Objective: A combination insulin infusion and glucose-sensing device will dramatically improve the ease of use for automated insulin delivery systems. The objective of this preclinical study was to collect safety and efficacy data during 7-day wear of a combined insulin-delivery and glucose-sensing device called the “Duo” set.

Method: In a type 1 diabetes (T1D) porcine model, each animal (N=6) wore the Duo set multiple times (on the abdomen) while receiving Novolog® insulin subcutaneously via a pump for one week or until set failure, determined by (1). blood glucose (BG) value not decreasing by at least 50 mg/dL an hour after a correction bolus for a BG level >350 mg/dL, or (2). evidence of infection at the infusion site. Blood glucose was measured five times/day with a BG meter, and pigs also wore a Guardian™ Sensor (3) glucose sensor (GS3) distant from the Duo-set site. Additionally, physical examination and serum panel tests were conducted for safety evaluation.

Result: There were 15 wears, with 10 wears lasting more than 7 days. Survival rate (67%) was similar to that of the Medtronic 7-day Extended Wear Infusion Set (EWIS) previously tested in the same porcine model (64%). There was no significant difference in total daily insulin dose (TDD) between the Duo set and the EWIS during the entire 7-day wear. There was no significant difference in glucose values between the Duo-set sensor and the GS3 (p>0.10), which agreed with the measured BG values in the range of 70-300 mg/dL (p>0.10). There was no significant device safety concern identified.

Conclusion: The results indicated that no interference of sensor signals was observed from insulin infused though the cannula of the same Duo set in the near proximity or from mechanical inference from the infusion-set movements. These data confirm the feasibility of a combined 7-day set which simultaneously infuses insulin and senses glucose subcutaneously in a T1D porcine model.

Disclosure

G. Zhang: Employee; Self; Medtronic. E. Anselmo: Employee; Self; Medtronic. L. To: None. S. Chattaraj: Employee; Self; Medtronic.

© 2021 by the American Diabetes Association
2021
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