Recruiting

Dexcom CGM

Sponsor:

DexCom, Inc.

Code:

NCT04645641

Conditions

Diabetes Mellitus

Eligibility Criteria

Sex: All

Age: 2+

Healthy Volunteers: Not accepted

Interventions

Continuous Glucose Monitoring System

Study Details

Brief summary:

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

Conditions

Diabetes Mellitus

Study ID

NCT04645641

Start date

Oct 12, 2020

Status verified date

Nov, 2020

Completion date

Dec, 2020

Anticipated

Primary completion date

Dec, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: CGM Users

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

Interventions

Continuous Glucose Monitoring System

Continuous Glucose Monitoring System

Primary outcome measure

  • System Performance [ Time Frame: 10 days ]

Central Contacts and Locations

Central contacts

Stayce Beck, PhD, MPH

858-203-6454stayce.beck@dexcom.com

Locations

AMCR Institute

Recruiting

Escondido, California, United States, 92025

Barbara Davis Center

Recruiting

Aurora, Colorado, United States, 80045

Rocky Mountain Clinical Research

Recruiting

Idaho Falls, Idaho, United States, 82404

Endeavor Clinical Trials

Recruiting

San Antonio, Texas, United States, 78229

More Information

Sponsor

DexCom, Inc.

Last update posted

Nov 27, 2020

Last verified

Nov, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by DexCom, Inc. on 2020-11-27.