Automated insulin delivery system

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Display demonstrating an 'artificial pancreas' at Thackray Museum of Medicine Artificial pancreas.jpg
Display demonstrating an 'artificial pancreas' at Thackray Museum of Medicine

Automated insulin delivery systems are automated (or semi-automated) systems designed to assist people with insulin-requiring diabetes, by automatically adjusting insulin delivery in response to blood glucose levels. Currently available systems (as of October 2020) can only deliver (and regulate delivery of) a single hormone—insulin. Other systems currently in development aim to improve on current systems by adding one or more additional hormones that can be delivered as needed, providing something closer to the endocrine functionality of the pancreas.

Contents

The endocrine functionality of the pancreas is provided by islet cells which produce the hormones insulin and glucagon. Artificial pancreatic technology mimics the secretion of these hormones into the bloodstream in response to the body's changing blood glucose levels. Maintaining balanced blood sugar levels is crucial to the function of the brain, liver, and kidneys. [2] Therefore, for people with diabetes, it is necessary that the levels be kept balanced when the body cannot produce insulin itself. [2]

Automated insulin delivery (AID) systems are often referred to using the term artificial pancreas, but the term has no precise, universally accepted definition. For uses other than automated insulin delivery, see Artificial pancreas (disambiguation).

General overview

History

The first automated insulin delivery system was known as the Biostator.[ citation needed ]

Classes of AID systems

Currently available AID systems fall into three broad classes based on their capabilities. The first systems released can only halt insulin delivery (predictive low glucose suspend) in response to already low or predicted low glucose. Hybrid ClosedLoop systems can modulate delivery both up and down, although users still initiate insulin doses (boluses) for meals and typically "announce" or enter meal information. Fully Closed Loops require no manual insulin delivery actions or announcement for meals. [ citation needed ]

Predictive Low Glucose Suspend (PLGS)

A step forward from threshold suspend systems, predictive low glucose suspend (PLGS) systems use a mathematical model to extrapolate predicted future blood sugar levels based on recent past readings from a CGM. This allows the system to reduce or halt insulin delivery prior to a predicted hypoglycemic event. [3]

Hybrid Closed Loop (HCL) / Advanced Hybrid Closed Loop (AHCL)

Hybrid closed loop (HCL) systems further expand on the capabilities of PLGS systems by adjusting basal insulin delivery rates both up and down in response to values from a continuous glucose monitor. Through this modulation of basal insulin, the system is able to reduce the magnitude and duration both hyperglycemic and hypoglycemic events. Users still must initiate manual mealtime boluses. [4] Advanced hybrid closed loop systems have advanced algorithms.

Fully Closed Loop (FCL)

Fully or full closed loop (FCL) systems adjust insulin delivery in response to changes in glucose levels without requiring input by users for mealtime insulin or announcements of meals. [5]

Required components

An automated insulin delivery system consists of three distinct components: a continuous glucose monitor to determine blood sugar levels, a pump to deliver insulin, and an algorithm that uses the data from the CGM and pump to determine needed insulin adjustments.

In the United States, the Food and Drug Administration (FDA) allows each component to be approved independently, allowing for more rapid approvals and incremental innovation. Each component is discussed in greater detail below.

Continuous glucose monitor (CGM)

Artificial pancreas feedback system Artificial Pancreas.jpg
Artificial pancreas feedback system

Continuous glucose monitors (CGMs) are wearable sensors which extrapolate an estimate of the glucose concentration in a patient's blood based on the level of glucose present in the subcutaneous interstitial fluid. A thin, biocompatible sensor wire coated with a glucose-reactive enzyme is inserted into the skin, allowing the system to read the voltage generated, and based on it, estimate blood glucose. The biggest advantage of a CGM over a traditional fingerstick blood glucose meter is that the CGM can take a new reading as often as every 60 seconds (although most only take a reading every 5 minutes), allowing for a sampling frequency that is able to provide not just a current blood sugar level, but a record of past measurements; allowing computer systems to project past short-term trends into the future, showing patients where their blood sugar levels are likely headed.

