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To be eligible for BioFit programs and use Stelo, you must be:
✅ Over 18 Years of Age
❌ Not on Insulin
❌ Not on Dialysis
❌ Without Problematic Hypoglycemia
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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.
WARNINGS: Choking 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 readings 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 health
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STELO BY DEXCOM APP: Before you complete your purchase, please confirm that your smartphone has at least iOS 16.2 or Android 12 OS installed.
BIOFIT APP: iOS 16.2 or Android 12 OS installed on your smartphone.
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All sales are final. There are no returns or exchanges. To the extent allowed by law, the Stelo Glucose Biosensor is provided to you without any warranty by Dexcom or BioFit. Dexcom and BioFit hereby disclaim all warranties(express, implied, and statutory) with respect to the sensor, including, but not limited to, the implied warranties of merchantability and fitness for a particular purpose. There are no warranties which can extend beyond the description herein.
Stelo is not intended for problematic hypoglycemia or anyone who has had a history of problematic hypoglycemia. Problematic hypoglycemia is generally defined as a condition where a person experiences two or more severe hypoglycemia episodes per year, or a single episode with certain complications associated with impaired awareness of hypoglycemia, extreme glycemic lability, or major fear and maladaptive behavior.