FDA Authorizes First Wearable Device That Continuously Monitors Both Ketone Levels and Blood Sugar

FDA Authorizes First Dual Ketone and Glucose Wearable

The U.S. Food and Drug Administration (FDA) has authorized the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System for individuals aged 2 years and older living with diabetes. This device marks a significant advancement as the first wearable in the U.S. to continuously monitor ketone levels and the first globally to continuously monitor both ketones and blood sugar (glucose) in a single unit. It aims to provide real-time data and alerts to help detect rising ketone levels early, potentially preventing life-threatening diabetic ketoacidosis (DKA), a serious complication particularly for the estimated 2.1 million Americans with type 1 diabetes.

• The Libre Duo 10 Day system introduces a breakthrough in diabetes management by offering continuous, simultaneous monitoring of both ketone and glucose levels. Unlike previous methods that provided only single, point-in-time ketone measurements, this device delivers real-time, around-the-clock data wirelessly to a compatible smartphone, including trending information and automatic alerts for concerning ketone thresholds.
• A primary benefit of the new device is its potential to enable early detection of rising ketone levels, which is critical for preventing diabetic ketoacidosis (DKA). DKA is a serious and rapidly developing complication that can become life-threatening if untreated. This continuous monitoring capability provides patients and caregivers with vital information to intervene promptly, significantly enhancing safety for individuals with diabetes.
• The FDA granted marketing authorization for the Libre Duo 10 Day through the De Novo premarket review pathway, following a Breakthrough Device designation. This authorization was supported by a comprehensive review of clinical and performance data from six studies involving over 600 participants, which demonstrated the device's accuracy in tracking clinically meaningful differences in ketone levels and identifying elevated levels before DKA onset.

Addressing the Critical Gap in Diabetes Ketone Monitoring

Current diabetes management faces a convergence of pharmacological, physiological, and behavioral challenges that limit therapeutic success across patient populations. Despite the expanding armamentarium of antihyperglycemic agents, a substantial proportion of patients fail to achieve adequate glycemic control, with downstream consequences for morbidity, mortality, and healthcare costs.

• Progressive beta-cell dysfunction: Significant loss of pancreatic beta-cell secretory capacity precedes the clinical diagnosis of T2D, and continues to worsen with disease duration, obesity, and chronic use of beta-cell–stimulating therapies. Patients with long disease duration, HbA1c ≥9%, or prolonged secretagogue exposure are at particular risk for treatment failure due to this underlying pathophysiology.

• Suboptimal glycemic control at the population level: Despite multiple available drug classes, a large proportion of people with diabetes do not meet glycemic targets, underscoring a fundamental gap between therapeutic availability and real-world effectiveness.

• Adverse effect profiles limiting adherence: Key tolerability issues vary by drug class — insulins and insulin secretagogues carry meaningful hypoglycemia risk; most second-line agents are associated with weight gain of 1.8–3.0 kg (exceptions include DPP-4 inhibitors, alpha-glucosidase inhibitors, and GLP-1 analogues); and gastrointestinal intolerance represents the primary barrier to GLP-1 receptor agonist uptake.

• Treatment burden and adherence failure: Unmet needs associated with treatment regimens negatively affect therapy acceptance and adherence, which in turn compromises glycemic management and increases both morbidity and healthcare expenditure.

• Macro- and microvascular complications: Diabetic complications — including retinopathy, nephropathy, neuropathy, coronary artery disease, peripheral vascular disease, and stroke — remain leading causes of blindness, end-stage renal disease, and cardiovascular morbidity. Notably, diabetic retinopathy affects approximately one-third of people with diabetes and is associated with elevated risk of stroke, coronary heart disease, and heart failure; current interventions such as laser therapy can preserve sight but have limited capacity to reverse established visual loss.

• Insufficient long-term outcomes data: Comparative evidence on second-line therapies remains limited with respect to diabetes complications, mortality, and quality-of-life endpoints, constraining evidence-based treatment sequencing decisions.

Transforming Diabetes Management with Continuous Dual Monitoring

Over the past five years, the diabetes treatment landscape has undergone a fundamental paradigm shift — moving well beyond glycemic control toward a multifaceted framework that prioritizes cardiovascular, cerebrovascular, and cardiorenal protection. SGLT2 inhibitors have emerged as cornerstone agents across this expanded therapeutic mandate. Trial data from DAPA-CKD demonstrated that dapagliflozin 10 mg/day significantly reduced the risk of kidney failure and prolonged survival in patients with CKD (eGFR 25–75 mL/min/1.73 m²), irrespective of type 2 diabetes status, with a 27% reduction in the primary composite endpoint among stage 4 CKD patients. Across the class, canagliflozin and empagliflozin have shown reductions in major adverse cardiovascular events (MACE), while dapagliflozin demonstrated meaningful reductions in heart failure–related death and hospitalization, along with emerging signals for dementia risk reduction. Ertugliflozin reduced heart failure hospitalization rates and, in network meta-analysis at 24–26 weeks, demonstrated superior HbA1c reduction compared to dapagliflozin 10 mg and empagliflozin 25 mg, both as monotherapy and in combination with metformin. Growing evidence also supports a class-level benefit in reducing hemorrhagic stroke risk and cognitive decline in high-cardiovascular-risk populations with type 2 diabetes.

