Accuracy Evaluation of a Novel Reusable Patch Pump Prototype
Open accessAbstract
A prototype of an insulin patch pump that operates with a double pump mechanism was tested. Accuracy of bolus delivery of 0.2 U and 1.0 U, and a basal rate of 1.0 U/h were evaluated with a microgravimetric method. In addition, occlusion detection time at basal rates of 0.1 U/h and 1.0 U/h was assessed. Mean deviation from target was lower than 2% for both bolus sizes. Regarding basal rate accuracy, mean deviation over 72 hours was lower than 1%. Occlusion detection occurred in less than 30 minutes with both basal rates. 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.
AI snapshot
Written from the paper’s full text.
TL;DR
This bench study evaluated a novel reusable patch pump prototype (Sigi) using microgravimetric methods. It found high bolus and basal delivery accuracy and faster occlusion detection than previously tested commercial pumps.
Key findings
- Bolus accuracy: mean deviations from target were +1.8% ± 2.5% for 0.2 U boluses and +0.3% ± 2.4% for 1.0 U boluses; 89.3% and 95.3% of boluses were within ±5%, respectively, and all boluses were within ±15%.
- Basal accuracy at 1.0 U/h over 72 hours: mean total deviation was −0.3% ± 0.3%; 97.7% of 1-hour windows were within ±5% and 99.8% within ±15% of target.
- Occlusion detection time: mean 29 minutes at 0.1 U/h (range 28-30 minutes) and 10 minutes at 1.0 U/h (range 8-18 minutes).
- The authors conclude the prototype’s delivery accuracy was similar or better than commercially available pumps tested in comparable settings, with distinctly shorter occlusion detection times.
Methods
- Bench microgravimetric study using 3 individual prototype devices; no human testing and no ethical approval required; testing was based on IEC 60601-2-24 and previously published procedures.
- Bolus accuracy: 0.2 U and 1.0 U boluses, 25 consecutive boluses per run, 6 runs each, with weight gain recorded 6 minutes after delivery start. Basal accuracy: 1.0 U/h over 72 hours, weight recorded every 2.5 minutes, repeated 6 times. Insulin aspart (NovoRapid PumpCart) was used with a density of 1.005 g/ml and a 30 cm fluoropolymer tube replacing the original cannula.
- Occlusion detection time: original cannula occluded with a clamp at basal rates of 0.1 U/h and 1.0 U/h, repeated 6 times per rate; mean, minimum, and maximum times were calculated.
Limitations
- The paper states comparability to previous studies is limited by differences in test setup, including a smaller number of individual pumps used and fewer repetitions performed.
- The paper states this was the first accuracy evaluation of the pump, which is still under development.
- Evident from the text: the study was bench-only, used only 3 prototype devices and 6 runs per condition, and did not assess clinical outcomes or in-human performance.
Model-written summary. Check it against the paper before relying on it.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
8 of 9 cited sources checked · 8 supported · 0 flagged
- Interpretationcitation§ Discussion · p. 4
Deviations from target for the prototype were similar or lower compared to other patch pumps currently available on the market tested in a similar experimental setting.
“However, the results of this investigation showed that deviations from target were similar or lower compared to other patch pumps currently available on the market and that have been tested in a similar experimental setting. 7,8”
Quote in the paperSubstantial claim2 of 2 sources checked- cites [7] 7. Ziegler R, Oliver N, Waldenmaier D, Mende J, Haug C, Freckmann G. Evaluation of the accuracy of current tubeless pumps for continuous subcutaneous insulin infusion. Diabetes Technol Ther . 2021;23(5):350-357. source
- cites [8] 8. Baumstark A, Mende J, Uchiyama J, Haug C, Freckmann G. Description of a novel patch pump for insulin delivery and comparative accuracy evaluation. J Diabetes Sci Technol . 2021:19322968211000441. <!-- image --> <!-- image --> <!-- image --> source
- Rests on an assumption: Despite differences in test setup, the results from previous studies of other pumps are comparable enough to support the conclusion that the prototype's deviations and ODT are similar or better.
