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

NCT07325461 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-03-05

No results posted yet for this study

Summary

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

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DEVICE

SteadiSet 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.

Sponsors & Collaborators

  • Tandem Diabetes Care, Inc.

    lead INDUSTRY

Principal Investigators

  • Jordan Pinsker, MD · Tandem Diabetes Care

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-02-18
Primary Completion
2027-03-01
Completion
2027-03-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07325461 on ClinicalTrials.gov