Materiały źródłowe

• #1 Hybrid closed-loop systems for managing blood glucose levels in type 1 diabetes: a systematic review and economic modelling.

  https://pmc.ncbi.nlm.nih.gov/articles/PMC11664472/

  Hybrid closed-loop systems are a new class of technology to manage type 1 diabetes mellitus. The system includes a combination of real-time continuous glucose monitoring from a continuous glucose monitoring device and a control algorithm to direct insulin delivery through an insulin pump. Evidence suggests that such technologies have the potential to improve the lives of people with type 1 diabetes mellitus and their families. […] The aim of this appraisal was to assess the clinical effectiveness and cost-effectiveness of hybrid closed-loop systems for managing glucose in people who have type 1 diabetes mellitus and are having difficulty managing their condition despite prior use of at least one of the following technologies: continuous subcutaneous insulin infusion, real-time continuous glucose monitoring or flash glucose monitoring (intermittently scanned continuous glucose monitoring).

• #2 Advances in Continuous Glucose Monitoring and Integrated Devices for Management of Diabetes with Insulin-Based Therapy: Improvement in Glycemic Control

  https://www.e-dmj.org/journal/view.php?doi=10.4093/dmj.2022.0271

  Continuous glucose monitoring (CGM) technology has evolved over the past decade with the integration of various devices including insulin pumps, connected insulin pens (CIPs), automated insulin delivery (AID) systems, and virtual platforms. CGM has shown consistent benefits in glycemic outcomes in type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM) treated with insulin. […] The combined effect of CGM and education have been shown to improve glycemic outcomes more than CGM alone. […] AID systems and virtual platforms made it possible to achieve target glycosylated hemoglobin in diabetes while minimizing hypoglycemia, which has always been challenging in T1DM. […] These advances in technology could reduce the burden associated with insulin treatment for diabetes. […] Achieving target glycosylated hemoglobin (HbA1c) while minimizing hypoglycemia has always been a challenge for diabetes treated with insulin.

• #3 Hybrid closed loop technology (artificial pancreas) | Breakthrough T1D UK

  https://breakthrought1d.org.uk/knowledge-support/managing-type-1-diabetes/guide-to-type-1-diabetes-technology/hybrid-closed-loop-technology-artificial-pancreas/

  Hybrid closed loop technology also known as the artificial pancreas automates many of the decisions that you have to make on a daily basis when you have type 1 diabetes. […] A hybrid closed loop system takes readings from a continuous glucose monitor and uses an algorithm to tell an insulin pump how much insulin to deliver. It does this 24 hours a day. […] If youre using a hybrid closed loop system, you use a CGM instead of a blood glucose meter, an insulin pump instead of a pen, and an algorithm instead of your brain. […] The CGM tells the algorithm what your glucose levels are and the algorithm tells the pump how much insulin to deliver. […] With hybrid closed loop systems, you can spend more time with your glucose levels in range, with less effort. […] Your insulin will also be slowed or turned off if the sensor detects that glucose levels are likely to dip into a hypo.

• #4 The Future of Blood Glucose Monitoring

  https://www.webmd.com/diabetes/future-blood-glucose-monitoring

  Blood glucose monitoring is an important part of managing diabetes. […] Monitoring blood glucose has come a long way since then. Technologies like continuous glucose monitoring (CGM), closed-loop systems, and noninvasive monitoring have automated the process. In some cases they’ve eliminated the dreaded fingerstick. […] All CGM systems work in much the same way. A small sensor placed under your skin — usually on your arm or belly — measures the glucose levels in the fluid between the cells every few minutes around the clock. […] Continuous glucose monitors (CGMs) let you make treatment decisions without having to manually recheck your blood sugar level. […] Most people who use CGM have type 1 diabetes, but it’s also being studied for type 2 diabetes. […] Most of the artificial pancreas systems available today are called hybrid closed-loop systems. They’re mainly for people with type 1 diabetes.

• #5 Continuous glucose monitoring and hybrid closed loop for diabetes – NHS

  https://www.nhs.uk/conditions/cgm-and-hcl-for-diabetes/

  Continuous glucose monitors and hybrid closed loop systems are technology that can help people with diabetes manage their blood glucose (sugar) levels. […] A continuous glucose monitor (CGM) is a device for people with diabetes that lets you check your glucose (sugar) levels at any time. […] It can help you control your blood glucose levels, as you’ll have more information and can take action quickly. […] A hybrid closed loop system (sometimes called an „artificial pancreas”) is technology that allows a CGM to work together with an insulin pump to help you manage your blood glucose. […] A hybrid closed loop system can improve your blood glucose levels, reduce the risk of hypos and make it easier to manage diabetes. […] CGM should be available on the NHS to anyone with type 1 diabetes.

• #6 Advances in Continuous Glucose Monitoring and Integrated Devices for Management of Diabetes with Insulin-Based Therapy: Improvement in Glycemic Control

  https://www.e-dmj.org/journal/view.php?number=2703

  Continuous glucose monitoring (CGM) technology has evolved over the past decade with the integration of various devices including insulin pumps, connected insulin pens (CIPs), automated insulin delivery (AID) systems, and virtual platforms. CGM has shown consistent benefits in glycemic outcomes in type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM) treated with insulin. […] The use of rtCGM reduces HbA1c by about 0.3% to 0.6%. […] The effectiveness of rtCGM has been confirmed in various randomized controlled trials (RCTs) with different types of diabetes and insulin regimens. […] The glycemic outcomes from isCGM and rtCGM are different. […] The importance of the device is the benefits in glycemic outcomes, but the number of studies is limited. […] Increasing evidence demonstrates the effectiveness of insulin pumps when used in combination with a CGM and closed-loop algorithm controller to automate basal insulin delivery, these are known as HCLS.

