Stelo Glucose Biosensor & App - 2-Pack (Up to 15 Days Each). iOS & Android

Product Description The Stelo Glucose Biosensor includes an applicator with an all-in-one sensor/transmitter, overpatch, and Stelo app (available on both iOS and Android). The biosensor is a small and flexible wire, which is inserted by the applicator under the skin. Stelo 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. 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. Don’t use if you are on insulin. 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 healthcare provider. DON’T CHANGE MEDICATIONS: Consult your healthcare 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. *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. †Results obtained from previous Dexcom device(s) in patients with diabetes. 1 For Stelo app compatibility information, visit stelo.com/compatibility. 2 Product issues will need to be confirmed with our technical agent. 3 Validated replacements are not limited. 4 Dexcom, data on file, 2024. 5 Stelo User Guide. 6 The Stelo biosensor is waterproof and may be submerged under eight feet of water for up to 24 hours without failure when properly installed. 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. 7 Layne JE, et al. Diabetes Technol Ther. 2024;26(12):925-31. 8 Porter, et al. J Diabetes Sci Technol. 2022;16(2):578-580. 9 Ehrhardt, et al. Clin Diab. 2020;38(2):1-6. 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. Dexcom, Dexcom Clarity, Dexcom Follow, Dexcom One, Dexcom Share, Stelo, any related logos and design marks are either registered trademarks or trademarks of Dexcom, Inc. in the United States and/or other countries. ©2026 Dexcom, Inc. All rights reserved. LBL-1005853 Rev 008 LBL-1005854 Rev 008. Google Play is a trademark of Google LLC. App Store is a registered trademark of Apple Inc. For product support, please refer to the troubleshooting section of User Guide, which can be found in the Product guides and documents section of this page. Manufacturer Contact Information Dexcom, Inc. 6340 Sequence Dr., San Diego, CA 92121