocrinology/news/artificial-pancreas-the-journey-continues/mac-20439176

  The next significant development in the field was the FDA approval of the hybrid closed loop system (670G) in September 2016. This system was also approved 90 days after submission of the application. The trial involved 124 people and was a single-arm three-month study. The study showed an 8.2 percent increase in time spent in target glucose range (70 to 180 mg/dL) and 44 percent and 11 percent respective decrease in times spent in the hypoglycemic and hyperglycemic ranges. […] At Mayo Clinic, we are also initiating studies aimed at developing the next-generation AP that will include nonglucose signals impacting glucose control such as physical activity and emotional stress.

• #20 Use of continuous glucose monitoring and hybrid closed-loop therapy in pregnancy – PubMed

  https://pubmed.ncbi.nlm.nih.gov/39411880/

  Continuous glucose monitoring (CGM) has led to a paradigm shift in the management of pregnant women with type 1 diabetes (T1D), with improved glycaemic control, less hypoglycaemia and fewer pregnancy complications. […] In addition to CGM, other technologies, such as advanced hybrid closed-loop (AHCL) systems have further improved glycaemic management in people with T1D. AHCL therapy adapts insulin delivery via a predictive algorithm integrated with CGM and an insulin pump. […] More evidence is needed on the impact of AHCL therapy on maternal and neonatal outcomes and on which glycaemic targets with CGM should be used in pregnant women with T2D and GDM.

• #21

  https://link.springer.com/article/10.1007/s00125-021-05391-w

  The impact of closed-loop technology on quality-of-life measures has been explored in several studies. […] The first commercial closed-loop system, the MiniMed 670G (Medtronic, Northridge, CA, USA) was approved by the US Food and Drug Administration in September 2016 for use in people with type 1 diabetes aged 14 years and older. […] A second-generation advanced hybrid closed-loop (AHCL [780G, Medtronic]) system has been developed to further improve glycaemic control and usability, with adjustable target glucose and automated correction boluses. […] The Diabeloop hybrid closed-loop system, comprising a handset containing the algorithm, Kaleido pump and Dexcom G6 sensor (DBLG1; Diabeloop, Grenoble, France), has been compared with sensor-augmented pump therapy in 68 adults with type 1 diabetes, in the home setting, with remote monitoring over 12 weeks.

• #22 Closed-Loop Insulin Delivery Systems: Past, Present, and Future Directions

  https://pmc.ncbi.nlm.nih.gov/articles/PMC9207329/

  The primary rationale for dual-hormone systems, which are capable of administering boluses of glucagon in addition to continuous insulin infusion, is that prevention of hypoglycemia is more effective with administration of glucagon than with suspension of insulin delivery. […] Compared with conventional insulin pump therapy, dual-hormone closed-loop systems have been shown to reduce hypoglycemia, improve mean glucose levels, and increase time spent in the target glycemic range. […] The past decade has seen rapid advances in the development and uptake of closed-loop systems, with the hybrid closed-loop system transitioning from research to commercial availability. […] The key open questions in closed-loop system development surround the capability of sensors, pumps, and algorithms to adapt to complex scenarios.

• #23

  https://link.springer.com/article/10.1007/s00125-021-05391-w

  The physiological glucagon response to hypoglycaemia is often impaired in type 1 diabetes; therefore, addition of glucagon to a closed-loop system confers additional protection from hypoglycaemia and may allow more aggressive insulin delivery to achieve improved glucose control. […] High quality user and healthcare professional training is essential for ensuring that the clinical benefits of hybrid closed-loop systems are realised in the real-world setting. […] Future closed-loop systems will benefit from improved individual components; smaller, more accurate CGM devices with longer wear-time and smaller insulin pumps with the user interface transferred to a smartphone/watch will improve usability and minimise device burden. […] The last 5 years has seen the successful transition of closed-loop systems from research into routine clinical practice for management of type 1 diabetes.

