Levels Safety, Regulation & Compliance Posture: An Independent Review

What Levels Actually Is (and Isn't)

Levels is a software company, not a medical device manufacturer. The platform interprets glucose data streamed from third-party CGMs and translates readings into a proprietary "Metabolic Score" ranging from 1 to 10. Users receive real-time feedback on how meals, exercise, sleep, and stress affect blood sugar.

This distinction matters for safety evaluation. The CGM sensors themselves (Abbott FreeStyle Libre, Dexcom G7) hold FDA 510(k) clearances as Class II medical devices [1]. Abbott's FreeStyle Libre received its initial FDA clearance in 2017 for adults with diabetes, and subsequent clearances expanded indications [2]. Dexcom's G7 earned FDA clearance in 2022 [3]. Both devices carry well-characterized safety profiles, including minor skin irritation at the sensor site (reported in 5-10% of users) and rare adhesive allergies.

Levels' own software layer has not undergone FDA review. The company positions itself as a general wellness product under FDA guidance on "General Wellness: Policy for Low Risk Devices" (2019), which exempts certain low-risk wellness products from premarket review if they do not make disease-specific claims [4]. This classification is legitimate but carries a key limitation: Levels cannot legally claim to diagnose, treat, or manage diabetes or any other medical condition.

FDA Regulatory Standing

The FDA's regulatory framework for CGM-adjacent software remains in flux. Levels falls into a gray zone between regulated Software as a Medical Device (SaMD) and unregulated wellness apps.

Under the FDA's 2023 draft guidance on clinical decision support software, a product that "analyzes medical device data" to make patient-specific recommendations could meet the definition of a medical device [5]. Levels has been careful to frame its outputs as educational rather than diagnostic. The Metabolic Score is presented as a wellness metric, not a clinical biomarker. The company's terms of service explicitly state that Levels "does not provide medical advice, diagnosis, or treatment."

This positioning is not unique to Levels. Nutrisense, Signos, and Veri use similar regulatory strategies. None of these consumer CGM platforms carry independent FDA device clearances for their software components.

A 2024 commentary in the Journal of Diabetes Science and Technology noted that "the proliferation of consumer CGM platforms operating outside FDA oversight raises questions about the accuracy and clinical validity of proprietary metabolic scores derived from glucose data" [6]. The authors called for standardized validation frameworks for CGM-derived wellness metrics. No such framework exists yet.

CGM Safety in Non-Diabetic Populations

The core safety question for Levels users is whether wearing a CGM poses risks for people without diabetes. The short answer: CGM hardware risks are minimal, but the clinical value for non-diabetic populations remains debated.

A 2023 study published in The Lancet Digital Health examined CGM use in 153 non-diabetic adults over 10 days and found no serious adverse events [7]. Skin reactions (erythema, itching) occurred in 12% of participants, all resolving within 48 hours of sensor removal.

The American Diabetes Association's 2024 Standards of Care affirm CGM safety and efficacy for diabetes management but do not endorse routine CGM use in non-diabetic populations [8]. The Endocrine Society has not issued formal guidance on consumer CGM use for metabolic optimization.

A key concern raised by clinicians is the potential for "glucose anxiety," where non-diabetic users develop disordered eating patterns or unnecessary food restriction based on normal postprandial glucose fluctuations. A 2024 cross-sectional survey of 512 consumer CGM users published in Diabetes Technology & Therapeutics found that 18% reported increased food-related anxiety after starting CGM use, though 73% reported improved dietary awareness [9].

Dr. Robert Gabbay, Chief Scientific and Medical Officer at the American Diabetes Association, stated in a 2024 interview: "There is no evidence that continuous glucose monitoring in people without diabetes improves long-term health outcomes. The technology is safe, but 'safe' and 'beneficial' are different questions."

Data Privacy and Security Practices

Levels collects sensitive health data, including continuous glucose readings, meal logs, exercise data, and biometric information. The company's privacy obligations fall under HIPAA (for data handled through its telehealth prescription pathway) and general consumer privacy statutes.

Levels claims SOC 2 Type II certification, an independent audit standard for data security controls. The company states it uses AES-256 encryption at rest and TLS 1.2+ in transit [10]. User data is stored on AWS infrastructure in the United States.

Under the Health Insurance Portability and Accountability Act (HIPAA), Levels' telehealth partners (the physicians who write CGM prescriptions) are covered entities, and Levels would function as a business associate for prescription-related data [11]. The company publishes a Business Associate Agreement (BAA) on its website.

For non-prescription data (meal logs, activity tracking, Metabolic Scores), HIPAA protections may not apply. This data falls under the company's own privacy policy, which states that Levels "does not sell personal health data to third parties." The policy permits de-identified, aggregated data use for research purposes.

California residents have additional protections under the California Consumer Privacy Act (CCPA), including the right to request data deletion [12]. Levels' privacy policy includes CCPA-specific disclosures. Users in states without comprehensive privacy laws rely primarily on Levels' voluntary commitments.

Prescription Pathway and Physician Oversight

Levels uses a telehealth model to prescribe CGMs to non-diabetic users. This is the most regulated component of the Levels workflow.

When a user signs up, they complete a health questionnaire. A licensed physician in Levels' partner network reviews the questionnaire and, if appropriate, writes a prescription for a CGM. This asynchronous telehealth encounter is subject to state medical board regulations, DEA registration requirements (though CGMs are not controlled substances), and informed consent obligations.