• #7 At a glance factsheet: Hybrid closed-loop therapy – DiabetesontheNet

  https://diabetesonthenet.com/diabetes-primary-care/factsheet-hybrid-closed-loop-therapy/

  In December 2023, NICE published the TA943 guidance, which lays out recommendations for use of hybrid closed-loop (HCL) systems in the management of type 1 diabetes, with a 5-year roll-out plan. […] An HCL system, also known as an artificial pancreas or Automated Insulin Delivery (AID) system, refers to the use of an insulin pump that is looped with an algorithm that continuously takes data from a continuous glucose monitoring (CGM) device to make and communicate decisions on insulin dosing to maintain glucose levels within the target range. […] The CGM device measures interstitial glucose every 15 minutes and transmits data by Bluetooth to the insulin management algorithm on either the pump or the smartphone. […] There is high-quality evidence that HCL technology results in better glycaemic control than insulin pump or sensor-augmented pump therapy, achieving more time in target glycaemic range, less time in hyper- and hypoglycaemia, less severe hypoglycaemia and improved HbA1c.

• #8 Point32 Continuous Glucose Monitoring and Diabetes Management Devices Form

  https://genhealth.ai/policy/point32/cbaf0c24-continuous-glucose-monitoring-and-diabetes-management-devices

  Continuous glucose monitoring systems come in two varieties: short-term professional systems store data for retrospective analysis by a physician to help develop more successful management regimens and long-term personal systems that display readings in real time to help users build more beneficial habits. […] Artificial pancreas device systems, also called sensor-enhanced insulin pumps and sensor-augmented insulin pump therapy, are systems in which the operation of an insulin pump is modified by the readings of a continuous glucose monitor. […] For the purposes of these guidelines, a hybrid closed loop device system is defined as an insulin pump that works in conjunction with a CGM, and the pump is able to both automatically stop and adjust the flow of insulin based on readings of the CGM.

• #9

  https://link.springer.com/article/10.1007/s41745-022-00348-3

  Over the past decade there have been many advances in diabetes technologies, such as continuous glucose monitors (CGMs), insulin-delivery devices, and hybrid closed loop systems. […] Most CGMs (Medtronic-Guardian, Dexcom-G6, and Abbott-Libre-2) have MARD values of 10%, in contrast to two decades ago when the MARD used to be 20%. […] In addition, the majority of the new CGMs do not require calibrations, and the latest CGMs last for 10-14 days. […] Recently, the FDA approved Libre 3 which provides real-time glucose values every minute. […] Even though it is approved as an iCGM it is not interoperable with automatic-insulin-delivery (AID) systems. […] We believe that in the next decade there will be a significant increase in the number of people who use CGM for their day-to-day diabetes care.

• #10 Advances in Continuous Glucose Monitoring and Integrated Devices for Management of Diabetes with Insulin-Based Therapy: Improvement in Glycemic Control

  https://www.e-dmj.org/journal/view.php?number=2703

  The advancement of CGM has enabled a complete glucose profile to be obtained, thus making it possible to diagnose the glycemic status of an individual precisely. […] The development of diabetes technology made it possible to avoid hyperglycemia without increasing hypoglycemia with a more comfortable fit and less effort, which could not previously be shown in diabetes with insulin therapy. […] It has become possible to fully diagnose an individual glycemic status through rapidly evolving CGM technology.

• #11 Advances in Continuous Glucose Monitoring and Integrated Devices for Management of Diabetes with Insulin-Based Therapy: Improvement in Glycemic Control

  https://www.e-dmj.org/journal/view.php?doi=10.4093/dmj.2022.0271

  The outcomes are well summarized in the review article by Moon et al. […] The advancement of CGM has enabled a complete glucose profile to be obtained, thus making it possible to diagnose the glycemic status of an individual precisely. […] The development of diabetes technology made it possible to avoid hyperglycemia without increasing hypoglycemia with a more comfortable fit and less effort, which could not previously be shown in diabetes with insulin therapy. […] It has become possible to fully diagnose an individual glycemic status through rapidly evolving CGM technology. […] CGM use is growing exponentially with valuable benefits on clinical outcomes, furthermore, various technologies can be integrated with it. […] This has resulted in a dramatic improvement in glycemic control.

• #12 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. […] Therefore, thanks to the CGM, a new approach has been found for the evaluation of metabolic compensation carried out through the outpatient glycaemic profile (AGP) which takes into consideration various parameters, of which the fundamental ones are HbA1c, TIR (70–180 mg/dl), and CV, or coefficient of variation. […] With regard the improvement of 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. […] A recent study found gender differences in the strategies adopted to prevent hypoglycaemic events related to exercise; a higher percentage of men eat carbohydrates before (M 70.8%, F 62.1%) and during (M 56.5%, F 42.7%) physical activity, while the frequency of insulin reduction is similar in both genders.

• #13

  https://link.springer.com/article/10.1007/s41745-022-00348-3

  The newer CGMs that are likely to be launched in the next few months in the USA include the 10-11 days Dexcom G7 (60% smaller than the existing G6), and the 7-days Medtronic Guardian 4. […] It has also been noticed that an arm insertion site might have better accuracy than abdomen or other sites, like the buttock for kids. […] Continuous glucose monitoring predicts progression to diabetes in autoantibody positive children. […] Continuous glucose monitoring system and new era of early diagnosis of diabetes in high risk groups. […] The hybrid closed-loop system: evolution and practical applications. […] Safety of a hybrid closed-loop insulin delivery system in patients with type 1 diabetes. […] Glucose outcomes with the in-home use of a hybrid closed-loop insulin delivery system in adolescents and adults with type 1 diabetes. […] A comparison of two hybrid closed-loop systems in adolescents and young adults with type 1 diabetes (FLAIR): a multicentre, randomised, crossover trial. […] The use and efficacy of continuous glucose monitoring in type 1 diabetes treated with insulin pump therapy: a randomised controlled trial.

