Last year brought the diabetes community a ton of great innovations from the medical device and medical software world. We saw incredible improvements in CGM technology, updated pumps, and numerous AI algorithms that turned more products than ever into hybrid closed-loop systems.
But we’re still waiting with great anticipation for the first truly closed-loop insulin delivery device. Will 2023 finally be the year someone cracks the code? With an array of promising diabetes care technology in the works and many big releases planned for this year, it may just be.
Insulin Pumps
Medtronic is expecting its newest pump model, the MiniMed 780g, to finally receive FDA approval and be available to US markets in 2023. This newest version, which is already available in Europe, builds on the hybrid closed-loop system first released in 2016. Compared to the recently released 670g, this pump features an updated AI algorithm that better predicts and reacts to highs. Specifically, the pump has the capability to give a correction bolus for CGM readings above a certain range.
The system will work with the currently available Guardian 3 sensor. It will also be compatible with the Guardian 4 CGM sensor, but the timeline for approval on that device is still hazy.
Tandem Diabetes is also planning a slew of updates and new releases for its pump product line over the next few years. This will most likely start with the unveiling of the new Mobi pump (formerly known as t:slim Sport). This pump will be half the size of the current t:slim X2, feature a 200-unit cartridge, inductive charging, and be fully waterproof. Like previous pumps, this one will have an onboard AI algorithm for hybrid closed-loop functionality. It is anticipated to be the first insulin pump fully controllable from the connected mobile app (an impressive MMA feat, to be sure).
Likely to follow the Mobi release will be the updated t:slim X3. This new generation pump promises a modernized user interface, greater processing power, and longer battery life. The software is also getting a major boost and will continue to support wireless software updates. It will be better able to utilize planned feature updates and support future algorithm advancements, as well.
Following the launch of the X3, Tandem is already planning for updates to the Mobi system. Its Mobi Tubeless option will allow users to use the new pump as a pump patch. Two different kinds of cartridges will allow Mobi to connect like a traditional insulin pump or adhere to the body to become a tubeless pump. This interchangeability is meant to give the user options within their own diabetes routine.
But hold on, there’s one more project in the works for Tandem. They recently acquired AMF Medical SA, developers of the Sigi Pump Patch. This pump patch option features a replaceable prefilled cartridge, a rechargeable pump, and a quick on-off connection. It is smaller and lighter than the current patch options and built to be closed-loop-ready. At this point, it is unclear whether the Sigi Pump Patch will be released as a Tandem product or used as a model for the Mobi tubeless currently in development.
While most pump companies are looking to create more advanced closed-loop systems for the type 1 diabetes market, Insulet is hoping to expand pump use within the type 2 community. Jim Hollingshead, President and CEO, says they have submitted a 510(k) to the FDA for a basal-only pod that would be marketed to those living with type 2 diabetes. The company plans to start clinical trials in 2023 with a projected launch date in 2024.
Insulin Pens
Eli Lilly made headlines in 2021 when they signed agreements with Dexcom, Glooko, myDiabby Healthcare, and Roche to offer diabetes platforms compatible with Lilly’s Tempo Pen. This year will see the launch of the final piece of this product puzzle, the Tempo Smart Button. This Bluetooth-enabled device attaches to the Tempo Pen to automatically send dosing information to connected apps owned by the aforementioned companies.
In a similar vein, Biocorp received 510(k) clearance from the FDA for their insulin pen connecting device this past December. This comes after signing agreements with Novo Nordisk, Sanofi, and Roche to create attachable Mallya devices for each company’s prefilled insulin pens. The first to launch will be the Sanofi Solostar-compatible Mallya connector, which should be available in the US this year.
Taking the smart insulin pen to a new level is Bigfoot Biomedical. The company’s new Bigfoot Unity product line takes a page from the book of the best insulin pumps and applies it to MDI pen injectors. The Bigfoot smartpen caps connect to the Freestyle Libre 2 sensor and compatible meters to display blood sugar information right on the cap’s digital screen. The system also uses inputted carb ratios and correction amounts to automatically calculate daily basal doses and bolus dosing needs throughout the day. Bigfoot Unity has been available in select markets since 2021, but the company expects to widen its market substantially in 2023.
