NCT07325461 Feasibility Study of Extended Wear Insulin Infusion Set Options During Home Use in People With Type 1 Diabetes
| NCT ID | NCT07325461 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tandem Diabetes Care, Inc. |
| Condition | Diabetes Mellitus, Type 1 |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-02-18 |
| Primary Completion | 2027-03-01 |
Trial Parameters
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Brief Summary
This feasibility study is a prospective, single center, multi-arm study evaluating possible enhancements to the SteadiSet extended wear infusion set.
Eligibility Criteria
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 * 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: 1. Huma
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