• #14 At a glance factsheet: Hybrid closed-loop therapy – DiabetesontheNet

  https://diabetesonthenet.com/diabetes-primary-care/factsheet-hybrid-closed-loop-therapy/

  In December 2023, NICE published the TA943 guidance, which lays out recommendations for use of hybrid closed-loop (HCL) systems in the management of type 1 diabetes, with a 5-year roll-out plan. […] An HCL system, also known as an artificial pancreas or Automated Insulin Delivery (AID) system, refers to the use of an insulin pump that is looped with an algorithm that continuously takes data from a continuous glucose monitoring (CGM) device to make and communicate decisions on insulin dosing to maintain glucose levels within the target range. […] The CGM device measures interstitial glucose every 15 minutes and transmits data by Bluetooth to the insulin management algorithm on either the pump or the smartphone. […] There is high-quality evidence that HCL technology results in better glycaemic control than insulin pump or sensor-augmented pump therapy, achieving more time in target glycaemic range, less time in hyper- and hypoglycaemia, less severe hypoglycaemia and improved HbA1c.

• #15 Hybrid Closed Loop systems, the Dexcom way | Dexcom Healthcare Professionals

  https://uk.provider.dexcom.com/connectivity/hybrid-closed-loop

  Hybrid Closed Loop (HCL) systems, also referred to as Automated Insulin Delivery (AID), are designed to mimic the activity of the pancreas. […] Combining knowledge of the bodys prevailing glucose level and where it’s heading (supplied by a real-time continuous glucose monitoring, or rtCGM, system), with a digitally-controlled insulin pump, HCL systems automatically adjust insulin delivery to meet the changing needs of the user. […] NICE recommends HCL technology for all people with diabetes meeting any of the following criteria: Age 18 or under with type 1 diabetes, Over 18 with HbA1c 7.5%, Suffer from disabling hypoglycaemia, Women who are pregnant or trying to conceive a baby. […] Given that Dexcom is the worlds most connected rtCGM family, its no surprise that Dexcom has more HCL studies with more AID systems than any other CGM brand.

• #16 Hybrid closed loop technology (artificial pancreas) | Breakthrough T1D UK

  https://breakthrought1d.org.uk/knowledge-support/managing-type-1-diabetes/guide-to-type-1-diabetes-technology/hybrid-closed-loop-technology-artificial-pancreas/

  Hybrid closed loop technology also known as the artificial pancreas automates many of the decisions that you have to make on a daily basis when you have type 1 diabetes. […] A hybrid closed loop system takes readings from a continuous glucose monitor and uses an algorithm to tell an insulin pump how much insulin to deliver. It does this 24 hours a day. […] If youre using a hybrid closed loop system, you use a CGM instead of a blood glucose meter, an insulin pump instead of a pen, and an algorithm instead of your brain. […] The CGM tells the algorithm what your glucose levels are and the algorithm tells the pump how much insulin to deliver. […] With hybrid closed loop systems, you can spend more time with your glucose levels in range, with less effort. […] Your insulin will also be slowed or turned off if the sensor detects that glucose levels are likely to dip into a hypo.

• #17 Hybrid closed loop technology (artificial pancreas) | Breakthrough T1D UK

  https://breakthrought1d.org.uk/knowledge-support/managing-type-1-diabetes/guide-to-type-1-diabetes-technology/hybrid-closed-loop-technology-artificial-pancreas/

  Similarly, if the sensor detects that your glucose level is likely to rise above target, it will temporarily increase the basal rate or deliver small corrective boluses or a combination of both. […] Using a hybrid closed loop system eases the burden of type 1 but doesnt mean that type 1 treatment is completely automated. […] Automated insulin delivery is another term for HCL which is being used more often. […] Continuous glucose monitoring can help you manage your glucose levels in real-time and relieve the burden of having to do multiple finger prick tests throughout the day. […] Nearly 20 years of Breakthrough T1D UK research has pushed forward the development of hybrid closed loop technology, changing the lives of people living with type 1.

• #18 Diabetes – Diagnosis and treatment – Mayo Clinic

  https://www.mayoclinic.org/diseases-conditions/diabetes/diagnosis-treatment/drc-20371451

  People who receive insulin therapy also may choose to monitor their blood sugar levels with a continuous glucose monitor. Although this technology hasn’t yet completely replaced the glucose meter, it can lower the number of fingersticks necessary to check blood sugar and provide important information about trends in blood sugar levels. […] A closed loop system is a device implanted in the body that links a continuous glucose monitor to an insulin pump. The monitor checks blood sugar levels regularly. The device automatically delivers the right amount of insulin when the monitor shows that it’s needed. […] The Food and Drug Administration has approved several hybrid closed loop systems for type 1 diabetes. They are called „hybrid” because these systems require some input from the user. For example, you may have to tell the device how many carbohydrates are eaten, or confirm blood sugar levels from time to time.

• #19 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. […] Data on CGM use in pregnant women with type 2 diabetes (T2D) are limited. […] A large randomized controlled trial (RCT) on CGM use in people with T2D in pregnancy is ongoing. […] Small studies on CGM use in women with gestational diabetes (GDM) have suggested improved glycaemic control and better qualification when insulin is needed. […] Several large RCTs are ongoing in women with GDM. […] In addition to CGM, other technologies, such as advanced hybrid closed-loop (AHCL) systems have further improved glycaemic management in people with T1D. […] A large RCT with the AHCL CamAPS FX demonstrated a 10% increase in time in range compared to standard insulin therapy in a pregnant population with T1D.

