Over-the-counter glucose monitors and at-home blood testing: what the data can tell healthy people, and where it can mislead.
Overall evidence: Early3 products · 14 key studiesReviewed October 7, 2026Researched with AI assistance · Not reviewed by a clinician · Our method
The verdict
What we know about glucose monitors & lab tests
You no longer need a prescription to wear a continuous glucose monitor, and consumer blood panels are easy to order. The measurements can be accurate, but research on whether they help people without diabetes is limited, and over-testing has real downsides. Here is a clear-eyed guide to the options.
Bottom line · Early
Over-the-counter glucose monitors are now FDA-cleared and can show how meals and activity move your blood sugar, but no trials show that wearing one improves long-term health in people without diabetes, and readings can be off by a meaningful margin. A few lab tests rest on strong evidence (LDL cholesterol or apoB, Lp(a) and HbA1c), while large consumer panels add cost and raise the odds of incidental findings that lead to follow-up testing without proven benefit.
FDA cleared Dexcom's Stelo in March 2024 as the first over-the-counter continuous glucose monitor for adults not on insulin, and extended it to people 2 and older in June 2026. Abbott's Lingo was cleared in June 2024 for adults not on insulin. Stelo is not designed to alert users to dangerous lows, and Lingo is not intended to diagnose diabetes or other diseases.
Glucose swings in people without diabetesModerate
In a study of 153 healthy, non-obese people, glucose stayed between 70 and 140 mg/dL a median 96% of the day, with readings above 140 mg/dL about 30 minutes a day. Responses to the same meal differ greatly between people, and one study found people with normal standard tests reached prediabetic-range values 15% of the time. Whether these short excursions matter for long-term health in healthy people has not been shown.
Personalized nutrition from glucose dataEarly
Algorithms can predict individual meal responses, but in a 6-month randomized trial a diet built around predicted glucose responses produced no more weight loss than a standard low-fat diet, and two CGMs worn at the same time ranked meals quite differently.
CGM accuracyEarly
The first independent test of OTC CGMs in adults without diabetes found an average error of 12.9% versus fingersticks, worse after sugary drinks and during fast changes, with about a 6-minute lag. In March 2025, FDA sent Dexcom a warning letter over a G6/G7 sensor material change made without a required FDA submission; data cited by FDA showed the new material performed worse for accuracy.
Health outcomes of CGM use in healthy peopleWeak
We found no randomized trial showing that wearing a CGM improves long-term health in people without diabetes. A 2024 meta-analysis of 25 CGM-feedback trials found modest HbA1c improvements, mostly in people with diabetes, and no significant effect on weight or BMI.
Blood tests with strong evidence (LDL/apoB, Lp(a), HbA1c)Strong
LDL is an established cause of atherosclerotic heart disease, and apoB (a measure of the number of atherogenic particles) best captured heart-attack risk in a UK Biobank analysis of nearly 390,000 adults. A European consensus recommends measuring Lp(a), a causal risk factor, at least once in adulthood. HbA1c strongly predicts future diabetes and heart disease.
Over-testing, false alarms and incidental findingsModerate
Testing healthy people for many markers raises the chance of incidental findings that trigger cascades of follow-up care. In a national survey, 99.4% of internists had seen such cascades, and many reported psychological, physical or financial harm to patients. Some popular add-ons, such as routine vitamin D testing, are not recommended for healthy people.
Evidence
What the research shows
Moderate
In healthy people, glucose stays between 70 and 140 mg/dL most of the day, and brief excursions above 140 mg/dL are also seen.1Non-obese volunteers wearing a sensor for up to 10 days; people over 60 averaged slightly higher.
Moderate
Glucose responses to the same meal vary widely from person to person.23These studies measured short-term post-meal glucose, not long-term health.
Early
Even people with normal standard glucose tests can show prediabetic-range CGM readings at times; what this means for health is unknown.3Not a population-based sample, and the readings were not linked to health outcomes.
Moderate
Personalizing diet around predicted glucose responses did not improve weight loss compared with a low-fat diet.4Trial in adults with abnormal glucose metabolism and obesity; personalization relied on algorithm-estimated responses delivered as app meal scores.
Early
Two CGMs worn at the same time can disagree about which meals raise glucose most.5Small inpatient study (16 adults) using older sensor models.
Early
OTC CGMs follow overall glucose trends but are less reliable for exact values, especially after sugar and during rapid changes.639 young adults; the comparison was against fingerstick meters rather than laboratory glucose.