Insulin pump

An insulin pump delivers insulin subcutaneously. The insulin pump body itself can also contain the algorithm used in an AID system, or it can connect via Bluetooth with a separate mobile device (such as a phone) to send data and receive commands to adjust insulin delivery.

Algorithm

The algorithm for each AID system differs. In commercial systems (see below), little is known about the details of how the control algorithm works. In open source systems, the code and algorithm are openly available. In general, all algorithms do the same basic functionality of taking in CGM data and based on predicted glucose level's and the user's personal settings (for basal rates, insulin sensitivity, and carbohydrate ratio, for example) then recommends insulin dosing to help bring or maintain glucose levels in target range.

Depending on the system, users may have the ability to adjust the target for the system, and may have different settings to ask the system to give more or less insulin in general.

Currently available systems

Commercial

Commercial availability varies by country. Approved systems in various countries, described further below, include MiniMed 670G or 780G, Tandem's Control-IQ, Omnipod 5, CamAPS FX, and Diabeloop DBLG1. [6]

MiniMed 670G

In September 2016, the FDA approved the Medtronic MiniMed 670G, which was the first approved hybrid closed loop system. The device automatically adjusts a patient's basal insulin delivery. [7] It is made up of a continuous glucose monitor, an insulin pump, and a glucose meter for calibration. It automatically functions to modify the level of insulin delivery based on the detection of blood glucose levels by continuous monitor. It does this by sending the blood glucose data through an algorithm that analyzes and makes the subsequent adjustments. [7] The system has two modes. Manual mode lets the user choose the rate at which basal insulin is delivered. Auto mode regulates basal insulin levels from the CGM readings every five minutes. [8]

Tandem Diabetes Care t:Slim X2 with Control IQ

The Tandem Diabetes Care t:Slim X2 was approved by the U.S. Food and Drug Administration in 2019 and is the first insulin pump to be designated as an alternate controller enabled (ACE) insulin pump. ACE insulin pumps allow users to integrate continuous glucose monitors, automated insulin dosing (AID) systems, and other diabetes management devices with the pump to create a personalized diabetes therapy system. Many users of the t:slim X2 integrate the pump with the Dexcom G6, a continuous glucose monitor approved by the FDA in 2018. It was the first CGM authorized for use in an integrated therapy system. The device does not require fingerstick calibrations. [9]

iLet Bionic Pancreas

In May 2023, the FDA approved the iLet Bionic Pancreas system for people with Type 1 diabetes of six years and older. [5] [4] The device uses a closed-loop system to deliver both insulin and glucagon in response to sensed blood glucose levels. The 4th generation iLet prototype, presented in 2017, is around the size of an iPhone, with a touchscreen interface. It contains two chambers for both insulin and glucagon, and the device is configurable for use with only one hormone, or both. [10] A 440-patient study of type I diabetes ran in 2020 and 2021 using a device configuration that delivered only insulin in comparison to standard of care; device use led to better circulating glucose control (measured by continuous monitoring) and a reduction in glycated hemoglobin (versus no change for the standard of care group). [11] However, the incidence of severe hypoglycemic events was more than 1.5 times higher among device users versus standard care patients. [11]

Non-Commercial

There are several non-commercial, non-FDA approved DIY options, [12] [13] using open source code, [14] including OpenAPS, [15] Loop, [16] and/or AndroidAPS. [17]

Systems in development

Luna Diabetes

Former founders of Timesulin, Welldoc, Companion Medical and Bigfoot Biomedical have joined together to create the world's first automated insulin delivery system for those that want to continue to use insulin pens. The team is calling it Episodic AID.