GLP-1 receptor agonists have similarly expanded their clinical footprint, with robust trial evidence confirming cardiorenal benefits in type 2 diabetes and significant weight management efficacy in obesity. Semaglutide at higher doses reduced body weight by up to 15% and lowered MACE risk by 20% in individuals with obesity without type 2 diabetes. In a notably distinct patient population — individuals with schizophrenia spectrum disorders on clozapine or olanzapine — adjunctive semaglutide 1 mg weekly produced a mean HbA1c reduction of −0.25% (95% CI: −0.33 to −0.16; P < .001), with 43% achieving low-risk HbA1c levels versus 3% on placebo, alongside significant reductions in body weight (−9.2 kg), waist circumference (−7.0 cm), and fat mass (−6.1 kg). The dual GIP/GLP-1 receptor agonist tirzepatide has further advanced the field, achieving up to 22.5% weight loss in phase 3 trials, demonstrating superior HbA1c and body weight reductions versus semaglutide, and generating preliminary evidence of improved kidney outcomes in type 2 diabetes patients with elevated cardiovascular risk. Meta-analyses of combination SGLT2i plus GLP-1RA therapy have shown significantly reduced risks across atherosclerotic cardiovascular, heart failure–associated, and mortality outcomes compared to either agent as monotherapy, reinforcing a combinatorial approach in patients with high or very high cardiovascular risk.

Technological innovation has further redefined the standard of care, particularly through advanced closed-loop insulin delivery systems. Fully closed-loop systems increased time in range to 77.7 ± 4.6% versus 41.1 ± 19.5% with standard care in post-pancreatectomy diabetes, while virtually eliminating severe hypoglycemia. The addition of empagliflozin 25 mg daily to automated insulin delivery improved time in target range by 7.2% versus placebo, with the combined closed-loop plus empagliflozin approach achieving a 17.5% improvement over sensor-augmented pump therapy with placebo — though uncomplicated ketosis events were more frequent on empagliflozin. Patient adoption data from a German survey of 1,054 individuals showed that DIY closed-loop users achieved superior time in range and lower HbA1c, with over 85% of respondents indicating willingness to use a commercial closed-loop system if available. Collectively, these advances reflect a treatment paradigm anchored in individualized, risk-stratified therapy that integrates next-generation pharmacology with precision delivery technology.

Clinical Data Supporting Libre Duo 10 Day Authorization

Recent clinical trials across multiple diabetes drug classes have generated substantial evidence informing both treatment selection and regulatory decision-making. The studies below span SGLT2 inhibitors, GLP-1 receptor agonists, and behavioral interventions, each contributing distinct safety and efficacy data relevant to diabetes management.

Dual Monitoring: A New Era for DKA Prevention and Diabetes Care

The FDA's authorization of the Libre Duo 10 Day system marks a significant leap forward in diabetes care, offering the first wearable device in the U.S. to continuously monitor ketone levels and the first globally to provide simultaneous glucose and ketone tracking. This innovation is poised to fundamentally reshape how diabetic ketoacidosis (DKA), a life-threatening complication, is managed.

For individuals with diabetes, particularly the millions living with type 1 diabetes, this device offers a proactive shield against DKA. Current methods of ketone monitoring are often suboptimal, leading to delayed detection. The Libre Duo's real-time data and alerts can empower patients and caregivers to intervene earlier, potentially preventing emergency room visits and hospitalizations. This is especially critical for vulnerable populations, including children and adolescents, where DKA is the leading cause of mortality.

Beyond DKA prevention, this technology unlocks new therapeutic possibilities. Sodium-glucose cotransporter-2 inhibitors (SGLT2-is) are highly effective for heart failure management, especially in type 1 diabetes, but their use has been limited by the risk of euglycemic DKA. Continuous ketone monitoring can mitigate this risk, allowing for safer integration of SGLT2-is into treatment regimens and potentially improving cardiovascular outcomes. However, the full clinical benefit of this integrated approach requires further dedicated clinical trials to establish new management protocols.

While the device represents a major advancement, challenges remain. Suboptimal adherence to monitoring instructions, even with advanced technology, could limit its real-world impact. Furthermore, ensuring the long-term accuracy and user convenience of the ketone sensor, particularly regarding factory calibration, is an ongoing technical consideration. Nevertheless, this dual monitoring system brings us closer to the vision of an external artificial pancreas, promising enhanced safety and efficacy in intensive insulin therapy and a new era of proactive diabetes management.