FAQ: Levels, CGM and the Diabetes Community
Answers to some common questions about Levels mission and process, and why we’re bringing CGM to a broader audience.
As a company focused on solving the metabolic health crisis, Levels’ work intersects with the Type 1 and Type 2 diabetes communities. For the moment, we use some of the same tools—particularly continuous glucose monitors—and frequently speak about glucose and insulin.
Because of this, we’ve heard some questions and concerns on social media about why we serve “healthy” people and whether our work affects people with diabetes. We want to be unequivocal in our support for the diabetes community and our commitment to promoting overall metabolic health in a way that does not harm the people who use this technology to manage their conditions.
Here we address some common misconceptions. If you have additional feedback or inquiries, please let us know on Twitter @levels.
For additional perspective on Levels from people with Type 1 diabetes, here are two recent articles:
- Why I want everyone, with or without diabetes, to have CGM access
- How wearing a CGM changed Este Haim’s life
How can a CGM help people without diabetes?
Our mission is to solve the metabolic health crisis and help people make healthy diet and lifestyle decisions that work for them. More than 128 million people in the U.S. have prediabetes or Type 2 diabetes, the vast majority of which is preventable through optimized dietary and lifestyle choices that keep glucose in a healthy range over time. We believe that empowering people to see for themselves how their choices affect their health gives them agency. The use of CGMs to promote better health in Levels members does not divert devices from people who need them or minimize the experience of living with diabetes.
Traditionally, only when a person reaches the diagnostic threshold of Type 2 diabetes can they access CGM for disease management and to understand how food affects their blood sugar. We believe that many people could avoid this outcome by having this insight earlier, before reaching Type 2 diabetes glucose levels. Additionally, understanding how non-food factors like stress, sleep, and exercise affect glucose levels may inspire more people to live healthier lives overall. We’ve found that this process builds understanding for how complex medication management can be for people with diabetes, given these many variables.
What Levels does—and why
Inside Levels
How does a CGM provide value beyond simply looking at food labels?
For starters, we (on average) eat nearly 10x more sugar per day than we did 100 years ago. Many of us don’t even realize it because sugar is so ubiquitous in our food culture and frequently hidden in food.
In addition, every person responds to carbohydrates differently, and what may cause a considerable glucose elevation for one person might not for another. What’s more, most people lack awareness of how stress, sleep, and exercise impact their glucose levels. Repeated high glucose spikes (and resultant insulin release) contribute to the mostly preventable insulin resistance that affects more than 128 million Americans.
CGM also contributes to overall metabolic fitness by helping people see if they are maintaining 24-hour glucose levels in a fairly narrow and healthy range and keeping fasting glucose (glucose levels measured after consuming no calories for at least 8 hours) in a healthy, low-risk range.
Are glucose spikes a normal part of how healthy people’s bodies process sugar?
We do expect our blood sugar levels to fluctuate somewhat throughout the day. Food, exercise, mood, and sleep can all lead to a small rise and fall. But degree matters. The purpose of this feedback is to help people understand how their diets affect their glucose levels. Diets and lifestyles that have less glycemic impact are better for health over time. Extreme glucose variability has been linked to heart disease, diabetes, and metabolic dysfunction. Currently, people don’t have a way to know how food affects their blood glucose levels personally, and we believe that this lack of awareness contributes to the fact that as much as 88% of the country is living with some form of metabolic dysfunction.
How do Levels members use the information they learn to build positive habits?
Levels aims to empower our members with personalized nutrition data that allows them to make healthy choices that work for them instead of living with the general anxiety that they are doing something “wrong.” Instead, we have consistent feedback that the 1-month Levels program improved members’ understanding of their diet and lifestyle. Many find a short period of using CGM liberating in learning what foods work for them, reducing the need for lifelong “trial and error” with diets that can lead to an unhealthy fixation on food choices.
As we are still in a beta period, optimizing our product and user experience, we take all feedback about this learning—positive or negative—and funnel it into building a better, more insightful version of the app. Our intention is focused on giving people an empowering experience as they learn which variables in the diet and lifestyle impact glucose levels and their overall health.
How do Levels members get CGM devices?
Even though CGMs are over-the-counter devices in many countries, including throughout Europe, they are only available by prescription to non-clinical populations in the US. All Levels members receive a prescription from a physician in their state for a CGM. Our physicians are 100% independent telehealth practitioners who operate their own practices or as part of a physician network. Members can learn more about their reviewing physician at any time. Find more information on the prescription process here.
Are there enough CGM devices for everyone who needs them?
There is no shortage of CGM hardware in the U.S., nor has the supply been affected by COVID. Abbott, one of the three major manufacturers (along with Dexcom and Medtronic), has said their manufacturing capacity will increase by 3x–5x in the next few years. Dexcom has had manufacturing constraints in the past but is looking to increase vastly in 2021 and beyond with its G7 sensor.
There are genuine access issues to CGM for people with Type 1 diabetes. However, this problem stems primarily from insurance coverage, not a shortage of devices. CGM use in Americans with Type 1 diabetes is growing exponentially, from 6% in 2011 to 38% in 2018. A CGM prescription for a Levels member does not take it out of the hands of someone with Type 1 diabetes; Levels members pay out of pocket for CGMs and are not utilizing an insurance pool.
Our mission aligns with increased CGM coverage, and our relationships with CGM manufacturers promote this. Expanding CGM use and awareness and making it the standard of care will pressure insurance companies to expand CGM access. Major hardware manufacturers have actively engaged in this market already, with Abbott Sense now available for people without diabetes in Europe. Levels creates software to make this data easier to understand and act on.
Where does Levels source its CGMs?
All Levels members receive CGMs fulfilled through a US pharmacy. We connect Levels members with telehealth physicians in their state, who make the prescription decision for that member. All Levels members receive CGMs …
- In manufacturer-sealed boxes
- Prescribed by a doctor
- From a US-pharmacy licensed in each member’s resident state
- With a prescription sticker and expiration date on each sealed sensor
- Additionally, each member’s prescription is available to them and visible on the box
How does Levels help drive down the cost of CGM?
Mass adoption of hardware drives down prices. If CGM becomes a tool for a larger audience, manufacturers will compete with each other for that market. We’ve seen CGM technology costs come down already, even within the limited market, as the main players compete with each other for share and adoption. As one market report notes: “The Dexcom G6, at $375 per transmitter bundle is 37% cheaper and 43% than the G5 and G4 at $599 per bundle and $660 per bundle respectively. We expect average costs across different brands to converge in the next few years, falling to $233 in 2024.”
CGM is more likely to follow the innovation and market path of consumer wearables than medical supplies like insulin, which has seen prices go up rather than down because it exists in a captive market, meaning its customers have to buy the product and have no other options. Insulin is expensive because the total market for individuals with Type 1 diabetes is only around 1.6 million people and won’t expand exponentially the way a device audience can. CGM has a potential audience of tens of millions of price-sensitive consumers for whom the device is optional—that drives competition up and price down.
How does Levels directly benefit those with Type 1 diabetes?
Levels is committed to solving the metabolic health crisis by empowering people with information to help them make positive lifestyle and nutrition choices. We have started in a wellness market to help the 88% of Americans with suboptimal metabolic health. By bringing CGM technology and a focus on glucose and insulin data to a broader population, we aim to lower CGM cost, drive innovation in glucose monitoring and analysis, lessen the stigma of CGM use and contribute to broader knowledge about metabolic issues. Our research collaborations with Brigham Young University, Thomas Jefferson University, and the University of South Florida are intended to bring greater scientific understanding to the physiology of glucose dysregulation, which is relevant to all individuals.
