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Investigational Extended Wear Insulin Infusion Set in People With Type 1 Diabetes

NCT06273124 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2025-09-24

Study results available
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Summary

The purpose of this study is to collect clinical data to support a 7-day wear of the Extended Wear Infusion Set (EWIS).

Participants will be asked to:

1. Wear the EWIS for up to 7 consecutive days for 12 consecutive wear periods
2. Perform blood glucose and ketone measurements if continuous glucose meter is ≥250mg/dL for one hour

Conditions

  • Type1diabetes

Interventions

DEVICE

SteadiSet Extended Wear Infusion Set

Each participant will be given 12 Extended Wear Infusion Sets to wear over 12 wear periods up to 168 hours each.

Sponsors & Collaborators

  • Jaeb Center for Health Research

    collaborator OTHER

  • Tandem Diabetes Care, Inc.

    lead INDUSTRY

Principal Investigators

  • Alayne Lehman, RN, MS · Capillary Biomedical

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-07
Primary Completion
2024-12-11
Completion
2024-12-11
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 NCT06273124 on ClinicalTrials.gov