The demand for glucose sensors or continuous glucose monitors (CGMs) is rapidly increasing.

• This includes not only individuals with diabetes who require intensive insulin treatment,
• but also those on basal-only insulin,
• and even those with diabetes who do not require insulin.

Leading companies in the CGM industry, such as Dexcom and Abbott, are making significant advancements.

In this blog post, we will explore recent developments in the field of CGMs:

1. National reimbursement of the FreeStyle Libre 2 for all people with diabetes on insulin in France.

2. Substantial data supporting the use of CGMs in individuals with diabetes NOT on insulin, as presented at the ADA2023.

3. Collaboration between ADA and Abbott to utilize CGMs for personalized therapeutic nutrition in individuals with diabetes.

4. Dexcom's introduction of a new CGM specifically designed for people with diabetes NOT on insulin.

5. Abbott's introduction of the FreeStyle Libre 2 without the need for scanning. 

⭐ National Reimbursement of FreeStyle Libre 2 for All Insulin Users in France

“The French national reimbursement decision is an important step in providing broader access to people with diabetes and we are working with other countries to extend this coverage to more people.” - Jared Watkin, Abbott diabetes care business senior vice-president

France is the first European country that embraces CGM as a reimbursed therapy for people with diabetes on basal-only insulin (June 22nd).

This decision follows similar coverage expansions in the US Medicare system and Japan.

Remember that that the latest guidelines from the American Diabetes Association (ADA) have updated their recommendation for CGM use in people with type 2 diabetes on basal-only insulin.

The guidance shifted from "can be used" in 2022    ====>   to "should be offered" in 2023, following the findings of the MOBILE study, which utilized Dexcom CGM.  

The coverage of the FreeStyle Libre 2 in France, on the other hand, stems from the RELIEF Study discussed at the EASD 2022 conference.

• This retrospective study evaluated the French national reimbursement claims database and looked for individuals who started using the FreeStyle Libre 2 between August 2017 and December 2018.
• The study analysed hospitalization claims for adverse diabetes events (ADEs), including severe hypoglycemic events, diabetic ketoacidosis events, comas, and hyperglycemia-related admissions.
• Comparisons were made between the claims data from 12 months before the initiation of FreeStyle Libre 2 and up to 24 months after.

The study identified 5,933 people with type 2 diabetes on basal-only insulin who had started using the FreeStyle Libre 2 during the specified period. Results showed that:

• in the year prior to starting FreeStyle Libre 2, 2.01% of these individuals had experienced at least one hospitalization for any ADE.
• However, after one year of using the FreeStyle Libre 2, the hospitalization rate dropped significantly to 0.75%, and further reduced to 0.60% after two years.
• The most remarkable reductions were observed in diabetic ketoacidosis (DKA) hospitalizations, which decreased by 75%,
• and hospitalizations related to severe hypoglycemia, which decreased by 44%.

This study highlights the effectiveness of the FreeStyle Libre system in reducing ADEs among people with type 2 diabetes in France who are are treated with basal-only insulin therapy.

(However, the high number of DKA events in individuals classified as having "type 2" diabetes is unusual, as this complication is typically associated with type 1 diabetes.)

Another interesting finding from a subanalysis presented at EASD2022 revealed that the reduction in hospitalizations due to ADEs was evident regardless of whether individuals received their CGM prescription from a specialist (n=2,597) or primary care (n=2,642) setting.

Considering these findings, it is important to inform general physicians who commonly treat people on basal-only insulin that the use of CGMs is becoming more prevalent

and they should be prepared for its adoption in their practice.

⭐ CGM Use Extends to People with Diabetes Not on Insulin

Data presented at the ADA2023 showcased the efficacy of CGM in individuals with diabetes who are not on insulin.

Dr. Gace encouraged healthcare providers to consider using CGM as a "first-line therapy" for all people with diabetes, advocating for the hashtag #CGM4ALL.

He argued that CGM can be effective in both populations, while acknowledging the differences in needs:

• intensive insulin users rely on CGM as a safety device to prevent hypoglycemia,
• while non-intensive insulin users utilize CGM as a behavior modification tool.

He emphasized that continuous feedback provided by CGM can significantly enhance lifestyle-based therapy.

#1 Dexcom G6 for People with Type 2 Diabetes Regardless of Insulin Use During 3 Months

#2 Dexcom G6 Real-World Study in People with Type 2 Diabetes NOT on Insulin During 3 Months

Also during ADA2023, Dexcom presented findings from a real-world study involving individuals with type 2 diabetes who were not using insulin (n=7,207).

The study demonstrated significant improvements in Glycemic Management Indicator (GMI) and Time in Range after a three-month period.

