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

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

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

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

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.