Description
Why You Will Love It
Stelo tracks glucose 24/7 via a small sensor worn on the arm. It shows your personal glucose trends and patterns to help you understand how food, exercise, and sleep can affect your glucose, empowering you to become a healthier you.||,1-4
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.
Biosensor
- Up to 15-day lifespan‡
- Small biosensor
- Size W: 24.14 mm x L: 27.4 mm x H: 4.72 mm
- 30-minute warmup
- 12-hour grace period upon session end
- Waterproof 8 feet up to 24 hours‡,§
Wear location
- Back of upper arm1
Stelo app
- Alert-free
- Available on iOS and Android
- Share with your doctor
†For Stelo app compatibility information, visit stelo.com/compatibility. ‡A study was conducted to assess the sensor life where 77.9% of sensors lasted the full 15 days. In other words, when using the product per the package labeling, approximately 20% of sensors may not last for the full 15 days, 10% of these sensors may last less than 12 days. §If you are in or near water, your smartphone may need to be closer than 20 feet to get readings. If you are in water, you may not get readings until you get out. ||Results obtained from previous Dexcom device(s).
1 Stelo User Guide. 2 Ehrhardt, et al. Clin Diab, 2020;38(2):1-6. 3 Porter, et al. J Diabetes Sci Technol. 2022;16(2):578-580. 4 Polonsky, et al. Diabetes Technol Ther. 2024;26(Supp 2):A47.
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.
The Stelo Glucose Biosensor System includes an applicator with an all-in-one sensor/transmitter, overpatch, and Stelo app (available on both iOS and Android). The sensor is a small and flexible wire, which is inserted by the applicator under the skin. The sensor has an expected wear time of up to 15 days‡ with an extended 12-hour grace period. The transmitter is connected to the sensor and is worn on the body using the patch and overpatch. The transmitter estimates the glucose values and sends them to the Stelo app via Bluetooth. The Stelo app displays the current glucose values and the direction the glucose is heading. The information can help users make better decisions about food and activity relating to their glucose management.
CONTRAINDICATIONS: No MRI/CT/diathermy – MR unsafe.
WARNINGS: Choking hazard. Don’t use if you have problematic hypoglycemia. Don’t use if you are on dialysis. Don’t ignore low/high symptoms: When your sensor readings are not consistent with your symptoms, consult your health care provider. Consult your health care provider before making any medication adjustments based on your sensor readings.
WHERE TO STORE: You can store your sensors at room temperature or in your refrigerator, between 36 F and 86 F, but not in the freezer.
Return & Warranty Policy:
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. Dexcom hereby disclaims 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.
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