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

Dexcom

Status: Unknown

Conditions: Diabetes Mellitus

Treatments: Device: Continuous Glucose Monitoring System

Study type: Interventional

Funder types: Industry

Identifiers

NCT04645641

PTL-904120

Details and patient eligibility

About

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

Full description

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

Enrollment: 150 estimated 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
• 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

CGM Users

Active Comparator group

Description:

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

Treatment:

Device: Continuous Glucose Monitoring System