295-OR: User Acceptance of the Eversense® CGM System in a Home Use Setting: The House Study

Abstract

Background: The Eversense® CGM System is the first implantable CGM available for long-term continuous glucose measurement with a single sensor. The small sensor is indicated for subcutaneous wear in the upper arm. This study was conducted to assess usability and preference for arm or abdominal sensor wear. Methods: HOUSE was a prospective, single-arm, two-center study conducted in two sequential 90-day periods in subjects with T1D. During the first period, subjects were inserted with 2 sensors: one in upper arm and one in abdomen. After 90 days, both sensors were removed and subjects chose either the upper arm or abdominal location for the next sensor. Study visits occurred every 30 d up to 180 d for device downloads/safety assessment. At the 90-day and 180-day visit, subjects filled out a custom-designed questionnaire on their experience with the CGM system. Results: Eighteen subjects participated (83% male, age 40±12.5 years, BMI 25.6±4.4kg/m2, 23 years from diabetes diagnosis; mean±SD). Sixty-one percent were on MDI and 89% had prior CGM experience. Two subjects withdrew consent due to personal reasons and 100% of the remaining sensors lasted each 90-day cycle. Ninety-four percent preferred to wear the sensor in the upper arm with 72% highly agreed/agreed that the transmitter was comfortable on the arm and 23% highly agreed/agreed that the transmitter was comfortable on the abdomen. The majority of subjects reported that sensor insertion was painless (69%) and that they were able to wear the transmitter in their everyday setting (94%). Product likeability scores were high: 94% on displaying readings on a smartphone and 75% on predicted hypo-/hyperglycemic alerts. The median wear time was 23.4 hours/day and 88% of subjects reported reviewing their CGM glucose values at least every other hour while awake. Conclusion: In a home-use setting with experienced CGM users, subjects preferred wearing the Eversense on the arm compared to the abdomen. The system was rated high for usability on either the arm or abdomen. Disclosure M. Londahl: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Novo Nordisk A/S, Sanofi. Speaker's Bureau; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Novo Nordisk A/S, Sanofi. M. Landin-Olsson: None. S. Attvall: None.