• #24

  https://link.springer.com/article/10.1007/s00125-016-4022-4

  The risk of hypoglycaemia may be further reduced with the use of bihormonal (also known as dual-hormone) closed-loop systems delivering subcutaneous glucagon when hypoglycaemia is detected or predicted. […] Evidence from transitional and home studies is encouraging, demonstrating progress towards real life closed-loop clinical use. […] Technological advances in glucose sensing may provide marginal improvements in glucose management outcomes with the use of closed-loop systems, but may be a key driver for the adoption of closed-loop therapy by users if the size of the glucose sensor is reduced, sensor wear time prolonged and the need for calibration avoided.

• #25 JMIR Diabetes – Clinician Experiences With Hybrid Closed Loop Insulin Delivery Systems in Veterans With Type 1 Diabetes: Qualitative Study

  https://diabetes.jmir.org/2023/1/e45241/

  Clinicians commonly commented on the frequent challenges they experienced when first prescribing an HCL system. […] Clinicians discussed various challenges patients face while initiating use of an HCL insulin pump. […] Clinicians noticed improved glucose control with less variability and fluctuations in patient blood sugars. […] Importantly, clinicians noted the reduction in hypoglycemia, especially nocturnal hypoglycemia and hypoglycemia surrounding physical activity. […] Additionally, clinicians discussed the multiple benefits of these systems, such as improved glucose control, reduced glucose variability, and a lower incidence of hypoglycemia.

• #26 Closed loop systems | Diabetes tech | Diabetes UK

  https://www.diabetes.org.uk/about-diabetes/looking-after-diabetes/technology/closed-loop-systems

  Hybrid closed loop systems are generally suitable for children and adults with type 1 diabetes, although it will depend on the licensing rules for each system. […] People with type 1 diabetes using a hybrid closed loop system can have a better quality of life, research shows, because of the benefits it brings. And it can also make life easier for people caring for them. Blood sugar levels may be more stable and there are no insulin injections to do and fewer finger prick tests. […] As the amount of insulin given is calculated more precisely and given more often, this can help keep blood sugar levels more stable. As a result, this can increase the amount of time you spend in your target blood sugar range. This can reduce hypos and lower your HbA1c and risk of diabetes complications. […] Research shows the benefits brought by closed loop systems can help give people with type 1 diabetes and people caring for them a better quality of life.

• #27 Closed-loop insulin system effective for pregnant women with type 1 diabetes

  https://evidence.nihr.ac.uk/alert/closed-loop-insulin-systems-are-effective-for-pregnant-women-with-type-1-diabetes/

  This study included pregnant women with type 1 diabetes, who were all using continuous glucose monitoring. A closed-loop system that automatically adjusts insulin delivery in real-time, was compared with standard therapy (a standard pump releasing low levels of insulin, topped up with injections). […] Closed-loop systems have been shown to improve blood sugar control in adults and children; however, before this study it was unclear whether they are effective in pregnancy. This trial compared closed-loop systems with standard insulin therapy in pregnant women with type 1 diabetes. […] In this study, closed-loop effectively controlled blood sugar levels in pregnant women with type 1 diabetes. […] This study provides convincing evidence that the best way to achieve this control is by offering all pregnant women with type 1 diabetes a hybrid closed-loop insulin delivery system, which is capable of targeting blood glucose levels of 5.5 mmol/L or lower. […] Closed-loop insulin delivery will become the gold standard treatment for pregnant women with type 1 diabetes and recently published NICE guidance, has advised that this will be the recommended standard of care.

• #28 UK study shows hybrid closed-loop technology improved maternal glucose levels during pregnancy complicated by type 1 diabetes | EurekAlert!

  https://www.eurekalert.org/news-releases/1003774

  On average, pregnant women used the hybrid closed-loop technology for more than 95% of the time. Using the technology helped to substantially reduce maternal blood sugars throughout pregnancy. Compared to traditional insulin therapy methods, women who used the technology spent more time in the target range for pregnancy blood sugar levels (68% vs 56% equivalent to an additional 2.5-3.0 hours every day throughout pregnancy). […] We know that for women with type 1 diabetes, unborn babies are exquisitely sensitive to small rises in blood sugars, so keeping blood sugar levels within the normal range during pregnancy is crucial to reduce risks for the mother and child. Previous studies have confirmed that every extra hour spent in the blood sugar target range reduces the risks of premature birth, being too large at birth and need for admission to neonatal intensive care unit. This technology is game changing, in that it will allow more women to have safer, healthier, more enjoyable pregnancies, with potential for lifelong benefits for their babies.

