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Characterizing normal-use temperature conditions of pumped insulin
Joshua K Herr1, Steven Keith2, Rick Klug1
1Becton Dickinson Technologies, Research Triangle Park, NC, USA.
Journal of Diabetes Science and Technology
|May 31, 2014
Summary
Insulin pump reservoir temperatures stayed between 25-37°C year-round, averaging near 30°C. This finding can improve insulin stability and compatibility testing protocols.
Area of Science:
- Biomedical Engineering
- Pharmaceutical Sciences
- Endocrinology
Background:
- Insulin pump therapy is crucial for diabetes management.
- Understanding in-use temperature profiles is vital for insulin stability.
- Current stability testing may not reflect real-world conditions.
Purpose of the Study:
- To characterize insulin pump reservoir temperature profiles during normal wear across seasons.
- To compare in-use reservoir temperatures with standard stability testing conditions.
- To inform the development of improved insulin formulation and delivery device testing.
Main Methods:
- Volunteers wore insulin pumps with thermocouples in reservoirs filled with diluent.
- Temperature and activity data were logged across winter, spring, and summer.
- Data collected over 7–14 days per season from 3–5 volunteers.
Main Results:
- Reservoir temperatures were consistently higher than ambient temperatures due to body heat.
- Temperatures fluctuated between 25°C and 37°C irrespective of season.
- Average reservoir temperature was approximately 30°C, lower than the 37°C used in many protocols.
Conclusions:
- Real-world insulin pump reservoir temperatures are moderate and stable across seasons.
- Existing stability testing at 37°C may not accurately represent typical usage.
- Study findings can guide the creation of more relevant testing methods for insulin products.
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