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"FEXIS": (Feasibility of an Extended Wear CSII Set in Participants With T1DM)

NCT04503564 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-03-07

Study results available
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Summary

Over 1 million patients globally currently manage their Type 1 Diabetes mellitus using continuous subcutaneous insulin infusion with an infusion set that needs to be changed every 3 days. This study will assess the feasibility and device performance of the study device, the Achilles infusion set over three periods during routine insulin infusion.

This study will include 20 participants and has 3 periods:

Period 1 (up to 7 days): Trial run with study device with saline infusion. Period 2 (up to 7 days): participants will manage their blood glucose solely with their insulin pump and the Achilles infusion set. Blood glucose will be closely monitored with a continuous glucose monitoring (CGM) device.

Period 3 (up to 7 days): Participants will return to study center to receive a fresh Achilles infusion set and continue blood glucose management at home until infusion set failure or 7 days.

Conditions

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

Interventions

DEVICE

coil-reinforced soft polymer indwelling cannula

This is a prospective, non-randomized, home-use feasibility study of device performance, usability, tolerability, and safety of the Capillary Biomedical, Inc. (CapBio) Achilles infusion set for continuous subcutaneous insulin infusion (CSII or insulin pump therapy) in up to 20 participants diagnosed with type 1 diabetes mellitus (T1DM).

Sponsors & Collaborators

  • Capillary Biomedical, Inc.

    lead INDUSTRY

Principal Investigators

  • David O'Neal, M.D. · St Vincent's Hospital Department of Medicine

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2019-11-13
Primary Completion
2020-11-11
Completion
2020-11-11
FDA Device
Yes

Countries

  • Australia

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 NCT04503564 on ClinicalTrials.gov