FDA Clears the First Over-the-Counter Continuous Glucose Monitor (2024)

Table of Contents

1. What the FDA Did
2. Who the Clearance Covers
3. How the System Works
4. What the Clinical Data Showed
5. The Reasons the FDA Gave
6. What the Clearance Does Not Do
7. The 2026 Follow-Up: Clearance for Children
8. What Published Research Reports on Glucose Monitoring Without Insulin
9. Dates and Status as of 11 October 2026
10. Primary Documents
11. Key Research Papers
12. Connections

1. What the FDA Did

The FDA news release “FDA Clears First Over-the-Counter Continuous Glucose Monitor” is dated 5 March 2024. It states that the agency “cleared for marketing the first over-the-counter (OTC) continuous glucose monitor (CGM).” The release describes the device as an integrated CGM (iCGM), and the action came from the agency’s Center for Devices and Radiological Health (CDRH), the part of the FDA that oversees medical devices.

The release’s word for the decision is “cleared for marketing.” The action was a decision on one device announced by press release; no Federal Register document was found for it (see section 9).

The release quotes Jeff Shuren, M.D., J.D., then director of CDRH: “CGMs can be a powerful tool to help monitor blood glucose. Today’s clearance expands access to these devices by allowing individuals to purchase a CGM without the involvement of a health care provider.”

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2. Who the Clearance Covers

According to the release, the system is intended “for anyone 18 years and older who does not use insulin.” The FDA gives two examples of the people it has in mind:

• People with diabetes treated with oral medications — that is, people whose diabetes is managed with tablets rather than insulin. The site’s Type 2 Diabetes page covers the condition.
• People without diabetes “who want to better understand how diet and exercise may impact blood sugar levels.” The site’s CGM for Non-Diabetics page covers this use.

The release excludes one group explicitly: the system “is not for individuals with problematic hypoglycemia (low blood sugar) as the system is not designed to alert the user to this potentially dangerous condition.”

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3. How the System Works

The release describes the system as a wearable sensor “paired with an application installed on a user’s smartphone or other smart device, to continuously measure, record, analyze and display glucose values.” The details it gives:

• Sensor life: each sensor can be worn for up to 15 days before it is replaced with a new one.
• Readings: the app presents glucose measurements and trends every 15 minutes.
• Medical decisions: the FDA states that “users should not make medical decisions based on the device’s output without talking to their healthcare provider.”

The site’s Continuous Glucose Monitoring page covers continuous glucose readings and terms such as time in range in general.

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4. What the Clinical Data Showed

The release reports two findings from the clinical study submitted to the FDA:

• Performance: the data “showed that the device performed similarly to other iCGMs.”
• Adverse events: those reported in the study “included local infection, skin irritation and pain or discomfort.”

The release does not give the study’s size, accuracy figures or how often each adverse event occurred, so none are reported here.

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5. The Reasons the FDA Gave

The release frames the clearance as a question of access. Its second sentence from the CDRH director reads: “Giving more individuals valuable information about their health, regardless of their access to a doctor or health insurance, is an important step forward in advancing health equity for U.S. patients.”

It closes by placing the action within CDRH’s “strategic priority to advance health equity,” stating that the center “will continue to support innovation that addresses health equity by moving care and wellness into the home setting.”

These are the agency’s stated reasons. The release makes no claim that wearing the device improves blood-sugar control or prevents diabetes in people who do not use insulin; published research on that question is summarized in section 8.

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6. What the Clearance Does Not Do

• It does not cover insulin users. The clearance is for people who do not use insulin.
• It is not a low-blood-sugar alarm. The FDA states that the system is not designed to alert the user to hypoglycemia and is not for people with problematic hypoglycemia.
• It clears one device. It is a decision on a single manufacturer’s system, not a rule for all CGMs.
• It did not cover children in 2024. The 2024 clearance was for adults aged 18 and older; the change for children came in June 2026 (section 7).
• It does not replace clinical advice. The FDA’s own release ties medical decisions based on the readings to a conversation with a health care provider.