Continuous Glucose Monitors
Dexcom plans to roll out its latest CGM version in early 2023 with the Dexcom G7. This new fully disposable transmitter with an attached sensor is much smaller and lighter than the current reusable transmitter of the G6. It also touts a two-times faster warm-up period and will roll out with a revamped smartphone app that combines CGM graphs, glucose metrics, and statistical analysis in one place.
This newer, lighter CGM that requires no charging, is likely to be a hit among the diabetes community. But Dexcom sees a much larger market. Much like the undersized Freestyle Libre, which has been used widely outside of diabetes management, Dexcom plans to market this new CGM to those living without diabetes. A number of non-mobile medical apps exist that use CGM data to help healthy individuals track metabolism, lose weight, and find the best diet for their bodies.
Another company hoping to wow patients with their upgraded CGM is Senseonic. The company’s Eversense implanted continuous glucose monitor received FDA clearance for an impressive 180-day wear time in 2022. Now they want to more than double that number by putting out an extended-wear 365-day Eversense sensor. The clinical trial for this upgraded sensor will begin soon. We should see results later this year and a potential market launch in 2024.
The second piece of Medtronic’s anticipated 780g insulin pump release, the upgraded Guardian 4 CGM sensor, is still awaiting FDA approval. The Guardian 4 promises fewer calibrations and is designed to reduce auto-mode exits when paired with the new 780g system.
The company is also working on a disposable sensor similar in size and design to the Dexcom G7. The Simplera sensor (formally Synergy) is less than half the size of the current Guardian sensors and requires no charging or additional taping. It is expected to be fully compatible with the new 780g system. Medtronic plans to submit this device to the FDA late this year for a 2024 or 2025 rollout.
Looped Systems
Abbott is anticipating joining the hybrid-closed loop market this year. They have entered into a collaboration with CamDiab and Ypsomed to create an artificial pancreas system using their Freestyle Libre 3 CGM. CamDiab already has a robust algorithm currently available in Europe through the CamAPS FX smartphone app. This new collaboration will integrate the algorithm with Ypsodmed’s insulin pump and the Libre 3 to create an automated insulin dosing device (AID). The Freestyle Libre 3 finally obtained FDA approval late last year. This delay could push the launch of the full AID system in the US out past 2023.
Diabeloop, a popular AI algorithm for automating insulin dosing in Europe may finally pop up stateside in 2023. The French tech company has tried multiple times to access the US market but has failed largely due to a lack of capital. In June of last year, Diabeloop received sizeable investments from Roche and others that could give the company what it needs to gain FDA approval. Their AI algorithm currently connects to Dexcom’s CGMs and multiple pump brands in Europe. A stateside launch would likely include collaborations with the big pump manufacturers here as well as smart pen companies.
Fittingly, Medtronic, seems poised to be the first company to launch a truly closed-loop AID system. While they are mute on specifics, recent upgrades to their CGMs and algorithms hint that the company is trying hard to capture that elusive white whale. Geoff Martha, Medtronic CEO, has spoken at length about the advancements in “technology ecosystems” and how he believes AIDs that can adjust for both basal and bolus doses without human input are on the horizon.
In 2019, Medtronic acquired Klue, a software company focused on behavior tracking. Such technology is expected to be integrated into Medtronic’s AID system to determine when and for how long the user is eating based on physical movement, giving the algorithm yet another metric to use to accurately dose for meals.
But, without a projected launch date for this new closed-loop AID, there is still time for someone else to beat Medtronic to market. The most likely candidate right now is Beta Bionics. Their iLet bionic pancreas has shown impressive results in clinical trials. The system, which consists of a small AI algorithm-enabled Beta Bionic pump, Dexcom G6, and smartphone app, automatically adjusts basal and bolus rates based on CGM input. While the user does still have to record when they eat, carb counting is not required. Instead, the user inputs whether the meal was normal, smaller, or larger than typical for that time of day.
At this time, there is still no word on when Beta Bionics might try for FDA approval, making a 2023 launch unlikely. But, given the impressive trial results and market demand for a truly closed-loop pump system, we’re not ruling it out.