No good evidence
There is no trial evidence that wearing a CGM improves long-term health in people without diabetes.7CGM-feedback trials have been mostly in diabetes, where modest HbA1c improvements were seen; absence of evidence is not evidence of harm.
Strong
LDL cholesterol causes atherosclerotic cardiovascular disease, and apoB best captures the risk carried by atherogenic particles.89The apoB comparison is observational; neither source tests consumer self-testing as a strategy.
Strong
Lp(a) is a causal cardiovascular risk factor, and experts recommend measuring it at least once in adulthood.10As of the 2022 consensus there were no approved Lp(a)-specific lowering drugs, so a high result mainly prompts closer management of other risk factors.
Strong
HbA1c strongly predicts future diabetes and coronary heart disease in adults without diabetes.11Observational data from one large US cohort.
Moderate
Routine vitamin D testing in healthy people is not supported by trial evidence.12Applies to people without an established medical reason for testing.
Moderate
Incidental findings frequently trigger cascades of follow-up care that can harm patients.1314Based on a physician survey and expert review; not measured specifically for consumer lab panels.
Key studies
The studies behind the ratings
Summaries are our own, from each study's published abstract. Follow the links for the full details.
Cohort study with continuous glucose monitoring and standardized meals · 2018
Glucotypes reveal new patterns of glucose dysregulation
Who:
Adults without diagnosed diabetes, spanning normoglycemic and prediabetic ranges by standard tests
What:
CGM wear, standardized meal challenges and metabolic testing
Found:
Defined 'glucotypes' from glucose patterns; people considered normoglycemic by standard measures still reached prediabetic-range glucose 15% of the time and diabetic-range 2% of the time, and responses to identical meals varied between individuals.
Limits:
Not population-based; glucose patterns were not linked to long-term outcomes.
Cohort study with machine-learning model plus a blinded randomized dietary intervention · 2015
Personalized Nutrition by Prediction of Glycemic Responses
Who:
800-person cohort (46,898 meals), validated in an independent 100-person cohort
What:
Week-long CGM with meal logging; diets personalized from predicted responses
Found:
Glucose responses to identical meals varied widely; an algorithm using blood tests, diet, body measures, activity and gut microbiome predicted personal responses, and a blinded randomized diet based on it lowered post-meal glucose responses.
Limits:
Short-term glucose responses rather than long-term health outcomes.
Continuous Glucose Monitoring Profiles in Healthy Nondiabetic Participants: A Multicenter Prospective Study
Who:
153 healthy, non-obese, nondiabetic children and adults aged 7–80 at 12 US centers
What:
Blinded Dexcom G6 CGM worn for up to 10 days
Found:
Average glucose was 98–99 mg/dL (104 mg/dL over age 60); median time between 70 and 140 mg/dL was 96%; median time above 140 mg/dL was 2.1% (about 30 min/day) and below 70 mg/dL 1.1% (about 15 min/day); within-person coefficient of variation averaged 17%.
Inpatient study with two CGMs worn simultaneously · 2020
Imprecision nutrition? Different simultaneous continuous glucose monitors provide discordant meal rankings for incremental postprandial glucose in subjects without diabetes
Who:
16 adults without diabetes over 28 inpatient days (760 meals)
What:
Dexcom G4 Platinum and Abbott FreeStyle Libre Pro worn at the same time
Found:
Within-person meal rankings by glucose response agreed only moderately between devices (mean Kendall rank correlation 0.43); choosing meals ranked low by one device gave about 50% less glucose reduction as measured by the other.
Effect of a Personalized Diet to Reduce Postprandial Glycemic Response vs a Low-fat Diet on Weight Loss in Adults With Abnormal Glucose Metabolism and Obesity: A Randomized Clinical Trial
Who:
204 adults with overweight or obesity (BMI 27–50) and HbA1c 5.7–8.0%
What:
6 months of a personalized diet using machine-learning estimates of post-meal glucose response vs. a standardized low-fat diet, both with behavioral counseling
Found:
Weight change was −4.31% on the low-fat diet vs. −3.26% on the personalized diet, not significantly different (P = .16); body composition did not differ.
Limits:
People with abnormal glucose metabolism rather than healthy adults; dietary self-monitoring adherence may have limited exposure.
