Effectiveness and Safety Study of the Dexcom G4 Platinum With Modified Algorithm

Dexcom

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Device: Continuous Glucose Monitoring

Study type: Interventional

Funder types: Industry

Identifiers

NCT02087995

PTL901100

Details and patient eligibility

About

To establish the performance of the Dexcom G4 Platinum with a Modified Algorithm continuous monitoring system when compared to a laboratory reference measurement.

Full description

A study to evaluate the performance of a modification to the G4 Platinum CGM system in adults with diabetes.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ages 18 years or older
• Diagnosis of Type 1 diabetes or Type 2 diabetes on Intensive Insulin Therapy (ITT)
• Willing to participate in a clinic session

Exclusion criteria

• Use of Acetaminophen during study period
• Pregnancy
• Hematocrit (HCT) <35% (females) and 38% (males)
• Dialysis, history of cardiovascular disease, epilepsy, severe migraines in the past 6 months, adrenal disease, syncope, significant hypoglycemia unawareness, or a history of severe hypoglycemia within the last 6 months.
• Any condition that, in the opinion of the Investigator, would interfere with their participation in the study or pose and excessive risk to study staff.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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51 participants in 1 patient group

Continuous Glucose Monitoring System

Experimental group

Description:

Single-Arm, CGM Device Glucose challenge performed during a clinic session to obtain accuracy data for the CGM system compared to a venous reference measurement

Treatment:

Device: Continuous Glucose Monitoring