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ARTIFICIAL PANCREAS TECHNOLOGY FOR DIABETES MANAGEMENT: TYPES AND BENEFITS

ARTIFICIAL PANCREAS TECHNOLOGY FOR DIABETES MANAGEMENT: TYPES AND BENEFITS

Medically Reviewed by Dr. Sony Sherpa (MBBS) - September 24, 2024

An artificial pancreas is a revolutionary medical device that can potentially transform the lives of people with diabetes for good.

When a person has type 1 diabetes, the beta cells in their pancreas fail to produce insulin. In the past, individuals with this condition needed to check their glucose levels and self-administer insulin constantly.

These days, people have the option of using an artificial pancreas. This technology mimics the function of a healthy pancreas. It automatically manages blood sugar levels, determines daily insulin requirements, and administers accordingly.

This article explores the types of artificial pancreas systems, their benefits and limitations, and the future of diabetes treatment.

What Is an Artificial Pancreas?

An artificial pancreas is a device that handles blood glucose levels in people with type 1 diabetes (T1D). It is also known as a closed-loop system, an insulin-delivery system, or a bionic pancreas.

An artificial pancreas aims to mimic the function of a healthy pancreas. It monitors glucose levels, calculates and delivers insulin, and helps sustain stable blood sugar levels at all times.

By doing so, it eliminates the need for insulin injections, protecting against hypoglycemia (low blood sugar) and hyperglycemia (high blood sugar).

How an Artificial Pancreas Works

Artificial pancreas systems consist of three components:

  1. Continuous glucose monitor
  2. Insulin pump
  3. Control algorithm

The continuous glucose monitor (GCM) measures the glucose levels in the body from a tiny implanted skin sensor. Data from the GCM reaches the control algorithm, which can be an app or part of an electronic insulin pump.

The algorithm calculates the appropriate amount of insulin needed to correct blood deficits. A message is sent to the insulin pump, allowing it to feed small amounts to the body as required. The insulin pump administers insulin via a skin patch and is usually fitted to the patient’s waist or kept in a pocket.

Efficacy and Testing. The efficacy of an artificial pancreas can be measured using the following parameters:

  • The time they keep patients within a healthy blood glucose range.
  • Their HbA1c levels (glycated hemoglobin), which are a measure of insulin sensitivity.
  • The number of adverse hypoglycemic events that take place.

Compared to no treatment, all approved artificial pancreas systems keep people in the healthy blood glucose target range for 5-21% more of the time. They also improve HbA1c by a minimum of 0.5%.

Types of Artificial Pancreas Systems

There are several types available currently, including:

  • Threshold suspend systems: These types track glucose levels and automatically stop insulin transmission when glucose levels drop below a specific limit (suggesting high insulin).
  • Predictive suspend systems: These use algorithms that predict the decline in glucose levels, averting hypoglycemia by ceasing insulin delivery ahead of time.
  • Insulin-only systems: These systems continuously monitor glucose levels and deliver insulin as needed. Insulin administration occurs when glucose levels are higher than the required insulin.
  • Dual hormone systems: These systems not only monitor glucose levels and deliver insulin, but they also deliver glucagon. Glucagon is another pancreatic hormone that raises blood sugar levels as needed. Delivery of both hormones aims to mimic a pancreas better.
  • Implanted artificial pancreas: In future systems, the patient could receive an insulin pump transplant. A transplant allows optimal freedom of movement and eliminates any potential skin rashes.

How Does an Artificial Pancreas Benefit Diabetes Patients?

An artificial pancreas offers numerous benefits for people with type 1 diabetes, including:

  • Continuous glucose monitoring.
  • Improved glycemic control, as reflected by lower H1Ac levels.
  • Automated insulin delivery that self-adjusts as needed.
  • Non-invasive insulin administration (no need for injections or needles).
  • Avoidance of hypoglycemia and hyperglycemia.
  • Remote monitoring and supervision by doctors.
  • Monitoring of blood glucose levels from smartphones.

Disadvantages

Mechanical pancreatic devices still need to be perfected. The disadvantages of an artificial pancreas include:

  • Routine upkeep to ensure the system functions properly.
  • Meal size recordings are mandatory for these devices every time one eats food.
  • Settings may need adjustment.
  • Managing high or low blood glucose levels may still be necessary.
  • Adhesive patches may cause skin redness or irritation.
  • Some medications may interfere with the glucose monitor.

The Artificial Pancreas Over Four Generations

There are currently several approved artificial pancreas systems available on the market. Most of them are close to being a nearly fully functional pancreas replacement option.

Companies that have developed artificial pancreas systems include Medtronic, Tandem Diabetes Care, Insulet Corporation, and Beta Bionics. Some of their products are reviewed in more depth below.

Medtronic Artificial Pancreas Systems

Medtronic has developed artificial pancreatic systems that monitor blood glucose levels and administer insulin as required every 5 minutes.

A chronological review of their technological developments follows:

  • MiniMed 670G

The Medtronic MiniMed 670G was the first hybrid closed-loop system, approved by the FDA in 2016.

It uses the Guardian Sensor 3, a highly accurate CGM, coupled with the SmartGuard Auto Mode algorithm. These automatically adjust insulin delivery every five minutes based on CGM readings.

Stats: This system improved blood sugar control in trials by lowering HbA1c from 7.4% to 6.9% and reducing the risk of hypoglycemia. In trials, it proved to keep blood glucose levels of people with T1D within a healthy range 72% of the day and 75% of the night, compared to a 67% average diabetic baseline.

  • MiniMed 770G

In 2020, the FDA approved the Medtronic MiniMed 770G System, a hybrid closed-loop diabetes management device. It automatically monitors glucose levels and adjusts insulin doses for children aged 2 to 6 with T1D. It is the first and only device for this age group.

