Ketoacidosis Rates Plummet with Continuous Glucose Monitoring Use (ADA2020)

Maintaining their target blood glucose levels as much as possible is critical to preventing various health complications for all people with diabetes. One deadly outcome of high blood glucose levels is diabetic ketoacidosis (DKA), which is a life-threatening emergency, but one that can typically be prevented with optimal glycemic management.

Checking blood glucose levels regularly and making the appropriate medication adjustments to keep in a safe blood glucose range is a challenge for many. Due to various factors, including sometimes a lack of access to a sufficient amount of test strips, patients may not be checking their blood glucose level as frequently as recommended.

Continuous glucose monitoring (CGM) technology is a relatively new development in diabetes care, but has already been shown to benefit many patients as related to glycemic management, mental wellbeing, and overall quality of life. By providing users with almost real-time data of their glucose levels, couples with the ability to set alarms to address blood sugar values that are out of range, prior to developing an emergency situation appears to be a critical tool to help people with diabetes better manage their condition and help safeguard against critical situations like severe hypoglycemia or DKA.

A new study conducted by a team of French researchers has just revealed striking results that underscore the benefits of CGM access for patients. The researchers just presented the major outcomes of the study at the American Diabetes Association (ADA) 80th Scientific Sessions this weekend.

Study Design

The researchers conducted a retrospective analysis of nationwide DKA records for patients with type 1 and type 2 diabetes one year prior to the initiation of the use of Abbott’s Freestyle Libre system and compared it to the recorded DKA rates one year after the initiation of CGM use in this population. Data from a total of 33,203 patients with type 1 diabetes and 40,955 with type 2 diabetes were included in the study.

Major Outcomes

The differences in the DKA rates before and after CGM use were striking. Overall, the rate of DKA decreased by 52% among those with type 1 diabetes and by 47% among those with type 2 diabetes. Furthermore, the researchers evaluated the impact of CGM technology on patients with different self blood glucose monitoring (fingerstick frequency) habits. The data revealed that the reduction in DKA rate was the most dramatic for those who do not check their blood glucose level daily, as well as for those who check their blood glucose more than five times per day. In fact, the baseline DKA rates were the highest for these two groups. This may seem counterintuitive, but it is likely that patients who check frequently may be doing so because of difficulty in managing their condition.

Roussel et al. (Presented at ADA 2020)

Conclusions

This retrospective analysis of data from a large cohort of patients prior to and after the use of CGM technology suggests that CGM use can help to dramatically decrease the incidence of DKA. The observed improvements in DKA rates were the most pronounced for those who check their blood glucose very little, but also for those who check frequently (more than five times per day). Overall, the study results highlight the potential health benefits of CGM use in preventing DKA in a very large group of patients. Unfortunately, today, access and affordability of CGM systems still remains a challenge for many patients.

Source: diabetesdaily.com

What’s Coming and What’s Delayed in Continuous Glucose Monitoring?

This content originally appeared on diaTribe. Republished with permission.

By Albert Cai

Updates and delays from Abbott, Dexcom, Medtronic, and Senseonics

With several clinical trials on hold due to the COVID-19 pandemic, we’re bringing you a roundup of the latest updates on future continuous glucose monitors (CGM). Understandably, the FDA also announced a few months ago that it would focus its efforts on devices related to COVID-19. With the disclaimer that it’s impossible to know exactly when the pandemic will subside, when trials might resume, and how FDA reviews might be affected, here is the latest news we’ve heard from companies.

Click to jump to a product, which are organized alphabetically.

Abbott FreeStyle Libre 2

CGM

Image source: Abbott FreeStyle

What’s new? FreeStyle Libre 2 keeps the same “scanning” feature as the original FreeStyle Libre, but adds Bluetooth connectivity. This is important because it enables optional high and low glucose alerts. Users who enable these alerts will be able to get a notification on their reader or phone whenever their glucose reading goes above or below their specified ranges. Looking ahead, the Bluetooth feature will also allow FreeStyle Libre 2 to be part of automated insulin delivery systems (AID), like Insulet’s Omnipod Horizon.

Like the original FreeStyle Libre, FreeStyle Libre 2 has 14-day wear, is factory-calibrated (no fingerstick calibrations required), and can be scanned with either a phone or a reader device (the reader for FreeStyle Libre 2 is blue, instead of black). Importantly, FreeStyle Libre 2 will be offered at the same price as the original FreeStyle Libre.

When’s it coming? The FreeStyle Libre 2 has already launched in a few European countries (we know of Germany and Norway) and will launch in others soon. In the US, FreeStyle Libre 2 has been under FDA review for over a year. In March, Abbott said that it was working through “some finishing items” and was “very confident” the device would be cleared soon.

Dexcom G7

Dexcom

Image source: Dexcom

What’s new? Dexcom’s G7 will be fully disposable (the transmitter and sensor are combined and thrown away together) and have longer wear (we believe somewhere around 14-16 days). Remember that the Dexcom G6 sensor lasts for 10 days but has a transmitter that is re-used for 90 days. The G7 will be considerably slimmer than G6 and will have a lower cost of manufacturing in bulk, though consumer pricing is not yet determined – we imagine it will be similar. The G7 will keep the same accuracy, no fingerstick calibrations, and Bluetooth connectivity as the G6.