Independent agreement study vs. capillary (fingerstick) glucose · 2026
Agreement of Over-the-Counter Continuous Glucose Monitors With Capillary-Meter Glucose in Young Adults Without Diabetes
Who:
39 young adults without diabetes
What:
Over-the-counter CGMs during rest or exercise sessions with placebo or sugar-sweetened drinks
Found:
Mean absolute relative difference was 12.9% (bias −4.8 mg/dL) with 66.5% of readings within 15%/15 mg/dL; agreement was worse after sugar than placebo (15.3% vs. 10.6%); readings lagged about 6 minutes; 13.8% of trend arrows were rated moderate- to extreme-risk.
Limits:
Small sample of young adults; fingerstick meters are not a laboratory reference; the abstract does not name the brands tested.
Systematic review and meta-analysis of randomized controlled trials · 2024
The efficacy of using continuous glucose monitoring as a behaviour change tool in populations with and without diabetes: a systematic review and meta-analysis of randomised controlled trials
Who:
25 trials with 2,996 adults; 17 in type 2 diabetes and only 3 in people with obesity
What:
CGM-based feedback to support behavior change vs. no CGM feedback
Found:
CGM feedback lowered HbA1c by 0.28 percentage points and increased time in range by 7.4%; effects on BMI and weight were not significant. 11 of 25 studies (44%) reported CGM-affiliated conflicts of interest.
Limits:
Few trials in people without diabetes; high heterogeneity; few trials measured diet or activity changes.
Low-density lipoproteins cause atherosclerotic cardiovascular disease. 1. Evidence from genetic, epidemiologic, and clinical studies. A consensus statement from the European Atherosclerosis Society Consensus Panel
Who:
More than 200 cohort, Mendelian randomization and randomized studies; over 2 million participants and more than 150,000 cardiovascular events
What:
LDL cholesterol (LDL particle exposure)
Found:
Found a consistent, dose-dependent log-linear relationship between LDL exposure and atherosclerotic cardiovascular disease and concluded that LDL causes ASCVD, with risk falling in proportion to the absolute and lasting reduction in LDL.
Limits:
Expert synthesis of existing studies rather than new data.
Prospective cohort analysis (UK Biobank plus FOURIER and IMPROVE-IT trial populations) · 2022
Association of Apolipoprotein B-Containing Lipoproteins and Risk of Myocardial Infarction in Individuals With and Without Atherosclerosis: Distinguishing Between Particle Concentration, Type, and Content
Who:
389,529 adults not taking lipid-lowering therapy and 40,430 statin-treated patients with atherosclerosis
What:
ApoB, non-HDL cholesterol, LDL cholesterol and triglycerides
Found:
When assessed together, only apoB was associated with heart attack risk in the primary-prevention group (adjusted HR 1.27 per standard deviation), and likewise in the secondary-prevention group.
Limits:
Observational association; does not test treatment strategies.
Lipoprotein(a) in atherosclerotic cardiovascular disease and aortic stenosis: a European Atherosclerosis Society consensus statement
Who:
Review of epidemiologic and genetic studies involving hundreds of thousands of individuals
What:
Lipoprotein(a) concentration
Found:
Concluded that Lp(a) has a causal, continuous association with cardiovascular outcomes and aortic valve stenosis, and recommended testing Lp(a) at least once in adults.
Limits:
At publication there were no specific Lp(a)-lowering therapies; many panel members reported industry relationships.
Glycated hemoglobin, diabetes, and cardiovascular risk in nondiabetic adults
Who:
11,092 Black or White adults without diabetes or cardiovascular disease
What:
Baseline glycated hemoglobin (HbA1c)
Found:
Compared with HbA1c 5.0–5.5%, adjusted hazard ratios for diagnosed diabetes were 1.86 (5.5–6.0%), 4.48 (6.0–6.5%) and 16.47 (6.5% or more); for coronary heart disease they were 1.23, 1.78 and 1.95. HbA1c was more strongly associated with cardiovascular disease and death than fasting glucose.
Clinical practice guideline (GRADE methodology) · 2024
Vitamin D for the Prevention of Disease: An Endocrine Society Clinical Practice Guideline
Who:
General populations without established indications for vitamin D treatment or testing
What:
Empiric vitamin D supplementation and 25(OH)D blood testing
Found:
Found no clinical trial evidence supporting routine 25(OH)D screening, including in people with obesity or dark complexion, and suggested against routine vitamin D testing in the populations considered.
Limits:
Does not apply to people with established medical indications for testing.
Cascades of Care After Incidental Findings in a US National Survey of Physicians
Who:
376 practicing US internists (44.7% response), weighted to be nationally representative
What:
Experiences with cascades of care after incidental findings
Found:
99.4% had experienced cascades; physicians reported that cascades caused patients psychological harm (68.4%), physical harm (15.6%) and financial burden (57.5%); in their most recent cascade, 33.7% said the test revealing the finding may not have been clinically appropriate.
