MedTrace Logo

Evaluation of Medtronic DUO Extended Set

NCT04823312 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-03-30

No results posted yet for this study

Summary

This study is a single-center, non-randomized, prospective single arm study of adult subjects with type 1 diabetes utilizing 670G insulin pump therapy with Continuous Glucose Monitoring (CGM). These subjects will be using 4 DUO Extended sets that will serve as an exploratory pilot study to assess the 7-day survival of the Duo Extended set.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DEVICE

Experimental prospective single arm evaluating the Medtronic Duo Extended Set

Subjects will be using 4 Duo extended sets that will serve as an exploratory pilot study to assess the 7-day survival of the Duo Extended set.

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Atlanta Diabetes Associates

    lead OTHER

Principal Investigators

  • Bruce W Bode, MD · Atlanta Diabetes Associates

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
2021-03-18
Primary Completion
2021-10-01
Completion
2021-11-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT04823312 on ClinicalTrials.gov