• #29 A Pilot randomized trial to examine effects of a hybrid closed-loop insulin delivery system on neurodevelopmental and cognitive outcomes in adolescents with type 1 diabetes | Nature Communications

  https://www.nature.com/articles/s41467-022-32289-x

  Type 1 diabetes (T1D) is associated with lower scores on tests of cognitive and neuropsychological function and alterations in brain structure and function in children. […] This proof-of-concept pilot study examined whether MRI-derived indices of brain development and function and standardized IQ scores in adolescents with T1D could be improved with better diabetes control using a hybrid closed-loop insulin delivery system. […] Adolescents in the hybrid closed-loop group showed significantly greater improvement in several primary outcomes indicative of neurotypical development during adolescence compared to the standard care group including cortical surface area, regional gray volumes, and fractional anisotropy. […] The hybrid closed loop group also showed higher Perceptual Reasoning Index IQ scores and functional brain activity more indicative of neurotypical development relative to the standard care group.

• #30 A Pilot randomized trial to examine effects of a hybrid closed-loop insulin delivery system on neurodevelopmental and cognitive outcomes in adolescents with type 1 diabetes | Nature Communications

  https://www.nature.com/articles/s41467-022-32289-x

  These results suggest that alterations to the developing brain in T1D might be preventable or reversible with rigorous glucose control. […] We designed the current proof-of-concept pilot study with the principal aim to investigate whether MRI metrics of gray and white-matter development in adolescents with early-onset T1D can be improved with rigorous diabetes control using currently available, hybrid closed-loop insulin delivery diabetes technology. […] Our primary hypothesis was that greater reduction of hyperglycemia in the CL group, relative to the SC group, would result in greater improvement in key brain metrics indicative of neurotypical development during adolescence. […] The secondary hypothesis was that the CL group would show higher scores on a standardized IQ assessment and functional brain activity more indicative of neurotypical development relative to the SC group.

• #31 A Pilot randomized trial to examine effects of a hybrid closed-loop insulin delivery system on neurodevelopmental and cognitive outcomes in adolescents with type 1 diabetes | Nature Communications

  https://www.nature.com/articles/s41467-022-32289-x

  Research results from the DirecNet consortium and other investigators indicate that hyperglycemia has measurable, deleterious effects on MRI metrics of brain development and standardized scores on tests of cognitive and neuropsychological function in children and adolescents with T1D. […] In this preliminary, proof-of-concept study of adolescents with T1D, we found that participants who were randomized to wearing a hybrid, closed-loop device over 6 months showed significant reductions in hyperglycemia and measures of glucose variation, relative to adolescents randomized to standard diabetes care. […] The observed increase in the Perceptual Reasoning Index (PRI) over 6 months in the CL group is noteworthy. […] The reduction in activation that we observed in the closed-loop group likely reflects a normalization of function in areas of the brain subserving attention and response inhibition.

• #32 A Pilot randomized trial to examine effects of a hybrid closed-loop insulin delivery system on neurodevelopmental and cognitive outcomes in adolescents with type 1 diabetes | Nature Communications

  https://www.nature.com/articles/s41467-022-32289-x

  The results presented here underscore the importance of assessing frontal cortical brain development in adolescents with T1D. […] The fact that significant changes can be observed over a period of six months offers hope that insults to the developing adolescent brain might be preventable or even reversible with rigorous glucose control.

• #33 JMIR Diabetes – Clinician Experiences With Hybrid Closed Loop Insulin Delivery Systems in Veterans With Type 1 Diabetes: Qualitative Study

  https://diabetes.jmir.org/2023/1/e45241/

  HCL pump initiation is a multi-step process requiring an interdisciplinary team of health care clinicians to ensure patient and pump success. […] Furthermore, HCL systems improve clinician confidence in overall diabetes management. […] Overall, participants provided insight into their experiences at both the Midwestern VA Healthcare System and the affiliated university health care system. […] Clinicians felt strongly that HCL systems are not a one-size-fits-all approach to diabetes care. […] Participants in our study described how each patient must be continuously assessed to ensure appropriate use. […] Overall, the provider assessment and evaluation of patients for HCL candidacy was highly individualized, reflecting their years of clinical experience and different examples of patients they had cared for during various clinic encounters.

