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. 2021 May;23(5):350-357.
doi: 10.1089/dia.2020.0525. Epub 2020 Dec 22.

Evaluation of the Accuracy of Current Tubeless Pumps for Continuous Subcutaneous Insulin Infusion

Ralph Ziegler  1 , Nick Oliver  2 , Delia Waldenmaier  3 , Jochen Mende  3 , Cornelia Haug  3 , Guido Freckmann  3
Affiliations

Evaluation of the Accuracy of Current Tubeless Pumps for Continuous Subcutaneous Insulin Infusion

Ralph Ziegler et al. Diabetes Technol Ther. 2021 May.

Erratum in

Abstract

Background: Recently two new tubeless pumps for insulin therapy were introduced. They were tested for accuracy and occlusion detection and compared with the established patch pump Omnipod® (OP). Methods: Using a modified setup for tubeless pumps based on IEC 60601-2-24, the basal rate and bolus delivery of the Accu-Chek® Solo micropump system (ACS) and the A6 TouchCare® System (A6) were measured with a microgravimetric method. Bolus sizes of 0.2, 1, and 10 U, and basal rates of 0.1 and 1 U/h were evaluated in nine repetitions. For each parameter, mean deviation and number of individual boluses or 1-h basal rate windows within ±15% from target were calculated. In addition, occlusion detection time at basal rates of 0.1 and 1 U/h was determined. Results: Mean deviation of boluses of different volumes in the pumps ranged from -3.3% to +4.0% and 40%-100% of individual boluses were within ±15% of the target. During basal rate delivery, 48% to 98% of 1-h windows were within ±15% of the target with a mean deviation between -5.3% and +6.5%. In general, considerable differences between pump models were observed and deviations decreased with increasing doses. In most parameters, ACS was more accurate, and A6 less accurate, than OP. Mean occlusion detection time ranged from ∼3 to 7.5 h at 1 U/h and was >24 h or absent at 0.1 U/h. Conclusions: In this evaluation, significant differences between the tested tubeless pump models were observed that became most evident when regarding delivery errors over short time and small volumes.

Keywords: Accuracy; Continuous subcutaneous insulin infusion; Insulin pump; Occlusion; Patch pump; Tubeless pump.

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Conflict of interest statement

R.Z. has received speaker's honoraria and/or served on advisory boards from/of Abbott, Animas, Ascensia, AstraZeneca, Lilly, Novo Nordisk, and Roche Diabetes Care. N.O. has received honoraria for speaking, and research funding for investigator-initiated studies from Dexcom; has received honoraria for participation in advice boards, and research funding from Roche Diabetes Care GmbH. G.F. is general manager of the IDT (Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany), which carries out clinical studies on the evaluation of BG meters and medical devices for diabetes therapy on its own initiative and on behalf of various companies. G.F. and IDT have received speakers' honoraria or consulting fees from Abbott, Ascensia, Bayer, Dexcom, LifeScan, Menarini Diagnostics, Metronom Health, Novo Nordisk, Roche, Sanofi, Sensile, and Ypsomed. D.W., J.M., and C.H. are employees of the IDT.

Figures

FIG. 1.
FIG. 1.
Setup for tests with tubeless pumps.
FIG. 2.
FIG. 2.
Accuracy of 1-h windows during 72 h basal rate delivery of 0.1 U/h (above) and 1 U/h (below). The black line represents target delivery, red lines represent target delivery ±15%, colored dashes represent the 1-h windows of individual measurements (nine repetitions). One measurement was stopped earlier due to an error notice.
FIG. 3.
FIG. 3.
Bolus delivery accuracy of different pumps (n = 225 boluses for 0.2 and 1 U, n = 108 boluses for 10 U from nine repetitions per pump) grouped by bolus size. Red dashed lines represent target delivery ±15%. Asterisks indicate statistically significant differences in percentage of individual boluses within ±15% of the target between pumps (χ-tests; P < 0.025).
FIG. 4.
FIG. 4.
Mean absolute relative differences (MARD) of boluses from target delivery (mean and SD of nine repetitions). SD, standard deviation.
FIG. 5.
FIG. 5.
One-hour window basal rate delivery accuracy of different pumps grouped by basal rate (n = 648 from nine repetitions per pump). Red dashed lines represent target delivery ±15%. Asterisks indicate statistically significant differences in percentage of 1-h windows within ±15% of the target between pumps (χ-tests; P < 0.025).
FIG. 6.
FIG. 6.
Mean absolute relative differences (MARD) of 1-h windows from target delivery during 72 h basal rate delivery (mean and SD of nine repetitions).
FIG. 7.
FIG. 7.
Occlusion detection time of different pumps grouped by basal rate (n = 9 repetitions).
See this image and copyright information in PMC

References

    1. American Diabetes Association: Standards of medical care in diabetes-2019. Diabetes Care 2019;24(Suppl1):S1–S193
    1. Adolfsson P, Ziegler R, Hanas R: Continuous subcutaneous insulin infusion: special needs for children. Pediatr Diabetes 2017;18:255–261 - PubMed
    1. Cobelli C, Renard E, Kovatchev B: Artificial pancreas: past, present, future. Diabetes 2011;60:2672–2682 - PMC - PubMed
    1. Zisser H, Breton M, Dassau E, et al. : Novel methodology to determine the accuracy of the OmniPod insulin pump: a key component of the artificial pancreas system. J Diabetes Sci Technol 2011;5:1509–1518 - PMC - PubMed
    1. Jahn LG, Capurro JJ, Levy BL: Comparative dose accuracy of durable and patch insulin infusion pumps. J Diabetes Sci Technol 2013;7:1011–1020 - PMC - PubMed

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