The working product name is Luna. [18]

Inreda AP

In collaboration with the Academic Medical Center in Amsterdam, Inreda Diabetic B.V. has developed a closed loop system with insulin and glucagon. The initiator, Robin Koops, started to develop the device in 2004 and ran the first tests on himself. In October 2016 Inreda Diabetic B.V. got the ISO 13485 license, a first requirement to produce its artificial pancreas. [19] The product itself is called Inreda AP, and soon made some highly successful trials. After clinical trials, it received the CE marking, noting that it complies with European regulation, in February 2020. [20]

In October 2020 the health insurance company Menzis and Inreda Diabetic then started a pilot with 100 patients insured by Menzis. These are all patients that face very serious trouble in regulating their blood glucose levels. They now use the Inreda AP instead of the traditional treatment. [21] Another large scale trial with the Inreda AP was set up in July 2021, and should determine whether Dutch health insurance should cover the device for all their insured. [22] A smaller improved version of the Inreda AP is scheduled for release in 2023.

Approaches

Medical equipment

The medical equipment approach involves combining a continuous glucose monitor and an implanted insulin pump that can function together with a computer-controlled algorithm to replace the normal function of the pancreas. [23] [24] [25] The development of continuous glucose monitors has led to the progress in artificial pancreas technology using this integrated system. [26]

Closed-loop systems

Unlike the continuous sensor alone, the closed-loop system requires no user input in response to reading from the monitor; the monitor and insulin pump system automatically delivers the correct amount of hormone calculated from the readings transmitted. The system is what makes up the artificial pancreas device. [27] [28]

Current studies

Four studies on different artificial pancreas systems are being conducted starting in 2017 and going into the near future. The projects are funded by the National Institute of Diabetes and Digestive and Kidney Diseases, and are the final part of testing the devices before applying for approval for use. Participants in the studies are able to live their lives at home while using the devices and being monitored remotely for safety, efficacy, and a number of other factors. [29]

The International Diabetes Closed-Loop trial, [30] led by researchers from the University of Virginia, is testing a closed-loop system called inControl, which has a smartphone user interface. 240 people of ages 14 and up are participating for 6 months. [29]

A full-year trial led by researchers from the University of Cambridge started in May 2017 and has enrolled an estimated 150 participants of ages 6 to 18 years. [29] The artificial pancreas system being studied uses a smartphone and has a low glucose feature to improve glucose level control. [31]

The International Diabetes Center in Minneapolis, Minnesota, in collaboration with Schneider Children's Medical Center of Israel, are planning a 6-month study that will begin in early 2019 and will involve 112 adolescents and young adults, ages 14 to 30. [29] [32] The main object of the study is to compare the current Medtronic 670G system to a new Medtronic-developed system. The new system has programming that aims to improve glucose control around mealtime, which is still a big challenge in the field. [32]

The current 6-month study led by the Bionic Pancreas team started in mid-2018 and enrolled 312 participants of ages 18 and above. [29]

Physiological

The Bio-artificial pancreas: this diagram shows a cross section of bio-engineered tissue with encapsulated islet cells which deliver endocrine hormones in response to glucose. Bio-artificial pancreas with Islet Sheet technology.JPG
The Bio-artificial pancreas: this diagram shows a cross section of bio-engineered tissue with encapsulated islet cells which deliver endocrine hormones in response to glucose.

The biotechnical company Defymed, based in France, is developing an implantable bio-artificial device called MailPan which features a bio-compatible membrane with selective permeability to encapsulate different cell types, including pancreatic beta cells. [33] The implantation of the device does not require conjunctive immuno-suppressive therapy because the membrane prevents antibodies of the patient from entering the device and damaging the encapsulated cells. After being surgically implanted, the membrane sheet will be viable for years. The cells that the device holds can be produced from stem cells rather than human donors, and may also be replaced over time using input and output connections without surgery. [33] [34] Defymed is partially funded by JDRF, formerly known as the Juvenile Diabetes Research Foundation, but is now defined as an organization for all ages and all stages of type 1 diabetes. [35] [36]

