Aim: To generate pilot data regarding acceptance, safety, and function of a novel long-term CGM. Methods: The investigational CGM (Eclipse 3, GlySens, San Diego, CA) was surgically inserted superficial to the rectus sheath in 8 type 1 diabetes adults (4 Female; Mean [SD] age 56 [7]; BMI 25 [3]). CGM data were masked to participants and processed retrospectively in simulated real-time with one capillary blood glucose calibration per day. Monthly visits evaluated: user acceptance by standardised questionnaire; health of implantation sites; safety by anti-glucose oxidase and anti-catalase antibodies; and performance benchmarked against YSI during standardised meal tests. Bluetooth communication between the sensor and an Apple iPhone was assessed continuously. Results: One sensor was removed at 4 months (participant withdrawal) due to impacted implant environment. There were no SAE’s. User acceptance remained high for the study duration. (Figure 1) Antibody levels did not rise. The lag corrected (23.3minutes) MARD (Median [range]) of 12.4% (1401 paired readings) was stable from month 1 (13.1%) to month 10 (14.0%). CGM readings within 20/20% and 30/30% of YSI values were 85% and 96%, respectively. The App received 95% of sensor data within 10 minutes. Conclusions: Our results provide initial data supporting participant acceptance, and safety of Eclipse 3. Further sensor refinement will reduce lag and improve performance. Disclosure A.Butler: Employee; GlySens Incorporated. J.Tan: None. D.N.O'neal: None. L.Robinson: None. V.R.Obeyesekere: None. H.Jones: None. Y.W.Kong: None. C.Yuan: None. K.Bertsch: Employee; GlySens Inc. T.L.Routh: Employee; GlySens Incorporated. S.L.Martha: Employee; GlySens Incorporated.
Aim: To compare device tolerance & participant’s subjective experience wearing a surgically implanted long term glucose sensor versus conventional CGM in adults with Type 1 Diabetes. Method: A prototype CGM (Eclipse 3 sensor, GlySens, San Diego, CA) with masked glucose data transmitted to a study iPhone was surgically inserted superficial to the rectus sheath in 8 Adults with Type 1 Diabetes (4 Female; Mean [SD] Age 56 [7]Y; BMI 25[3]). One daily fingerstick glucose calibration was required. Participants simultaneously wore a conventional TGA approved multi-Day sensor that also transmitted unblinded glucose information to the Study iPhone. The two systems were compared using a standardized 5-point Leichardt scale questionnaire completed by participants at day 1, 7 and 14 post-implantation and monthly thereafter for the duration of study participation. Results: The investigation and comparator sensors were worn 100% and 98% percent of the time respectively over the study duration. Figure 1 summarizes the participant experience. Conclusions: Over time there was a general trend by all participants to favour the GlySens sensor and experience over the comparator CGM. . Figure 1: Participant experience over 10 months of sensor implantation. Disclosure L.Robinson: None. J.Tan: None. S.L.Martha: Employee; GlySens Incorporated. D.N.O'neal: None. V.R.Obeyesekere: None. H.Jones: None. Y.W.Kong: None. C.Yuan: None. K.Bertsch: Employee; GlySens. T.L.Routh: Employee; GlySens Incorporated. C.M.Sims: Stock/Shareholder; Medtronic. A.Butler: Employee; GlySens Incorporated.
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