Safety Information
Stelo Glucose Biosensor safety statements
STELO IMPORTANT INFORMATION
Consult your healthcare provider before making any medication adjustments based on your sensor readings and do not take any other medical action based on your sensor readings without consulting your healthcare provider. Do not use if you have problematic hypoglycemia. Failure to use Stelo and its components according to the instructions for use provided and to properly consider all indications, contraindications, warnings, and cautions in those instructions for use may result in you missing a severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) occurrence. If your sensor readings are not consistent with your symptoms, a blood glucose meter may be an option as needed and consult your healthcare provider. Seek medical advice and attention when appropriate, including before making any medication adjustments and/or for any medical emergency.
Indications for use
The Stelo Glucose Biosensor System is an over-the-counter (OTC) integrated Continuous Glucose Monitor (iCGM) intended to continuously measure, record, analyze, and display glucose values in people 18 years and older not on insulin. The Stelo Glucose Biosensor System helps to detect normal (euglycemic) and low or high (dysglycemic) glucose levels. The Stelo Glucose Biosensor System may also help the user better understand how lifestyle and behavior modification, including diet and exercise, impact glucose excursion.
The user is not intended to take medical action based on the device output without consultation with a qualified healthcare professional.
Contraindications
No MRI/CT/diathermy — MR unsafe: Don't wear any Stelo Glucose Biosensor System component during magnetic resonance imaging (MRI) or high-frequency electrical heat (diathermy) treatment. However, it's safe to have a CT scan if you keep the sensor out of the scanned area and cover the sensor with a lead apron during the scan.
The Stelo Glucose Biosensor System hasn't been tested in those situations when used during an MRI scan, diathermy, or in the scanned area of a CT scan. The magnetic fields and heat could damage Stelo Glucose Biosensor System components, which may cause inaccurate sensor readings.
WARNINGS
Chocking hazard: The Stelo Glucose Biosensor System contains small parts and may pose a choking hazard if swallowed.
Don't use if you have problematic hypoglycemia: The Stelo Glucose Biosensor System hasn't been designed for these populations. Consult with your healthcare provider to discuss which Dexcom product is right for you.
Don't use if you are on dialysis: The Stelo Glucose Biosensor System performance hasn't been evaluated in this population and sensor reading may be inaccurate.
Don't ignore low/high symptoms: Consult your healthcare provider when your sensor readings are not consistent with your symptoms of low or high glucose.
Don't change medications: Consult your healthcare provider before making any medication adjustments based on your sensor readings.