Dexcom has been developing G7 in partnership with Verily, the division of Alphabet formerly known as Google Life Sciences. There has been mention from Verily that an accelerometer may also be built-in to the G7 device, but we aren’t sure if that feature made it into the final version of G7. Having a built-in accelerometer could allow the G7 to also track physical activity, like a Fitbit or other fitness tracker.

When’s it coming? Dexcom planned on launching G7 in “early 2021,” but with most clinics placing new trials on hold, Dexcom is expecting a “minimum delay of approximately six months.” It’s difficult to know when clinics will be able to conduct trials (and when people will feel comfortable enrolling in trials), but assuming a six-month delay, G7 could be on the US market sometime in the second half of 2021.

Medtronic “Project Zeus” CGM

Abbott FreeStyle

Image source: Medtronic

What’s new? Medtronic’s next CGM, referred to as “Project Zeus,” will reduce the number of required fingerstick calibrations and have improved accuracy (compared to its current offering, Guardian Sensor 3). The new CGM will require day-one calibration (unclear on the number of fingersticks that will be required on day one), compared to Guardian Sensor 3, which requires at least two fingerstick calibrations every day. Medtronic expects Project Zeus to launch with a “non-adjunctive” indication, meaning users will be able to bolus insulin based on CGM reading alone, and not have to perform a confirmatory fingerstick. the new CGM will keep the same seven-day wear, size and shape, and reusable transmitter component as the Guardian Sensor 3 (pictured above).

When’s it coming? The trial for Project Zeus began in June 2019 and is expected to wrap up within the next month. Medtronic expects to submit the CGM to the FDA by the “end of the summer.”

Senseonics Eversense XL (180-day)

Eversense XL

Image source: Eversense XL

What’s new? The “XL” extended life-version of Senseonics’ Eversense in the U.S. will have the same size and features as the original Eversense, but the Eversense XL is implanted for 180 days, rather than the 90-day Eversense. As a reminder, the Eversense sensor is implanted in the users’ upper arm in a clinic and remains there for the sensor duration; a silver-dollar sized on-body transmitter is worn on the outside of the arm to deliver readings to a smartphone. Senseonics is targeting reducing calibrations from 2 per day to 1 per day with same non-adjunctive indication.

When’s it coming? Eversense XL is already available in Senseonics’ European markets. The trial for Eversense XL in the US wrapped up in late March, and Senseonics has previously aimed for FDA clearance in “late” 2020. We aren’t sure whether that timeline has been pushed back due to COVID-19, but the fact that the trial has already completed is encouraging.

Source: diabetesdaily.com

Omada’s Type 2 Diabetes Coaching Program Will Now Include Abbott FreeStyle Libre

This content originally appeared on diaTribe. Republished with permission.

By Emily Fitts

Omada Health and Abbott partner to bring FreeStyle Libre to Omada Health’s digital coaching program for people with type 2 diabetes

Under a new partnership between Omada Health and Abbott, participants in Omada Health’s type 2 diabetes program will receive the FreeStyle Libre continuous glucose monitor (CGM). Any person with type 2 diabetes who is enrolled in Omada’s program will be eligible to receive FreeStyle Libre following a personal online consultation with a doctor. The FreeStyle Libre will be delivered directly to the participant’s home.

When the FreeStyle Libre is scanned, glucose data will be sent to the Omada Health app and will be available for users to see patterns, track progress, and get personalized recommendations from their assigned coach. This technology enables coaches to give specific advice based on unique patterns and allows users better understand the way their daily decisions affect their blood sugar, as well as mood, weight, sleep, and more.

Omada’s type 2 diabetes program provides participants with an app, access to coaches, connected devices (including a wireless weight scale, blood pressure meter, glucometer, and now a FreeStyle Libre CGM), educational materials, and a peer support group, all of which aim to help people change their behavior using tailored coaching and care.

Beyond type 2 diabetes, Omada offers programs for prediabetes, hypertension, and anxiety and depression. In particular, Omada’s original program – a digital version of the Diabetes Prevention Program (DPP) – is the largest digitally-delivered DPP in the US and has shown positive results for participants in terms of weight loss and A1C reduction.

Omada’s programs are primarily offered through employers and health plans that cover the costs of the program, although individuals can sign up independently and pay for the program themselves. Take this short survey to see if you are eligible.

To find out about other similar programs, read our article on how to get unlimited test strips and personal diabetes coaching.

Source: diabetesdaily.com

How to Use FreeStyle Libre Trend Arrows to Adjust Insulin Doses

This content originally appeared on diaTribe. Republished with permission.By Jimmy McDermott, Maeve Serino, and Adam Brown New Endocrine Society guidelines for FreeStyle Libre users to adjust insulin doses based on trend arrows. Plus, additional guidelines on scanning time and frequency The Endocrine Society recently published guidelines on adjusting insulin dosing based on FreeStyle Libre continuous glucose monitor […]
Source: diabetesdaily.com

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