Indications for Use

The t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM (“t:slim X2 System”) consists of the t:slim X2 Insulin Pump paired with the Dexcom G5 Mobile Sensor and Transmitter.

The t:slim X2 Insulin Pump is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The t:slim X2 Insulin Pump can be used solely for continuous insulin delivery and as part of the t:slim X2 System to receive and display continuous glucose measurements from the Dexcom G5 Mobile Sensor and Transmitter.

The t:slim X2 System also includes continuous glucose monitoring (CGM) indicated for the management of diabetes. The Dexcom G5 Mobile CGM is designed to replace fingerstick blood glucose testing for diabetes treatment decisions. The t:slim X2 System aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments, which may minimize these excursions. Interpretation of the t:slim X2 System results should be based on the trends and patterns seen with several sequential readings over time.

The t:slim X2 System is indicated for use in individuals 6 years of age and greater. The t:slim X2 System is intended for single patient use and requires a prescription. The device is indicated for use with NovoLog or Humalog U-100 insulin.

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Contraindications

The t:slim X2 System is not intended for anyone unable or unwilling to:

• Test blood glucose (BG) levels as recommended by your healthcare provider
• Demonstrate adequate carbohydrate-counting skills (preferred, not required)
• Maintain sufficient diabetes self-care skills
• See your healthcare provider(s) regularly

You must also have adequate vision and/or hearing in order to recognize your System alerts.

The t:slim X2 Pump, Dexcom G5 Mobile Transmitter, and Dexcom G5 Mobile Sensor must be removed before Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or diathermy treatment. Exposure to MRI, CT, or diathermy treatment can damage the System.

Taking medications with acetaminophen (such as Tylenol) while wearing the sensor may falsely raise your sensor glucose readings. The level of inaccuracy depends on the amount of acetaminophen active in your body and may be different for each person.

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System Warnings

/!\WARNINGS – t:slim X2 Insulin Pump

DO NOT start to use your t:slim X2 System before reading the User Guide. Failure to follow the instructions in the User Guide can result in over delivery or under delivery of insulin. This can cause very low or very high blood glucose which could -) result in serious injury or death. If you have questions or need further clarification on your System use, ask your healthcare provider or call our around-the-clock Customer Technical Support Department at (877) 801-6901.

DO NOT start to use your t:slim X2 System before you have been appropriately trained on its use by a certified t:slim X2 System trainer. Consult with your healthcare provider for your individual training needs for the entire t:slim X2 System. Failure to complete the necessary training on the System could result in serious injury or death. 

DO NOT use any other insulin with your System other than U-100 Humalog® or NovoLog®. Only Humalog® and NovoLog® have been tested and found to be compatible for use in the System. Use of insulin with lesser or greater concentration can result in under delivery or over delivery of insulin. This can cause very high or a very low blood glucose.

DO NOT put any other drugs or medications inside your System cartridge. The System is designed only for Continuous Subcutaneous Insulin Infusion (CSII) using Humalog® or NovoLog® insulin. Use of other drugs or medications can damage the pump and result in injury if infused.

DO NOT start to use your System before consulting with your healthcare provider to determine which features are most appropriate for you. Only your healthcare provider can determine and help you adjust your Basal Rate(s), Carb Ratio(s), Correction Factor(s), Target BG, and duration of insulin action. In addition, only your healthcare provider can determine your CGM settings and how you should use your sensor trend information to help you manage your diabetes. Incorrect settings can result in over delivery or under delivery of insulin. This can cause very low or very high blood glucose.

DO be prepared to inject insulin with an alternative method if delivery is interrupted for any reason. Your t:slim X2 System is designed to deliver insulin reliably, but because it uses only rapid-acting insulin, you will not have long-acting insulin in your body. Failure to have an alternative method of insulin delivery can lead to very high blood glucose or Diabetic Ketoacidosis (DKA).

DO use only FDA cleared insulin infusion sets with a tubing connector and follow their instructions for use. Failure to do so may result in over delivery or under delivery of insulin and may cause very low or very high blood glucose.

DO NOT place your infusion set on any scars, lumps, moles, stretch marks or tattoos. Placing your infusion set in these areas can cause swelling, irritation or infection. This can affect insulin absorption and cause high or low blood glucose.