• #20

  https://www.trialx.com/clinical-trials/listings/230796/dexcom-hybrid-closed-loop-insulin-pump-study-in-type-1-diabetes/

  The Tandem t:slim X2 insulin pump has recently become available in NHS Scotland and can link with the Dexcom G6 continuous glucose monitoring (CGM) system. […] The Tandem Control IQ hybrid closed loop system is made up of the Tandem insulin pump communicating wirelessly with the Dexcom G6 CGM. The algorithm within the pump then automatically controls the background (basal) insulin infusion rate. […] This system is designed to finely tune insulin delivery and increase the amount of time that glucose is in the target range, reducing hypoglycaemia and hyperglycaemia. […] The Dexcom G6 continuous glucose monitoring (CGM) system provides continuous glucose monitoring (without requiring any scanning by the patient) but is not currently funded within NHS Scotland, except for special circumstances.

• #21 Dexcom Hybrid Closed Loop Insulin Pump Study in Type 1 Diabetes | Clinical Research Trial Listing

  https://www.centerwatch.com/clinical-trials/listings/NCT05059860/dexcom-hybrid-closed-loop-insulin-pump-study-in-type-1-diabetes

  The Tandem t:slim X2 insulin pump has recently become available in NHS Scotland and can link with the Dexcom G6 continuous glucose monitoring (CGM) system. […] The Tandem Control IQ hybrid closed loop system is made up of the Tandem insulin pump communicating wirelessly with the Dexcom G6 CGM. The algorithm within the pump then automatically controls the background (basal) insulin infusion rate. […] This system is designed to finely tune insulin delivery and increase the amount of time that glucose is in the target range, reducing hypoglycaemia and hyperglycaemia. […] The Dexcom G6 continuous glucose monitoring (CGM) system provides continuous glucose monitoring (without requiring any scanning by the patient) but is not currently funded within NHS Scotland, except for special circumstances.

• #22 Guide to type 1 diabetes technology | Breakthrough T1D UK

  https://breakthrought1d.org.uk/knowledge-support/managing-type-1-diabetes/guide-to-type-1-diabetes-technology/

  Continuous glucose monitors give you real-time information on your glucose levels and alert you if your levels are going too high or too low. […] Hybrid closed loop technology, also known as the artificial pancreas, takes readings from a CGM to tell a pump how much insulin to deliver. It can relieve much of the burden of daily type 1 management. […] In an historic advancement in the treatment of type 1 diabetes, the National Institute for Health and Care Excellence (NICE) today approves hybrid closed loop for the majority of people living with type 1 diabetes in England and Wales. […] The announcement is the biggest treatment breakthrough for type 1 diabetes since the discovery of insulin. […] Insulet, the company who make Omnipod products, has announced that their Omnipod 5 hybrid closed loop (HCL) technology is now available in the UK.

• #23 Advanced Hybrid Closed-Loop Technology Could Improve Quality of Life in Type 1 Diabetes

  https://www.drugtopics.com/view/advanced-hybrid-closed-loop-technology-could-improve-quality-of-life-in-type-1-diabetes

  A 1-year observational follow-up of a 3-month randomized controlled trial provides insight into the benefits of advanced hybrid closed-loop system use in people with type 1 diabetes using multiple daily injections and self-monitoring of blood glucose. […] Results of the study, which examined quality of life over 1-year after initiating use of an advanced hybrid closed-loop system, suggest use of diabetes technology was associated with notable improvements in quality of life. […] To the best of our knowledge, this is the first long-term follow-up study investigating the psychological well-being of adult people with T1D previously nave to diabetes technology (treated with multiple daily injections and self-monitoring of blood glucose) who experience a direct switch to the advanced hybrid closed loop system with novel calibration-free sensors, and the sustainability of the obtained changes in their quality of life, wrote investigators.

• #24 Initial results of effectiveness of a hybrid closed loop system via omnipod 5 and dexcom g6 system on glycaemic control | BSPED2024 | 51st Annual Meeting of the British Society for Paediatric Endocrinology and Diabetes | Endocrine Abstracts

  https://www.endocrine-abstracts.org/ea/0103/ea0103p88

  Initial results of effectiveness of a hybrid closed loop system via omnipod 5 and dexcom g6 system on glycaemic control […] Glucose monitoring and administration of insulin are critical components of type 1 diabetes management in children. Increasingly, technology such as continuous glucose monitors (CGMs) and insulin pumps are being used in a closed loop system to effectively manage diabetes in children. […] To evaluate the impact of a closed loop system via the Omnipod 5 pump and Dexcom G6 CGM system on glycaemic control in a cohort of children at South Tees Hospitals NHS trust. […] Initiation of a closed loop system via Omnipod and Dexcom G6 was associated with a mean improvement in HbA1c and TIR within a 3-month period for our patients which has been maintained at their 6-month review.

• #25 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

  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). […] 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. […] Hybrid closed-loop systems (HCL) are technologies used to treat type 1 diabetes. They combine an insulin pump, continuous glucose monitoring, and an algorithm for automated insulin delivery. […] Open-loop systems combine an insulin pump and continuous glucose monitoring (CGM). Unlike closed-loop systems, which automatically adapt insulin delivery, an open-loop system requires the user to make manual adjustments to insulin administration.

• #26 Hybrid closed-loop systems for managing blood glucose levels in type 1 diabetes: a systematic review and economic modelling.

  https://pmc.ncbi.nlm.nih.gov/articles/PMC11664472/

  The clinical evidence identified 12 randomised controlled trials that compared hybrid closed loop with continuous subcutaneous insulin infusion + continuous glucose monitoring. Hybrid closed-loop arm of randomised controlled trials achieved improvement in glycated haemoglobin per cent [hybrid closed loop decreased glycated haemoglobin per cent by 0.28 (95% confidence interval -0.34 to -0.21), increased per cent of time in range (between 3.9 and 10.0 mmol/l) with a MD of 8.6 (95% confidence interval 7.03 to 10.22), and significantly decreased time in range (per cent above 10.0 mmol/l) with a MD of -7.2 (95% confidence interval -8.89 to -5.51), but did not significantly affect per cent of time below range ( 3.9 mmol/l)]. […] Randomised controlled trials of hybrid closed-loop interventions in comparison with continuous subcutaneous insulin infusion + continuous glucose monitoring achieved a statistically significant improvement in glycated haemoglobin per cent in time in range between 3.9 and 10 mmol/l, and in hyperglycaemic levels. […] Studies that looked at hybrid closed loop in people with type 1 diabetes mellitus seem to suggest that it is better for diabetes management in terms of glucose levels, better time in range between 3.9 and 10 mmol/l, and less hyperglycaemic levels.

