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Insulet Artificial Pancreas Free-Living IDE3

NCT03216460 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2019-08-02

No results posted yet for this study

Summary

Subjects will undergo a 7±1 day outpatient, standard therapy phase during which sensor and insulin data will be collected. Subjects or their caregivers will manage their diabetes at home per their usual routine using the study CGM and remain on current MDI or pump therapy. This will be followed by a 5-day/4-night or from approximately 48 to 72 hours for children ages 2.0-5.9 years, hybrid closed-loop phase conducted in a supervised hotel/rental house setting.

Conditions

  • Type1 Diabetes Mellitus

Interventions

DEVICE

Insulet automated glucose control system

Insulet AP (artificial pancreas) system, using the Omnipod® insulin management system, Dexcom G4Share® AP System and personalized model predictive control algorithm.

Sponsors & Collaborators

  • Insulet Corporation

    lead INDUSTRY

Principal Investigators

  • Bruce Buckingham, MD · Stanford University

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-04
Primary Completion
2019-05-28
Completion
2019-05-28
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 NCT03216460 on ClinicalTrials.gov