In November 2018, it was announced that Defymed would partner with the Israel-based Kadimastem, a bio-pharmaceutical company developing stem-cell based regenerative therapies, to receive a two-year grant worth approximately $1.47 million for the development of a bio-artificial pancreas that would treat type 1 diabetes. [33] [37] Kadimastem's stem cell technology uses differentiation of human embryonic stem cells to obtain pancreatic endocrine cells. These include insulin-producing beta cells, as well as alpha cells, which produce glucagon. Both cells arrange in islet-like clusters, mimicking the structure of the pancreas. [38] The aim of the partnership is to combine both technologies in a bio-artificial pancreas device, which releases insulin in response to blood glucose levels, to bring to clinical trial stages. [33]

The San Diego, California based biotech company ViaCyte has also developed a product aiming to provide a solution for type 1 diabetes which uses an encapsulation device made of a semi-permeable immune reaction-protective membrane. The device contains pancreatic progenitor cells that have been differentiated from embryonic stem cells. [39] After surgical implantation in an outpatient procedure, the cells mature into endocrine cells which arrange in islet-like clusters and mimic the function of the pancreas, producing insulin and glucagon. [40] [41] The technology advanced from pre-clinical studies to FDA approval for phase 1 clinical trials in 2014, and presented two-year data from the trial in June 2018. [39] They reported that their product, called PEC-Encap, has so far been safe and well tolerated in patients at a dose below therapeutic levels. The encapsulated cells were able to survive and mature after implantation, and immune system rejection was decreased due to the protective membrane. The second phase of the trial will evaluate the efficacy of the product. [42] ViaCyte has also been receiving financial support from JDRF on this project. [41]

Initiatives around the globe

In the United States in 2006, JDRF (formerly the Juvenile Diabetes Research Foundation) launched a multi-year initiative to help accelerate the development, regulatory approval, and acceptance of continuous glucose monitoring and artificial pancreas technology. [43] [44]

Grassroots efforts to create and commercialize a fully automated artificial pancreas system have also arisen directly from patient advocates and the diabetes community. [45]

In April 2024, the NHS announced it would, over the next five years, offer use of a Hybrid Closed Loop system to Type 1 diabetes patients in England. [46]

Related Research Articles

<span class="mw-page-title-main">Insulin pump</span> Medical device to administer insulin

An insulin pump is a medical device used for the administration of insulin in the treatment of diabetes mellitus, also known as continuous subcutaneous insulin therapy. The device configuration may vary depending on design. A traditional pump includes:

<span class="mw-page-title-main">Blood glucose monitoring</span> Use of a glucose monitor for testing the concentration of glucose in the blood

Blood glucose monitoring is the use of a glucose meter for testing the concentration of glucose in the blood (glycemia). Particularly important in diabetes management, a blood glucose test is typically performed by piercing the skin to draw blood, then applying the blood to a chemically active disposable 'test-strip'. The other main option is continuous glucose monitoring (CGM). Different manufacturers use different technology, but most systems measure an electrical characteristic and use this to determine the glucose level in the blood. Skin-prick methods measure capillary blood glucose, whereas CGM correlates interstitial fluid glucose level to blood glucose level. Measurements may occur after fasting or at random nonfasting intervals, each of which informs diagnosis or monitoring in different ways.

Breakthrough T1D is a nonprofit 501(c)(3) organization that funds type 1 diabetes (T1D) research, provides a broad array of community and activist services to the T1D population and actively advocates for regulation favorable to medical research and approval of new and improved treatment modalities. It was initially founded as the JDF, the Juvenile Diabetes Foundation, before changing its name to Juvenile Diabetes Research Foundation, later shortened to JDRF. As of 2024 it is known as Breakthrough T1D.

<span class="mw-page-title-main">Type 1 diabetes</span> Form of diabetes mellitus

Type 1 diabetes (T1D), formerly known as juvenile diabetes, is an autoimmune disease that originates when cells that make insulin are destroyed by the immune system. Insulin is a hormone required for the cells to use blood sugar for energy and it helps regulate glucose levels in the bloodstream. Before treatment this results in high blood sugar levels in the body. The common symptoms of this elevated blood sugar are frequent urination, increased thirst, increased hunger, weight loss, and other serious complications. Additional symptoms may include blurry vision, tiredness, and slow wound healing. Symptoms typically develop over a short period of time, often a matter of weeks if not months.