• #27 Hybrid closed-loop systems for managing blood glucose levels in type 1 diabetes: a systematic review and economic modelling.

  https://pmc.ncbi.nlm.nih.gov/articles/PMC11664472/

  The clinical evidence identified 12 randomised controlled trials that compared hybrid closed loop with continuous subcutaneous insulin infusion + continuous glucose monitoring. Hybrid closed-loop arm of randomised controlled trials achieved improvement in glycated haemoglobin per cent [hybrid closed loop decreased glycated haemoglobin per cent by 0.28 (95% confidence interval -0.34 to -0.21), increased per cent of time in range (between 3.9 and 10.0 mmol/l) with a MD of 8.6 (95% confidence interval 7.03 to 10.22), and significantly decreased time in range (per cent above 10.0 mmol/l) with a MD of -7.2 (95% confidence interval -8.89 to -5.51), but did not significantly affect per cent of time below range ( 3.9 mmol/l)]. […] Randomised controlled trials of hybrid closed-loop interventions in comparison with continuous subcutaneous insulin infusion + continuous glucose monitoring achieved a statistically significant improvement in glycated haemoglobin per cent in time in range between 3.9 and 10 mmol/l, and in hyperglycaemic levels. […] Studies that looked at hybrid closed loop in people with type 1 diabetes mellitus seem to suggest that it is better for diabetes management in terms of glucose levels, better time in range between 3.9 and 10 mmol/l, and less hyperglycaemic levels.

• #28

  https://www.bjd-abcd.com/bjdvd/index.php/bjd/article/view/1191

  Those living with type 1 diabetes (T1DM) require daily adjustments of exogenous insulin doses and frequent glucose monitoring to optimally manage their condition. […] Recent years have seen major progress in the management of T1DM, with minimally invasive glucose monitoring technology and glucose-responsive insulin delivery systems, also called hybrid closed-loop systems. This narrative review focuses on three key areas: continuous glucose monitoring (CGM), hybrid closed-loop (HCL) systems, and connected pen devices, sometimes known as smart pens. […] Randomised controlled trials and real-world studies of CGM devices have shown improved haemoglobin A1c (HbA1c) levels, improved sensor-based metrics such as higher time spent in the target glucose range, and reduced rates of hypoglycemia. HCL studies have similarly shown improved HbA1c and other sensor-based glucose outcomes.

• #29 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. […] 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. […] 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. […] The primary objectives of the study were to determine the rates of severe hypoglycemia and ketoacidosis. […] The results: People using hybrid closed-loop therapy had a significantly lower rate of rate of hypoglycemic coma (0.62 per 100 patient-years) than those using open-loop therapy (0.91 per 100 patient-years).

• #30 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

  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). […] 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. […] Hybrid closed-loop systems (HCL) are technologies used to treat type 1 diabetes. They combine an insulin pump, continuous glucose monitoring, and an algorithm for automated insulin delivery. […] Open-loop systems combine an insulin pump and continuous glucose monitoring (CGM). Unlike closed-loop systems, which automatically adapt insulin delivery, an open-loop system requires the user to make manual adjustments to insulin administration.

• #31 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. […] Data on CGM use in pregnant women with type 2 diabetes (T2D) are limited. […] A large randomized controlled trial (RCT) on CGM use in people with T2D in pregnancy is ongoing. […] Small studies on CGM use in women with gestational diabetes (GDM) have suggested improved glycaemic control and better qualification when insulin is needed. […] Several large RCTs are ongoing in women with GDM. […] In addition to CGM, other technologies, such as advanced hybrid closed-loop (AHCL) systems have further improved glycaemic management in people with T1D. […] A large RCT with the AHCL CamAPS FX demonstrated a 10% increase in time in range compared to standard insulin therapy in a pregnant population with T1D.

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

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

  Recently, an RCT of an AHCL system not approved for use in pregnancy (780G MiniMed) has also demonstrated additional benefits of AHCL therapy compared to standard insulin therapy, with improved time in range overnight, less hypoglycaemia and improved treatment satisfaction. […] 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. […] We review the current evidence on the use of CGM and AHCL therapy in pregnancy.

• #33 Long-term assessment of the NHS hybrid closed-loop real-world study on glycaemic outcomes, time-in-range, and quality of life in children and young people with type 1 diabetes | BMC Medicine | Full Text

  https://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-024-03396-x

  Hybrid closed-loop (HCL) systems seamlessly interface continuous glucose monitoring (CGM) with insulin pumps, employing specialised algorithms and user-initiated automated insulin delivery. This study aimed to assess the efficacy of HCLs at 12 months post-initiation on glycated haemoglobin (HbA1c), time-in-range (TIR), hypoglycaemia frequency, and quality of life measures among children and young people (CYP) with type 1 diabetes mellitus (T1DM) and their caregivers in a real-world setting. […] Results demonstrated significant improvements in HbA1c (average reduction at 12 months 7 mmol/mol; P0.001), time-in-range (TIR) (average increase 13.4%; P0.001), hypoglycaemia frequency (50% reduction), hypoglycaemia fear, and quality of sleep (P0.001) among CYP over a 12-month period of HCL usage.

