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Performance Evaluation of an Advanced Algorithm With CGM in Adults, Adolescents, and Pediatrics

NCT03966911 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 335

Last updated 2021-06-07

Study results available
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Summary

The purpose of this study is to demonstrate the performance of the Guardian™ Sensor (3) with an advanced algorithm in subjects age 2 - 80 years, for the span of 170 hours (7 days).

Conditions

  • Type 1 Diabetes Mellitus
  • Type2 Diabetes Mellitus

Interventions

DEVICE

Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter

Continuous Glucose Monitoring and frequent sample testing

Sponsors & Collaborators

  • Medtronic Diabetes

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2019-06-14
Primary Completion
2020-05-13
Completion
2020-05-13
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 NCT03966911 on ClinicalTrials.gov