Despite the rapid development of science and technology in healthcare, diabetes remains an incurable lifelong illness. Diabetes education aiming to improve the self-management skills is an essential way to help patients enhance their metabolic control and quality of life.
- Artificial intelligence (AI) technologies have made significant progress in transforming available genetic data and clinical information into valuable knowledge. The application of AI tech in disease education would be extremely beneficial considering their advantages in promoting individualization and full-course education intervention according to the unique pictures of different individuals.
The artificial pancreas (AP), also known as “closed-loop control” system, an “automated insulin delivery” system, or an “autonomous system for glycemic control”, is an “all-in-one” diabetes management system that tracks blood glucose levels using a continuous glucose monitor (CGM) and automatically delivers the hormone insulin when needed using an insulin pump. The system replaces reliance on testing by fingerstick or CGM with separate delivery of insulin by multiple daily injections or a pump.
According to 2019 worldwide statistics by the International Diabetes Federation (IDF),
- Approximately 463 million adults (20-79 years) were living with diabetes; by 2045 this will rise to 700 million
- The proportion of people with type 2 diabetes is increasing in most countries
- 79% of adults with diabetes were living in low- and middle-income countries
- The greatest number of people with diabetes were between 40 and 59 years of age
- 1 in 2 (232 million) people with diabetes were undiagnosed
- Diabetes caused 4.2 million deaths
- Diabetes caused at least $760 billion dollars in health expenditure in 2019, that is ~10% of total spending on adults
- More than 1.1 million children and adolescents are living with type 1 diabetes
- More than 20 million live births (1 in 6 births) are affected by diabetes during pregnancy
- 374 million people are at increased risk of developing type 2 diabetes
Life-changing technologies such as continuous glucose monitors (CGMs) and first-generation artificial pancreas (AP) systems are now a reality. Next-generation therapies such as fully automated AP systems, beta cell replacement, immunotherapies, and prevention therapies are now in human clinical trials, while groundbreaking research continues toward ultimate cures.
Continuous Glucose Monitoring Market
With number of newly diagnosed diabetes patients rising every year worldwide, the sales of continuous glucose monitors (CGMs) that continuously check blood readings in real-time or monitor glucose readings over a period of time using below-the-skin sensor and wirelessly stream data to an external reader is growing exponentially.
The global sales of continuous glucose monitoring devices estimated to expanding at a double-digit CAGR of 17.8% over the coming years, primarily driven by rising diabetes population, growing aging population and pressure to reduce healthcare costs.
Currently, the CGM market is dominated by Abbott Laboratories, Inc., Dexcom, Inc., Senseonics Holdings, Inc. and Medtronic plc. Other companies operating in this segment include Bayer AG, GlySens Inc., Nemaura Medical, and Nova Biomedical Corp.
- Both Abbott and Dexcom have US-FDA-approved CGMs in the market for “non-adjunctive” use, where insulin delivery can be made without the need for separate confirmation from a blood glucose meter, and no fingersticks for dosing and device calibration.
- Abbott’s FreeStyle Libre system, a 14-day system is the globally leading CGM device, which replaced the original 10-day sensor system for patients and the Free-Style Libre Pro for healthcare professionals.
- Dexcom is presently developing the next generation smaller, fully disposable and easier to use, and less costly G7 CGM compared its presently marketed G6 CGM, which has a 10-day sensor.
- Senseonics markets its FDA approved implantable CGM which can be used for up to 90 days and 180 days before replacing for non-adjunctive use, in the US and Europe, respectively. Along with the CGM, company’s Eversense mobile app allows making dosing decisions without the need to test blood glucose levels.
- Medtronic is also developing its next-generation Guardian CGM sensor, which will reduce fingerstick calibration by about 95% for non-adjunctive use.
Overall, there is a strong need to lessen the patient burden and for less complex devices that improve accuracy and glycemic control while lowering healthcare costs and improving quality of life. CGMs will play a pivotal role in addressing these needs with CGM companies aggressively competing on affordability, convenience, ease of use, more comfortable sensors and longer sensor wear.
However, CGM devices coupled with an insulin pump, offers patients more flexibility because the algorithm in the embedded sensor modulates insulin delivery throughout the day and night, which helps patients stay within set glycemic targets.
Insulin Pump Manufacturers
The worldwide insulin pumps market is expected to witness double-digit growth (~12% CAGR) over the next few years. The global market is highly competitive and undergoing significant change, predominantly marked by four major players and several innovative start-ups.
The global market for insulin infusion pumps is not only driven by technological innovation, but also by the diabetes community by pressurizing regulators to approve products faster, and reduce the diabetic care costs by making insurance companies more flexible.
The diabetes care industry is changing rapidly, by developing automated systems to achieve better glycemic control by the insulin pump manufacturers. There is a strong need for improved, automated insulin delivery to lessen the complexity, daily burden and potential health risks that result from multiple daily insulin injections.
The global insulin pump market has been dominated by key players such as Medtronic plc, Insulet Corp. and Tandem Diabetes Care, Inc. and Valeritas Holdings, Inc. In the coming years, these companies are expected to launch several next-generation integrated hybrid closed-loop systems to collect and interpret data, and manage the disease in this segment.