• #34 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. […] Data on CGM use in pregnant women with type 2 diabetes (T2D) are limited. […] A large randomized controlled trial (RCT) on CGM use in people with T2D in pregnancy is ongoing. […] Small studies on CGM use in women with gestational diabetes (GDM) have suggested improved glycaemic control and better qualification when insulin is needed. […] Several large RCTs are ongoing in women with GDM. […] In addition to CGM, other technologies, such as advanced hybrid closed-loop (AHCL) systems have further improved glycaemic management in people with T1D. […] A large RCT with the AHCL CamAPS FX demonstrated a 10% increase in time in range compared to standard insulin therapy in a pregnant population with T1D.

• #35 At a glance factsheet: Hybrid closed-loop therapy – DiabetesontheNet

  https://diabetesonthenet.com/diabetes-primary-care/factsheet-hybrid-closed-loop-therapy/

  In December 2023, NICE published the TA943 guidance, which lays out recommendations for use of hybrid closed-loop (HCL) systems in the management of type 1 diabetes, with a 5-year roll-out plan. […] An HCL system, also known as an artificial pancreas or Automated Insulin Delivery (AID) system, refers to the use of an insulin pump that is looped with an algorithm that continuously takes data from a continuous glucose monitoring (CGM) device to make and communicate decisions on insulin dosing to maintain glucose levels within the target range. […] The CGM device measures interstitial glucose every 15 minutes and transmits data by Bluetooth to the insulin management algorithm on either the pump or the smartphone. […] There is high-quality evidence that HCL technology results in better glycaemic control than insulin pump or sensor-augmented pump therapy, achieving more time in target glycaemic range, less time in hyper- and hypoglycaemia, less severe hypoglycaemia and improved HbA1c.

• #36 At a glance factsheet: Hybrid closed-loop therapy – DiabetesontheNet

  https://diabetesonthenet.com/diabetes-primary-care/factsheet-hybrid-closed-loop-therapy/

  In pregnancy, HCL leads to substantial improvements in glucose control, which will translate into improved outcomes for both mother and baby. […] Most importantly, HCL is associated with improved quality of life; generally positive user experience, including reassurance and reduced anxiety; improved sleep and confidence; and a reduction in the demands of living with type 1 diabetes. […] NICE TA943 guidance recommends HCL systems as an option for managing blood glucose levels in children and young people with type 1 diabetes. […] The guidance also highlights the requirement for a cost-effective pricing structure between the technology companies and NHS England. […] One third of people living with type 1 diabetes do not access specialist services. […] In 2022, the updated NICE NG17 guideline recommended CGM for all people living with type 1 diabetes.

• #37 At a glance factsheet: Hybrid closed-loop therapy – DiabetesontheNet

  https://diabetesonthenet.com/diabetes-primary-care/factsheet-hybrid-closed-loop-therapy/

  In December 2023, NICE published the TA943 guidance, which lays out recommendations for use of hybrid closed-loop (HCL) systems in the management of type 1 diabetes, with a 5-year roll-out plan. […] An HCL system, also known as an artificial pancreas or Automated Insulin Delivery (AID) system, refers to the use of an insulin pump that is looped with an algorithm that continuously takes data from a continuous glucose monitoring (CGM) device to make and communicate decisions on insulin dosing to maintain glucose levels within the target range. […] The CGM device measures interstitial glucose every 15 minutes and transmits data by Bluetooth to the insulin management algorithm on either the pump or the smartphone. […] There is high-quality evidence that HCL technology results in better glycaemic control than insulin pump or sensor-augmented pump therapy, achieving more time in target glycaemic range, less time in hyper- and hypoglycaemia, less severe hypoglycaemia and improved HbA1c.

• #38 Overview | Hybrid closed loop systems for managing blood glucose levels in type 1 diabetes | Guidance | NICE

  https://www.nice.org.uk/guidance/ta943

  Evidence-based recommendations on hybrid closed loop systems for managing blood glucose levels in type 1 diabetes. […] This guidance updates and replaces NICE diagnostics guidance on integrated sensor-augmented pump therapy systems for managing blood glucose levels in type 1 diabetes (DG21).

• #39 Hybrid closed loop systems for managing blood glucose levels in type 1 diabetes – Primary Care Notebook

  https://primarycarenotebook.com/pages/diabetes-and-endocrinology/hybrid-closed-loop-systems-for-managing-blood-glucose-levels-in-type-1-diabetes

  the NICE committee noted „… that the clinical-effectiveness evidence showed that HCL systems are likely to improve blood glucose control in type 1 diabetes. This effect appears to be greater for people with higher baseline HbA1c levels, although the extent of the true effect is uncertain. The committee noted that HCL systems are also effective for people with lower baseline HbA1c levels of around 58 mmol/mol (7.5%)…”

• #40 Diabetes – Diagnosis and treatment – Mayo Clinic

  https://www.mayoclinic.org/diseases-conditions/diabetes/diagnosis-treatment/drc-20371451

  The best current treatment for type one diabetes is an automated insulin delivery system. This system includes a continuous glucose monitor, insulin pump, and a computer algorithm that continually adjusts insulin responding to the continuous glucose monitoring signal. […] Testing using a glucose meter is not enough because glucose measurements in people with type one diabetes, vary from normal to low and normal to high very rapidly in the course of a day, a continuous glucose monitor is needed to assess whether treatment is effective and also to determine how to improve treatment. […] Current guidelines recommend use of a continuous glucose monitor. The percentage of time that is spent daily with glucose between 70 and 180 milligram per deciliter is the main measurement of appropriate treatment.

• #41 What are Automated Insulin Delivery Systems? | Medtronic

  https://www.medtronicdiabetes.com/treatments/automated-insulin-delivery

  Automated insulin delivery (AID) systems combine an insulin pump and continuous glucose monitor (CGM) to help people living with type 1 diabetes manage their blood sugar levels. […] AID systems, also known as hybrid closed loop systems, can detect changes in a persons sugar levels in real time and automatically adjust insulin doses in response. […] The CGM tracks your sugar levels every few minutes through a small sensor inserted under the skin. […] The algorithm uses current and past sugar level trends to anticipate, adjust, and correct insulin delivery. […] Its no surprise why the American Diabetes Association calls automated insulin delivery systems the standard of care for people with type 1 diabetes. […] The MiniMed 780G system is intended for continuous delivery of basal insulin at selectable rates, and the administration of insulin boluses at selectable amounts for the management of type 1 diabetes mellitus in persons seven years of age and older requiring insulin as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin.

