Just over one year ago, BD split off its diabetes business to create the independent, diabetes-focused company, Embecta. This was a huge move considering BD has been producing diabetes treatment equipment since it launched its first insulin needle in 1924. Embecta spared no time in continuing the legacy of its former company by partnering with Tidepool, a nonprofit dedicated to helping people living with diabetes improve their lives using advanced technology.
Tidepool received FDA clearance earlier this year for their smartphone app that allows users to build their own automated insulin dosing (AID) system utilizing a range of pump and CGM devices. Now, with their Embecta partnership, the company is looking to bring similar technology to the type 2 diabetes space.
Connected devices are relatively new to the type 2 diabetes treatment world. But this partnership shows just how quickly this market is advancing and provides insight into future opportunities that exist here.
Embecta-Tidepool Partnership Signals Next Step in Type 2 Management
Tidepool Loop, the customizable AID platform that received FDA clearance in January, is only approved for people living with type 1 diabetes. Embecta hopes to utilize a similar algorithm to create an easy-to-use automated insulin dosing system for those living with type 2 diabetes.
Henry Anhalt, D.O., Embecta’s chief medical officer, outlined the need for such technology in an announcement released in May.
“A large segment of the diabetes community is made up of people living with T2D. However, the existing AID systems are not tailored to meet their unique needs. We believe that the combination of the Embecta and Tidepool teams will lead to the development of a user-centric T2D AID system that fills a need for improved glucose management.”
This news comes on the heels of Embecta receiving breakthrough designation from the FDA for an insulin patch pump specifically designed for people living with type 2. Tidepool’s innovative software promises to transform this yet-to-be-released pump into the first AID device made specifically for the type 2 community.
The Growing Type 2 Insulin Pump Market
Type 2 diabetes represents roughly 90% of people living with diabetes. In America alone, 37 million people are currently living with the condition with more than 30% of those needing insulin to manage the disease.
Traditionally, insulin-requiring type 2 diabetes was treated with multiple daily injections of basal insulin, with some people also requiring bolus insulin injections for meals. More recently, diabetes companies have begun seeking approval for their modified insulin pumps to be used for those living with type 2. These types of pumps come in three distinct categories.
Basal-Only Insulin Pumps
The first insulin pumps to receive approval for type 2 use were basal-only devices. These pumps release a continuous dose of fast-acting insulin into the body throughout the day and night. This process better replicates the body’s natural insulin release patterns compared to syringe-dosed specialized long-acting insulins given once or twice per day.
There are currently a number of basal-only pumps approved for type 2 use. Insulet’s Omnipod Go is a simple patch pump system that works without a connected app to deliver a continuous dose of fast-acting insulin based on one of seven pre-programmed rates. Other options utilize a similar preprogrammed basal rate that is determined by the manufacturer or input via the connected application.
Basal-Bolus Insulin Pumps
The second generation of insulin pumps for the type 2 community includes not just basal functionality, but the ability to take extra bolus insulin as needed for meals. Many popular insulin pumps have received general clearance for use in patients with diabetes mellitus requiring insulin. While the official indications verbiage isn’t specific to type 1, these products are largely utilized by those living with type 1 diabetes.
More recently, pump companies have begun marketing pumps specifically to people living with type 2 diabetes. Many of these pumps are the same ones that have a general clearance, including Medtronic’s 630G and Insulet’s Omnipod DASH system. Only a few, including the V-Go patch pump, have an intended use specific to type 2 diabetes.
Automated Insulin Dosing Pumps
In the rapidly evolving automated insulin dosing market, there are a number of systems cleared for general use for diabetes mellitus requiring insulin. But again, these are rarely marketed to and even more rarely prescribed for people living with type 2.
This is where Embecta plans to differentiate itself. Their AID pump is likely to be the first created and approved specifically for people living with type 2 diabetes. While both type 1 and type 2 patients can benefit from the automated dosing functionality of AID systems, insulin needs, dosing, and sensitivity to insulin varies greatly between the two diseases. Creating a system that uses a type-2-specific algorithm has the potential to produce better results and more effectively reduce the treatment burden associated with type 2 compared to the current AID systems available.
Clinical Research Backs Pump Use
While insulin pump use is still relatively low in the type 2 community, research has shown these devices have the potential to increase positive outcomes and make the disease easier to manage.
Multiple studies have found that type 2 patients on insulin pumps have significantly better glycemic control compared to participants who remain on daily injections. One long-term study found that people living with type 2 who use pumps have a reduced risk of microvascular complications compared to those who use multiple daily injections(1).
In addition to physiological benefits, insulin pumps have a huge potential to reduce treatment burden. Indeed, the ability of pumps to simplify insulin dosing is one of the major reasons their popularity has grown within the type 1 community over the past decade. AID systems, which adjust insulin dosing automatically to account for changes in lifestyle, stress load, hormones, and other influences on blood sugar, have an even greater impact on treatment burden reduction and are associated with increased quality of life metrics.
Future Opportunities In the Type 2 Diabetes Connected Device Market
As technology advances, it will become easier to create highly intelligent, highly usable connected devices at a lower price point. Since price and complexity are the two greatest restricting factors in bringing insulin pumps and AID systems to the type 2 diabetes market, this forecast bodes well for innovative MedTech and SaMD companies looking for opportunities within this niche.
Automated insulin dosing systems created for the specific needs of people living with type 2 diabetes, like the system Embecta and Tidepool are trying to create, have the potential to revolutionize the treatment of this disease. As is the case in many other connected device niches, companies that can capitalize on advancements in AI and machine learning and leverage interoperability with other connected devices are sure to outcompete competitors looking to take advantage of this growing market.