Ningbo KeXon Plastic Co., Ltd.

Reported Insulin Plastic Pump Temperature Fluctuations Lack Clinical Relevance

新闻   •   2019年04月03日 11:46 CST

First, the temperature probe used by the investigators was attached to the rear of the t:slim Insulin Plastic Pump(KEXON), on the outside of the cartridge. Insulin inside the cartridge is surrounded by a plastic sheath and covered by polycarbonate, providing 2 layers of material between the fluid and the temperature probe. Based on data from the study in question, an estimate of the temperature of fluid within the cartridge is pure speculation.

Second, the investigators charged the insulin pumps in a sealed chamber heated to 35°C (95°F) for a period of 180 minutes (3 hours). The extreme conditions created in the investigators’ laboratory are not applicable to user experiences. It is highly unlikely that users will charge their Insulin Pumps in an unventilated environment in extreme heat for an extended time. In contrast to the authors’ statement that charging the Insulin plastic pump for 3 hours is “not an unlikely scenario”, our findings suggest otherwise. Analysis of data from patient uploads into Diabetes Management Application software found that the average time per charging session for the Insulin Pump is 30 minutes. The authors’ own data demonstrate that charging the Insulin Pump under ambient conditions, even for an excessive period of time, did not result in a significant temperature increase.

A user of any insulin plastic pump who finds themselves in extreme conditions similar to the heated test in this study should be taking precautions to protect their insulin, as indicated in their plastic pump and insulin labeling.

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