• The study analyzed data from US adults (>18 years) that uploaded their CGM data to the Dexcom G6 app between September 2021 and December 2022.
• The inclusion criteria encompassed individuals with a self-reported diagnosis of type 2 diabetes, no use of insulin, and a TIR < 70% during the initial 10 days of CGM use.
• During the initial 10-day period of CGM use, the cohort had a mean GMI of 8.2% and a TIR of 40%.
• However, after three months, there was a notable improvement in glycemic control, with GMI decreasing to 7.7% and TIR increasing to 56%.

Based on the outcomes of this study, Dexcom took the opportunity to announce the development of a new CGM specifically designed for individuals with type 2 diabetes who do not use insulin.

(See below for more info on this.)

#3 FreeStyle Libre for People with Type 2 Diabetes NOT on Insulin During 3 Months

At the ADA conference, researchers from Thomas Jefferson University shared an insightful study on the use of FreeStyle Libre (1) in individuals with type 2 diabetes who were NOT using insulin. 

This study aimed to evaluate how flash glucose monitoring affected behavior modification, quality of life, treatment satisfaction, and glycemic management measured by A1c.

• The study participants (n=45), who were CGM-naïve and had an A1c level between ≥7% and <9%, received a 12-week supply of FreeStyle Libre 14-day sensors during their first visit.
• No changes were made to their medications, and no specific lifestyle or dietary guidance was provided to ensure accurate results.
• After the 12-week period, participants returned for a follow-up visit where data was collected and analyzed.

The results were encouraging:

• The study demonstrated a significant decrease in mean A1c levels from 7.7% to 7.35% after just three months of using FreeStyle Libre.
• Moreover, participants reported noteworthy improvements in their quality of life across various domains, and treatment satisfaction increased among the participants.

These findings indicate that initiating CGM use in individuals with type 2 diabetes who are NOT on insulin can lead to improved glycemic control and might positively impact their daily lives.

These early-stage studies on CGM use in individuals with type 2 diabetes who are not on insulin have limitations.

• They are small-scale and short-term,
• and mostly involve people with poor blood sugar control (HbA1c >7% or TIR <70%).
• The improvement in HbA1c levels varies among the studies.

While these studies emphasize the ease of introducing CGM through primary care, thus expanding its accessibility,

we should not overlook the importance of diabetes education to guide individuals.

Providing education on how to properly use and interpret CGM will enhance the benefits of CGM and is certainly not redundant.

Looking ahead, the widespread availability of CGM for this population depends on several factors, such as healthcare policies and reimbursement decisions.

It remains to be seen whether primary care physicians will wait for formal reimbursement or begin encouraging individuals to cover the costs of CGM sensors themselves.

As the demand for improved diabetes management grows, the future integration of CGM technology holds great potential to transform the lives of people with type 2 diabetes NOT using insulin.

⭐ ADA and Abbott Join Forces to Investigate CGM for Personalized, Therapeutic Nutrition

In an exciting collaboration, ADA CEO Mr. Chuck Henderson and Abbott CEO Mr. Robert Ford announced a partnership between the American Diabetes Association (ADA) and Abbott, centered around therapeutic nutrition.

The objective of this partnership is to explore how continuous glucose monitoring (CGM) can empower individuals with diabetes to make informed choices about

• their diet,
• physical activity,
• and behavior.

As part of the collaboration, Abbott will generously provide a grant of $2.65 million over the next three years to support the ADA's efforts.

• The grant will facilitate several important initiatives, including key opinion leaders to evaluate existing clinical evidence on the use of CGM systems for personalized, therapeutic nutrition.
• The partnership will also involve launching two pilot programs targeting adults with type 2 diabetes, aimed at understanding how CGM can play a pivotal role in nutrition management.
• Additionally, roundtable discussions will be conducted to review and assess current clinical literature, enabling better-informed nutrition recommendations.

Mr. Henderson emphasized his hope that this collaboration will unlock valuable insights into the impact of food choices on glycemic management. 

• He shared his personal experience, describing CGM as a "game changer" due to its ability to provide immediate feedback on behavioral decisions.
• Mr. Henderson expressed his aspiration that the partnership's data will enhance our understanding of individual responses to different foods, leading to more personalized nutrition approaches and a reduced risk of diabetes-related complications.
• Furthermore, he expressed a desire for the partnership's outcomes to influence updates to the current consensus guidelines for nutrition, which were last revised in 2019.

Both Mr. Henderson and Mr. Ford emphasized the significant potential of this partnership to enhance guidance and knowledge for primary care providers,

particularly considering that a majority of individuals with type 2 diabetes do not have access to specialist care.