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7. The 2026 Follow-Up: Clearance for Children

On Friday 12 June 2026 the FDA issued a second release, “FDA Clears First Over-the-Counter Continuous Glucose Monitor for Children.” It cleared the same system over the counter for people two years of age and older who do not use insulin, and states that the FDA had “previously cleared” the system for people 18 and older in March 2024. What the 2026 release adds:

• Who: children, including those with diabetes who take oral medication, and people who want to understand how diet, exercise and other lifestyle changes affect their glucose. For children, the release states that the device is to be used under the supervision of an adult caregiver, and the app can run on a parent’s or caregiver’s phone.
• Sensor wear: each sensor still lasts up to 15 days, although the release notes that wear time may be shorter in children than in adults.
• Evidence: the FDA describes the clearance as an example of its use of real-world evidence. The manufacturer and the FDA used earlier clinical study data from children and adults together with real-world data on current iCGM use in both groups to understand expected performance in children over the full 15-day wear period. Participants in the earlier study reported mild adverse events including local infection, skin irritation, and pain or discomfort.
• Limits: the system remains not for people with problematic hypoglycemia, because it does not alert users to low blood sugar, and the release adds that it is also not for people on dialysis. It states that people with a history of disordered eating or eating disorders are to talk with their health care provider before using it.
• Rationale: the release says prediabetes is increasingly affecting children in the United States, placing millions at higher risk of progressing to type 2 diabetes, and links the clearance to the FDA’s “Home as a Health Care Hub” initiative. It quotes the CDRH director, Michelle Tarver, M.D., Ph.D.: “Children deserve access to the best tools available to manage their health.” The site’s Prediabetes page covers the condition.

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8. What Published Research Reports on Glucose Monitoring Without Insulin

The FDA releases cite no published studies. The papers below, each checked on PubMed for this page, describe what continuous glucose readings look like in people without diabetes and what trials found when people with type 2 diabetes not using insulin wore a sensor. None of them tested the device cleared in 2024; they used other sensors.

• Reference values in healthy people (Shah 2019). In 153 healthy, non-obese children and adults aged 7 to 80 who wore a blinded sensor for up to 10 days, mean glucose was 98 to 99 mg/dL in every age group except those over 60 (104 mg/dL). Median time between 70 and 140 mg/dL was 96 percent; glucose was above 140 mg/dL for a median 2.1 percent of the time (about 30 minutes a day) and below 70 mg/dL for 1.1 percent (about 15 minutes a day). The authors present these as benchmark data.
• Meals and exercise in the same group (DuBose 2021). Mean peak glucose after a meal rose from 93 mg/dL before eating to 130 mg/dL, reached on average about 97 minutes after the meal started; exercise lowered sensor glucose by a mean 15 mg/dL from baseline to its lowest point.
• Young children (DuBose 2022). In 39 healthy children aged 1 to 6, mean glucose was 103 mg/dL and median time between 70 and 140 mg/dL was 96 percent.
• “Glucotypes” (Hall 2018). A Stanford study reported that even people classed as having normal glucose by standard tests showed high glucose variability on a sensor, reaching prediabetic and diabetic ranges 15 percent and 2 percent of the time, and that responses to identical meals differed widely between individuals.
• Estimated A1c in people without diabetes (Shah 2023). The glucose management indicator, a formula that estimates HbA1c from sensor glucose, averaged 0.59 percentage points higher than laboratory HbA1c in 153 people without diabetes; the authors concluded it does not accurately estimate HbA1c in this group.
• Type 2 diabetes without insulin, Japan (Wada 2020). In a 24-week randomized trial of 100 patients, HbA1c fell in both the sensor group and the conventional fingerstick self-monitoring group at 12 weeks; at 24 weeks, after monitoring had stopped, the reduction persisted only in the sensor group, with a between-group difference of 0.29 percentage points.
• Type 2 diabetes without insulin, Canada (Aronson 2023). In a 16-week randomized trial of 116 adults with HbA1c of 7.5 percent or higher, adding an intermittently scanned sensor to diabetes self-management education gave 9.9 percent more time in range (2.4 hours a day) and a 0.3-point greater HbA1c reduction than education alone; low-glucose events were few in both groups.

