Evaluation of the Dexcom G6 Continuous Glucose Monitoring System With a Non-Interferent Sensor

Dexcom

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Device: Acetaminophen Challenge (G6 CGM)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03087877

PTL902020

Details and patient eligibility

About

The objective of the study is to demonstrate effectiveness of the G6 sensor membrane, in preventing acetaminophen's interference effect on glucose sensing.

Full description

The interference effect of the sensor will be evaluated by comparing the bias in the glucose values exhibited from the G6 CGM system after administration of acetaminophen. Bias will be evaluated by comparing CGM values to a laboratory referenceusing venous sample measurements.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ages 18 or older
• Diagnosis of diabetes

Exclusion criteria

• Pregnancy
• Known gastroparesis
• Abnormal liver function

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

70 participants in 1 patient group

CGM Users

Other group

Description:

Prospective, non-randomized, single-arm. Continuous Glucose Monitoring. Acetaminophen challenge is the intervention.

Treatment:

Device: Acetaminophen Challenge (G6 CGM)