Limits:
Self-reported physician perceptions; not specific to consumer-ordered tests.
Direct-to-Consumer Testing: Benefits and Concerns of Commercially Accessed Laboratory Tests
Who:
Not applicable
What:
Direct-to-consumer laboratory testing
Found:
Concluded that consumer-ordered testing may help in a few selected situations but carries a substantial risk of medicalizing healthy people, often without the protections and interpretation support of regular health care.
OTC CGMs such as Stelo are not for people who use insulin or have problematic hypoglycemia; Stelo is not designed to alert users to dangerously low glucose.1516
FDA advises users not to make medical decisions based on an OTC CGM's output without talking to their health care provider.15
People with a history of eating disorders are advised to talk with a health care provider before using an OTC CGM program.1617
Do not rely on smartwatches or smart rings that claim to measure blood glucose without piercing the skin; FDA has authorized none, and inaccurate readings can lead to dangerous medication errors for people with diabetes.18
Wearing a CGM sensor can cause local infection, skin irritation, and pain or discomfort.15
Large consumer lab panels can produce incidental findings that lead to cascades of testing with psychological, physical and financial harms.1314
This is general information, not medical advice. If you have a heart condition, are pregnant, take medication or have any health concern, ask a clinician first.
FDA has cleared these sensor-based systems; it has authorized no smartwatch or ring that measures glucose on its own.18
Sensor life and reading interval (Stelo: up to 15 days per sensor, readings every 15 minutes)
Sensor life drives monthly cost, and the reading interval sets how much detail you see.15
Sensor life (Lingo: 14-day biosensor)
Useful for comparing cost per day of monitoring across brands.17
Low-glucose alerts
Stelo is not designed to alert users to dangerously low glucose, so OTC models are not suited to people prone to hypoglycemia.15
Short trial vs. ongoing subscription
With no proven long-term benefit for healthy users, a short trial may answer most curiosity-driven questions at lower cost.
Lab panels: apoB or a standard lipid panel
LDL is an established cause of heart disease, and apoB best captured heart-attack risk in a large UK cohort.9
Lab panels: Lp(a) measured at least once
A European consensus recommends testing Lp(a), a causal cardiovascular risk factor, at least once in adulthood.10
Lab panels: HbA1c
HbA1c strongly predicts future diabetes and coronary heart disease in adults without diabetes.11
Vitamin D add-on tests
A 2024 Endocrine Society guideline suggested against routine vitamin D testing in people without a specific medical reason.12
Very large 'everything' panels
More tests mean more incidental findings, which often lead to cascades of follow-up care with potential harms.13
A plan for clinician review and follow-up of results
Consumer-ordered testing often lacks the interpretation support and protections of regular health care.14
Compare prices
Glucose monitors & lab tests: current prices
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Long-form interviews and explainers from researchers and clinicians. Their views are their own; check claims against the studies above.
Why I’m Obsessed with Health Wearables (and You Should Be Too) | Michael Snyder | TED
TED
Stanford geneticist Michael Snyder argues that smartwatches and glucose monitors can make medicine predictive, citing examples such as flagging illness before symptoms appear.
Dr. Michael Snyder on Continuous Glucose Monitoring and Deep Profiling for Personalized Medicine
FoundMyFitness
Stanford's Michael Snyder discusses 'deep profiling' with consumer wearables, continuous glucose monitoring and other data streams to catch health changes early and personalize care.
A Stanford clinical pharmacist explains how continuous glucose monitors work, how to improve accuracy and handle costs, and how new over-the-counter biosensors compare with prescription CGMs.
Should you wear a Continuous Glucose Monitor (CGM)?
Nutrition Made Simple!
Gil Carvalho, MD, PhD, weighs the pros and cons of CGMs for healthy people versus those with prediabetes or diabetes, drawing on a discussion with diabetes researcher Nicola Guess.
Understanding Glucose Spikes | ft. Mario Kratz PhD
Nutrition Made Simple!
Long-form conversation with nutrition scientist Mario Kratz on what post-meal glucose spikes are, whether they are harmful in people without diabetes, and which tactics meaningfully blunt them.
Transform Your Metabolic Health & Longevity by Knowing Your Unique Biology | Dr. Michael Snyder
Andrew Huberman
Michael Snyder explains why people differ in their glucose responses to foods and interventions, what kind of "glucose responder" you might be, and why responses to fiber types vary.
