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Pharmacokinetics (PK)/ Pharmacodynamics (PD) of an Extended Wear Infusion Set for Continuous Subcutaneous Insulin Infusion (CSII) in Type 1 Diabetes Mellitus (T1DM) Patients ("PEXIS")

NCT04398030 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2022-08-11

Study results available
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Summary

This study has been designed as a prospectively enrolled, randomized sequence, 2-way crossover study of device performance, tolerability and safety of an investigational insulin infusion set using a coil-reinforced soft polymer indwelling cannula versus a commercial insulin infusion set using a soft Teflon indwelling cannula, during two 7-day home use periods with 4 in-clinic euglycemic clamp sessions during each of the 7-day periods. After a wash-out period, subjects will cross over into the investigational or control group, respectively.

Conditions

Interventions

DEVICE

coil-reinforced soft polymer indwelling cannula

Insulin infusion set will be used for up to 7 days of continuous use or until failure

DEVICE

soft Teflon indwelling catheter

Insulin infusion set will be used for up to 7 days of continuous use or until failure

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • AMCR Institute

    collaborator OTHER

  • Integrated Medical Development

    collaborator INDUSTRY

  • Capillary Biomedical, Inc.

    lead INDUSTRY

Principal Investigators

  • Timothy Bailey, MD · AMCR Institute

Study Design

Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2020-07-17
Primary Completion
2021-04-22
Completion
2021-04-22
FDA Device
Yes

Countries

  • United States

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 NCT04398030 on ClinicalTrials.gov