In real-world settings, insulin pumps and reservoirs are exposed to temperature fluctuations during the course of normal use. The stability of insulin and the compatibility with delivery devices may be affected by these temperature changes. To date, the temperature exposure range of pumped insulin has not been thoroughly characterized in a real-world setting.Most stability and compatibility studies are performed at a single temperature, testing at or close to 37ºC, with additional agitation or humidity control commonly employed. [1][2][3][4][5][6] Testing based on worst-case temperature conditions (37ºC) offers critical information to satisfy regulatory requirements, but provides no indication as to the actual product stability and compatibility lifetime under real-world settings. Shnek et al describe a method to characterize insulin stability by cycling exposure temperatures between 25ºC and 37ºC with agitation, and though more realistic than single-point testing, this was not correlated to patient usage patterns. 7 This report details testing performed to examine insulin exposure temperatures based on real pump wear data from volunteers over winter, spring, and summer months. Results from this study could be utilized to develop more accurate stability and compatibility testing procedures for new insulin formulations and/or delivery devices.
MethodsWire thermocouples (part # 5SRTC-TT-K-30-36, Omega Engineering, Stamford, CT) were secured into a female Luer connector by epoxy, with the active element of the thermocouple extending past the connector by 1 inch. The Luer connector was then attached to a fluid reservoir (Part # 100-124-02, Animas, West Chester, PA) filled with 2.0 mL insulin diluent (part # ND 800, Lilly, Indianapolis, IN). The active element of the thermocouple was located inside the fluid reservoir as shown in Figure 1a. The electrical connector of the thermocouple was attached to the temperature logger (part # 177-T4, Omega Engineering, Stamford, CT). The reservoir with thermocouple was then loaded into an insulin pump (Animas OneTouch Ping).Volunteers were asked to wear pumps and temperature data loggers for a target wear period of 72 hours while continuing with their normal day-to-day activities (Figure 1b).
AbstractIn this study, the temperature profiles of insulin pump reservoirs during normal wear conditions across multiple seasons were characterized. Thermocouples secured in reservoirs filled with insulin diluent were loaded in infusion pumps worn by volunteers. Reservoir and ambient environmental temperature data and activity levels were logged during the course of normal daily activities in February (winter), April (spring), and August (summer). Each seasonal data set comprised 7 to 14 days of wear from 3 to 5 volunteers. Reservoir temperature profiles were generally higher than ambient temperatures, likely due to heat transfer from the wearer when the pump was placed close to the body. Temperature conditions inside pump reservoirs fluctuated between 25ºC and 37ºC regardless of seasonal ...