University of Bath metabolic physiologist James Betts discusses how to interpret CGM data and research on fasting and meal timing without overstating what the evidence shows.
Researchers Mario Kratz and Nicola Guess discuss when post-meal glucose rises are normal versus a concern, and whether people without diabetes should worry about "spikes".
Internist Austin Baraki explains why blood levels of nutrients such as calcium, sodium and vitamin D often fail to reflect nutritional status, a key caution for direct-to-consumer lab panels.
Andy Galpin covers choosing blood markers for performance goals, timing and preparing for blood draws, natural variability, and how to read reference ranges.
Jim Otvos, developer of NMR lipoprotein testing, explains LDL particle number and apoB versus standard cholesterol tests and what NMR can reveal about insulin resistance and inflammation.
Latest research
New studies and news
Collected automatically from PubMed, safety recalls and science news. Not yet reviewed by us; inclusion is not an endorsement.
Not for any proven health reason. FDA cleared Stelo and Lingo for adults not on insulin, including people without diabetes who are curious about diet and exercise, but trials of CGM feedback have been mostly in people with diabetes and have not shown long-term health benefits for healthy users. It can be an educational tool rather than a necessity.715
Is a glucose spike after a meal bad?
Brief rises are common even in healthy people: in a 153-person study, glucose was above 140 mg/dL about 30 minutes a day on average while staying between 70 and 140 mg/dL a median 96% of the time. Whether short spikes in healthy people affect long-term health has not been established.13
How accurate are over-the-counter CGMs?
In the first independent test in adults without diabetes, OTC CGMs averaged 12.9% error against fingersticks, with 66.5% of readings within 15% or 15 mg/dL, and accuracy was worse after sugary drinks and during fast changes. They are better for spotting trends than for exact numbers.6
Can a CGM tell me my personal best diet?
Not reliably yet. Responses to the same food differ between people, but a 6-month randomized trial found that a diet personalized to predicted glucose responses produced no more weight loss than a low-fat diet, and two CGMs worn at the same time ranked meals quite differently.245
Which blood tests have the strongest evidence?
LDL cholesterol or apoB, a one-time Lp(a) test and HbA1c stand out. LDL is an established cause of heart disease, apoB best captured heart-attack risk in a large UK study, experts recommend measuring Lp(a) at least once, and HbA1c strongly predicts future diabetes and heart disease.891011
What's the downside of a huge 'everything' lab panel?
The more markers tested in a healthy person, the more likely something gets flagged and leads to repeat tests, imaging or specialist visits. In a national survey, nearly all internists had seen such cascades, and many reported psychological, physical or financial harm to patients. Reviewers also warn that consumer-ordered testing can medicalize healthy people.1314
Should I add a vitamin D test?
For most healthy people, guidelines say no. The Endocrine Society's 2024 guideline found no trial evidence supporting routine vitamin D testing and suggested against it for people without a specific medical reason.12
Can my smartwatch or ring measure blood sugar?
No. FDA has not authorized any smartwatch or smart ring to measure or estimate blood glucose on its own and has warned consumers not to use products that claim to do so without piercing the skin.18
Can kids use an over-the-counter CGM?
