Basal Rate Delivery of Different Insulin Pumps—An Accuracy Evaluation

Background: The detection of insulin infusion set (IIS) occlusions is an important feature of insulin pumps with regard to patient safety. However, there are no requirements for a time limit until an alarm has to be triggered after an occlusion occurred. The standard IEC 60601-2-24 is applicable for insulin pumps and describes test settings and procedures to determine occlusion detection time (ODT). Methods: In this study, ODT of six different insulin pump models with different IIS (in total 10 different insulin pump systems) was tested for two basal rates (1.0 U/h and 0.1 U/h). Results: Differences were seen between the tested pump systems. At a basal rate of 1.0 U/h all insulin pump systems showed an acceptable ODT of less than 5 hours. However, at a basal rate of 0.1 U/h, as often used in children, the median ODT ranged from approximately 4 hours to more than 40 hours. With the lower basal rate, median ODT was longer than 6-8 hours for 9 of the 10 systems. Conclusions: Insulin pump users should not blindly rely on occlusion alarms but perform regular glucose monitoring and manufacturers should develop mechanisms that allow an earlier detection at low basal rates.

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Description of a Novel Patch Pump for Insulin Delivery and Comparative Accuracy Evaluation

Journal of Diabetes Science and Technology ◽

10.1177/19322968211000441 ◽

2021 ◽

pp. 193229682110004

Author(s):

Annette Baumstark ◽

Jochen Mende ◽

Joji Uchiyama ◽

Cornelia Haug ◽

Guido Freckmann

Keyword(s):

Continuous Subcutaneous Insulin Infusion ◽

Insulin Infusion ◽

Insulin Delivery ◽

Accuracy Evaluation ◽

Subcutaneous Insulin ◽

Stepping Motor ◽

Basal Rate ◽

Comparative Accuracy

A new insulin patch pump for continuous subcutaneous insulin infusion was developed. The pump is composed of reusable and disposable parts and operates with a stepping motor. This pump was compared to a patch pump and a durable pump regarding basal rate and bolus accuracy. Using a microgravimetric method, boluses of 0.2 U, 1 U and 7 U, and a basal rate of 1 U/h were tested. For all pumps, bolus accuracy was higher when larger volumes were delivered. While median deviations were similar for all pumps, there were differences in the precision of individual boluses and when regarding basal rate delivery divided into 1-h windows.

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Establishing Methods to Determine Clinically Relevant Bolus and Basal Rate Delivery Accuracy of Insulin Pumps

Journal of Diabetes Science and Technology ◽

10.1177/1932296818788349 ◽

2018 ◽

Vol 13 (1) ◽

pp. 60-67 ◽

Cited By ~ 6

Author(s):

Ulrike Kamecke ◽

Delia Waldenmaier ◽

Cornelia Haug ◽

Ralph Ziegler ◽

Guido Freckmann

Keyword(s):

Clinical Relevance ◽

Clinical Use ◽

Clinical Perspective ◽

Insulin Pumps ◽

Basal Rate ◽

Evaluation Procedures ◽

Delivery Accuracy ◽

Accuracy Data ◽

Measurement Period

Background: Adequate testing of delivery accuracy of insulin pumps is under discussion. Especially for patch pumps, test settings are challenging. In addition, evaluation and presentation of accuracy results in a way that is reasonable and useful for clinicians, not only for technicians, is important. Methods: Test setups based on IEC 60601-2-24 were used and, in addition, different setups for patch pumps were compared to identify an adequate alternative for pumps without external infusion set. These setups are applicable for both bolus and basal rate accuracy testing. In addition, evaluation procedures considering clinical relevance were compiled. Results: A setup for patch pumps that provides reliable results could be realized. Evaluation of basal rate accuracy data should also consider the actual clinical use of insulin pumps and thus, deviating from IEC 60601-2-24, compose the whole measurement period without excluding the first 24 hours. In addition to the presentation using trumpet curves, accuracy of 1-hour windows should be evaluated and displayed. Conclusions: This article proposes an approach on how to test, evaluate, and present bolus and basal rate accuracy of insulin pumps from a clinical perspective.

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