FDA authorizes continuous ketone monitor
Patients aged 2 years and older with diabetes are eligible to use the wearable.
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By
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Kathryn Wighton
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August 26, 2026
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Clinical Scorecard: FDA authorizes continuous ketone monitor
At a Glance
| Category | Detail |
|---|
| Condition | Continuous Glucose and Ketone Monitoring |
| Key Mechanisms | Continuous measurement of glucose and ketone levels in interstitial fluid at 1-minute intervals. |
| Target Population | Individuals aged 2 years and older with diabetes. |
| Care Setting | Home and outpatient settings. |
Key Highlights
- First device in the US to continuously monitor both glucose and ketone levels.
- Automated notifications for concerning ketone levels.
- Accurate tracking of ketone levels over 10 days.
- Identifies elevated ketone levels prior to diabetic ketoacidosis onset.
- Received Breakthrough Device designation from the FDA.
Guideline-Based Recommendations
Diagnosis
- Interpret ketone measurements alongside glucose readings and clinical symptoms.
Management
- Utilize the device for continuous monitoring to prevent diabetic ketoacidosis.
Monitoring & Follow-up
- Monitor glucose and ketone levels at 1-minute intervals.
Risks
- Excessive ketone production can lead to diabetic ketoacidosis.
Patient & Prescribing Data
Individuals with diabetes requiring monitoring of glucose and ketone levels.
Device provides real-time data and trends for better management of diabetes.
Clinical Best Practices
- Use the device in conjunction with clinical assessments.
- Educate patients on interpreting device readings.
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