⭐ Dexcom to Introduce New CGM for People with Type 2 Diabetes NOT on Insulin in 2024

"This population is looking for personalised and actionable nutrition and exercise evalution and advice. They want insights about that, but they don't want to be interupted during the day by a set of alarms, that they feel are unnecessary. They might want more of a longer term evaluation about their nutrition and exercise plan. This is a really highly motivated group of people, they have a deep fear of progressing to injectable therapies. They are more likely to be making their own decisions about CGM without advice of a physician and they really want to feel empowered to take control of their health." - Teri Lawyer, Dexcom Chief Commercial Officer at Diabetes Connections July 4th, 2023

During the Dexcom 2023 Investor Day in June, an exciting announcement was made regarding Dexcom's plans to launch a new CGM product in 2024,

specifically designed for individuals with type 2 diabetes who are not on insulin.

This unique CGM offering aims to cater to the distinct needs of this particular population.

The upcoming CGM will:

• take the form of the Dexcom G7,
• be the first Dexcom CGM with a 15-day wear time,
• have a custom software package with different features compared to Dexcom's current CGM lineup,
• and not include alarms as part of its features. 

Dexcom is dedicated to delivering the right product for each segment of the population, recognizing that diverse needs exist.

They envision the development of different versions over time to address specific requirements and preferences.

Additionally, other noteworthy announcements made at the Investor Day included

• the plan to launch the direct-to-Apple Watch feature of the Dexcom G7 by the end of 2023,
• as well as the availability of Dexcom ONE in the G7 form in the first quarter of 2024.

During this recent interview, Dexcom's CEO Kevin Sayer also provided insights into Dexcom's upcoming extended wear CGM designed for insulin users.

• He revealed that a clinical study for the device is planned to commence before the end of 2024.
• Dexcom anticipates achieving an impressive Mean Absolute Relative Difference (MARD) of less than 8%, and possibly even less than 7%.
• Furthermore, the sensor's duration might surpass the standard 15 days, with the actual wear time being dependent on the tape used rather than the sensor life itself.

Meanwhile, the availability of the Dexcom G7 CGM is expanding to more countries,

• including the UK, Ireland, Germany, Austria, Hong Kong, New Zealand, the US, and the Netherlands.
• There are also plans for further expansion, with Canada being among the targeted countries.

There is hope that as Dexcom strives to make its CGM more accessible to a larger population, it will lead to decreased costs for individuals with diabetes.

• In the previous Investor Call Dexcom's Chief Financial Officer, Mr. Jereme Sylvain, expressed the company's goal of reducing the cost of their 10-day sensor to $10, equivalent to $1 per day.
• Additionally, Dexcom's CEO, Mr. Kevin Sayer, mentioned before that the Dexcom G7 has a lower manufacturing cost "at scale," partially due to its 60% smaller size compared to its predecessor.

The increase in the global market for the Dexcom G7, along with lower manufacturing costs, raises optimism for a significant price reduction for Dexcom users.

This development has the potential to enhance affordability and accessibility to Dexcom CGM technology for individuals managing diabetes.

⭐ Abbott Enables Real-Time CGM Use of the FreeStyle Libre 2 in the UK

“We welcome this development that will give people using the Freestyle Libre 2 in the UK the ability to use the device as a real time CGM. Some people will prefer this and there is evidence to suggest it is more effective than intermittently scanning to check blood glucose levels.”  - Nikki Joule, Policy Manager at Diabetes UK July 2023

CGM technology is undeniably advancing and becoming more prevalent in the management of diabetes.

The guidelines recommending CGM for people with diabetes on basal-only insulin are gradually transforming into reality in countries like Japan, the US, and now France.

The evidence supporting the use of CGM in individuals with diabetes NOT on insulin is mounting, and primary care physicians are gearing up to embrace this new approach to diabetes care.

CGM will serve as a valuable tool for behavior modification, and guidelines and devices are being developed to utilize CGM as a behavioral tool.

As we embark on this new era of glucose data interpretation, 

there will undoubtedly be questions about how to respond to glucose fluctuations in individuals not on insulin and the clinical significance of these findings,

particularly in those without diabetes.

We are already witnessing dieticians utilizing CGM to guide individuals in making informed food choices, even in those without diabetes.

However, the clinical relevance of glucose excursions in non-diabetic individuals and their impact on time in range (TIR) and glucose management index (GMI) is still relatively unknown.

In the coming years, we will undoubtedly gain valuable insights into how different foods affect sensor glucose

and how this differs between individuals with and without diabetes.

These discoveries may lead to new conclusions and possibly even new dietary guidelines in the future.

To stay up-to-date with the latest developments in diabetes technology and the evolving landscape of CGM, consider subscribing to this blog. Click HERE if you don't want to miss out on the latest insights, advancements, and potential changes in diabetes management.

Let's embark on this exciting journey together as we uncover the impact of CGM and nutrition on our health and well-being.

Kind regards,