The 770G adjusts insulin delivery based on continuous glucose monitor values. Children using it must manually request an appropriate insulin dose at meal times. They also need to supply two insulin readings from finger-stick tests daily. It uses a 780G insulin pump with the same GCM and algorithm as the 760G model.

Stats: It is an improvement from the previous models, such as the 760G, offering enhanced control and accuracy. It proved to lower HbA1c by 0.5% (from 8% to 7.5%) and kept children within the healthy blood sugar range for up to 64% of the time (compared with 55% previously).

  • MiniMed 780G

The Medtronic MiniMed 780G System received FDA approval in 2023. This system is an upgraded version of the 770G, using the same 780G pump with a better algorithm.

The 780G uses a greatly improved GCM and insulin pump. No components require manual input or finger-sticks to monitor insulin levels. It can service those aged 7-80 years.

Stats: The results reveal that the device allows one to remain in a healthy glucose range 80% of the time.

Tandem Control-IQ Algorithm

In 2019, Control-IQ was the first approved generic algorithm for any artificial pancreas system. This system can work with a CGM and insulin pump of any brand. Manufacturers commonly pair it with Tandem’s t:slim X2 insulin pump and Dexcom’s G6 CGM.

Insulet Omnipod 5

Insulet got approval for their Omnipod 5 in 2023. The Omnipod is a wearable, tubeless, waterproof insulin pump. It provides continuous insulin and eliminates the need for multiple daily injections, finger-stick tests, or tubes. It comes with an app that allows one to monitor their vitals.

Stats: This technology is effective in terms of results and freedom of movement. According to trials, it increased the time spent in the healthy blood glucose range by just over 21% and improved insulin sensitivity by 1.3%.

Beta Bionic iLet Bionic Pancreas

Beta Bionics endeavors to make the first fully functional implantable pancreas. They recently developed a closed-loop artificial pancreas system: the iLet Bionic Pancreas.

The FDA approved the system in 2023. It uses a dual-chamber infusion pump that delivers insulin and glucagon to regulate blood glucose. Currently, the iLet bionic pancreas is the closest device to a complete artificial pancreas implant.

It uses advanced technology that calculates dosages and administers as required, whether consuming food or not. The iLet pancreas monitors the body's reaction to the insulin it gives and makes adjustments accordingly.

Stats: The pilot trial revealed that it improves blood glucose levels and insulin sensitivity over three months. HbA1c levels dropped from 7.9% to 7.3%. The only drawback was the risk of hypoglycemia, which increased by roughly 45% in users of the device.

With future modification, this could replace a diseased pancreas entirely.

Who Can Use an Artificial Pancreas? 

Patients suffering from type 1 diabetes or late-stage type 2 diabetes can use an artificial pancreas system after careful evaluation and under the guidance of a doctor. They are now available for adults and children over two years old.

Challenges and Limitations

While an artificial pancreas shows great promise, there are still some challenges and limitations to address.

Accuracy and Reliability: Guaranteed accuracy and reliability of artificial pancreas systems remain one of the biggest challenges to their implementation. The CGM must be highly accurate for the control algorithm to make the correct insulin dosing decisions. Any errors or malfunctions in the system could have severe consequences for the user.

Cost: The cost of an artificial pancreas is also a limitation for many people. The current systems on the market can cost thousands of dollars, and insurance coverage may vary. As a result, some people may find it challenging to access this life-changing technology.

User Training and Education: Another challenge is ensuring that users are adequately trained and educated on using these devices. Training needs to include understanding how to interpret CGM readings, adjust insulin dosing, and troubleshoot any problems. Proper education is crucial for the safe and effective use of an artificial pancreas.

Future of the Artificial Pancreas

An artificial pancreas can prospectively change the lives of those with type 1 diabetes.

As technology advances, we expect to see more refinements to closed-loop systems and potentially even an artificial pancreas implant. Implanting the control algorithm and insulin pump directly into the body would eliminate the need for an external insulin pump.

In addition, ongoing research and development focuses on improving their accuracy and reliability and reducing costs. Future breakthroughs will make artificial pancreas systems more accessible to larger populations and improve the lives of people with type 1 diabetes.

Conclusion

An artificial pancreas can be a game-changing technology for people with type 1 diabetes. It delivers numerous benefits, including enhanced blood sugar control, reduced risk of hypoglycemia, and a better quality of life. While there are still some challenges, the future looks bright for this revolutionary medical device. With ongoing research and development, we expect to see even more advanced closed-loop systems and potentially an artificial pancreas implant in the near future.

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Sources:

  • www.niddk.nih.gov/health-information/diabetes/overview/managing-diabetes/artificial-pancreas
  • www.jdrf.org/press-releases/jdrf-celebrates-fda-approval-of-artificial-pancreas-system/
  • www.fda.gov/news-events/press-announcements/fda-approves-first-its-kind-automated-insulin-delivery-and-monitoring-system-use-young-pediatric
  • https://diatribe.org/minimed-770g-automated-insulin-delivery-cleared-children
  • https://www.jdrf.org/blog/2023/04/24/fda-approves-medtronic-780g-artificial-pancreas-system/
  • www.jdrf.org/blog/2019/12/13/jdrf-reports-fda-authorizes-second-artificial-pancreas-system/
  • www.insulet.com/
  • https://pubmed.ncbi.nlm.nih.gov/36787903/
  • https://www.bu.edu/articles/2023/fda-clears-bionic-pancreas-for-type-1-diabetes/
  • https://www.nejm.org/doi/full/10.1056/NEJMoa2205225

 

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