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

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Device: Dexcom Continuous Glucose Monitoring System

• Registration Number: NCT04794478
• Lead Sponsor: DexCom, Inc.

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2021-02-19
• Study First Submitted: 2021-03-02
• Study First Submitted QC: 2021-03-10
• Study First Posted: 2021-03-12
• Primary Completion: 2021-08-09
• Study Completion: 2021-10-31
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-17
• Last Update Posted: 2022-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 482

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CGM Users	Dexcom Continuous Glucose Monitoring System	Glucose challenge during clinic sessions to assess performance of CGM compared to comparator measurement.

Primary Outcome Measures

Name	Time	Method
Dexcom Continuous Glucose Monitoring System Performance	10 days	The Dexcom Continuous Glucose Monitoring (CGM) System performance will be assessed compared to the Yellow Springs Instrument (YSI) comparator venous plasma measurements

Secondary Outcome Measures

Name	Time	Method
System Related Adverse Device Effects	10 days	The Dexcom Continuous Glucose Monitoring (CGM) System will be characterized by Adverse Device Effects experienced by study participants

Trial Locations

Locations (12)

Rocky Mountain Clinical Research; 🇺🇸 Idaho Falls, Idaho, United States

Barbara Davis Center; 🇺🇸 Aurora, Colorado, United States

Joslin Diabetes Center; 🇺🇸 Boston, Massachusetts, United States

Clinical Trials of Texas, Inc. (CTT); 🇺🇸 San Antonio, Texas, United States

Diabetes & Glandular Disease Clinic, P.A.; 🇺🇸 San Antonio, Texas, United States

Advanced Research; 🇺🇸 Ogden, Utah, United States

UVA Center for Diabetes Technology; 🇺🇸 Charlottesville, Virginia, United States

ProSciento; 🇺🇸 Chula Vista, California, United States

AMCR Institute; 🇺🇸 Escondido, California, United States

Diablo Clinical Research; 🇺🇸 Walnut Creek, California, United States

Sansum Diabetes Research Institute; 🇺🇸 Santa Barbara, California, United States

Endeavor Clinical Trials; 🇺🇸 San Antonio, Texas, United States