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Status unknownNCT04645641Updated Nov 27, 2020

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

An interventional study of Continuous Glucose Monitoring System in Diabetes Mellitus, sponsored by DexCom, Inc.. Status unknown at 4 sites in United States. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2020-11-27.

Sponsored by DexCom, Inc. · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Nov 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Not applicable
Ages
2 Years and older
Sex
All
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Diabetes Mellitus
03

In context

Lead sponsor

DexCom, Inc. is the lead sponsor of 35 studies on the registry; 1 is open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Active comparator
    CGM Users

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

    Device: Continuous Glucose Monitoring System

Interventions

  • DeviceContinuous Glucose Monitoring System

    Continuous Glucose Monitoring System

06

What researchers measure

Primary outcomes

  1. System Performance

    System Performance will be characterized with respect to comparator venous plasma measurements.

    Time frame: 10 days

Secondary outcomes

  1. System Related Adverse Device Effects

    System will be characterized by Adverse Device Effects experienced by study participants

    Time frame: 10 days

07

Study locations

4 of 4 sites recruiting
  • AMCR Institute
    Escondido, California 92025, United States
    Recruiting
  • Barbara Davis Center
    Aurora, Colorado 80045, United States
    Recruiting
  • Rocky Mountain Clinical Research
    Idaho Falls, Idaho 82404, United States
    Recruiting
  • Endeavor Clinical Trials
    San Antonio, Texas 78229, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 27, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04645641
Lead sponsor
DexCom, Inc.
Responsible party
Sponsor
First posted
Nov 27, 2020
Start date
Oct 12, 2020
Primary completion
Dec 2020 (estimated)
Completion
Dec 2020 (estimated)
Last update
Nov 27, 2020

Study contacts

Stayce Beck, PhD, MPH
Contact
stayce.beck@dexcom.com
858-203-6454

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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DexCom, Inc.

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