Innovations in Insulin Delivery: Patch Pumps and Automated Insulin Delivery Systems

Insulin delivery methods have seen significant advancements over the past few decades, which have helped improve the quality of life and health outcomes of people with diabetes.

Traditional injections and tubed pumps are being replaced by more advanced systems that can automate insulin dosing and personalize it to match individual needs.

Two key innovations that stand out are patch pumps and automated insulin delivery. The former are matchbox-sized pumps that adhere directly to the skin without external pumps. In contrast, the latter are sophisticated, multi-component systems that continuously monitor glucose levels and adjust insulin dosing accordingly using control algorithms.

You can read on to learn more about patch pumps for insulin and automated insulin delivery systems.

Insulin patch pumps are small, lightweight devices that deliver insulin directly to the patient's skin. They’re sometimes referred to as tubeless insulin pumps.

The entire device, which consists of an insulin reservoir and a cannula, is contained in a small patch that sticks to the body using an adhesive layer.

This eliminates the need for the tubing connections common with traditional insulin pump therapy and ensures continuous subcutaneous insulin infusion in a discreet, tubeless format.

Patch pumps are a relatively new technology, becoming available as a therapeutic option in the last 18 years. In fact, the first commercially available insulin patch pump, the OmniPod System, was launched in 2005!

Currently, two different PPs are available in the U.S.: the OmniPod Insulin Management System and V-Go, both suitable for patients with type 1 and type 2 diabetes.

Though limited options exist as of today, many companies are working on developing new patch pumps and releasing them in the coming years.

Insulin patch pumps work by continuously delivering preset or variable amounts of rapid-acting insulin under the skin, with the cannula inserting automatically upon patch application.

Users can program or adjust their patch pump insulin delivery by setting a basal rate to maintain glucose levels between meals and bolus insulin delivery around mealtimes.

Most patch pumps have a reservoir that can hold enough insulin for 2-3 days before requiring replacement. You simply remove and replace the patch pump when the reservoir is empty or the adhesive weakens.

PPs are conveniently controlled wirelessly via a handheld remote device or a smartphone app that communicates with the tubeless insulin pump via Bluetooth. You can adjust the delivery settings and monitor your insulin delivery through the controller/app’s interface.

Most PPs are waterproof, making them more convenient than conventional insulin pumps for everyday activities, such as showering, swimming, and exercise.

Patch insulin infusion pumps are divided into three categories based on functionality and ease of use, additional features, and interoperability with other devices like automated insulin delivery systems.

Here’s a brief overview of each type:

Source: Medical Wholesale

This category comprises simple PPs that are very small and easy to handle, intended mainly for people with type 2 diabetes. They’re limited in terms of features and variability.

Examples include:

• V-Go from Zealand Pharma
• Simplicity from CeQur
• PaQ from CeQur

These advanced pumps offer features such as adjustable basal rates, integrated bolus calculators, and connectivity with continuous glucose monitors.

They’re intended for intensive insulin therapy in both type 1 and type 2 diabetes, which involves multiple daily injections—three or more.

Example include:

• OmniPod DASH from Omnipod
• A6 TouchCare from Medtrum
• Accu-Chek Solo from Roche

These are specialty pumps designed to integrate with automated insulin delivery (AID) systems and algorithms that adjust insulin dosing.

Examples include:

• OmniPod 5 from Omnipod
• Panda from SFC Fluidics

Note: AID-compatible PPs must meet very strict FDA interoperability requirements.

Insulin patch pumps can be useful for people who have diabetes regardless of age and gender, especially those with type 1 diabetes.

Trying an insulin patch pump isn’t a long-term or irreversible commitment. Put differently, if you don’t like it, you can go back to traditional injections or experiment with a different type of insulin pump.

Insulin PPs may be especially advantageous for diabetics who experience severely low blood sugar reactions, as the steady insulin delivery can help reduce rapid glucose drops.

They’re also perfect for those who lead an active lifestyle, as they allow for uninterrupted insulin delivery even during activities that would typically require you to disconnect tubing in the case of traditional insulin delivery.

Children and teenagers with type 1 diabetes may find patch pumps appealing due to their non-intrusive, tubeless design. They can be useful in maintaining consistent dosing around a young patient’s school and activity schedules.

Several key advantages make patch pumps an appealing alternative to traditional insulin delivery methods, including:

• The small, low-profile design allows for discreet application under clothing. This helps in ensuring comfort and avoiding unwanted attention.
• Patch pumps allow for high-precision insulin delivery during activities like showering and intimacy where tubed pumps would be difficult to manage.
• The wireless control mechanisms, along with the lack of tubing, make patch pumps a lot easier to learn and use than a conventional insulin pump.
• Adhesive pumps are notably lighter in weight than tubed pumps. Couple that with direct skin adhesion and you’re guaranteed a great deal of convenience.
• The tubeless design of patch pumps helps eliminate pump-site problems like occlusions, kinking, and pulling, which can all interrupt insulin delivery.