DO NOT ignore infusion set cannula fractures. Infusion set cannulas may fracture on rare occasions. If an infusion set cannula breaks and no portion of it is visible above the skin, do not attempt to remove it. Seek professional medical help if you have symptoms of infection or inflammation—redness, swelling or pain—at the insertion site. If you experience a broken infusion set cannula, please report this to Tandem Customer Technical Support at (877) 801-6901.

NEVER fill your tubing while your infusion set is connected to your body. Always ensure that the infusion set is disconnected from your body before filling the tubing. Failure to disconnect your infusion set from your body before filling the tubing can result in over delivery of insulin. This can cause serious injury or death from very low blood glucose.

DO NOT reuse cartridges or use cartridges other than those manufactured by Tandem Diabetes Care, Inc. Use of cartridges not manufactured by Tandem Diabetes Care, Inc. or reuse of cartridges may result in over delivery or under delivery of insulin. This can cause very low or very high blood glucose.

ALWAYS twist the tubing connector between the cartridge tubing and the infusion set tubing an extra quarter of a turn to ensure a secure connection. A loose connection can cause insulin to leak, resulting in under delivery of insulin. This can cause high blood glucose.

DO NOT disconnect the tubing connector between the cartridge tubing and the infusion set tubing. If the connection comes loose, disconnect the infusion set from your body before tightening. Failure to disconnect before tightening can result in over delivery of insulin. This can cause low blood glucose.

DO NOT remove or add insulin from a filled cartridge after loading onto the pump. This will result in an inaccurate display of the insulin level on the Home Screen and you could run out of insulin before the pump detects an empty cartridge. This can cause very high blood glucose, or Diabetic Ketoacidosis (DKA).

DO NOT deliver a bolus until you have reviewed the calculated bolus amount on the pump display. If you dose an insulin amount that is too high or too low, this could cause very high or very low blood glucose. You can always adjust the insulin units up or down before you decide to deliver your bolus.

DO NOT allow small children (either pump users or non-users) to ingest small parts, such as the rubber USB port cover and cartridge components. Small parts could pose a choking hazard. If ingested or swallowed, these small component pieces may cause internal injury or infection.

The System includes parts (such as the USB cable and infusion set tubing) that could pose a strangulation or asphyxiation hazard. Always use the appropriate length of infusion set tubing and arrange cables and tubing to minimize the risk of strangulation. ENSURE that these parts are stored in a secure place when not in use.

For patients who do not self-manage their disease, the Feature Lock function should ALWAYS be ON when the pump is not being used by a caregiver. The Feature Lock function is intended to prevent inadvertent button presses that may lead to insulin delivery or changes in the pump settings. These changes can potentially lead to hypoglycemic or hyperglycemic events. For patients whose insulin administration is managed by a caregiver, ALWAYS turn off the Quick Bolus feature to avoid inadvertent bolus delivery.

If the Feature Lock is turned on, the Quick Bolus feature is automatically disabled. Inadvertent button presses or tampering with the insulin pump could result in over delivery or under delivery of insulin. This can cause very low or very high blood glucose which could result in serious injury or death.

 
/!\WARNING – Radiology and Medical Procedures and your t:slim X2 System

ALWAYS notify the provider/technician about your diabetes and your t:slim X2 System. If you need to discontinue use of the System for medical procedures, follow your healthcare provider’s instructions to replace missed insulin when you reconnect to the pump. Check your blood glucose before disconnecting from the pump and again when you reconnect and treat high blood glucose levels as recommended by your healthcare provider.

DO NOT expose your pump, transmitter, or sensor to:

• X-ray
• Computed Tomography (CT) scan
• Magnetic Resonance Imaging (MRI)
• Positron Emission Tomography (PET) scan
• Other exposure to radiation

The t:slim X2 System is magnetic resonance (MR) Unsafe. You must take off your pump, transmitter, and sensor and leave them outside the procedure room if you are going to have any of the above procedures.

In addition to the above, DO NOT expose your pump, transmitter, or sensor to:

• Pacemaker/Automatic Implantable Cardioverter Defibrillator (AICD) placement or reprogramming
• Cardiac Catheterization
• Nuclear Stress Test

You must take off your pump, transmitter, and sensor and leave them outside the procedure room if you are going to have any of the above medical procedures.

