This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: t:slim X2 Insulin Pump with Basal-IQ Technology
PMA Applicant: Tandem Diabetes Care, Inc.
Address: 11045 Roselle Street Suite 200, San Diego, CA 92121
Approval Date: June 21, 2018
Approval Letter: https://www.accessdata.fda.gov/cdrh_docs/pdf18/P180008A.pdf
What is it? The t:slim X2 Insulin Pump with Basal-IQ Technology (the System) consists of a continuous glucose monitor (CGM) and an insulin pump with Basal-IQ technology. The System is intended to monitor glucose (sugar) levels and to deliver insulin for the management of diabetes. The Basal IQ technology feature of the insulin pump predicts whether glucose levels will fall below a predefined threshold to suspend insulin delivery. Diabetes is a disease in which your blood sugar or blood glucose levels can go too low or too high.
How does it work? The t:slim X2 Insulin Pump with Basal-IQ Technology works by measuring glucose levels and automatically adjusts insulin delivery by either administering or withholding insulin. The t:slim X2 Insulin Pump with Basal-IQ Technology is designed to communicate with a CGM to continuously display glucose readings, trend information, alerts, alarms, in addition to infusion pump data. The CGM measures sugar (glucose) levels and the insulin pump can be programmed to automatically suspend delivery of insulin when the sensor glucose level falls below a predefined glucose level. Every 5 minutes, the Basal-IQ technology feature of the insulin pump assesses the user's glucose information provided by the CGM and predicts whether glucose levels will fall too low in the next 30 minutes or if glucose levels are already too low. Under these conditions, the pump will suspend insulin delivery; otherwise insulin delivery to the user continues as normal. After insulin delivery is suspended, delivery resumes when the system detects the user's glucose levels begin to rise.
When is it used? The t:slim X2 Insulin Pump with Basal-IQ Technology (the System) is used for the continuous delivery of basal insulin (at user selectable rates) and administration of insulin boluses (in user selectable amounts) in persons six years of age and older with diabetes. The t:slim X2 Insulin Pump with Basal-IQ Technology can be used solely as an insulin pump, with the Dexcom G5 Mobile CGM, or with a compatible integrated continuous glucose monitoring (iCGM) system. When used with a compatible CGM the t:slim X2 Insulin Pump with Basal-IQ Technology displays continuous glucose measurements and automatically suspend delivery of insulin to the user based on the glucose levels. The System is intended for single patient use, requires a prescription, and is intended for use with NovoLog or Humalog U-100 insulin.
What will it accomplish? People with diabetes can use the glucose information from the CGM to help determine patterns in their glucose levels. The t:slim X2 Insulin Pump with Basal-IQ Technology can alert users when glucose levels are approaching potentially dangerously high (hyperglycemic) and/or dangerously low (hypoglycemic) levels. The t:slim X2 Insulin Pump with Basal-IQ Technology can also help people with diabetes make long-term adjustments to their treatment plan to keep blood glucose levels in a safe range.The Basal IQ feature of the insulin pump provides the user with additional diabetes management assistance by temporarily suspending insulin delivery when the glucose sensor detects or predicts a future low glucose level, and resumes insulin delivery when the glucose level begins to rise.
When should it not be used?
The t:slim X2 Insulin Pump with Basal-IQ Technology should not be used by:
- Patients whose vision and/or hearing does not allow the user to recognize System alerts.
- Patients unable or unwilling to:
- Test blood glucoselevels as recommended by their healthcare professional;
- Demonstrate adequate carbohydrate-counting skills (preferred, not required);
- Maintain sufficient diabetes self-care skills; or
- See their healthcare professional(s) regularly
Patients should not expose their sensor or transmitter to Magnetic Resonance Imaging (MRI) equipment, diathermy services or other devices that generate strong magnetic fields (for example, x-ray, CT scan, or other types of radiation). Exposure to a strong magnetic field has not been evaluated and can cause the device to malfunction, result in serious injury or be unsafe. If the sensor or transmitter are exposed to a strong magnetic field, use should be discontinued.
Taking medications with acetaminophen including but not limited to Tylenol, cold medicine, or paracetamol while wearing the Dexcom G5 Mobile Sensor may falsely raise sensor glucose readings. The level of inaccuracy depends on the amount of acetaminophen active in the body and may be different for each person.
Additional information (including warnings, precautions, and adverse events):