Abstract

The Enlite subcutaneous glucose sensor was previously evaluated in adults and children and shown to be accurate for 6 days, durable, and acceptable to patients and parents/caregivers. A pivotal 6-day trial in adults was conducted at 7 US investigational centers. Sensors were self-inserted and taped. Accuracy was evaluated vs frequently-sampled YSI plasma glucose values. Hypoglycemia and hyperglycemia were induced on days 1 (immediately after initial calibration), day 3, and day 6. Patient satisfaction with Enlite was also evaluated with a 7-point Likert-type questionnaire. Adults with type 1 (n=65) or type 2 (n=25) diabetes (mean age 44, range 18-71) wore either 1 or 2 sensors on their abdomens for 6 days. Accuracy was demonstrated for 6 days at all glucose concentrations despite including sparse and uneven calibration events. Valid sensor readings were obtained soon after insertion and reflected blood glucose values with minimal lag time. Patient satisfaction surveys indicated that the Enlite sensor was easy to insert, comfortable to wear, and easy to remove. There were no device-related adverse events. The Enlite sensor is accurate, durable, comfortable, safe, and easy to use. Improvements in continuous glucose sensing should expedite development of semi-automated insulin delivery features in modern pumps.