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

Not Applicable

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

• Registration Number: NCT04645641
• Lead Sponsor: DexCom, Inc.

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-10-12
• Status Verified: 2020-11
• Study First Submitted: 2020-11-02
• Study First Submitted QC: 2020-11-25
• Last Update Submitted: 2020-11-25
• Study First Posted: 2020-11-27
• Last Update Posted: 2020-11-27
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Primary Outcome Measures

Name	Time	Method
System Performance	10 days	System Performance will be characterized with respect to comparator venous plasma measurements.

Secondary Outcome Measures

Name	Time	Method
System Related Adverse Device Effects	10 days	System will be characterized by Adverse Device Effects experienced by study participants

Trial Locations

Locations (4)

AMCR Institute; 🇺🇸 Escondido, California, United States

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

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

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