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

Dexcom

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Device: CGM

Study type: Interventional

Funder types: Industry

Identifiers

NCT02880267

PTL-902220

Details and patient eligibility

About

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

Full 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.

Enrollment: 304 patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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304 participants in 1 patient group

CGM Users

Other group

Description:

Glucose challenge during a clinic sessions to assess performance of CGM compared to reference measurement

Treatment:

Device: CGM