• #42 Azthena logo with the word Azthena

  https://www.news-medical.net/news/20240411/Study-shows-daily-glucose-levels-fluctuate-more-than-we-thought-challenging-diabetes-diagnosis.aspx

  In a recent study published in the journal Nature Medicine, researchers examined fasting glucose (FG) variability in nondiabetic adults using continuous glucose monitoring (CGM), assessing its impact on diabetes classification and its association with clinical measures. […] CGM devices, which measure interstitial glucose levels, offer improved accuracy over time and are now used independently or in hybrid closed-loop systems for insulin dosing. […] Further research is needed to develop CGM-based diagnostic criteria that accurately reflect the intrapersonal variability of FG levels and their clinical implications. […] The research particularly emphasized FG measurements during morning hours, utilizing CGM data to observe intrapersonal variability and its potential impact on diabetes diagnosis.

• #43 At a glance factsheet: Hybrid closed-loop therapy – DiabetesontheNet

  https://diabetesonthenet.com/diabetes-primary-care/factsheet-hybrid-closed-loop-therapy/

  The automated feedback loop between CGM and pump insulin delivery means that, in the event of falling glucose levels or impending hypoglycaemia, insulin delivery is slowed or suspended, helping to avoid hypoglycaemia or limit its severity. […] Consequently, self-management of hypoglycaemia in the context of HCL systems requires different advice. […] The NICE TA943 recommendations have the potential to substantially change the management and improve the outcomes of people living with type 1 diabetes across England.

• #44 At a glance factsheet: Hybrid closed-loop therapy – DiabetesontheNet

  https://diabetesonthenet.com/diabetes-primary-care/factsheet-hybrid-closed-loop-therapy/

  The automated feedback loop between CGM and pump insulin delivery means that, in the event of falling glucose levels or impending hypoglycaemia, insulin delivery is slowed or suspended, helping to avoid hypoglycaemia or limit its severity. […] Consequently, self-management of hypoglycaemia in the context of HCL systems requires different advice. […] The NICE TA943 recommendations have the potential to substantially change the management and improve the outcomes of people living with type 1 diabetes across England.

• #45 The Future of Blood Glucose Monitoring

  https://www.webmd.com/diabetes/future-blood-glucose-monitoring

  A closed-loop system monitors your blood glucose level throughout the day using CGM. Based on your blood glucose level, it figures out how much insulin you need and delivers it through a pump. […] Researchers are working on developing a dual hormone system, and it may be available in the future. […] New technologies in development could one day measure blood glucose with no sticks at all, using methods like an electric current, light, and microneedles. […] sugarBEAT calls itself the world’s first noninvasive CGM. It’s a patch that runs a very slight electric current through your skin to measure glucose in the fluid under your skin. […] Other glucose monitoring methods don’t require any contact with your blood or fluids. These noninvasive testing methods measure glucose in your body’s fluids through the skin of your finger, belly, wrist, or earlobe. […] Time will tell which, if any, of these monitoring systems will be able to give a result accurate enough to be useful for people with diabetes.

• #46 What can we learn from the continuous glucose monitoring device market? | EY – Switzerland

  https://www.ey.com/en_ch/insights/life-sciences/what-can-we-learn-from-the-continuous-glucose-monitoring-device-market

  The continuous glucose monitoring device or CGM market is booming, as illustrated by the J.P. Morgan Healthcare conference earlier this year, where market leaders reported record expected growth, exciting product launches, as well as a commitment to reach sales of USD 20B by 2028. […] The technology has revolutionized the treatment and management of diabetes in combination with hybrid closed-loop systems, even enabling diabetes type 1 patients to participate and successfully finish in such strenuous activities as the 250 km ultramarathon Marathon des Sables in the Sahara Desert, a feat unimaginable with traditional diabetes management methods even a decade ago. […] For instance, for diabetes type 1 patients, continuous monitoring and hybrid closed loop technologies are worth investing in due to the severity of the disease and risk of complications.

• #47 Advanced Hybrid Closed-Loop Technology Could Improve Quality of Life in Type 1 Diabetes

  https://www.drugtopics.com/view/advanced-hybrid-closed-loop-technology-could-improve-quality-of-life-in-type-1-diabetes

  The current study was designed by a team of investigators from institutions in Poland led by Katarzyna Cyranka, PhD, MA, of the University Hospital in Krakow, as a 9-month observational continuation of a 3-month randomized controlled trial, with the aim of exploring the effect of 1-year of use of an advanced hybrid closed-loop system on quality of life, level of anxiety, and self-efficacy. […] The primary outcomes of interest for the trial were change in quality of life, level of anxiety, and level of self-efficacy. […] Evaluation of patients quality of life is a well-grounded indicator of the effectiveness of provided healthcare and may be helpful for health professionals and healthcare policymakers in their efforts to improve the well-being of patients, wrote investigators. […] Further, the authors of the Standards of Care in Diabetes 2025 highlighted the benefits of continuous glucose monitoring systems and recommend initiating these as soon as possible.

• #48 Hybrid Closed Loop Workforce Capacity Modelling Tool – Health Innovation Network

  https://healthinnovationnetwork.com/resources/hybrid-closed-loop-workforce-capacity-modelling-tool/

  In December 2023, NICE released guidance that adults with Type 1 diabetes are to be offered to be put on a Hybrid Closed Loop (HCL) system. This is a device which links continuous glucose monitoring with insulin pump technology to monitor blood glucose and automatically adjust the amount of insulin given through a pump. […] Under this new guidance, there are five times as many people who are now eligible for HCL technologies compared to current insulin pump use, offering a big step forward in diabetes care. […] This tool supports services to quantify the capacity needed to implement HCL technology while ensuring effective service delivery.

