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Clinical Startup of the 670G Closed Loop Insulin Delivery System

NCT03017482 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 85

Last updated 2019-09-19

No results posted yet for this study

Summary

The purpose of this project is to track initiation and the first year of clinical use of the newly FDA approved 670G closed loop insulin delivery system by patients who have requested this system. Our goal is to evaluate our clinical approach to starting this newly approved system. Since the investigators are only following patients who have already decided to start the 670G, the investigator does not assign specific interventions to the subjects of the study; thus this is a Observational study.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DEVICE

Medtronic 670G

This is an open labeled follow up of a clinical startup of a newly approved FDA closed loop insulin delivery system. It is essentially a "prospective" chart review of the clinically startup of a FDA closed loop system and has many elements of a quality improvement project with additional features of: * Questionnaires about the utility and impact of the device * Use of the device in children younger than the current FDA approval range

Sponsors & Collaborators

Principal Investigators

  • Darrell M Wilson, MD · Stanford University

Eligibility

Min Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-15
Primary Completion
2019-08-30
Completion
2019-08-30

Countries

  • United States

Study Locations

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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 NCT03017482 on ClinicalTrials.gov