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9. Dates and Status as of 11 October 2026

• 5 March 2024: FDA clears the first over-the-counter CGM for adults 18 and older who do not use insulin.
• 12 June 2026: FDA clears the same system over the counter for people aged two and older who do not use insulin.
• Status as of 11 October 2026: final clearance in effect, extended to children. The 2024 clearance was a final device decision, not a proposal, and the June 2026 release confirms it and widens the age range. A query of the Federal Register for FDA documents mentioning continuous glucose monitors from January 2024 through 11 October 2026 found no document withdrawing or changing the clearance; the only match was a routine June 2025 update to the FDA’s list of recognized device standards.

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10. Primary Documents

1. U.S. Food and Drug Administration (2024). FDA Clears First Over-the-Counter Continuous Glucose Monitor. FDA News Release, 5 March 2024 — fda.gov press announcement
2. U.S. Food and Drug Administration (2026). FDA Clears First Over-the-Counter Continuous Glucose Monitor for Children. FDA News Release, 12 June 2026 — fda.gov press announcement

Neither action was published in the Federal Register, so there is no FR citation or docket number for either.

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Key Research Papers

1. Shah VN, DuBose SN, Li Z, Beck RW, Peters AL, Weinstock RS, et al. (2019). Continuous Glucose Monitoring Profiles in Healthy Nondiabetic Participants: A Multicenter Prospective Study. Journal of Clinical Endocrinology and Metabolism 104(10):4356-4364 — PubMed PMID: 31127824
2. DuBose SN, Li Z, Sherr JL, Beck RW, Tamborlane WV, Shah VN (2021). Effect of Exercise and Meals on Continuous Glucose Monitor Data in Healthy Individuals Without Diabetes. Journal of Diabetes Science and Technology 15(3):593-599 — PubMed PMID: 32064911
3. DuBose SN, Kanapka LG, Bradfield B, Sooy M, Beck RW, Steck AK (2022). Continuous Glucose Monitoring Profiles in Healthy, Nondiabetic Young Children. Journal of the Endocrine Society 6(6):bvac060 — PubMed PMID: 35506147
4. Hall H, Perelman D, Breschi A, Limcaoco P, Kellogg R, McLaughlin T, Snyder M (2018). Glucotypes reveal new patterns of glucose dysregulation. PLoS Biology 16(7):e2005143 — PubMed PMID: 30040822
5. Shah VN, Vigers T, Pyle L, Calhoun P, Bergenstal RM (2023). Discordance Between Glucose Management Indicator and Glycated Hemoglobin in People Without Diabetes. Diabetes Technology and Therapeutics 25(5):324-328 — PubMed PMID: 36790875
6. Wada E, Onoue T, Kobayashi T, Handa T, Hayase A, Ito M, et al. (2020). Flash glucose monitoring helps achieve better glycemic control than conventional self-monitoring of blood glucose in non-insulin-treated type 2 diabetes: a randomized controlled trial. BMJ Open Diabetes Research and Care 8(1):e001115 — PubMed PMID: 32518063
7. Aronson R, Brown RE, Chu L, Bajaj HS, Khandwala H, Abitbol A, Malakieh N, Goldenberg R (2023). IMpact of flash glucose Monitoring in pEople with type 2 Diabetes Inadequately controlled with non-insulin Antihyperglycaemic ThErapy (IMMEDIATE): A randomized controlled trial. Diabetes, Obesity and Metabolism 25(4):1024-1031 — PubMed PMID: 36546594

PubMed Topic Searches

1. PubMed: continuous glucose monitoring in people without diabetes
2. PubMed: CGM in non-insulin-treated type 2 diabetes
3. PubMed: over-the-counter continuous glucose monitors

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Connections

• FDA Actions of 2024
• FDA and Regulation
• Continuous Glucose Monitor (CGM)
• CGM for Non-Diabetics
• Continuous Glucose Monitoring
• Blood Sugar Remedies
• Type 2 Diabetes
• Prediabetes
• Yogurt and Type 2 Diabetes Health Claim (2024)
• Laboratory-Developed Tests Rule (2024)
• Semaglutide Heart-Risk Indication (2024)

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