Establishing Methods to Determine Clinically Relevant Bolus and Basal Rate Delivery Accuracy of Insulin Pumps
Open accessAbstract
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.
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
A layer of paraffin oil of less than 3 mm thickness floated on the water eliminates evaporation and is shown to produce more accurate results.
“A layer of paraffin oil of <3 mm thickness was floated on the water to eliminate evaporation and is shown to produce more accurate results.20,22,23”
From Bench-Side Dose Accuracy of an Open-Source Ultra-Low-Cost Insulin-Pump, With Testing Conducted to IEC 60601-2-24 (2024) · cites this paper as [22]
The Test Setting for Durable Pumps section says the water was covered with mineral oil to avoid evaporation, but specifies a layer of at least 5 mm, contrary to the claimed thickness of less than 3 mm. The Results section found evaporation negligible; it does not show that the oil layer produced more accurate results. Page numbers are unavailable in our copy. (LLM, conf=0.89)
Experimental — accuracy not yet measuredExperimental 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 [5]
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
No citation lists for this paper
No citation lists for this paper yet — checked again daily.
References 18 · Cited by 25
Research works printed but not linked: 14
- Phillip M, Battelino T, Rodriguez H, Danne T, Kaufman F. Use of insulin pump therapy in the pediatric age-group: con- sensus statement from the European Society for Paediatric Endocrinology, the Lawson Wilkins Pediatric Endocrine Society, and the International Society for Pediatric and Adolescent Diabetes, endorsed by the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2007;30(6):1653-1662.
- Chan A, Breton MD, Kovatchev BP. Effects of pulsatile subcu- taneous injections of insulin lispro on plasma insulin concen- tration levels. J Diabetes Sci Technol. 2008;2(5):844-852.
- 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(6):1509-1518.
- Jahn LG, Capurro JJ, Levy BL. Comparative dose accuracy of durable and patch insulin infusion pumps. J Diabetes Sci Technol. 2013;7(4):1011-1020.
- Borot S, Franc S, Cristante J, et al. Accuracy of a new patch pump based on a microelectromechanical system (MEMS) compared to other commercially available insulin pumps: results of the first in vitro and in vivo studies. J Diabetes Sci Technol. 2014;8(6):1133-1141.
- Bowen JL, Allender CJ. A Comparative pulse accuracy study of two commercially available patch insulin infusion pumps. Eur Endocrinol. 2016;12(2):79-84.
- Zisser H. Insulin pump (dose-to-dose) accuracy: what does it mean and when is it important? J Diabetes Sci Technol. 2014;8(6):1142-1144.
- Zisser HC, Bevier W, Dassau E, Jovanovic L. Siphon effects on continuous subcutaneous insulin infusion pump delivery performance. J Diabetes Sci Technol. 2010;4(1):98-103.
- Lopez PE, King BR, Goss PW, Chockalingam G. Bubble for- mation occurs in insulin pumps in response to changes in ambi- ent temperature and atmospheric pressure but not as a result of vibration. BMJ Open Diabetes Res Care. 2014;2(1):e000036.
- Walsh J, Roberts R, Bailey T. Guidelines for insulin dosing in continuous subcutaneous insulin infusion using new formulas from a retrospective study of individuals with optimal glucose levels. J Diabetes Sci Technol. 2010;4(5):1174-1181.
- Ward LG, Heckman MG, Warren AI, Tran K. Dosing accuracy of insulin aspart flexpens after transport through the pneumatic tube system. Hosp Pharm. 2013;48(1):33-38.
- Hildebrandt P, Birch K, Jensen BM, Kuhl C. Subcutaneous insulin infusion: change in basal infusion rate has no imme- diate effect on insulin absorption rate. Diabetes Care. 1986;9(6):561-564.
- Heinemann L, Nosek L, Kapitza C, Schweitzer MA, Krinelke L. Changes in basal insulin infusion rates with subcutane- ous insulin infusion: time until a change in metabolic effect is induced in patients with type 1 diabetes. Diabetes Care. 2009;32(8):1437-1439.
- Bachran R, Beyer P, Klinkert C, Heidtmann B, Rosenbauer J, Holl RW. Basal rates and circadian profiles in continuous sub- cutaneous insulin infusion (CSII) differ for preschool children, prepubertal children, adolescents and young adults. Pediatr Diabetes. 2012;13(1):1-5.
- Authors
- Kamecke, U., Waldenmaier, D., Haug, C., Ziegler, R., & Freckmann, G.
- Affiliations
- Universität Ulm (DE)
- Diabetes Clinic for Children and Adolescents, Muenster, Germany
- Corresponding author
- Kamecke, Ulrike
- Venue
- Journal of Diabetes Science and Technology
- Publisher
- SAGE Publications
- Published
- 2018-07-13
- Volume
- 13
- Issue
- 1
- Pages
- 60-67
- ISSN
- 1932-2968 (ISSN-L)
- PMC
- PMC6313283
- OpenAlex
- W2884623485
- Cited by
- 25
- References
- 18
- Citations by year
- 2024: 1 · 2023: 3 · 2022: 9 · 2021: 4 · 2020: 4 · 2019: 3 · 2018: 1
- FWCI
- 2.39
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Journal of Diabetes Science and Technology (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Roche Diabetes Care Germany
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Physical Sciences › Engineering › Biomedical Engineering › Intravenous Infusion Technology and Safety
- Health Sciences › Medicine › Surgery › Healthcare Technology and Patient Monitoring
- Keywords
- insulin pump, delivery accuracy, diabetes technology
- MeSH terms
- Blood Glucose, Circadian Rhythm, Diabetes Mellitus, Type 1, Drug Administration Schedule, Equipment Design, Humans, Hypoglycemic Agents, Infusion Pumps, Insulin, Insulin Infusion Systems, Reproducibility of Results, Transdermal Patch
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