There are other procedures where you should proceed with caution:

• Laser Surgery – Your System can usually be worn during the procedure. However, some lasers can create interference and cause the System to alarm.
• General Anesthesia – Depending on the equipment being used, you may or may not need to remove your System. Be sure to ask your healthcare provider.

There is no need to disconnect for electrocardiograms (EKGs) or colonoscopies. If you have questions, contact Tandem Diabetes Care Customer Technical Support at (877) 801-6901.

 
/!\WARNINGS – Using Dexcom G5 Mobile CGM with your t:slim X2 Insulin Pump

DO NOT ignore symptoms of high and low glucose. If your sensor glucose alerts and readings do not match your symptoms, measure your blood glucose with a blood glucose meter even if your sensor is not reading in the high or low range.

CALIBRATE your CGM at least once every 12 hours. Calibrating less often than every 12 hours might cause sensor glucose readings to be inaccurate and glucose alerts to become unreliable. This could result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.

DO NOT ignore sensor fractures. Sensors may fracture on rare occasions. If a sensor breaks and no portion of it is visible above the skin, do not attempt to remove it. Seek professional medical help if you have symptoms of infection or inflammation—redness, swelling or pain—at the insertion site. If you experience a broken sensor, please report this to Tandem Diabetes Care Customer Technical Support at (877) 801-6901.

DO NOT use Dexcom G5 Mobile CGM in pregnant women or persons on dialysis. The System is not approved for use in pregnant women or persons on dialysis and has not been evaluated in these populations. Sensor glucose readings may be inaccurate in these populations and could result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.

DO NOT use Dexcom G5 Mobile CGM in critically ill patients. It is not known how different conditions or medications common to the critically ill population may affect the performance of the System. Sensor glucose readings may be inaccurate in critically ill patients, and solely relying on the sensor glucose alerts and readings for treatment decisions could result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.

DO NOT insert the sensor in sites other than the abdomen (belly) or upper buttocks (for ages 6–17 only). Other sites have not been studied and are not approved. Use in other sites might cause sensor glucose readings to be inaccurate and could result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.

DO NOT expect CGM alerts until after the 2-hour startup. You will NOT get any sensor glucose readings or alerts until after the 2-hour startup ends AND you complete the startup calibration. During this time you might miss severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.

DO NOT use your transmitter if it is damaged/cracked. This could create an electrical safety hazard or malfunction, which might cause electrical shocks.

STORE the Dexcom G5 Mobile CGM sensor at temperatures between 36°F to 77°F for the length of the sensor’s shelf life. You may store the sensor in the refrigerator if it is within this temperature range. The sensor should not be stored in a freezer. Storing the sensor improperly might cause the sensor glucose readings to be inaccurate, and you might miss severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.

DO NOT allow young children to hold the sensor, transmitter or transmitter kit box without adult supervision. The sensor and transmitter include small parts that may pose a choking hazard. Keep the transmitter kit box away from young children; it contains a magnet that should not be swallowed.

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System Precautions

/!\PRECAUTIONS – t:slim X2 Insulin Pump

DO NOT open or attempt to repair your System. The System is a sealed device that should be opened and repaired only by Tandem Diabetes Care, Inc. Modification could result in a safety hazard. If your System seal is broken, the System is no longer watertight and the warranty is voided.

CHANGE your infusion set every 48 to 72 hours as recommended by your healthcare provider. Wash your hands with anti-bacterial soap before handling the infusion set and thoroughly clean the insertion site on your body to avoid infection. Contact your healthcare provider if you have symptoms of infection at your insulin infusion site.

ALWAYS remove all air bubbles from the System before beginning insulin delivery. Ensure there are no air bubbles when drawing insulin into the filling syringe, hold the pump with the white fill port pointed up when filling the tubing, and ensure that there are no air bubbles in the tubing when filling. Air in the system takes space where insulin should be and can affect insulin delivery.

CHECK your infusion site daily for proper placement and leaks. REPLACE your infusion set if you notice leaks around the site. Improperly placed sites or leaks around the infusion site can result in under delivery of insulin.

CHECK your infusion set tubing daily for any leaks, air bubbles, or kinks. Air in the tubing, leaks in the tubing, or kinked tubing may restrict or stop insulin delivery and result in under delivery of insulin.