• #34 Insulin edema after initiation of hybrid closed-loop insulin pump therapy with continuous glucose monitoring: a case report | Cardiovascular Diabetology – Endocrinology Reports | Full Text

  https://clindiabetesendo.biomedcentral.com/articles/10.1186/s40842-022-00143-0

  Insulin edema is a rare complication which can present after initiation or intensification of insulin therapy in people with diabetes. […] Initiation of closed-loop hybrid insulin pump therapy can result in rapid improvement in glycemic control for people with diabetes. […] To our knowledge, this is the first case of insulin edema reported in a person with type 1 diabetes using CGM and a hybrid closed-loop insulin pump system. […] Use of hybrid closed-loop systems can help achieve rapid improvement in glycemic control in people with diabetes. […] This case suggests that consideration should be given to adjusting initial blood glucose targets when starting these remarkable new technologies in people with baseline poor glycemic control. […] The pathogenesis of insulin edema is not known. The most commonly proposed mechanisms relevant to our patient are the antinatriuretic effect of insulin and increased capillary permeability associated with chronic hyperglycemia.

• #35 Insulin edema after initiation of hybrid closed-loop insulin pump therapy with continuous glucose monitoring: a case report | Cardiovascular Diabetology – Endocrinology Reports | Full Text

  https://clindiabetesendo.biomedcentral.com/articles/10.1186/s40842-022-00143-0

  In this case, insulin delivery increased significantly after initiation of hybrid closed-loop therapy with an approximately 75% increase in total daily insulin dose. […] It would be expected that adults with poor glycemic control, who are underinsulinized will experience an increase in overall dose with hybrid closed-loop systems. […] This rare case of insulin edema reminds us of the potential risks of rapid reductions in HbA1c that can be associated with the use of these remarkable new technologies. […] Given the increasing use of automated insulin delivery systems in type 1 diabetes, future studies examining the best approaches for initiating this therapy in people with high insulin requirements should be considered.

• #36 Continuous Glucose Monitoring Sensors for Diabetes Management: A Review of Technologies and Applications

  https://www.e-dmj.org/journal/view.php?doi=10.4093/dmj.2019.0121

  A retrospective analysis of 3-month real-world glucose data has shown improved clinical outcomes in patients using the Auto Mode of the MiniMed 670G, compared to patients on Manual Mode. […] While research in AP is progressively increasing the safety and effectiveness of such devices, also exploring bi-hormonal systems allowing controlled delivery of both insulin and glucagon, patients have shown an increased interest for the AP technology. […] The advent of CGM sensors has revolutionized the glucose monitoring in T1DM. […] The integration of CGM data with data of insulin pump and other wearable sensors, like activity trackers, will allow improving algorithms for glucose prediction and automatic basal insulin modulation. […] This will allow the generation of a digital ecosystem of diabetes data that could be exploited to extract novel insights on the mechanisms of diabetes progression and develop cutting-edge data analytics for personalized diabetes management and prevention of related complications.

• #37 Machine Learning Approach for Care Improvement of Children and Youth with Type 1 Diabetes Treated with Hybrid Closed-Loop System

  https://www.mdpi.com/2079-9292/11/14/2227

  The t:slim X2’ insulin pump system, launched in 2016 by Tandem’ Diabetes Care, is one of them. […] The challenges of the AP are gradually being addressed with the development of advanced algorithmic strategies to improve the devices’ performance as well as the customization of the algorithms, in order to make these devices more accessible and easier to be used. […] Continuous Blood Monitoring (CGM) devices and insulin pumps represent the new frontier to be investigated and enhanced. […] The application of artificial intelligence and, more specifically, of ML in diabetes is feasible and desirable for the development of effective data processing and management tools and devices. […] The usage of ML in diabetes care is huge and it varies from the predictions and analysis of glucose levels to the optimization of hypo and hyperglycemia situations, and for insulin pumps improvements. […] Therefore, the scope of this study is to further analyze and improve the knowledge about which ML algorithms can advance diabetes management and, subsequently, the time in range, in young populations, using data provided by the Tandem’s t:slim X2’ coupled with the DexCom G6 sensor.