- Medtronic led the combined insulin pumps market based on total sales of MiniMed hybrid closed-loop systems such as MiniMed 670G, MiniMed 630G, MiniMed 640G and related accessories.
- Other similar hybrid closed-loop products in pipeline include MiniMed 770G and MiniMed 780G.
- Tandem has recently launched its new user-friendly automated touchscreen t:slim X2 insulin pump system with its proprietary enhanced Control-IQ algorithm technology, in addition to already marketed t:slim X2 with Basal-IQ insulin pump system.
- Other advanced products such as t:sport and t:connect insulin pumps with Control-IQ technology connected to mobile apps are under development.
- These will allow patients to wirelessly upload data from their pump in CGM to their mobile management applications.
- Insulet has two products (Omnipod Insulin Management System, and an interoperable automated insulin delivery system, Omnipod DASH) in the market with strong sales.
- The Omnipod is a wireless Bluetooth system that connects to a touchscreen, handheld personal diabetes manager (PDM) with a waterproof, tubeless continuous insulin delivery pump.
- The PDM, which controls insulin delivery, looks like a smartphone and is available with two new apps that help users manage and share diabetes data and accessories.
- The company’s next-generation Omnipod Horizon Hybrid Closed-Loop System is under active clinical trials.
- Valeritas has V-Go insulin pump in the market, which is a small, wearable insulin delivery system designed specifically for type 2 diabetes patients using multiple daily injection (MDI) therapy.
- Roche has only one product, Accu-Chek Solo micropump available in European market in selected countries.
Artificial Pancreas Device Systems in Market
The new artificial pancreas system which automatically monitors and regulates blood glucose levels has found that the new system was more effective than existing treatments at controlling blood glucose levels in people with type 1 diabetes.
The Artificial Pancreas Device System (APDS) closely mimics the glucose regulating function of a healthy pancreas. The system consists of three types of devices already familiar to many people with diabetes: a continuous glucose monitoring system (CGM) and an insulin infusion pump. A blood glucose device (such as a glucose meter) is used to calibrate the CGM.
An Artificial pancreas device system not only monitors glucose levels in the body, but also automatically adjusts the delivery of insulin to reduce high blood glucose levels (hyperglycemia) and minimize the incidence of low blood glucose (hypoglycemia) with little or no input from the patient. A computer-controlled algorithm connects the CGM and insulin infusion pump to allow continuous communication between the two devices.
In the coming years, several start-ups, including Bigfoot Biomedical Inc., Beta Bionics Inc., Diabeloop, EOFlow and Ypsomed are expected to launch new APDS products into the global market.
- Beta Bionics received breakthrough device designation from the US-FDA for its iLet Bionic Pancreas System.
- The pocket-sized, wearable device allows patients to enter only their body weight for the device to automatically start controlling blood glucose levels. It does not require the user to count carbohydrates, set insulin delivery rates or deliver bolus insulin for meals or corrections.
- The iLet is designed to function as three medical devices in one. It can be configured as an insulin-only bionic pancreas, a glucagon-only bionic pancreas or a bihormonal bionic pancreas using both insulin and glucagon.
- Beta Bionics has entered into strategic partnerships with Dexcom Inc. and Senseonics Holdings Inc. to evaluate their CGM G5 system and Eversense CGM with the iLet in clinical trials, respectively.
- Bigfoot Biomedical also received FDA breakthrough designation for its Bigfoot Loop AP system, a closed-loop Bigfoot Autonomy automated insulin pump.
- In order to commercialize its insulin pumps, the company has partnered with Abbott Laboratories Inc. and Dexcom, to integrate their next-generation FreeStyle Libre glucose-sensing technology and CGM system into its insulin delivery system, respectively.
- Diabeloop introduced its hybrid closed-loop system DBLG1 in Europe, and also planning to commercialize it in the United States.
- The DBLG1 system is an external medical device that uses machine learning and connects three components: a Dexcom G6 10-day wear CGM, a waterproof, three-day wear patch insulin pump and a locked-down handset smartphone that hosts the Diabeloop algorithm and user interface.
- The system wirelessly transmits glucose data from the CGM every five minutes to the smartphone, which is used by the DBLG1’s algorithm to analyze data in real-time, taking into account a user’s physiology, history, meals and exercise habits to automatically determine the precise dose of insulin to administer.
- DBLG1 is currently approved for adults 22 years or older, and devices for children are in development.
- Ypsomed has partnered with Juvenile Diabetes Research Foundation (JDRF), a nonprofit that funds type 1 diabetes (T1D) research, developing its next-generation mylife YpsoPump device.
- The pump integrates CGM data and feature interoperability with open-protocol communication for personalized therapy, by wirelessly communicating with third-party smartphone apps for secure, seamless connectivity with the mylife YpsoPump.
- The device is already available in several European countries and recently introduced in Canada. EOFlow received FDA breakthrough device designation for its EOPancreas system, a CGM-integrated, wearable, disposable patch which runs on a secure, validated cloud to allow customization for individual patients.
- The company also partnered with the JDRF to develop a next-generation wearable pump with an integrated continuous glucose sensor, run by a closed-loop program.
- Other players include Pancreum, Inc., and TypeZero Technologies, LLC.