RecruitingNot ApplicableNCT07325461

Feasibility Study of Extended Wear Insulin Infusion Set Options During Home Use in People With Type 1 Diabetes

Sponsor

Tandem Diabetes Care, Inc.

Enrollment

20 participants

Start Date

Feb 18, 2026

Study Type

INTERVENTIONAL

Conditions

Diabetes Mellitus, Type 1

Summary

This feasibility study is a prospective, single center, multi-arm study evaluating possible enhancements to the SteadiSet extended wear infusion set.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria17

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

Exclusion Criteria22

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 history of any of the following conditions:
Cushing's Disease
Adrenal insufficiency
Pancreatic islet cell tumor
Insulinoma
Lipodystrophy
Extensive lipohypertrophy, as assessed by the investigator
Undergoing treatment with systemic oral or intravenous corticosteroids, at or within the last 8 weeks from screening. Inhaled glucocorticoids are allowed.
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 Tandem Diabetes Care

Interventions

DEVICESteadiSet Infusion Set

Participants will use the SteadiSet Infusion set with an enhanced filling process for three wear periods and the Steadiset Infusion Set only for three wear periods.