Rush for COVID Vaccine Hinders Diabetes Tech Advancements

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.

Medtronic 780G

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.

Dexcom G7

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. 

Source: diabetesdaily.com

Study Compares MiniMed 780G and MiniMed 670G Algorithms

This content originally appeared on diaTribe. Republished with permission.

By Albert Cai

A new study in adolescents and young adults with type 1 diabetes directly compared two automated insulin delivery algorithms. Medtronic’s newer Advanced Hybrid Closed Loop (built into the MiniMed 780G system) improved glucose management more than the MiniMed 670G, though both systems showed impressive increases in Time in Range for this population. Ultimately, the 670G gave users over an hour and a half more time in range each day, while the 780G gave wearers over two hours every day in range!

Two Medtronic automated insulin delivery algorithms, the Advanced Hybrid Closed Loop and the MiniMed 670G, were recently compared in a cross-over study, allowing 113 participants to use both algorithms. Results from the study were published in the medical journal The Lancet. Notably, the study tested this technology in adolescents and young adults with type 1 diabetes ­– a group for which diabetes management is notoriously challenging. View our resources for adolescents with diabetes here.

For an introduction to automated insulin delivery (AID), check out our piece on current and coming-soon AID systems in 2021.

What is the MiniMed 670G?

The MiniMed 670G is an AID system that has been available since spring 2017 – it was the first system ever to “close the loop.” The system includes the MiniMed 670G pump, the Guardian Sensor 3 continuous glucose monitor (CGM), and an automated insulin adjustment algorithm. The algorithm adjusts basal insulin delivery every five minutes based on CGM readings, and a target of 120 mg/dl.

What is Advanced Hybrid Closed Loop?

Advanced Hybrid Closed Loop (AHCL) is Medtronic’s next-generation AID algorithm. The AHCL algorithm is used in Medtronic’s MiniMed 780G system, which is currently available in at least twelve countries in Europe. While it is not yet available in the US, Medtronic hopes to launch the 780G in the US this spring. In addition to automatic basal rate adjustments, the AHCL algorithm can also deliver automatic correction boluses and has an adjustable glucose target that goes down to 100 mg/dl. This is big news because many people using closed loop do not want to target the higher 120 mg/dl, even as a safety measure. The 780G algorithm is designed to have fewer alarms and even simpler operation than the MiniMed 670G system.

What was the study?

The newly published FLAIR (Fuzzy Logic Automated Insulin Regulation) study was conducted over six months across seven diabetes centers (four in the US, two in Europe, and one in Israel). The study enrolled 113 adolescents and young adults (ages 14-29) with type 1 diabetes. The study sample is notable, because teens and young adults with type 1 diabetes have the highest average A1C levels of any age group.

At the beginning of the study, participants performed their usual diabetes management routine for two weeks to establish their baseline glucose levels. Half of the group was then randomly assigned to use the MiniMed 670G system, while the other half of the group used the same pump and CGM, but with the new AHCL algorithm. After three months – the halfway point of the study – the two groups “crossed over,” switching to the opposite technology.

What were the results?

Nearly every measure of glucose management favored the AHCL period over the MiniMed 670G:

  • Compared to baseline, participants reduced time spent above 180 mg/dl by 1.2 hours per day when using MiniMed 670G and 1.9 hours per day when using AHCL.
  • Time in Range (TIR, time between 70-180 mg/dl) improved from a baseline of 57% to 63% using Minimed 670G and to 67% using AHCL.
  • Time spent below 70 mg/dl fell 0.2% of the time. While those 28 minutes a day may not be statistically significant – and time in severe hypoglycemia, or below 54 mg/dl, did not increase from baseline when using either algorithm – many people with diabetes would benefit from that additional half hour in range.

The graph below shows the time spent in glucose ranges during baseline, MiniMed 670G, and AHCL periods. For both algorithms, the Time in Range increase from baseline was significant – use of either AID system led to at least 14 hours more each week spent in range. Nevertheless, we also point out, of course, that the group (again, the group that has the most challenges of any age group managing diabetes) still experienced a fair amount of time above 250 mg/dl. This is  another reason for healthcare professionals and people with diabetes to think about the “whole person” when considering diabetes management, and another reason why we always recommend Adam Brown’s Bright Spots and Landmines for ways to improve diabetes management in terms of food, exercise, mindset, and sleep – it includes many strategies for people, especially teens and young adults, to use each day.

AID comparison

Image source: diaTribe

  • The biggest Time in Range improvement came overnight (between midnight to 6am). During this six-hour overnight period, AHCL users spent an average of 4.4 hours in range (74% TIR), compared to 4.2 hours (70% TIR) for 670G, and 3.5 hours (58% TIR) during baseline. While the overnight Time in Range difference between AHCL and 670G may not seem large, it added up to nearly a 22-hour difference over the three-month the AHCL period.
  • With daytime numbers, the average AHCL user spent 63 more hours (about 2.6 days) in range than the average 670G user in each three-month study period.

The graph below shows daytime and nighttime differences in time spent in range (70-180 mg/dl), and the data is included in a table at the end of this article. Better sleep the night before can also make diabetes management more effective during the day.

Comparison

Image source: diaTribe

  • Using MiniMed 670G drove an average A1C improvement from 7.9% to 7.6%, while AHCL use improved A1C from 7.9% to 7.4%.

Both systems showed extremely positive results and were found to be safe for use in young people with type 1 diabetes. The AID algorithms led to dramatic increases in Time in Range in a population that stands to benefit – over the course of a year, adolescents and young adults could spend more than ten additional days in range. The direct comparison between these two AID algorithms is highly informative – we hope to see similar trials in the future.

Comparison

Image source: diaTribe

Source: diabetesdaily.com

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