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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04794478
• Other study ID #: PTL-903880
• Status: Completed
• Phase: N/A
• Start date: February 19, 2021
• Est. completion date: October 31, 2021

Study information

• Verified date: February 2022
• Source: DexCom, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 482
• Est. completion date: October 31, 2021
• Est. primary completion date: August 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• Dexcom Continuous Glucose Monitoring System
Dexcom Continuous Glucose Monitoring System

Locations

Country	Name	City	State
United States	Barbara Davis Center	Aurora	Colorado
United States	Joslin Diabetes Center	Boston	Massachusetts
United States	UVA Center for Diabetes Technology	Charlottesville	Virginia
United States	ProSciento	Chula Vista	California
United States	AMCR Institute	Escondido	California
United States	Rocky Mountain Clinical Research	Idaho Falls	Idaho
United States	Advanced Research	Ogden	Utah
United States	Clinical Trials of Texas, Inc. (CTT)	San Antonio	Texas
United States	Diabetes & Glandular Disease Clinic, P.A.	San Antonio	Texas
United States	Endeavor Clinical Trials	San Antonio	Texas
United States	Sansum Diabetes Research Institute	Santa Barbara	California
United States	Diablo Clinical Research	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
DexCom, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dexcom Continuous Glucose Monitoring System Performance	The Dexcom Continuous Glucose Monitoring (CGM) System performance will be assessed compared to the Yellow Springs Instrument (YSI) comparator venous plasma measurements	10 days
Secondary	System Related Adverse Device Effects	The Dexcom Continuous Glucose Monitoring (CGM) System will be characterized by Adverse Device Effects experienced by study participants	10 days