Since June 2026, Dexcom's Stelo has been FDA-cleared for people 2 and older who do not use insulin, with adult supervision for children. It is not intended for people with problematic hypoglycemia or on dialysis, and FDA advises anyone with a history of disordered eating to talk with a provider first.16
Sources
References
On March 5, 2024, FDA cleared Dexcom's Stelo Glucose Biosensor System as the first over-the-counter CGM: an integrated CGM for adults 18+ who do not use insulin, showing glucose every 15 minutes with sensors worn up to 15 days. FDA said it is not for people with problematic hypoglycemia and that users should not make medical decisions from it without their provider. 15
On June 12, 2026, FDA cleared Stelo for over-the-counter use by people 2 years and older who do not use insulin. It is not for people with problematic hypoglycemia or on dialysis, and FDA advised people with a history of disordered eating to talk with a provider first. 16
On June 10, 2024, Abbott announced FDA clearance of two over-the-counter CGM systems: Lingo, for users 18+ not on insulin and not intended for diagnosing diseases including diabetes, and Libre Rio, for adults with type 2 diabetes who do not use insulin. 17
On February 21, 2024, FDA warned consumers not to use smartwatches or smart rings that claim to measure blood glucose without piercing the skin, stating it has not authorized any smartwatch or smart ring intended to measure or estimate blood glucose on its own. 18
On March 4, 2025, FDA issued a warning letter to Dexcom after inspections of its San Diego and Mesa facilities, citing quality-system violations and a change to a sensor resistance-layer material in G6 and G7 sensors made without a required premarket notification; FDA noted the new material showed twofold greater variability in glucose sensitivity. The letter does not mention Stelo, and no close-out letter appeared on the FDA page when checked. 19
FDA's revised General Wellness guidance (January 6, 2026) lists continuous glucose monitoring systems among products that are not general wellness products, and describes a microneedle glucose wearable as not a low-risk wellness product because it penetrates the skin. 20
Continuous Glucose Monitoring Profiles in Healthy Nondiabetic Participants: A Multicenter Prospective Study. J Clin Endocrinol Metab 2019.PubMed 31127824
Personalized Nutrition by Prediction of Glycemic Responses. Cell 2015.PubMed 26590418
Glucotypes reveal new patterns of glucose dysregulation. PLoS Biol 2018.PubMed 30040822
Effect of a Personalized Diet to Reduce Postprandial Glycemic Response vs a Low-fat Diet on Weight Loss in Adults With Abnormal Glucose Metabolism and Obesity: A Randomized Clinical Trial. JAMA Netw Open 2022.PubMed 36169954
Imprecision nutrition? Different simultaneous continuous glucose monitors provide discordant meal rankings for incremental postprandial glucose in subjects without diabetes. Am J Clin Nutr 2020.PubMed 32766882
Agreement of Over-the-Counter Continuous Glucose Monitors With Capillary-Meter Glucose in Young Adults Without Diabetes. J Diabetes Sci Technol 2026.PubMed 42764665
The efficacy of using continuous glucose monitoring as a behaviour change tool in populations with and without diabetes: a systematic review and meta-analysis of randomised controlled trials. Int J Behav Nutr Phys Act 2024.PubMed 39716288
Low-density lipoproteins cause atherosclerotic cardiovascular disease. 1. Evidence from genetic, epidemiologic, and clinical studies. A consensus statement from the European Atherosclerosis Society Consensus Panel. Eur Heart J 2017.PubMed 28444290
Association of Apolipoprotein B-Containing Lipoproteins and Risk of Myocardial Infarction in Individuals With and Without Atherosclerosis: Distinguishing Between Particle Concentration, Type, and Content. JAMA Cardiol 2022.PubMed 34773460
Lipoprotein(a) in atherosclerotic cardiovascular disease and aortic stenosis: a European Atherosclerosis Society consensus statement. Eur Heart J 2022.PubMed 36036785
Glycated hemoglobin, diabetes, and cardiovascular risk in nondiabetic adults. N Engl J Med 2010.PubMed 20200384
Vitamin D for the Prevention of Disease: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab 2024.PubMed 38828931
Cascades of Care After Incidental Findings in a US National Survey of Physicians. JAMA Netw Open 2019.PubMed 31617925
Direct-to-Consumer Testing: Benefits and Concerns of Commercially Accessed Laboratory Tests. Clin Chem 2025.PubMed 39964351
On March 5, 2024, FDA cleared Dexcom's Stelo Glucose Biosensor System as the first over-the-counter CGM: an integrated CGM for adults 18+ who do not use insulin, showing glucose every 15 minutes with sensors worn up to 15 days. fda.gov
On June 12, 2026, FDA cleared Stelo for over-the-counter use by people 2 years and older who do not use insulin. fda.gov
On June 10, 2024, Abbott announced FDA clearance of two over-the-counter CGM systems: Lingo, for users 18+ not on insulin and not intended for diagnosing diseases including diabetes, and Libre Rio, for adults with type 2 diabetes who do not use insulin. abbott.mediaroom.com
On February 21, 2024, FDA warned consumers not to use smartwatches or smart rings that claim to measure blood glucose without piercing the skin, stating it has not authorized any smartwatch or smart ring intended to measure or estimate blood glucose on its own. fda.gov
On March 4, 2025, FDA issued a warning letter to Dexcom after inspections of its San Diego and Mesa facilities, citing quality-system violations and a change to a sensor resistance-layer material in G6 and G7 sensors made without a required premarket notification; FDA noted the new material showed twofold greater variability in glucose sensitivity. fda.gov
FDA's revised General Wellness guidance (January 6, 2026) lists continuous glucose monitoring systems among products that are not general wellness products, and describes a microneedle glucose wearable as not a low-risk wellness product because it penetrates the skin. fda.gov
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