IMPACT OF INSULIN EXCIPIENTS AND INFUSION SET WEAR TIME ON INSULIN PK/PD

Session Name
NEW INSULIN DELIVERY SYSTEMS: INHALED, TRANSDERMA, IMPLANTED DEVICES
Session Type
E-POSTER VIEWING (EXHIBITION HOURS)
Date
20.02.2020, Thursday
Session Time
09:30 - 15:30
Channel
E-Poster Area
Lecture Time
09:37 - 09:38
Presenter
  • Ronald J. Pettis, United States of America
Authors
  • Ronald J. Pettis, United States of America
  • Lynnette M. Hull, United States of America
  • Matthew Novak, United States of America
  • Alfred Harvey, United States of America
  • Didier Morel, France
  • Diane Sutter, United States of America
  • Marcus Hompesch, United States of America
  • Linda Morrow, United States of America

Abstract

Background and Aims

CSII set wear duration is typically limited to three-day best practice. Insulin preservatives may create local irritation contributing to altered insulin uptake and BG responses noted in literature, but limited paired PK/PD data exist for >3-day set wear. We clinically examined preservative impact on bolus insulin PK/PD during 7-day extended wear.

Methods

In a double-blind, randomized crossover study, n=25 T1D subjects received continuous SC infusions of insulin diluent (1.60/0.65 mg/mL, m-cresol/phenol) or 0.9% saline (negative control) via steel infusion sets during two 7-day inpatient periods. Insulin boli were administered via these same catheters on days 1, 3, 5, and 7, with accompanying standardized meals and blood sampling for insulin concentration PK and post-prandial blood glucose (PD). An additional set provided required insulin during non-test periods.

Results

All sets survived the 7d wear period without occlusion alarm, undue irritation or required replacement. Diluent treatment accelerated early-phase absorption with Tmax and InsT50% max-rising (P<0.05) compared to saline across all days. Insulin AUC0-1hr and Cmax were not affected by treatment but showed significant increases with time at each successive dose (P<0.05). Despite faster absorption, there were few significant PD treatment differences; however, both showed strong trends of decreasing % time-in-range (70-180 mg/dL) and increasing hyperglycemia (% time>180 mg/dL) with increased wear time.

Conclusions

While inconclusive on phenolic preservatives impact, these data demonstrate potential for extended set survivability and provide paired PK/PD over extended wear time. Further investigation is required to understand the mechanisms affecting both insulin absorption and BG control.

Hide