CHECK the tubing connection between your cartridge tubing and infusion set tubing daily to ensure it is tight and secure. Leaks around the tubing connection can result in under delivery of insulin.

DO NOT change your infusion set before bedtime or if you will not be able to test your blood glucose 1–2 hours after the new infusion set is placed. It is important to confirm that the infusion set is inserted correctly and delivering insulin. It is also important to respond quickly to any problems with the insertion to ensure continued insulin delivery.

ALWAYS check that your cartridge has enough insulin to last through the night before going to bed. If you are sleeping, you could fail to hear the Empty Cartridge Alarm and miss part of your basal insulin delivery.

CHECK your System’s personal settings regularly to ensure they are correct. Incorrect settings can result in over delivery or under delivery of insulin. Consult with your healthcare provider as needed.

ALWAYS make sure that the correct time and date are set on your System. When editing time, always check that the AM/PM setting is accurate. AM is to be used from midnight until 11:59 AM. PM is to be used from noon until 11:59 PM. Not having the correct time and date setting may affect safe insulin delivery.

CONFIRM that the screen display turns on, you can hear audible beeps, feel the pump vibrate, and see the green LED light blinking around the edge of the Screen On Button when you connect a power source to the USB port. These features are used to notify you about alerts, alarms, and other conditions that require your attention. If these features are not working, discontinue use of the System and contact Tandem Diabetes Care Customer Technical Support at (877) 801-6901.

CHECK your System regularly for potential alarm conditions that may display. It is important to be aware of conditions that may affect insulin delivery and require your attention so you can respond as soon as possible.

DO NOT use the vibrate feature for alerts and alarms during sleep unless otherwise directed by your healthcare provider. Having the volume for alerts and alarms set to high will help ensure that you don’t miss an alert or alarm.

ALWAYS look at the screen to confirm correct programming of the bolus amount when you first use the Quick Bolus feature. Looking at the screen will ensure that you are correctly using the beep/vibration commands to program the intended bolus amount.

DO NOT use your pump if you think it might be damaged due to dropping it or hitting it against a hard surface. Check that the System is working properly by plugging a power source into the USB port and confirming that the display turns on, you hear audible beeps, feel the pump vibrate, and see the green LED light blinking around the edge of the Screen On Button. If you are unsure about potential damage, discontinue use of the System and contact Tandem Diabetes Care Customer Technical Support at (877) 801-6901.

AVOID exposure of your System to temperatures below 40°F (5°C) or above 99°F (37°C). Insulin can freeze at low temperatures or degrade at high temperatures. Insulin that has been exposed to conditions outside of the manufacturer’s recommended ranges can affect the safety and performance of the System.

AVOID submersing your pump in fluid beyond a depth of 3 feet or for more than 30 minutes (IPX7 rating). If your pump has been exposed to fluid beyond these limits, check for any signs of fluid ingress. If there are signs of fluid entry, discontinue use of the pump and contact Tandem Diabetes Care Customer Technical Support at (877) 801-6901.

AVOID areas where there may be flammable anesthetics or explosive gases. The System is not suitable for use in these areas and there is a risk of explosion. Remove your pump if you need to enter these areas.

MAKE SURE to not move further than the length of the USB cable when you are connected to the pump and to a charging source. Moving further than the length of the USB cable may cause the cannula to be pulled out of the infusion site. For this reason it is recommended not to charge the pump while sleeping.

DISCONNECT your infusion set from your body while on high-speed/high gravity amusement park thrill rides. Rapid changes in altitude or gravity can affect insulin delivery and cause injury.

DISCONNECT your infusion set from your body before flying in an aircraft without cabin pressurization or in planes used for aerobatics or combat simulation (pressurized or not). Rapid changes in altitude or gravity can affect insulin delivery and cause injury.

CONSULT your healthcare provider about lifestyle changes such as weight gain or loss, and starting or stopping exercise. Your insulin needs may change in response to lifestyle changes. Your basal rate(s) and other settings may need adjustment.

CHECK your blood glucose using a blood glucose meter following a gradual elevation change of up to 1,000 feet, such as when snow skiing or driving on a mountain road. Delivery accuracy can vary up to 15% until 3 units of total insulin have been delivered or elevation has changed by more than 1,000 feet. Changes in delivery accuracy can affect insulin delivery and cause injury.

