Effectiveness and Safety of the Dexcom™ G6 Continuous Glucose Monitoring System

• Sponsor: DexCom, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02880267
• Collaborator: (none)
• Enrollment: 304
• Locations: 9
• Arm: 1
• Actual Duration (Months): 16
• Patients Per Site: 33.8
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

Effectiveness and Safety of the Dexcom G6 Continuous Glucose Monitoring (CGM) System

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus	Device: CGM	N/A

Detailed Description

The objective of the study is to establish performance of the System compared to a laboratory reference measurement. The effectiveness of the System will be evaluated by comparison of CGM values to a laboratory reference, Yellow Spring Instrument (YSI), using arterialized venous sample measurements. Performance will be evaluated in terms of point and rate accuracy of the System in reference to YSI.

The safety profile of the System will be characterized by the incidence of device-related Adverse Events (AEs) experienced by study subjects.

Study Design

• Study Type: Interventional
• Actual Enrollment: 304 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Effectiveness and Safety of the Dexcom™ G6 Continuous Glucose Monitoring System
• Actual Study Start Date: May 1, 2016
• Actual Primary Completion Date: Jul 1, 2017
• Actual Study Completion Date: Sep 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Other: CGM Users Glucose challenge during a clinic sessions to assess performance of CGM compared to reference measurement	Device: CGM; Glucose challenge during a clinic session to assess CGM performance compared to a laboratory reference measurement.

Outcome Measures

Primary Outcome Measures

1. Proportion of blood glucose values, compared between CGM and a lab glucose analyzer that are matched relative to a proportion of blood glucose values, compared between CGM and a lab glucose analyzer matched to an accuracy measurement of %20/20 mg/dL [10 Days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Ages 2 or older

• Diagnosis of Type 1 diabetes or Type 2 diabetes, on intensive insulin therapy

• Willing to participate in a clinic session involving venous sampling for evaluation of study end point

Exclusion Criteria:

• Use of acetaminophen

• Known allergy to medical-grade adhesives

• Pregnancy

• Hematocrit outside specification of the study-assigned blood glucose meter

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AMCR Institute	Escondido	California	United States
2	Stanford	Palo Alto	California	United States
3	Sansum	Santa Barbara	California	United States
4	Diablo	Walnut Creek	California	United States
5	Barbara Davis Center	Aurora	Colorado	United States
6	Atlanta Diabetes	Atlanta	Georgia	United States
7	Joslin Diabetes Center	Boston	Massachusetts	United States
8	Oregon Health Science University	Portland	Oregon	United States
9	Rainier	Seattle	Washington	United States

Sponsors and Collaborators

• DexCom, Inc.

Investigators

• Study Director: David PRice, MD, DexCom, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: DexCom, Inc.
• ClinicalTrials.gov Identifier: NCT02880267
• Other Study ID Numbers: PTL-902220
• First Posted: Aug 26, 2016
• Last Update Posted: Dec 31, 2018
• Last Verified: Dec 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Study Results

No Results Posted as of Dec 31, 2018