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The Relationship Between Different Bench Test Methodologies and Accuracy of Insulin Infusion Pumps: A Systematic Literature Review

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Abstract

Diabetes technology has rapidly evolved, and insulin infusion pumps (IIPs) have gained worldwide acceptance in diabetes care. The safety of medical equipment is highly discussed, imposing complex challenges in its use. The accuracy of IIPs can be determined through laboratory tests, generally following the IEC 60601-2-24 protocol. Studies have evaluated the accuracy and precision of IIPs, and there are discrepant results. So, we conducted a Systematic Literature Review to assess the methodologies used to evaluate the accuracy of IIPs, organizing the findings in a compiled perspective. The methodology was based on Kitchenham and Biolchini guidelines, and when possible it was carried out the Bayesian meta-analyses to compare the accuracy of IIPs. Most studies used the microgravimetric technique to evaluate the device accuracy, and some proposed adaptations for the standard protocol. The variation of results was recurrent, and the establishment of a protocol, especially to evaluate patch pumps, is necessary. The present study gives enough data to understand the scenario of the IIPs evaluation, as well as the different protocols that can be explored for its evaluation. This highlights the need for a reliable, practical, and low-cost methodology to assist the evaluation of IIPs.

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Figure 1

(Adapted from Refs. 5,24,38)

Figure 2
Figure 3

(Adapted from Ref. 1)

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(Adapted from Ref. 15)

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Abbreviations

CSII:

Continuous subcutaneous insulin infusion

DM:

Diabetes Mellitus

HPD:

Highest posterior density

IEEE:

Institute of electrical and electronics engineers

IEC:

International electrotechnical commission

IIPs:

Insulin infusion pumps

MARD:

Mean absolute relative dispersion

PIV:

Particle image velocimetry

RQ:

Research question

SLR:

Systematic Literature Review

T1D:

Type 1 Diabetes Mellitus

T2D:

Type 2 Diabetes Mellitus

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Funding

This work was funded by the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior—Brasil (CAPES, Finance Code 001/Postgraduate Program in Translational Medicine), Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP, grant number 2018/22094-0) and Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq 308721/2020-9).

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Authors and Affiliations

  1. Escola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, Brazil

    Fernanda Silva Tenorio, Camila Bertini Martins & Ana Lucia Domingues Neves

  2. Instituto de Ciência e Tecnologia, Universidade Federal de São Paulo, São José dos Campos, Brazil

    Luiz Eduardo Galvão Martins, Glória Sthefany Pereira da Silva & Tatiana Sousa Cunha

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  1. Fernanda Silva Tenorio
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Correspondence to Tatiana Sousa Cunha.

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Tenorio, F.S., Martins, L.E.G., da Silva, G.S.P. et al. The Relationship Between Different Bench Test Methodologies and Accuracy of Insulin Infusion Pumps: A Systematic Literature Review. Ann Biomed Eng 50, 1255–1270 (2022). https://doi.org/10.1007/s10439-022-03027-7

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