ALWAYS check with your healthcare provider for specific guidelines if you want or need to disconnect from the pump for any reason. Depending on the length of time and reason you are disconnecting, you may need to replace missed basal and/or bolus insulin. Check your blood glucose before disconnecting from the pump and again when you reconnect, and treat high blood glucose (BG) levels as recommended by your healthcare provider.

ENSURE that your personal insulin delivery settings are programmed into the pump before you use the System if you receive a warranty replacement. Failure to enter your insulin delivery settings could result in over delivery or under delivery of insulin. This can cause very low or very high blood glucose which could result in serious injury or death. Consult your healthcare provider as needed.

Interference with your System’s electronics by cell phones can occur if worn in close proximity. It is recommended that your pump and cell phone be worn at least 6.4 inches apart.

ALWAYS dispose of used System components such as cartridges, syringes, needles, infusion sets, and CGM sensors following the instructions from your healthcare provider. Wash your hands thoroughly after handling used System components.

 
/!\PRECAUTIONS – Using Dexcom G5 Mobile CGM with your t:slim X2 Insulin Pump

DO NOT open the sensor package until you have washed your hands with soap and water, and let them dry. You may contaminate the insertion site and suffer an infection if you have dirty hands while inserting the sensor.

DO NOT insert the sensor until you have cleaned the skin with a topical antimicrobial solution, such as isopropyl alcohol, and allowed the skin to dry. Inserting into unclean skin might lead to infection. Do not insert the sensor until the cleaned area is dry so the sensor adhesive will stick better.

AVOID using the same spot repeatedly for sensor insertion. Rotate your sensor placement sites, and do not use the same site for two sensor sessions in a row. Using the same site might cause scarring or skin irritation.

AVOID inserting the sensor in areas that are likely to be bumped, pushed or compressed, or areas of skin with scarring, tattoos, or irritation as these are not ideal sites to measure glucose. Insertion in those areas might affect accuracy and could result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.

AVOID injecting insulin or placing an infusion set within 3 inches of the sensor. The insulin might affect sensor accuracy and could result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.

DO NOT use the sensor if its sterile package has been damaged or opened. Using an unsterile sensor might cause infection. To calibrate the CGM System, DO enter the exact blood glucose value that your blood glucose meter displays within 5 minutes of a carefully performed blood glucose measurement. Do not enter sensor glucose readings for calibration. Entering incorrect blood glucose values, blood glucose values obtained more than 5 minutes before entry, or sensor glucose readings might affect sensor accuracy and could result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.

DO NOT calibrate if your blood glucose is changing at a significant rate, typically more than 2 mg/dL per minute. Do not calibrate when your receiver screen is showing the rising or falling single arrow or double arrow, which indicates that your blood glucose is rapidly rising or falling. Calibrating during significant rise or fall of blood glucose may affect sensor accuracy and could result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events. The System accuracy may be affected when your glucose is changing at a significant rate (e.g. 2 to 3 mg/dL/min or more than 3 mg/dL each minute), such as during exercise or after a meal.

AVOID separating the transmitter and pump by more than 20 feet. The transmission range from the transmitter to the pump is up to 20 feet without obstruction. Wireless communication does not work well through water so the range is much less if you are in a pool, bathtub, or on a water bed, etc. Types of obstruction differ and have not been tested. If your transmitter and pump are farther than 20 feet apart or are separated by an obstruction, they might not communicate or the communication distance may be shorter and result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.

DO NOT use alternative blood glucose site testing (blood from your palm or forearm, etc.) for calibration. Alternative site blood glucose values may be different than those taken from a fingerstick blood glucose value and may not represent the timeliest blood glucose value. Use a blood glucose value taken only from a fingerstick for calibration. Alternative site blood glucose values might affect sensor accuracy and result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.

ENSURE that your transmitter ID is programmed into the pump before you use the System if you receive a warranty replacement pump. The pump cannot communicate with the transmitter unless the transmitter ID is entered. If the pump and transmitter are not communicating, you will not receive sensor glucose readings and you might miss severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.

DO NOT discard your transmitter. It is reusable. The same transmitter is used for each session until you have reached the end of the transmitter battery life.

The Dexcom G5 Mobile Sensor, Transmitter, and Receiver are not compatible with the SEVEN/SEVEN PLUS Transmitter and Receiver. Different generations will not connect with each other and will not work.