• #49 Diabetes hybrid closed loop systems | HFMA

  https://www.hfma.org.uk/publications/diabetes-hybrid-closed-loop-systems-0

  NICE concluded that HCL systems would reduce some of this burden, and improve quality of life for people, their families and carers. […] The HCL can also be used by a much wider range of people than is appropriate for separate CGM and insulin pump technology, because it lessens the number of manual calculations made with the separate technologies, therefore it could be rolled out to those who would not manage a single digital device for example adults with special educational needs. […] The NICE programme estimated the cost over a 60-year time horizon with the patients HbA1C score (time in range) assumed to remain constant. […] The NICE analysts modelled the impact of avoiding adverse events and complications, including AE attendance, admission for severe and non-severe hypo or hyper glycaemic event, non-fatal stroke, fatal stroke, kidney complications and eye complications.

• #50 Diabetes hybrid closed loop systems | HFMA

  https://www.hfma.org.uk/publications/diabetes-hybrid-closed-loop-systems-0

  This case study explains the technology currently being rolled out by the NHS in England, describes the condition it aims to support, and how the roll out is to be funded by NHS England. […] The technology is NICE recommended and has been subject to a large scale pilot, proving the worth to persons living with diabetes and the potential cost savings for the NHS. […] This case study describes how a technology the hybrid closed loop digital system is enabling a better quality of life for people with type 1 diabetes, reducing the number of life-threatening complications and expensive healthcare events. […] The National Institute for Health and Care Excellence (NICE) guidance has recommended the use of the system, and NHS England has agreed funding for the roll out of a five-year programme.

• #51 Diabetes hybrid closed loop systems | HFMA

  https://www.hfma.org.uk/publications/diabetes-hybrid-closed-loop-systems-0

  The widely recognised measure of average blood glucose level is the test for glycated haemoglobin, known as HbA1C. […] NICE advises adults with type 1 diabetes to aim for a fasting plasma glucose level of 5 to 7 mmol/litre on waking and a plasma glucose level of 4 to 7 mmol/litre before meals at other times of the day. […] Self-management and preventative treatment for people with type 1 diabetes is intended to increase the time that blood glucose levels are in a healthy range, thereby reducing the number of adverse events and risks of other conditions. […] NICE made evidence-based recommendations for the HCL technology for NHS patients in December 2023. […] NICE states that trial and real-world evidence shows that HCL systems are more effective than standard care at maintaining blood glucose levels within a healthy range.

• #52 Is a hybrid closed-loop system safe for my son who has T1D?

  https://www.icliniq.com/qa/continuous-glucose-monitoring-sensor/do-hybrid-closed-loop-systems-benefit-t1d-management

  Unexplained blood sugar spikes could indicate that his pump settings, especially basal and bolus ratios need adjustment. […] Regularly reviewing and adjusting his insulin settings is essential as his body changes. […] Guidelines for teenagers: Regular monitoring: Analyze CGM (continuous glucose monitor) data to optimize insulin settings. […] Adjustments: Modify basal rates and carbohydrate-to-insulin ratios as needed. […] Consulting with his healthcare team can help fine-tune his management plan.

• #53 Continuous glucose monitoring and hybrid closed loop for diabetes – NHS

  https://www.nhs.uk/conditions/cgm-and-hcl-for-diabetes/

  Hybrid closed loop systems are being made available on the NHS to some people with type 1 diabetes. […] Hybrid closed loop is planned to be available to all children and young people with type 1 diabetes, and eventually to adults with type 1 diabetes who either: have blood glucose levels (HbA1c levels) of 58 mmol/mol or more, have serious problems with hypos despite using an insulin pump or CGM on its own and carefully trying to manage their blood glucose, are pregnant or planning to get pregnant. […] Insulin pumps and hybrid closed loop systems are not currently available on the NHS for people with type 2 diabetes.

• #54 Hybrid closed loop systems recommended for people living with type 1 diabetes (1) – Diabetes Research & Wellness Foundation

  https://www.drwf.org.uk/news-and-events/news/hybrid-closed-loop-systems-recommended-for-people-living-with-type-1-diabetes-1/

  Hybrid closed loop management system is expected to be available via the NHS following a recommendation from NICE. […] The hybrid closed loop system, also referred to as an artificial pancreas, can help people living with type 1 diabetes to improve management of their blood glucose levels. […] Hybrid closed loop (HCL) systems work by linking an insulin pump and continuous glucose monitor (CGM) with a computer algorithm that can calculate the amount of insulin someone needs based on their blood glucose readings, helping people manage diabetes with minimal user interaction. […] According to HCL users participating in the study there were numerous benefits to HCL, including improvements in quality of life (52%), time in range (46%), productivity at work (44%), sleep (42%) and reduced stress related to diabetes (40%).

• #55 Hybrid closed loop systems recommended for people living with type 1 diabetes (1) – Diabetes Research & Wellness Foundation

  https://www.drwf.org.uk/news-and-events/news/hybrid-closed-loop-systems-recommended-for-people-living-with-type-1-diabetes-1/

  Healthcare providers were also in agreement at the potential of HCL to change lives for people living with type 1 diabetes for the better (99%), while 98% said they would want all people with the condition to have access to HCL. […] Every single person (100%) surveyed with type 1 diabetes said that being on an HCL system has reduced the burden of managing their diabetes and 98% of healthcare practitioners say they would want all people with type 1 diabetes to have access to HCL. […] I can honestly say using the Dexcom G6 continuous glucose monitoring device to power my HCL system has changed my life.

Zobacz więcej