A New Era in Insulin Delivery
The first insulin pump, the Biostator, was created in 1974. Continuous subcutaneous insulin infusion (CSII) devices have come a long way from that clunky bedside model. Many of today’s pumps can fit in the palm of the hand. Until recently, however, all of these devices were appropriate only for the treatment of Type 1 Diabetes. Insulin pump technology for Type 2 Diabetes had remained elusive. However, the FDA has recently cleared the very first automated insulin pump for adults with Type 2 diabetes, Insulet’s Omnipod system.
Background
Insulin pumps provide continuous, targeted, subcutaneous delivery of insulin. Traditional pumps consist of the pump itself, including controls, a processing module, and batteries; a disposable reservoir for insulin, and an infusion system that consists of a cannula and tubes. Newer pumps include a means for calculating the necessary amount of bolus insulin, as well as a means of tracking insulin use. Some models allow this tracking information to be uploaded and graphed, in order to allow for analysis of trends.
Many modern models also integrate with glucose meters and continuous glucose monitoring systems. In 2016, the FDA approved the first hybrid closed loop system that could sense a patient's basal insulin requirement and automatically adjust insulin delivery. In 2019, the FDA approved the first insulin pump system with an external control. In 2022, the first hybrid closed loop system controlled with a smartphone (Insulet’s Omnipod 5) received FDA approval.
Previously, continuous subcutaneous insulin infusion technology had not been shown to be effective in the treatment of Type 2 Diabetes.The Omnipod 5, however, differs from its predecessors in this way. In fact, according to Insulet, patients using the Omnipod system spent 20 percent more time in a healthy blood sugar range than patients taking insulin via manual injections.
And considering that, by current estimates, only an estimated quarter of people taking insulin to manage Type 2 Diabetes are meeting their HbA1c goals of 75 or less, that’s big news.
How it Works
Insulet’s Omnipod 5 system consists of two components: the pod–an insulin reservoir and delivery system–and the controller–a smartphone app. The system is made to operate in conjunction with one of two wearable glucose monitors: the Dexcom G6 sensor or the FreeStyle Libre 2 Plus sensor. The components are connected via Bluetooth, and the delivery system is tubeless and waterproof.
The pod contains an insulin reservoir that can hold 200 units of insulin. It attaches to the skin with adhesive, and has a cannula for subcutaneous delivery. The pods receive glucose information from glucose sensors via Bluetooth, and use this information to automate insulin delivery. The pod can be worn for up to 72 continuous hours.
The Omnipod app is used to activate and deactivate the pod. It receives insulin and sensor information from the pod (which receives it from the sensor). The app also displays insulin alerts and alarms, and issues meal and correction boluses. Some healthcare organizations, for example, Britain’s Bupa, allow patients to upload their data via the app to share it with their physicians.
The Omnipod 5 has both an automatic delivery mode and a manual mode, for maximum flexibility.
Advantages
The most obvious advantage is that the Omnipod 5 is available to Type 2 diabetics. According to the FDA, automated insulin dosage technology has previously only been available to those with Type 1 Diabetes, as its effectiveness could not be demonstrated in Type 2 patients. However, in a clinical trial, the Omnipod 5 lowered participants’ HbA1c by 0.8 percentage points overall, and by 2.1 points in adults with Type 2 Diabetes who started the study at 9 percent or higher.
The company also reports that the system reduced the total number of daily insulin doses, and increased the time spent in patients’ healthy blood sugar range by 20 percent over manual injections with an insulin pen or syringe.
In terms of patient experience, automated glucose readings, bolus calculations, and insulin delivery can increase flexibility in everyday lifestyle, improving patients’ quality of life. Eliminating the need for self-injecting is another benefit. Considering that more than 529 million people worldwide are living with diabetes–and some 96 percent of these cases are Type 2–this could be a serious game changer.
Potential Disadvantages
Not every Type 2 Diabetes patient has a smartphone or is comfortable with smartphone technology. Physical, mental, and age-related issues that make smartphone use difficult for some could be a barrier to use of this product. Also, glucose sensors are not part of the package. Users must acquire sensors separately. Many sensors must be operated via their own apps, which adds another layer of complexity.
Cost may be an issue for users whose health plan won’t pay for an insulin pump. In addition to the cost of the unit itself, one must consider the ongoing cost of skin preparation and cleaning materials, and, as mentioned previously, the wearable glucose sensor must be purchased separately.
In addition, as the device controller is a smartphone app, it’s important to be aware of smartphone compatibility issues, including the possibility that upgrades or switching devices could potentially cause a disruption in the pump’s functioning.
A Big Step Forward
Despite issues of cost, complexity, and maintaining smartphone compatibility, the clearing and approval of a device that automates glucose readings and subsequent insulin delivery in the treatment of Type 2 Diabetes offers a significant chance to improve the health and quality of life for the more than 500 million Type 2 Diabetes sufferers worldwide.