Modern science is amazing. The COVID-19 pandemic, which is still shaking the world as we know it, is quickly getting controlled due to fast scientific progress and the vaccine rollout (in the United States, at least).
Having an effective vaccine come to market within a year of the appearance of a novel disease is unheard of; most medicines take decades for adequate approval processes within the Food and Drug Administration (FDA) to be completed. This feat is incredible.
That being said, with all of the rush to get a vaccine to the masses, the FDA pushed the Pfizer, Moderna, and Johnson & Johnson vaccines literally to the front of the approval line, delaying other important medical and technological advancements, including those related to diabetes.
While the vaccine did (and should!) take precedent here, the delays have been tough for people with diabetes in many ways.
The head of the FDA’s device center, Jeff Shuren, described a “tsunami” of product applications from companies hoping to join the fight against the COVID-19 pandemic.
Those applications include over 1,200 submissions for products like diagnostic tests, ventilators, and digital technology, all of which have slowed their work in other diseases, including diabetes.
Shuren went on to say that review times had begun to increase amid growing backlogs due to the high volume.
The agency is trying to make as much space as possible to approve COVID-19 related vaccines, medicine, and technology quickly to end the pandemic, which has taken precedence over almost everything else. Experts suspect that the FDA may not be able to meet its own timelines going forward.
In addition, lockdowns and social distancing regulations halted clinical trials and product releases. It’s been a tough year for diabetes tech firms to get much done.
The following products, and their release dates, have been most affected by the pandemic:
Senseonics’ 180-Day Eversense Glucose Monitor
The Eversense continuous glucose monitor (CGM) is a device implanted under the skin that lasts for 90 days. The newest version of their CGM system aims to double its lifespan to 180 days without changing a sensor.
What was supposed to be released in early 2021 now faces delays of up to two months for its application to the FDA while the agency tasks its staff with emergency reviews of coronavirus tests and other medical devices. The new release date of the model is scheduled for mid-2021.
The Omnipod 5 (Originally “Horizon”)
Insulet’s Omnipod 5 system, which utilizes CGM data to make automated adjustments to basal insulin throughout the day, will be the company’s first hybrid-closed loop system.
Similar to the T-slim Control IQ system, this insulin pump will provide mobile app control and insulin dosing from a smartphone, eliminating the need to carry their hallmark Personal Diabetes Manager (PDM) around to control the release of insulin.
While significantly delayed due to the COVID-19 pandemic, Insulet said during its Nov. 4, 2020 investor update call that it had recently finished its clinical trial and was finalizing its FDA submission.
They hope to launch their product by June of 2021.
Also known as the Advanced Hybrid-Closed Loop (AHCL) system, this system will improve upon its first iterations of the hybrid-closed loop system, the 670g and 770g. Hoping to seek approval for adults and children as young as two, this system includes:
- A CGM sensor that will require just one calibration on the first day of wear and no further calibrations after that
- Automatic correction bolus delivery every 5 minutes, in conjunction with CGM readings, that can automatically bolus for missed meal doses.
- A lower glucose target range, adjustable between 100-120 mg/dL
- Different insulin duration times, to adjust for the “tail” of your insulin (eg, Fiasp vs. Humalog)
- Built-in Bluetooth to share data and provide remote software updates
Due to the pandemic, the approval for this device has been delayed, but Medtronic confirmed that it had submitted its application for review to the FDA in February, 2021.
They hope to have a commercial launch sometime in 2021.
The much-anticipated Dexcom G7 continuous glucose monitor (CGM) was also delayed due to the pandemic, but it should be worth the wait. You’ll no longer need to buy separate transmitters; each sensor is a complete and disposable transmitter/sensor integrated system. Some other great features include:
- No calibrations, much like the G6
- At the start, wear time will be 10 days, but eventual use will include a 14-15 day feature, also without any calibrations
- Smaller and thinner: the newest CGM will be 60% smaller than the G6
- One hour warm-up period
Dexcom CEO Kevin Sayer said that the company eventually plans to have different versions of the G7 for different people.
For example, people with type 2 diabetes who don’t use insulin (or even the general public) might opt for a much simpler interface than people with type 1 diabetes, who will want all of the alarms and settings.
Abbott Freestyle Libre 3
For years, the FreeStyle Libre from Abbott Diabetes was a considered Flash Glucose Monitor (FGM), because it only reported blood sugar levels whenever a user scanned their sensor with a receiver or smartphone.
That will change with the new edition: The Freestyle Libre 3 will function as a real-time CGM, because it won’t require sensor scanning to get a “flash” of blood glucose data. It will instead provide trends and graphs to track blood sugars throughout the day.
The Libre 3 generates real-time blood sugar readings every minute (as opposed to Dexcom’s every 5 minutes), displaying the result on a mobile app on your smartphone. This version also has optional high and low blood sugar alarms, a feature introduced with the Libre 2 in 2020.
Additionally, the sensor is much smaller and thinner (a 70% size reduction), and is kinder to the earth, using 41% less plastic overall.
The Libre 3 received global approval in September 2020. The timeline in the US has been pushed backwards, but with clinical trials now complete, we’ll likely see the Libre 3 applications submitted to the FDA mid-2021.
While the hustle for an effective COVID-19 vaccine has been nothing short of miraculous, people with diabetes don’t want to wait any longer!
Hopefully, with the hastened release of the vaccine, we can see more diabetes technology hit the market in 2021.