The prescribing model has attracted scrutiny. CGMs are FDA-cleared for diabetes management, so prescribing them to non-diabetic individuals constitutes off-label use. Off-label prescribing is legal and common in medicine. A 2021 study in JAMA Internal Medicine estimated that 20-30% of all prescriptions in the U.S. are written for off-label indications [13]. The prescribing physician assumes clinical responsibility for this decision.

Levels' telehealth model does not include ongoing physician oversight. After the initial prescription, users interact primarily with the software. There is no scheduled follow-up, no lab review, and no clinical intervention if glucose patterns suggest a problem. This gap differs from clinical CGM programs at endocrinology practices, where CGM data is reviewed by a care team at regular intervals.

Levels' Metabolic Score: Validation Status

The proprietary Metabolic Score is Levels' core differentiator. It translates raw glucose data into a single daily score using an algorithm that weighs factors including average glucose, glucose variability, time in range (70-110 mg/dL for non-diabetic targets), and postprandial glucose excursions.

As of May 2026, no peer-reviewed, independently conducted validation study of the Levels Metabolic Score has been published. The company has cited internal data presented at conferences but has not submitted this work for peer review in indexed journals.

This matters for two reasons. First, without independent validation, users cannot assess whether the Metabolic Score accurately reflects metabolic health. Second, the score's thresholds and weightings are proprietary, making it impossible for clinicians to interpret or compare across platforms.

By contrast, established metrics like time in range (TIR) have been validated in large cohort studies. A 2019 consensus statement endorsed by the American Diabetes Association and the European Association for the Study of Diabetes defined TIR targets and established correlations between TIR and HbA1c [14]. Levels uses TIR as one input to its score, but the composite algorithm has not been similarly validated.

A 2023 comparison study in Nutrients evaluated four consumer CGM platforms (including Levels) and found "substantial variability" in how each platform scored identical glucose profiles, raising concerns about inter-platform reliability [15].

Levels vs. Alternatives: Comparative Assessment

Levels competes with Nutrisense, Signos, Veri, and January AI. None of these platforms hold FDA clearance for their software. The competitive differences are primarily in pricing, coaching models, and algorithmic approach.

Nutrisense includes access to a registered dietitian for data interpretation, providing a layer of clinical oversight that Levels lacks. Signos incorporates a weight-loss focus with a calorie-adjusted scoring system. Veri targets a European market with CE-marked device compatibility. January AI uses predictive glucose modeling rather than real-time scoring.

On pricing, Levels charges $199/year for its membership plus the cost of CGM sensors (typically $75-150 per month depending on insurance coverage and sensor brand). Nutrisense ranges from $225 to $399/month including dietitian access. Signos costs approximately $199/month.

No head-to-head clinical trial has compared health outcomes across these platforms. The choice between them is driven by feature preferences, budget, and whether a user values dietitian access (Nutrisense) versus self-directed data exploration (Levels).

Known Adverse Events and Complaint History

A search of the FDA's Manufacturer and User Facility Device Experience (MAUDE) database shows no adverse event reports filed against Levels Health Inc. as of May 2026 [16]. This is expected, given that Levels does not manufacture a medical device. Adverse events related to CGM hardware (skin reactions, sensor malfunctions, inaccurate readings) are reported under the device manufacturers (Abbott, Dexcom).

The Better Business Bureau (BBB) shows Levels Health with an unrated profile and fewer than 10 customer complaints, most related to subscription billing and refund processing. Trustpilot reviews are mixed, with a 3.8/5 average based on approximately 400 reviews as of early 2026.

No class-action lawsuits, FDA warning letters, or FTC enforcement actions have been filed against Levels Health as of the date of this review.

Clinical Evidence Gap: What the Research Actually Shows

The broader question behind Levels' value proposition is whether CGM-guided metabolic optimization improves health outcomes in non-diabetic adults. The evidence is early-stage and inconclusive.

A 2022 randomized controlled trial published in JAMA Network Open assigned 116 non-diabetic adults to CGM-guided dietary counseling versus standard counseling for 12 weeks [17]. The CGM group showed a statistically significant reduction in postprandial glucose variability (mean amplitude of glycemic excursions decreased by 11.2 mg/dL, P=0.003) but no significant difference in HbA1c, fasting glucose, or weight.

The LIMIT study (2023), a multicenter trial of 225 prediabetic adults using CGM-informed lifestyle coaching, found modest improvements in time in range (4.2 percentage points, P=0.01) and self-reported dietary quality at 6 months, but no reduction in progression to type 2 diabetes at 12 months [18]. The authors concluded that "CGM may enhance short-term behavioral engagement, but long-term clinical benefit remains unproven."

These findings suggest that CGMs can modify behavior but have not yet been shown to prevent disease or improve hard clinical endpoints in non-diabetic populations. Levels' marketing emphasizes the behavioral engagement angle, which is supported by the available data. Claims about long-term metabolic health improvement are not yet evidence-based.

The Bottom Line on Safety and Legitimacy

Levels is a legitimate company using FDA-cleared hardware in a legal regulatory framework. The CGM sensors it provides access to are safe and well-characterized. The company's data-privacy practices meet industry standards, and its telehealth prescription model operates within established medical-legal norms.

The areas of uncertainty are the clinical validity of its proprietary scoring algorithm (unvalidated in peer-reviewed literature), the absence of ongoing physician oversight after initial prescription, and the unresolved question of whether CGM use improves outcomes in non-diabetic adults. Users should approach the Metabolic Score as an educational tool rather than a clinical metric until independent validation data are published. Current pricing for a Levels membership plus CGM sensors runs approximately $300-400 per month out of pocket, as most insurers do not cover CGM for non-diabetic use.