Evaluation of the Safety and Effectiveness of the Dexcom Continuous Glucose Monitoring (CGM) System

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

482 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-19

Study Completion Date

2021-10-31

Brief Summary

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Evaluation of the Safety and Effectiveness of the Dexcom Glucose Monitoring (CGM) System

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Detailed Description

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The objective of this study is to establish performance of the Dexcom CGM System (System) in comparison to a blood glucose comparator method.

Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

All systems worn will be blinded. Sensor wear locations will be pre-assigned. All sensor insertions will be performed at the clinic by subjects and/or caregivers.

Study Groups

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CGM Users

Glucose challenge during clinic sessions to assess performance of CGM compared to comparator measurement.

Group Type ACTIVE_COMPARATOR

Dexcom Continuous Glucose Monitoring System

Intervention Type DEVICE

Dexcom Continuous Glucose Monitoring System

Interventions

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Dexcom Continuous Glucose Monitoring System

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Ages 2 or older
* Diagnosis of Type 1 diabetes or Type 2 diabetes
* Willing to wear the required number of Systems for the total duration of study wear
* Willing to participate in Clinic Session(s) during study wear

Exclusion Criteria

* Presence of extensive skin changes/diseases at sensor wear site(s) that preclude wearing the sensor(s) on skin
* Known allergy to medical-grade adhesives
* Pregnancy
* Hematocrit outside specification
* ≥ 18 years of age:

* Male: 36.0%;
* Female: 33.0%;
* 13-17 years of age: 35.0%;
* 7 years - 12 years of age: 32.0%;
* End stage renal disease and currently managed by dialysis or anticipating initiating dialysis during the study wear period
* Required or scheduled to have a Magnetic Resonance Imaging (MRI) scan, Computed Tomography (CT) scan, or diathermy during the study wear period

Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No