FDA authorizes continuous ketone monitor - Scorecard - MDSpire
Coming Soon: Introducing MDSpire News. Learn more
Conexiant’s news site is now MDSpire News. Learn more

FDA authorizes continuous ketone monitor

  • By

  • Kathryn Wighton

  • August 26, 2026

  • 2 min

Share

Clinical Scorecard: FDA authorizes continuous ketone monitor

At a Glance

CategoryDetail
ConditionContinuous Glucose and Ketone Monitoring
Key MechanismsContinuous measurement of glucose and ketone levels in interstitial fluid at 1-minute intervals.
Target PopulationIndividuals aged 2 years and older with diabetes.
Care SettingHome 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.

Related Resources & Content

Original Source(s)

Related Content