The term diabetes includes several different metabolic disorders that all, if left untreated, result in abnormally high concentrations of a sugar called glucose in the blood. Diabetes mellitus type 1 results when the pancreas no longer produces significant amounts of the hormone insulin, usually owing to the autoimmune destruction of the insulin-producing beta cells of the pancreas. Diabetes mellitus type 2, in contrast, is now thought to result from autoimmune attacks on the pancreas and/or insulin resistance. The pancreas of a person with type 2 diabetes may be producing normal or even abnormally large amounts of insulin. Other forms of diabetes mellitus, such as the various forms of maturity-onset diabetes of the young, may represent some combination of insufficient insulin production and insulin resistance. Some degree of insulin resistance may also be present in a person with type 1 diabetes.

Noninvasive glucose monitoring (NIGM), called Noninvasive continuous glucose monitoring when used as a CGM technique, is the measurement of blood glucose levels, required by people with diabetes to prevent both chronic and acute complications from the disease, without drawing blood, puncturing the skin, or causing pain or trauma. The search for a successful technique began about 1975 and has continued to the present without a clinically or commercially viable product.

<span class="mw-page-title-main">Insulin (medication)</span> Use of insulin protein and analogs as medical treatment

As a medication, insulin is any pharmaceutical preparation of the protein hormone insulin that is used to treat high blood glucose. Such conditions include type 1 diabetes, type 2 diabetes, gestational diabetes, and complications of diabetes such as diabetic ketoacidosis and hyperosmolar hyperglycemic states. Insulin is also used along with glucose to treat hyperkalemia. Typically it is given by injection under the skin, but some forms may also be used by injection into a vein or muscle. There are various types of insulin, suitable for various time spans. The types are often all called insulin in the broad sense, although in a more precise sense, insulin is identical to the naturally occurring molecule whereas insulin analogues have slightly different molecules that allow for modified time of action. It is on the World Health Organization's List of Essential Medicines. In 2021, it was the 179th most commonly prescribed medication in the United States, with more than 2 million prescriptions.

<span class="mw-page-title-main">Minimed Paradigm</span> Insulin pumps

MiniMed Paradigm is a series of insulin pumps manufactured by Medtronic for patients with diabetes mellitus. The pump operates with a single AAA battery and uses a piston-plunger pump to infuse a programmed amount of insulin into the patient through a length of tubing. The Paradigm uses a one-way wireless radio frequency link to receive blood sugar measurements from select glucose meters. The Paradigm RT series adds the ability to receive data from a mated continuous blood-glucose monitor. Although the pump can use these measurements to assist in calculating a dose of insulin, no actual change in insulin delivery occurs without manual user-intervention.

DexCom, Inc. is a company that develops, manufactures, produces, and distributes continuous glucose monitoring (CGM) systems for diabetes management. It operates internationally with headquarters in San Diego, California, and has manufacturing facilities in Mesa, Arizona and Batu Kawan, Malaysia.

Bruce Bode, MD, FACE is a diabetes specialist with the Atlanta Diabetes Associates in Atlanta, GA and is a clinical associate professor at Emory University in the Department of Medicine. He has served on the board of directors of the Atlanta chapters of the Juvenile Diabetes Research Foundation (JDRF), the American Diabetes Association (ADA), and various Georgia-based diabetes camps. Bode is a member of the board of directors of Glytec and an active member of the JDRF research team validating the efficacy and safety of real-time continuous glucose monitoring (CGMS), and is a former president of the ADA Georgia Affiliate and editor of the ADA's 2004 edition of Medical Management of Type 1 Diabetes.

