2182-PUB: Feasibility of Extended Calibration Intervals with a Long-Term, Implantable CGM System

Abstract

Background: Continuous Glucose Monitoring (CGM) technology has improved glycemia in people with diabetes. However, user burden including frequent calibration, and reinsertion of short-term devices limits adoption of this technology. Aim: Our objective was to retrospectively analyze CGM data from a fully implanted prototype sensor to assess feasibility of an extended calibration interval. Methods: The Eclipse® ICGM® System was surgically inserted in the lower abdomen, superficial to the rectus muscle sheath (Figure 1) in 6 adults with T1 diabetes, Mean (SD) age 42(12) years; 33% Females, HbA1c 7.1% (1.2)%/54(13) mmol/mol. For 6 months participants self-monitored blood glucose 4 times/day and wore a Dexcom G5 CGM. In addition, monthly clinic visits include meal-tests with frequent sampling YSI plasma glucose for paired analyses. Analyses of investigational device CGM data was retrospective against benchmark measurements. Results: There were no device associated adverse events. Data from three participants demonstrate intervals of 30, 48 and 85 days between calibrations without impacting overall performance. Preliminary measures show clinically relevant accuracy of >95 % within the A+B ranges. Conclusion: Interim data supports extended interval calibration for the fully implanted prototype Eclipse® ICGM® System which holds promise of CGM with fewer device interactions and enhanced patient experience. Disclosure P. Gupta: Employee; Self; GlySens Incorporated. A. Butler: Employee; Self; GlySens Incorporated. K. Bertsch: None. H. Jones: None. M.H. Lee: Research Support; Self; Medtronic. Speaker’s Bureau; Self; AstraZeneca, Medtronic. V.R. Obeyesekere: None. S.L. Martha: None. A. Jenkins: Advisory Panel; Self; Abbott, Medtronic. Research Support; Self; Abbott, GlySens Incorporated, Medtronic, Sanofi-Aventis. D.N. ONeal: None.