The launch of the primary over-the-counter glucose sensors final yr has raised a debate about who advantages from these gadgets. The Meals and Drug Administration cleared gadgets made by Dexcom and Abbott final yr with a broad indication, permitting anybody who doesn’t take insulin to make use of them.
Throughout a session on the American Diabetes Affiliation’s Scientific Periods in June, a pharmacist and a doctor debated the advantages and dangers of those new gadgets. They each supported making CGMs extra accessible to folks with diabetes, however disputed the usefulness of the gadgets for adults with out diabetes.
Diana Isaacs, a pharmacist and director of schooling and coaching in diabetes tech on the Cleveland Clinic, argued in favor of over-the-counter CGMs, saying they may very well be useful for individuals who don’t have insurance coverage protection or who may need a tough time getting right into a specialist for a prescription. David Ahn, an endocrinologist and chief of diabetes companies at Hoag Hospital’s Mary and Dick Allen Diabetes Heart, agreed that having glucose displays simply accessible is “actually thrilling,” however raised issues that sufferers may misread the information and that the gadgets aren’t designed for accuracy in a narrower glucose vary.
The ADA debate was a part of a broader dialogue that’s taking place after HHS Secretary Robert F. Kennedy Jr. touted CGMs at a current congressional listening to, saying he would really like all People to be carrying a well being wearable inside 4 years.
The distinction between OTC and prescription CGMs
At the moment, two over-the-counter CGMs are available on the market: Dexcom’s Stelo machine, which is marketed to folks with Sort 2 diabetes who don’t take insulin, and Abbott’s Lingo, which is tailor-made to the wellness market. Abbott obtained FDA clearance for an additional over-the-counter machine, referred to as Libre Rio, which is meant for folks with Sort 2 diabetes, however the firm has not but shared a timeframe for launch.
One key distinction between over-the-counter and prescription CGMs is that the over-the-counter variations don’t present hypoglycemia alerts. In addition they show a narrower vary of glucose values. Dexcom’s G7 has a reportable glucose vary of 40 to 400 milligrams per deciliter, whereas its Stelo app solely shows ranges of 70 to 250 mg/dL. Dexcom’s Stelo additionally gives glucose readings each quarter-hour, whereas its G7 sensor gives them each 5 minutes.
Abbott’s Lingo equally gives a variety of fifty to 200 mg/dL, whereas its Libre Rio is anticipated to have a measurement vary consistent with prescription CGMs.
The over-the-counter gadgets concentrate on measuring glucose spikes, with Stelo issuing a “spike alert” whereas Lingo points “factors” for will increase in glucose all through the day.
Challenges with decoding CGM knowledge
One problem for folks with out diabetes who might use a CGM is that glucose spikes aren’t properly outlined, Ahn stated. For instance, how do you distinguish if the “spike” is only a response to emphasize versus from having a high-carb meal?
It additionally raises the query of what the purpose is for sufferers.
“Is our final purpose to not have any spikes in any respect and to have a flat line as a blood sugar?” he stated. “Absolutely that’s not the case.”
Whereas there are robust tips for time in vary for folks with diabetes, he added, there isn’t a consensus assertion or guideline for what “regular” is for folks with out diabetes.
Ahn additionally stated CGMs are higher at detecting excessive and low blood sugar ranges, and could also be much less correct in a tighter vary. He wore each Dexcom’s Stelo and Abbott’s Libre 2 Plus for 13 days, and had a mean glucose studying of 113 mg/dL from Stelo however a mean of 85 mg/dL from Libre 2 Plus.
“Glucose spikes and misinterpreting knowledge can result in confusion, nervousness, and worse, disordered consuming,” he stated.
The argument for OTC gadgets
Isaacs regarded to the historical past of diabetes gadgets to construct an argument for over-the-counter CGMs.
At one level, finger sticks used to measure blood glucose have been solely accessible in medical doctors’ workplaces. Now, they are often purchased with no prescription. When the primary CGMs got here to market, they have been solely accessible for individuals who had the privilege of having the ability to afford them and get a prescription, Isaacs stated.
“I bear in mind very vividly, within the earlier days of CGM, we had sufferers with Sort 1 diabetes the place some healthcare suppliers stated, ‘Oh, I feel that particular person goes to get too anxious seeing their numbers the entire time,’” Isaacs stated. “Let the particular person determine.”
CGMs are rather more accessible at this time. However for folks with out insurance coverage protection or a prescription, an over-the-counter CGM would typically be cheaper than paying for a prescription machine with money, Isaacs stated.
One space of potential profit is for folks with prediabetes, which accounted for roughly 38% of U.S. adults in 2021, in line with the Facilities for Illness Management and Prevention. Many individuals don’t know they’re dwelling with this situation, Isaacs stated. Although CGMs aren’t supposed to diagnose diabetes, the outcomes might immediate an individual to see their doctor and get testing, she stated.
Isaacs additionally sees the gadgets as useful for folks with gestational diabetes, as a result of lots of these sufferers don’t take insulin, which might make it more durable to get insurance coverage protection for a CGM.
For folks with out diabetes, Isaacs nonetheless sees CGMs as having a job in educating folks about what meals and different way of life elements can result in glucose excursions.
“What I’d argue is that the profit, for certain, outweighs the chance,” Isaacs stated.
