Clinical Trials

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. If not available must be performed for study qualification.
• 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 up to 7 days during the study.
• Willing to perform serum 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/m^2, 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 insulin lispro or aspart for a minimum of 3 months 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 and upload photographs.
• Has the ability to understand and comply with protocol procedures and to provide informed consent.

Exclusion Criteria:

• 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).
• Female subject is pregnant, planning to become pregnant, or not using adequate method of contraception.
• Episodes of severe hypoglycemia in the last 6 months resulting in:
  • Medical Assistance (i.e., paramedics, hospital evaluation or hospitalization);
  • Loss of consciousness;
  • Seizures.
• One or more episodes of diabetic ketoacidosis (DKA) in the last 6 months requiring hospitalization.
• 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.
• 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.
• 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.
• 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.
• Current participation in another clinical drug or device study.
• 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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 7/21/23. Questions regarding updates should be directed to the study team contact.