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SteadiSet™ Pilot Study (SteP Study)

NCT04591925 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2022-02-11

No results posted yet for this study

Summary

This study will evaluate the safety and effectiveness of how well blood glucose is managed when a participate wears the investigational SteadiSet™ Infusion Set (SteadiSet device) for up to 14 days post-insertion when compared to a Teflon Control infusion set.

Conditions

  • Diabetes Mellitus, Type I
  • IDDM
  • Diabetes Mellitus, Insulin-Dependent, 1
  • Type 1 Diabetes
  • Type 1 Diabetes Mellitus

Interventions

DEVICE

Control Device insulin infusion devcie

Control Device - Commercially available insulin infusion device using a soft Teflon indwelling cannula

DEVICE

Investigative insulin infusion devcie

Investigative insulin infusion device with coil-reinforced soft polymer indwelling cannula

Sponsors & Collaborators

  • Capillary Biomedical, Inc.

    lead INDUSTRY

Principal Investigators

  • Julia Mader, Professor · Medical University of Graz

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2021-02-05
Primary Completion
2021-11-02
Completion
2021-11-02
FDA Device
Yes

Countries

  • Austria

Study Locations

More Related Trials

Entities

Diseases

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 NCT04591925 on ClinicalTrials.gov