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Calibration of insulin pumps based on discrete doses at given cycle times
METAS Federal Institute of Metrology, Switzerland.
RISE Research Institutes of Sweden, Safety and Transport, Measurement Technology.ORCID iD: 0000-0001-5118-0150
RISE Research Institutes of Sweden, Safety and Transport, Measurement Technology.ORCID iD: 0000-0003-2334-065X
IPQ Metrology Department, Portugal.
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2023 (English)In: Biomedizinische Technik (Berlin. Zeitschrift), ISSN 1862-278X, E-ISSN 0013-5585, Vol. 68, no 1, p. 67-77Article in journal (Refereed) Published
Abstract [en]

One application in the medical treatment at very small flow rates is the usage of an Insulin pump that delivers doses of insulin at constant cycle times for a specific basal rate as quasi-continuous insulin delivery, which is an important cornerstone in diabetes management. The calibration of these basal rates are performed by either gravimetric or optical methods, which have been developed within the European Metrology Program for Innovation and Research (EMPIR) Joint Research Project (JRP) 18HLT08 Metrology for drug delivery II (MeDDII). These measurement techniques are described in this paper, and an improved approach of the analytical procedure given in the standard IEC 60601-2-24:2012 for determining the discrete doses and the corresponding basal rates is discussed in detail. These improvements allow detailed follow up of dose cycle time and delivered doses as a function of time to identify some artefacts of the measurement method or malfunctioning of the insulin pump. Moreover, the calibration results of different basal rates and bolus deliveries for the gravimetric and the optical methods are also presented. Some analysis issues that should be addressed to prevent misinterpreting of the calibration results are discussed. One of the main issues is the average over a period of time which is an integer multiple of the cycle time to determine the basal rate with the analytical methods described in this paper. 

Place, publisher, year, edition, pages
De Gruyter Open Ltd , 2023. Vol. 68, no 1, p. 67-77
Keywords [en]
calibration, dose accuracy, insulin pump, traceability, Controlled drug delivery, Insulin, Pumps, Targeted drug delivery, Cycle time, Diabetes management, Insulin delivery, Insulin pumps, Medical treatment, Optical methods, Pump-based, Small flow-rate
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Clinical Medicine
Identifiers
URN: urn:nbn:se:ri:diva-61247DOI: 10.1515/bmt-2022-0040Scopus ID: 2-s2.0-85139486442OAI: oai:DiVA.org:ri-61247DiVA, id: diva2:1714861
Note

Funding details: Horizon 2020 Framework Programme, H2020; Funding details: European Metrology Programme for Innovation and Research, EMPIR; Funding text 1: Research funding: This project 18HLT08 MEDDII has received funding from the EMPIR programme co-financed by the Participating States and from the European Union’s Horizon 2020 research and innovation programme.

Available from: 2022-11-30 Created: 2022-11-30 Last updated: 2024-04-17Bibliographically approved

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Büker, OliverStolt, Krister

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