Investigational Extended Wear Insulin Infusion Set in People With Type 1 Diabetes

Inclusion Criteria

• •1. Age 18 to 80 years old inclusive
• •2. Generally in good health, as determined by the investigator
• •3. Living in the United States with no plans to move outside the United States during the study
• •4. Diagnosis of T1D for at least 12 months
• •5. Minimum of 6 months of insulin pump experience and at least 3 months of current experience with a Tandem pump
• •6. Using Tandem t:slim X2 insulin pump with Control-IQ technology for a minimum of 1 month at the time of enrollment
• •7. Minimum of 14 days of Control-IQ data immediately preceding screening that demonstrate pump use compliance, including at least 85% of time with Control-IQ technology active
• •8. HbA1c \<9.0% in the last 6 months.
• •9. Willing to implement and adhere to pump alert/alarm settings on a study-provided pump as instructed during the study
• •10. Willing to wear each investigational infusion set for up to 7 days during each of the 12 consecutive wear periods in the study
• •11. Willing to perform blood ketone and blood glucose (fingerstick) measurements as directed using provided ketone and blood glucose meters and strips
• •12. Access to internet for required periodic uploads of study device data
• •13. BMI in the range 18-35 kg/m2, both inclusive
• •14. Currently using one of the following insulins with no expectation of a need to change insulin type during the study:
• •1. Humalog™\* (insulin lispro)
• •2. NovoLog™\* (insulin aspart)
• •15. Using Humalog™ insulin lispro or NovoLog™ insulin aspart for a minimum of 1 month at the time of enrollment
• •16. Willing to change insulin cartridge every 48-72 hours, as recommended by patient's healthcare provider during the study
• •17. Has routine access to a smart phone e.g., ability to receive text messages
• •18. Has the ability to understand and comply with protocol procedures and to provide informed consent (i.e., English proficient in both verbal and written communication)