Saudi FDA Grants Marketing Authorization for First Dual Glucose-and-Ketone Monitoring Device in Saudi Arabia
SFDA Grants Marketing Authorization for First Dual Glucose-and-Ketone Monitoring Device in Saudi Arabia
The Saudi Food and Drug Authority (SFDA) has granted marketing authorization for a next-generation biosensor device that continuously and simultaneously tracks blood glucose and ketone levels. This is the first device of its kind authorized for use in the Kingdom, and among the first such authorizations worldwide. The approval, announced August 20, 2026, was granted through the SFDA's Innovative Medical Devices Pathway, a route designed to accelerate market entry for breakthrough health technologies while maintaining rigorous safety and performance standards.
According to the SFDA, the device underwent a full scientific and regulatory evaluation, including review of technical and clinical documentation, safety and performance data, and clinical trial results. The authority described the milestone as supporting Saudi Vision 2030's Health Sector Transformation Program and the National Biotechnology Strategy.
Expert Perspective
"Diabetic ketoacidosis remains alarmingly common among people with type 1 diabetes, both here in the MENA region and globally, and it continues to take a real toll (not just physically, but on the mental health and daily peace of mind of patients and their caregivers)," said Dr. Mohammed Al-Sofiani, endocrinologist, Vice President of the Saudi Society of Endocrinology and Metabolism, and an author of the international consensus recommendations on continuous ketone monitoring. "Bringing continuous ketone monitoring into routine care is expected to meaningfully ease that burden by catching problems earlier and giving families more confidence day to day. This technology also has real value for people using SGLT2 inhibitors, including those with type 1 diabetes who are using them off-label to support their cardiorenal health, a group where early ketone detection is especially important given the added risk of euglycemic DKA." (Dr. Mohammed Al-Sofiani)
Why It Matters
Until now, ketone testing has meant a fingerstick blood draw or a urine strip. Such approach to measuring ketone gives a snapshot in time that most patients simply don't use consistently, even when they're sick. Continuous ketone monitoring (CKM), delivered through a wearable sensor alongside glucose data, changes that by giving patients and clinicians an ongoing view of rising ketones, often before symptoms of diabetic ketoacidosis (DKA) appear.
This arrives at a moment when the global evidence base for CKM is catching up to the technology. A newly published international expert consensus, endorsed by the International Society for Pediatric and Adolescent Diabetes (ISPAD), lays out the first practical framework for how clinicians should interpret and act on CKM data.
The Clinical Case for Continuous Ketone Monitoring
DKA remains one of the most preventable, yet still most common, causes of diabetes-related hospitalization. International registry data cited in the consensus show annual DKA hospitalization rates as high as 5–7% among children and adolescents with type 1 diabetes in several countries, and DKA is associated with long-term risks including cardiovascular events, kidney disease, and increased mortality.
A growing complication is euglycemic DKA, where ketones and acidosis rise even though glucose stays under the classic diagnostic threshold. It's increasingly seen with SGLT2 inhibitor use and in pregnancy. This form of DKA is of particular concern because it doesn't present with obvious hyperglycemia and glucose monitoring alone can miss it entirely. A continuous ketone signal closes that gap, which is exactly the rationale behind pairing glucose and ketone sensing in a single device.
A New Framework for Interpreting Ketone Data
Rather than the "none, trace, small, moderate, large" language of urine strips, the international consensus proposes four objective categories for interstitial β-hydroxybutyrate readings, modeled on the traffic-light logic already familiar from CGM reporting:
| Category | Ketone level (mmol/L) | Recommended action |
|---|---|---|
| Normal | < 0.6 | No action necessary |
| Elevated | 0.6 – 1.5 | Monitor glucose closely; check pump/insulin delivery; follow sick-day guidance |
| High | > 1.5 – < 3.0 | As above, plus contact your health-care professional |
| Urgent High | ≥ 3.0 | Seek immediate medical attention |
Notably, the panel recommends that these action thresholds apply regardless of diabetes type, and that they hold even when the device's trend arrow points in a reassuring direction. The ketone concentration itself, not the trajectory, should drive the patient's action. Trend arrows remain useful, but mainly to help clinicians fine-tune advice once contacted, and are considered clinically meaningful only at a rate of roughly 0.4 mmol/L per hour.
Guarding Against Alarm Fatigue
Alarm fatigue is the most common reason patients abandon CGM technology, and the expert panel expects the same risk with CKM. Their recommendation is to make ketone alerts optional and customizable below the urgent-high threshold, while requiring a mandatory alert at ≥ 3.0 mmol/L. All CKM users should still be equipped with a capillary blood ketone meter and strips as backup. If symptoms don't match the sensor reading, a fingerstick confirmation is advised.
Who Stands to Benefit Most
The consensus identifies priority groups where CKM is likely to have the largest early clinical impact: people with recurrent DKA, patients on SGLT2 inhibitors, pregnant women with diabetes, insulin pump and automated insulin delivery users (where infusion-site failure is a recognized DKA trigger), people on low-carbohydrate or ketogenic diets, older or frail adults, young adults transitioning from pediatric to adult care, and those with chronic kidney disease or comorbid mental health conditions.
What We Still Don't Know
The consensus authors are candid about the evidence gaps behind these recommendations. The 3.0 mmol/L threshold long used to diagnose DKA is graded as low-quality evidence, based on only two prior studies, and newer data suggest the true equivalence to clinically significant acidosis may sit closer to 4.3 mmol/L in adults (possibly varying further with renal function). There are no published data yet on the normal day-to-day fluctuation of ketones in people with diabetes, nor on how CKM profiles might flag individuals at higher future DKA risk before an acute event occurs. The authors call on device manufacturers to make de-identified data available for research as real-world adoption grows.
The Regulatory Picture Beyond Saudi Arabia
Saudi Arabia's authorization lands amid a broader wave of regulatory movement on this technology globally: a major device-maker secured European CE mark clearance for a dual glucose-ketone sensor earlier this year and has an application pending with the U.S. FDA, with a decision expected later in 2026. The SFDA's own announcement did not name the specific manufacturer or product authorized in the Kingdom, but framed the Kingdom as being "among the first regulatory authorities globally" to clear this device category, placing Saudi Arabia at the front of international adoption rather than following it.
Bottom Line for Practice
With marketing authorization now granted, clinicians across Saudi Arabia should expect patient questions about this technology to arrive soon, particularly from those managing pump users, SGLT2 inhibitor patients, or anyone with a history of recurrent DKA. Being ready to counsel using the normal/elevated/high/urgent-high framework above, and remembering that a normal glucose reading no longer rules out a ketone problem, will matter from day one of clinical availability.
Sources:
SFDA. "Among the First Worldwide: SFDA Grants Marketing Authorization for Innovative Dual Glucose and Ketone Monitoring Device." August 20, 2026.
Dhatariya K, Bergenstal RM, Al-Sofiani M, et al. Continuous ketone monitoring for people with diabetes: international expert recommendations on the application of a new technology. Lancet Diabetes Endocrinol. 2026;14(1):82-92.