• #38 Fully automated closed-loop insulin delivery in adults with type 2 diabetes: an open-label, single-center, randomized crossover trial | Nature Medicine

  https://www.nature.com/articles/s41591-022-02144-z

  In adults with type 2 diabetes, the benefits of fully closed-loop insulin delivery, which does not require meal bolusing, are unclear. […] Closed-loop insulin delivery offers a new, glucose-responsive method of glucose control and comprises a continuous glucose monitor, an insulin pump and a control algorithm that automatically modulates subcutaneous insulin delivery. […] Fully closed-loop systems, which are more convenient and have no requirement for user input at meal times, have previously been shown to improve glucose control in people with type 2 diabetes in the inpatient setting, and in those requiring dialysis over a period of 20 days in an outpatient setting. […] Here we proposed that fully closed-loop insulin delivery in people with type 2 diabetes may improve glycemic control compared with standard insulin therapy, without increasing the risk of hypoglycemia over an 8-week period of unrestricted living.

• #39 Fully automated closed-loop insulin delivery in adults with type 2 diabetes: an open-label, single-center, randomized crossover trial | Nature Medicine

  https://www.nature.com/articles/s41591-022-02144-z

  The present study shows that fully closed-loop insulin delivery is a safe and effective approach to improve glycemic control in people with type 2 diabetes during 8 weeks of use in the outpatient setting. […] The closed-loop system improved the proportion of time spent in target glucose range by 35 percentage points (an additional 8 hours per day), and reduced mean glucose, compared with standard insulin therapy, without increasing the time spent in hypoglycemia. […] As a considerable proportion of people with type 2 diabetes struggle to achieve the recommended glycemic targets with currently available therapies, including insulin therapy, fully closed-loop systems offer a new approach to improve glycemic outcomes to reduce the risk of long-term complications. […] We have shown that fully closed-loop insulin delivery does not increase the risk of hypoglycemia despite improved glycemic control and there were no episodes of severe hypoglycemia during closed-loop therapy. […] In conclusion, this study suggests that fully closed-loop insulin delivery is a safe and efficacious approach to manage type 2 diabetes in adults.

• #40 Closed-loop for people living with cystic fibrosis-related diabetes — Radcliffe Department of Medicine

  https://www.rdm.ox.ac.uk/about/our-clinical-facilities-and-units/DTU/current-trials/closed-loop-for-people-living-with-cystic-fibrosis-related-diabetes-cl4p-cf

  Cystic fibrosis related diabetes (CFRD) affects more than 30% of adults with cystic fibrosis (CF) in the UK. […] The Diabetes Trial Unit and the University of Cambridge are together conducting a trial, CL4P-CF, designed to test the efficacy, safety and quality of life of hybrid closed-loop glucose control compared with standard insulin therapy plus continuous glucose monitoring (CGM) in young people (16 years) and adults with cystic fibrosis-related diabetes. […] A hybrid closed-loop system includes a glucose sensor, a pump to deliver insulin subcutaneously, and an algorithm that automatically calculates how much insulin is needed in response to sensor glucose levels. […] The goal of the trial is to determine if the hybrid closed-loop achieves better control of blood glucose compared with standard care.

• #41 Closed-loop for people living with cystic fibrosis-related diabetes — Radcliffe Department of Medicine

  https://www.rdm.ox.ac.uk/about/our-clinical-facilities-and-units/DTU/current-trials/closed-loop-for-people-living-with-cystic-fibrosis-related-diabetes-cl4p-cf

  To determine if the closed-loop system can improve glucose control determined by the proportion of time in target glucose range compared to standard insulin therapy with CGM in young people (16 years) and adults with CFRD. […] To compare closed-loop glucose control against standard insulin therapy with CGM in terms of 1) efficacy, 2) safety, 3) acceptability and 4) value for money to the NHS.

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