- Interpretationown data§ Abstract · p. 1
The prototype's delivery accuracy is similar or even better than that of all commercially available pumps tested in a comparable experimental setting.
“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.”
- Also stated in: § Conclusions · p. 4 · plain
“This first study's results showed that the tested insulin patch pump prototype provides a delivery accuracy that is similar or even better compared to all commercially available pumps that have been tested in a comparable experimental setting and that ODT was distinctly shorter.”
Quote in the paperSubstantial claim2 of 2 sources checked- cites [7] 7. Ziegler R, Oliver N, Waldenmaier D, Mende J, Haug C, Freckmann G. Evaluation of the accuracy of current tubeless pumps for continuous subcutaneous insulin infusion. Diabetes Technol Ther . 2021;23(5):350-357. source
- cites [8] 8. Baumstark A, Mende J, Uchiyama J, Haug C, Freckmann G. Description of a novel patch pump for insulin delivery and comparative accuracy evaluation. J Diabetes Sci Technol . 2021:19322968211000441. <!-- image --> <!-- image --> <!-- image --> source
- Rests on an assumption: Despite differences in test setup, the results from previous studies of other pumps are comparable enough to support the conclusion that the prototype's deviations and ODT are similar or better.
- Also stated in: § Conclusions · p. 4 · plain
- Findingown data§ Results · p. 4
For 1.0 U boluses, 95.3% were within ±5% of target.
“The percentage of boluses within ± 5% of the target was 89.3% for the 0.2 U bolus and 95.3% for the 1 U bolus (Figure 4).”
Quote in the paperSubstantial claim - Findingown data§ Results · p. 4
For 0.2 U boluses, 89.3% were within ±5% of target.
“The percentage of boluses within ± 5% of the target was 89.3% for the 0.2 U bolus and 95.3% for the 1 U bolus (Figure 4).”
Quote in the paperSubstantial claim - Findingown data§ Results · p. 4
For basal rate 1.0 U/h over 72 hours, 97.7% of 1-hour windows were within ±5% of target.
“Mean total deviation from target over 72 hours was -0.3% ± 0.3% with 99.8% of 1-hour windows within ± 15% from target and 97.7% of 1-hour windows within ± 5% from target.”
Quote in the paperSubstantial claim
- Findingown data§ Results · p. 4
For basal rate 1.0 U/h over 72 hours, the mean total deviation from target was -0.3% ± 0.3%.
“Mean total deviation from target over 72 hours was -0.3% ± 0.3% with 99.8% of 1-hour windows within ± 15% from target and 97.7% of 1-hour windows within ± 5% from target.”
Quote in the paperSubstantial claim - Findingown data§ Results · p. 4
For basal rate 1.0 U/h over 72 hours, 99.8% of 1-hour windows were within ±15% of target.
“Mean total deviation from target over 72 hours was -0.3% ± 0.3% with 99.8% of 1-hour windows within ± 15% from target and 97.7% of 1-hour windows within ± 5% from target.”
Quote in the paperSubstantial claim - Findingown data§ Results · p. 4
For 0.2 U boluses, the mean deviation from target was +1.8% ± 2.5% (150 boluses assessed).
“Mean deviations from target were + 1.8% ± 2.5% for the 0.2 U boluses and + 0.3% ± 2.4% for the 1.0 U boluses, respectively.”
Quote in the paperSubstantial claim - Findingown data§ Results · p. 4
For 1.0 U boluses, the mean deviation from target was +0.3% ± 2.4% (150 boluses assessed).
“Mean deviations from target were + 1.8% ± 2.5% for the 0.2 U boluses and + 0.3% ± 2.4% for the 1.0 U boluses, respectively.”
Quote in the paperSubstantial claim - Findingown data§ Results · p. 4
Mean occlusion detection time was 29 minutes at basal rate 0.1 U/h.
“Mean ODT of 6 repetitions was 29 minutes at a BR of 0.1 U/h and 10 minutes using a BR of 1.0 U/h (Figure 6).”
