Observational Study to Evaluate the Effectiveness and Safety Study of the Dexcom G4™ Continuous Glucose Monitoring System

Inclusion criteria

• Age 18 years or older;
• Have been diagnosed with insulin-requiring diabetes
• Abstain from injecting insulin or wear an insulin pump insertion set within 3 inches from the sensor site during sensor wear;
• Insert sensors on their own and wear 2 systems simultaneously;
• Use only the blood glucose meter provided for all blood glucose measurements performed during sensor wear and not allow others to use this meter during the study;
• Participate in one in-clinic session comprising of fingersticks per hour and have blood draws for the entire in-clinic session;
• Have an intravenous catheter inserted for 4 blood draws per hour
• Willing to perform SMBG during home use with the meter provided;
• Refrain from the use of acetaminophen during sensor wear period and the day prior to sensor insertion;
• Speak, read, and write English;
• Willing and able to be compliant with provisions laid out in this protocol.

Exclusion criteria

• Have extensive skin changes/diseases that preclude wearing devices on normal skin (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis) at the proposed wear sites;
• Allergy to medical-grade adhesives;
• Pregnant as demonstrated by a positive pregnancy test within 72 hours of sensor insertion,
• Dialysis treatment;
• Hematocrit that is outside the range of 30-55% at screening visit;