International Diabetes Center at Park Nicollet (IDC) is a center for diabetes care, research and education located in Minneapolis, Minnesota, United States. The center provides clinical, motivational and educational services for people with diabetes. It is part of HealthPartners Institute.

The Journal of Diabetes Science and Technology(JDST) is a bimonthly peer-reviewed medical journal covering all aspects of diabetes. JDST covers all aspects of diabetes technology including glucose monitoring; insulin and metabolic peptide delivery; the artificial and bioartificial pancreas, telemedicine; software for modeling; physiologic monitoring; technology for managing obesity; diagnostic tests of glycation; and the use of bioengineered tools such as MEMS, new biomaterials, and nanotechnology to develop new sensors and actuators to be applied to diabetes. Articles in JDST cover both basic research and clinical applications of technologies being developed to help people with diabetes. It is published by SAGE Publishing on behalf of the Diabetes Technology Society. The journal was established in 2007 and the editor-in-chief is David C. Klonoff.

Tandem Diabetes Care, Inc. is an American medical device manufacturer based in San Diego, California. The company develops medical technologies for the treatment of diabetes and specifically insulin infusion therapy.

Ambulatory glucose profile (AGP) is a single-page, standardized report for interpreting a patient's daily glucose and insulin patterns. AGP provides both graphic and quantitative characterizations of daily glucose patterns. First developed by Drs. Roger Mazze and David Rodbard, with colleagues at the Albert Einstein College of Medicine in 1987, AGP was initially used for the representation of episodic self-monitored blood glucose (SMBG). The first version included a glucose median and inter-quartile ranges graphed as a 24-hour day. Dr. Mazze brought the original AGP to the International Diabetes Center (IDC) in the late 1980s. Since then, IDC has built the AGP into the internationally recognized standard for glucose pattern reporting.

Bigfoot Biomedical Inc. is a medical technology start-up headquartered in Milpitas, California, founded by a team of people with personal connections to type 1 and type 2 diabetes.

Boris Petrov Kovatchev is a professor at the University of Virginia where he is the founding Director of the UVA Center for Diabetes Technology, and a principal investigator of the JDRF Artificial Pancreas Project.

Nightscout is a free and open-source project, and associated social movement, that enables accessing and working with continuous glucose monitor (CGM) data. Nightscout software aims to give users access to their real time blood sugar data by putting this data in the cloud. In addition to browser-based data visualization, Nightscout can also be used to review data from a phone or smartwatch, or to remotely monitor CGM data for individuals with type 1 diabetes. Associated with Nightscout software is a broader "CGM in the Cloud" social movement, supporting individuals seeking to access and use realtime CGM data through commercial and DIY approaches.

The Open Artificial Pancreas System (OpenAPS) project is a free and open-source project that aims to make basic artificial pancreas system (APS) technology available to everyone. The OpenAPS project was designed with the idea of quickly getting the APS technology to more people using a direct approach, rather than waiting for clinical trials to be completed and regulatory approval to be granted.

<span class="mw-page-title-main">Continuous glucose monitor</span> Blood glucose monitoring device

A continuous glucose monitor (CGM) is a device used for monitoring blood glucose on a continual basis instead of monitoring glucose levels periodically by drawing a drop of blood from a finger. This is known as continuous glucose monitoring. CGMs are used by people who treat their diabetes with insulin, for example people with type 1 diabetes, type 2 diabetes, or other types of diabetes, such as gestational diabetes.

Robin Koops is a Dutch mechanical engineer, designer and inventor. He is known for developing an artificial pancreas.

References

Notes

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  44. ↑ KMorandi says (2017-08-10). "Insurers can profit while improving the lives of people with type 1 diabetes". STAT. Retrieved 2017-08-10.
  45. ↑ Hurley, Dan (24 December 2014) WIRED Magazine, Diabetes Patients Are Hacking Their Way Toward a Bionic Pancreas
  46. ↑ "NHS England » NHS rolls out artificial pancreas in world first move". www.england.nhs.uk. Retrieved 2024-04-11.
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