Quote in the paperNot a substantial claim - Findingown data§ Results · p. 4
Mean occlusion detection time was 10 minutes at basal rate 1.0 U/h.
“Mean ODT of 6 repetitions was 29 minutes at a BR of 0.1 U/h and 10 minutes using a BR of 1.0 U/h (Figure 6).”
Quote in the paperNot a substantial claim - Interpretationreasoning§ Discussion · p. 4
Comparability to data of previous studies is limited because of differences in test setup (e.g., smaller number of individual pumps used and fewer repetitions performed).
“Comparability to data of previous studies is limited because of differences in the test setup (eg, a smaller number of individual pumps used and fewer repetitions performed).”
Quote in the paperNot a substantial claim
- May combine two claims. 6
- Classified as probably not a substantial claim. 4
May combine two claims.
Interpretationcitation§ Abstract · p. 1The 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.”
- Also stated in: § Conclusions · p. 4 · plain
“This first study's results showed that the tested insulin patch pump prototype provides a delivery accuracy that is similar or even better compared to all commercially available pumps that have been tested in a comparable experimental setting and that ODT was distinctly shorter.”
- Also stated in: § Discussion · p. 4 · boosted
“In this bench test, occlusion alarms, which are an important safety feature of insulin pumps, were triggered noticeably quicker than for any insulin pump tested so far. 4,7”
Quote in the paperSubstantial claim2 of 2 sources checked- cites [4] 4. Freckmann G, Kamecke U, Waldenmaier D, Haug C, Ziegler R. occlusion detection time in insulin pumps at two different basal rates. J Diabetes Sci Technol . 2018;12(3):608-613. source
- cites [7] 7. Ziegler R, Oliver N, Waldenmaier D, Mende J, Haug C, Freckmann G. Evaluation of the accuracy of current tubeless pumps for continuous subcutaneous insulin infusion. Diabetes Technol Ther . 2021;23(5):350-357. source
- Rests on an assumption: Despite differences in test setup, the results from previous studies of other pumps are comparable enough to support the conclusion that the prototype's deviations and ODT are similar or better.
- Also stated in: § Conclusions · p. 4 · plain
Classified as probably not a substantial claim. May combine two claims.
Study design and conductcitation§ Methods · p. 2Experimental 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”
Quote in the paperSubstantial claim2 of 3 sources checked- cites [3] 3. IEC 60601-2-24:2012 Medical electrical equipment-Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers [German version EN 60601-2-24:2015].
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
- cites [4] 4. Freckmann G, Kamecke U, Waldenmaier D, Haug C, Ziegler R. occlusion detection time in insulin pumps at two different basal rates. J Diabetes Sci Technol . 2018;12(3):608-613. source
- cites [5] 5. Kamecke U, Waldenmaier D, Haug C, Ziegler R, Freckmann G. Establishing methods to determine clinically relevant bolus and basal rate delivery accuracy of insulin pumps. J Diabetes Sci Technol . 2019;13(1):60-67. source
May combine two claims.
Findingown data§ Results · p. 4Minimum and maximum occlusion detection times at basal rate 0.1 U/h were 28 and 30 minutes.
“Minimum and maximum ODT were 28 minutes and 30 minutes at a BR of 0.1 U/h and 8 minutes and 18 minutes at a BR of 1.0 U/h, respectively.”
Quote in the paperNot a substantial claimMay combine two claims.
Findingown data§ Results · p. 4All delivered boluses (0.2 U and 1.0 U) were within ±15% of target.
“All boluses were within ± 15% from target.”
Quote in the paperSubstantial claimMay combine two claims.
Findingown data§ Results · p. 4Minimum and maximum occlusion detection times at basal rate 1.0 U/h were 8 and 18 minutes.
“Minimum and maximum ODT were 28 minutes and 30 minutes at a BR of 0.1 U/h and 8 minutes and 18 minutes at a BR of 1.0 U/h, respectively.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing), S4 (based).
Premisenone given§ Corresponding Author: · p. 1The lever actuations synchronized with the advancements of the primary mechanism together shall ensure precise insulin delivery.
