Feasibility Study of Extended Wear Insulin Infusion Set Options During Home Use in People With Type 1 Diabetes
This feasibility study is a prospective, single center, multi-arm study evaluating possible enhancements to the SteadiSet extended wear infusion set.
• Age 18 to 80 years old inclusive
• Generally in good health, as determined by the investigator
• Living in the United States with no plans to move outside the United States during the study
• Diagnosis of T1D for at least 12 months
• Currently using a Tandem pump
• Current Dexcom CGM user
• HbA1c \<9.0% in the last 6 months.
• Willing to implement and adhere to pump alert/alarm settings on a study-provided pump as instructed during the study
• Willing to wear each investigational infusion set for up to 7 days during each of the wear periods in the study
• Willing to perform blood ketone and blood glucose (fingerstick) measurements as directed using provided ketone and blood glucose meters and strips
• If using Tandem Mobi, has a compatible cellular phone that can run the Tandem Mobi Mobile App
• BMI in the range 18-35 kg/m2, both inclusive
• Currently using one of the following insulins with no expectation of a need to change insulin type during the study:
‣ Humalog™ (or generic insulin lispro)
⁃ NovoLog™ (or generic insulin aspart)
• Willing to change insulin cartridge every 48-72 hours, as recommended by patient's healthcare provider during the study
• Has the ability to understand and comply with protocol procedures and to provide informed consent