Occlusion Detection Time in Insulin Pumps at Two Different Basal Rates
Open accessAbstract
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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Occlusion alarms can take time to trigger depending on the pump's infusion rate, with delays up to 40 hours post-failure.
“Furthermore, occlusion alarms can take time to trigger depending on the pump's infusion rate, with delays up to 40 hours post-failure.17”
From Development of a Real-time Force-based Algorithm for Infusion Failure Detection (2024) · cites this paper as [17]
The Results report that occlusion detection took substantially longer at 0.1 U/h than at 1.0 U/h, supporting the infusion-rate dependence. But “up to 40 hours” understates the observed delays: the longest median was 41 hours 21 minutes, and an individual alarm took 65 hours 40 minutes. (LLM, conf=0.87)
Experimental — accuracy not yet measuredCurrent insulin pump systems exhibit substantial variability in occlusion detection times, with delayed alarms-especially at lower basal rates-heightening the risk of unnoticed infusion failures and prolonged hyperglycemic excursions.
“As demonstrated by Freckmann et al, current insulin pump systems exhibit substantial variability in occlusion detection times, with delayed alarms—especially at lower basal rates—heightening the risk of unnoticed infusion failures and prolonged hyperglycemic excursions.23”
From Clinical utility of the twiist Automated Insulin Delivery System: first study with twiist (2026) · cites this paper as [23]
The prototype's occlusion detection time was similar or better (distinctly shorter) than that of commercially available pumps tested in comparable settings.
“Our study results suggest that the tested pump prototype provides delivery accuracy and occlusion detection that is similar or even better compared to all commercially available pumps tested with a similar experimental approach.”
From Accuracy Evaluation of a Novel Reusable Patch Pump Prototype (2023) · cites this paper as [4]
Experimental testing was based on IEC 60601-2-24 and on procedures published previously.
“Experimental testing was based on IEC 60601-2-24 and on procedures published previously. 3-5”
From Accuracy Evaluation of a Novel Reusable Patch Pump Prototype (2023) · cites this paper as [4]
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Self-citation
- Authors
- Freckmann, G., Kamecke, U., Waldenmaier, D., Haug, C., & Ziegler, R.
- Affiliations
- Universität Ulm (DE)
- Diabetes Clinic for Children and Adolescents, Muenster, Germany
- Corresponding author
- Freckmann, Guido
- Venue
- Journal of Diabetes Science and Technology
- Publisher
- SAGE Publications
- Published
- 2017-12-29
- Volume
- 12
- Issue
- 3
- Pages
- 608-613
- ISSN
- 1932-2968 (ISSN-L)
- PMC
- PMC6154229
- OpenAlex
- W2781380700
- Cited by
- 18
- References
- 12
- Citations by year
- 2026: 2 · 2025: 2 · 2024: 2 · 2023: 4 · 2022: 2 · 2021: 2 · 2020: 3 · 2018: 1
- FWCI
- 0.87
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Journal of Diabetes Science and Technology (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Physical Sciences › Engineering › Biomedical Engineering › Intravenous Infusion Technology and Safety
- Health Sciences › Health Professions › Emergency Medical Services › Patient Safety and Medication Errors
- Keywords
- insulin pump, patient safety, children, glucose monitoring
- MeSH terms
- Equipment Failure, Humans, Hypoglycemic Agents, Insulin, Insulin Infusion Systems
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