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

Prior treatment

• Currently on a ketogenic or low-carbohydrate diet of less than 60 grams of carbohydrates per day, or intending to begin one during the study period
• Currently undergoing treatment with:
  • Systemic oral or intravenous corticosteroids (current or within the last 8 weeks from screening),
  • Thyroid hormones, unless use has been stable during the past 3 months
• Current participation in another clinical drug or device study

Other illness

• Episodes of severe hypoglycemia in the last 6 months resulting in:
  • Medical Assistance (i.e., paramedics, hospital evaluation or hospitalization)
  • Loss of consciousness
  • Seizures
• Known cardiovascular disease considered to be clinically relevant by the investigator
• Known history of any of the following conditions:
  • Cushing's Disease
  • Pancreatic islet cell tumor
  • Insulinoma
  • Lipodystrophy
  • Extensive lipohypertrophy, as assessed by the investigator
• Significant history of any of the following, that in the opinion of the investigator would compromise safety or successful study participation:
  • Alcoholism
  • Drug abuse
• Significant acute or chronic illness, that in the opinion of the investigator might interfere with safety or integrity of study results

Lab values

• Concurrent use of any non-insulin glucose-lowering agent, other than metformin (for example, GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas)

Other

• Female subject is pregnant, planning to become pregnant, or not using adequate method of contraception
• One or more episodes of diabetic ketoacidosis (DKA) in the last 6 months requiring hospitalization
• Immediate family member (spouse, biological or legal guardian, child, sibling, parent) who is a study site personnel directly affiliated with this study or who is an employee of Capillary Biomedical

• Inclusion Criteria:
  • 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
  • Minimum of 6 months of insulin pump experience and at least 3 months of current experience with a Tandem pump
  • Using Tandem t:slim X2 insulin pump with Control-IQ technology for a minimum of 1 month at the time of enrollment
  • 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
  • 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 12 consecutive 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
  • Access to internet for required periodic uploads of study device data
  • 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™\* (insulin lispro)
  • NovoLog™\* (insulin aspart)
  • Using Humalog™ insulin lispro or NovoLog™ insulin aspart for a minimum of 1 month at the time of enrollment
  • Willing to change insulin cartridge every 48-72 hours, as recommended by patient's healthcare provider during the study
  • Has routine access to a smart phone e.g., ability to receive text messages
  • 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)