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Potential Benefits From Using the System

• The t:slim X2 System provides an automated way to deliver basal and bolus insulin. Delivery can be fine-tuned based on up to 6 customizable Personal Profiles, each with up to 16 time-based settings for Basal Rate, Carb Ratio, Correction Factor, and Target BG. In addition, the Temp Rate feature allows you to program a temporary basal rate change for up to 72 hours.
• The t:slim X2 System gives you the option of delivering a bolus all at once, or delivering a percentage over an extended period of time without navigating to different menus. You can also program a bolus more discreetly using the Quick Bolus feature, which can be used without looking at the pump, and can be programmed in increments of either units of insulin or grams of carbohydrate.
• From the bolus screen, the “calculator within a calculator” feature allows you to enter multiple carbohydrate values and add them together. The System’s bolus calculator will recommend a bolus based on the entire amount of carbohydrates entered, which can help eliminate guesswork.
• The System keeps track of the amount of active insulin from food and correction boluses (IOB). When programming additional food or correction boluses, the pump will subtract the amount of IOB from the recommended bolus if your BG is below the target set in your active Personal Profile. This can help prevent insulin stacking, which can lead to hypoglycemia.
• You can program a number of reminders that will prompt you to retest your BG after a low or high BG is entered, as well as a “Missed Meal Bolus Reminder” which will alert you if a bolus isn’t entered during a specified period of time. If activated, these can help reduce the likelihood that you will forget to check your blood glucose or bolus for meals.
• You have the ability to view a variety of data right on your screen, including the time and amount of your last bolus, your total insulin delivery by day, as well as broken into basal, food bolus, and correction bolus.
• When paired with Dexcom G5 Mobile Transmitter and Sensor, your t:slim X2 System can receive CGM readings every 5 minutes, which are displayed as a trend graph on the Home Screen. You can also program your pump to alert you when your CGM readings are above or below a given level, or are rising or falling quickly. Unlike the readings from a standard blood glucose meter, CGM readings allow you to view trends in real time, as well as capture information when you would otherwise be unable to check your blood sugar, such as while you are asleep. This information can be useful for you and your health care provider when considering changes to your therapy. In addition, the programmable alerts can help you to spot potential low or high blood glucose sooner than you would using a only a blood glucose meter.
• CGM use has been shown to increase time in your target glucose range, without increasing time spent above or below your target range. Real-time CGM can help improve diabetes control (lower A1c values, reducing glycemic variability and time spent in low and high blood glucose ranges)^1,2,3 which can help reduce diabetes related complications.^4,5 These benefits can be seen especially with using real-time CGM at least 6 days per week² and can be sustained over time.⁶ In some cases, patients perceived an increase in their quality of life and peace of mind when using real-time CGM as well as reporting a high satisfaction with CGM.⁷

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Possible Risks from Using the System

As with any medical device, there are risks associated with using the t:slim X2 System. Many of the risks are common to insulin therapy in general, but there are additional risks associated with continuous insulin infusion and continuous glucose monitoring. Reading your User Guide and following the Instructions for Use are critical for the safe operation of your system. Consult your health care provider about how these risks may impact you.

 
Risks associated with using the pump functionality of the System

Inserting and wearing an infusion set might cause infection, bleeding, pain or skin irritations (redness, swelling, bruising, itching, scarring or skin discoloration).

There is a remote chance that an infusion set cannula fragment could remain under your skin if the cannula breaks while you are wearing it. If you think a cannula has broken under your skin, contact your healthcare provider and call Tandem Diabetes Care Customer Technical Support at (877) 801-6901.

Other risks associated with infusion sets include occlusions and air bubbles in the tubing, which can affect insulin delivery.

Risks that could result from pump failure include the following:

• possible hypoglycemia (low blood glucose) from over-delivery of insulin due to a hardware defect
• hyperglycemia (high blood glucose) and ketosis possibly leading to Diabetic Ketoacidosis (DKA) due to pump failure resulting in cessation of insulin delivery due to either a hardware defect or software anomaly

 
Risks associated with using the CGM functionality of the System

Inserting the sensor and wearing the adhesive patch might cause infection, bleeding, pain and skin irritations (readiness, swelling, bruising, itching, scarring, or skin discoloration).

