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

Running, not enrolling · Not applicable

Conditions studied: Diabetes Mellitus, Type 1

In brief

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

Key facts

Study ID

NCT07325461

Run by

Tandem Diabetes Care, Inc.

People needed

20

Starts

2026-02-18

Expected to finish

2027-03-01

Last updated by the study team

2026-06-01

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Stanford University — Stanford, California, United States

Full record on ClinicalTrials.gov

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