While promising, patch pumps aren’t exactly without downsides. Some of the limitations of these innovative devices include:

• PPs tend to cost more than injections and tubed pumps. And it’s not just the upfront cost, unfortunately; long-term costs are associated with replacing the disposable components every 2-3 days.
• The single-use design of most insulin patch pumps generates plastic waste, which raises environmental concerns.
• Precision-wise, some patch pumps may be less accurate in delivering very small insulin doses compared to traditional pumps.
• Patch pumps may not be covered by all insurance providers since they’re relatively new. That’s not to mention that PP options are still limited.
• Since the infusion site is under the device, it can be more challenging to visually inspect it compared to conventional means of insulin delivery.

Automated insulin delivery (AID) systems are an even newer diabetes management innovation than patch pumps, with the first hybrid closed-loop AID systems were approved by the FDA in 2016-2017—though research on AID systems has been ongoing for decades.

These automated (or semi-automated) systems are designed to help people with diabetes control their blood glucose levels by automatically adjusting their insulin delivery to match their needs.

AID systems consist of three key components:

• A continuous glucose monitor (CGM) that constantly measures glucose levels.
• A control algorithm that calculates and doses insulin based on the user’s glucose levels.
• An insulin pump that delivers the insulin.

AID systems are sometimes called an “artificial pancreas,” as they automatically release insulin when glucose levels rise—after a meal, for example—and reduce or stop insulin delivery when glucose levels fall. This eliminates the need to test and calculate insulin doses manually.

Recently, the FDA cleared the iLet Dosing Decision Software and Beta Bionics iLet ACE Pump for those aged six years and older struggling with type 1 diabetes.

These two devices, coupled with an integrated continuous glucose monitor that’s FDA-cleared, will form a new system called the iLet Bionic Pancreas. Read all about it here.

AID systems are more sophisticated than patch pumps as far as how they work. To begin with, the CGM is inserted under the skin and measures interstitial fluid glucose levels every few minutes.

The data from the CGM is sent wirelessly to the control algorithm. The algorithm uses this data and optional user-inputted data (such as meals, stress levels, and exercise) to calculate the amount of insulin needed.

From there, the algorithm sends dosing instructions to the insulin pump, delivering the insulin subcutaneously through an infusion set under the skin.

Note: Clinicians can upload and review the data generated by AID systems for optimized therapy.

AID systems fall into three broad classes based on their capabilities: Predictive Low Glucose Suspend (PLGS), Hybrid Closed Loop (HCL), and Fully Closed Loop (FCL).

Here’s a brief overview of each class:

The PLGS system extrapolates predicted future blood sugar levels using a mathematical model that relies on recent readings from a CGM.

It reduces or completely halts insulin delivery before a predicted hypoglycemic event.

The HCL system is more advanced than PLGS, as it can adjust basal insulin delivery rates up and down in response to CGM readings.

As a result, it’s able to reduce the magnitude and duration of hyperglycemic and hypoglycemic events.

Like the HCL system, the FCL system adjusts insulin delivery in response to changes in glucose levels. 

The main difference is that the FCL requires minimal user input, whereas the HCL requires some user input (like announcing meals and initiating manual mealtime boluses).

AID systems have proven effective and safe when it comes to improving glycemic outcomes in individuals with type 1 diabetes.

They’re also suitable for individuals who struggle with glucose management due to the “dawn phenomenon,” where glucose rises in the early morning.

AID systems can also greatly help young children who require insulin delivery but cannot yet independently manage a standard pump. They, in turn, reduce the management burden for caregivers.

People who do shift work, have irregular schedules/meals, or have trouble counting their carbs can also benefit from using an AID system.

Automated insulin delivery systems tick quite a few boxes that set them apart from other means of diabetes management.

They excel at the following:

• They can react faster to fluctuations in blood glucose levels and provide more precise insulin dosing than other diabetes management devices.
• The risk of hypoglycemia is significantly reduced with AID systems, as constant glucose monitoring reduces insulin delivery upon detecting low blood sugar levels.
• AID systems allow for increased flexibility with meals and activities. You won’t have to manually calculate insulin doses or closely coordinate your eating and activities with your injections.
• They can incorporate user data around insulin sensitivity, basal rates, carb ratios, and more into their control algorithm, which allows for personalized dosing.
• AID systems receive remote software updates to the control algorithm for optimized therapy. They can also be monitored remotely by clinicians.

Clearly, AID systems have a lot to offer, but they do have a few downsides that are worth noting, which are:

• Automated insulin delivery systems aren’t as accessible as most other diabetes care devices because of their high cost and relative novelty.
• These systems are quite complex, and dealing with connectivity issues, broken pumps, and malfunctioning CGM sensors can be frustrating.
• Ongoing user input is still required. Yes, these systems are more automated but still need users to announce their meals and exercise changes. This is especially the case with HCL systems.
• Having a CGM sensor inserted for long periods can cause skin irritation and maybe even an infection.
• With such sophisticated and complex systems, there are always concerns about system failure, which may lead to a severe hypoglycemic or hyperglycemic reaction.

As the global diabetes epidemic continues to rise, innovations in insulin delivery are desperately needed to ease the burden of management. Patch pumps and automated insulin delivery systems represent promising advances, offering flexibility, discretion, and personalized therapy.

Though still in development with limitations to overcome, their ability to optimize the patient’s treatment as per their individual needs paves the way for tighter diabetes control and healthier outcomes.

Going forward, optimizing these systems’ accuracy and accessibility while reducing costs will be key to translating this life-changing technology from trials into the hands of millions struggling with the relentless chronic disease.