There is a remote chance that a sensor fragment could remain under your skin if the sensor breaks while you are wearing it. If you think a sensor has broken under your skin, contact your healthcare provider and call Tandem Diabetes Care Customer Technical Support at (877) 801-6901.

Other risks associated with CGM use include the following:

• You will not get sensor glucose alerts when the alert function is turned off, your transmitter and pump are out of range, or when your pump is not showing sensor glucose readings. You might not notice alerts if you are unable to hear them or feel the vibration.
• There are a number of risks as a result of the fact that the Dexcom G5 Mobile CGM takes readings from fluid below the skin (interstitial fluid) instead of blood. There are differences in how glucose is measured in the blood compared to how it is measured in interstitial fluid, and glucose is absorbed into the interstitial fluid slower than it is absorbed into the blood, which can cause CGM readings to lag behind readings from a blood glucose meter.

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Working with your Healthcare Provider

Any clinical language presented in this User Guide is based on the assumption that you have been educated by your healthcare provider on certain terms and how they apply to you in your diabetes management. Your healthcare provider can help you establish diabetes management guidelines that best fit your lifestyle and needs.

Monitor your blood glucose (BG) with the guidance of your healthcare provider. According to the American Association of Diabetes Educators’ white paper Insulin Pump Therapy: Guidelines for Successful Outcomes, patients should routinely check their BG levels at least 4 times daily (optimally 6 to 8 times daily) in order to detect hyperglycemia (high blood glucose) and hypoglycemia (low blood glucose) early. Undetected hyperglycemia or hypoglycemia can result without proper monitoring.

Consult your healthcare provider before using the System to determine which features are most appropriate for you. Only your healthcare provider can determine and help you adjust your basal rate(s), insulin-to-carbohydrate ratio(s), correction factor(s), blood glucose (BG) target, and duration of insulin action. In addition, only your healthcare provider can determine your CGM settings and how you should use your sensor trend information to help you manage your diabetes.

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Emergency Kit

Make sure that you always have an insulin syringe and vial of insulin with you as a backup for emergency situations. You should also always have an appropriate emergency kit with you. Talk with your healthcare provider regarding what items this kit should include.

Supplies to carry every day:

• Blood glucose testing supplies: meter, strips, control solution, lancets, meter batteries
• Fast-acting carbohydrate to treat low blood glucose
• Extra snack for longer coverage than fast-acting carbohydrate
• Glucagon emergency kit
• Rapid-acting insulin and syringes
• Infusion sets (minimum of 2)
• Insulin pump cartridges (minimum of 2)
• Infusion site preparation products (antiseptic wipes, skin adhesive)
• Diabetes identification card or jewelry

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Verification of Proper Functionality

A power supply (AC adapter with micro-USB connector) is provided as part of the System. Before using your System, ensure that the following occur when you connect a power supply into the USB port of your t:slim X2 Pump:

• You hear an audible alert
• Your see the green light illuminate from the edge around the Screen On/Quick Bolus Button
• You feel a vibratory alert
• You see a charge symbol (lightning bolt) on the battery level indicator

In addition, before using the System, ensure the following:

• Press the Screen On/Quick Bolus Button to turn the screen on so that you can see the display
• When the display screen is on, the touch screen responds to your finger tap

 
/!\PRECAUTION

CONFIRM that the screen display turns on, you can hear audible beeps, feel the pump vibrate, and see the green LED light blinking around the edge of the Screen On Button when you connect a power source to the USB port. These features are used to notify you about alerts, alarms, and other conditions that require your attention. If these features are not working, discontinue use of the System and contact Tandem Diabetes Care Customer Technical Support at (877) 801-6901.

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Wireless Co-existence and Data Security

The t:slim X2 System is designed to work safely and effectively in the presence of wireless devices typically found at home, work, retail stores, and places of leisure where daily activities occur. See Section 30.11 for more information. The t:slim X2 System is designed to accept BluetoothTM Low Energy (BLE) communication only from a linked Dexcom G5 Mobile Transmitter. BLE communication is not established until you enter the unique Dexcom Transmitter ID into your pump. The t:slim X2 System and system components ensure data security via proprietary means and ensure data integrity using error checking processes, such as cyclic redundancy checks.

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