“These lever actuations are synchronized with the advancements of the primary mechanism, which together shall ensure precise insulin delivery.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing), S4 (based).
Study design and conductnone given§ Methods · p. 3Room temperature and humidity were within a controlled range.
“Room temperature and humidity were within a controlled range.”
Quote in the paperNot a substantial claimMay combine two claims.
Interpretationown data§ Discussion · p. 4The prototype showed a high level of accuracy regarding the tested basal rate and both tested bolus sizes.
“The prototype showed a high level of accuracy regarding the tested BR and both tested boluses sizes.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S4 (based).
Premisereasoning§ Introduction · p. 1Associating the primary piston pump and secondary micro-delivery mechanism shall ensure both short- and long-term pumping accuracy and precision.
“Associating the 2 technologies shall ensure both short- and long-term pumping accuracy and precision.”
Quote in the paperNot a substantial claim- Rests on an assumption: Piston pumps are very accurate on average delivered volume but may lack precision on each pumping cycle due to stick-slip of the piston inside the cartridge.
- The authors state this as an assumption: Micro-pumps are very precise on each delivery cycle, but if not calibrated correctly, will cumulate error and result in less accuracy of the volume injected on the long run.
The paper relies on this without support.
Piston pumps are very accurate on average delivered volume but may lack precision on each pumping cycle due to stick-slip of the piston inside the cartridge.
“The reason for this combination is that, from experience piston pumps are very accurate on the average delivered volume but may lack precision on each pumping cycle due to the stickslip of the piston inside the cartridge.”
The authors state this as an assumption.
Micro-pumps are very precise on each delivery cycle, but if not calibrated correctly, will cumulate error and result in less accuracy of the volume injected on the long run.
“On the other hand, micro-pumps are assumed to be very precise on each delivery cycle, but, if not calibrated correctly, will cumulate the error and thus result in less accuracy of the volume injected on the long run.”
The paper relies on this without support.
Despite differences in test setup, the results from previous studies of other pumps are comparable enough to support the conclusion that the prototype's deviations and ODT are similar or better.
“Comparability to data of previous studies is limited because of differences in the test setup (eg, a smaller number of individual pumps used and fewer repetitions performed).”
“However, the results of this investigation showed that deviations from target were similar or lower compared to other patch pumps currently available on the market and that have been tested in a similar experimental setting. 7,8”
The paper relies on this without support.
This was the first accuracy evaluation study with this insulin pump prototype.
“This was the first accuracy evaluation study with this insulin pump which is currently under development.”
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
Each contradiction between two passages listed here was confirmed by an independent check.
Abstract says all occlusions were detected in less than 30 minutes
MinorThe abstract says detection occurred in less than 30 minutes at both basal rates, but the reported maximum at 0.1 U/h was 30 minutes.
“Occlusion detection occurred in less than 30 minutes with both basal rates.”
“Minimum and maximum ODT were 28 minutes and 30 minutes at a BR of 0.1 U/h and 8 minutes and 18 minutes at a BR of 1.0 U/h, respectively.”
Cites
Patch Pumps: Are They All the Same?
Heinemann, L., Waldenmaier, D., Kulzer, B., Ziegler, R., Ginsberg, B. H., & Freckmann, G. (2018) · Journal of Diabetes Science and Technology · doi:10.1177/1932296818795150 · Cited by 37 · see citing works
Self-citationKamecke, U., Waldenmaier, D., Haug, C., Ziegler, R., & Freckmann, G. (2019) · Journal of Diabetes Science and Technology · doi:10.1177/1932296818788349 · Cited by 25 · see citing works
Self-citationOcclusion Detection Time in Insulin Pumps at Two Different Basal Rates
Freckmann, G., Kamecke, U., Waldenmaier, D., Haug, C., & Ziegler, R. (2018) · Journal of Diabetes Science and Technology · doi:10.1177/1932296817750404 · Cited by 18 · see citing works
Self-citationDosing Accuracy of Insulin Aspart FlexPens after Transport through the Pneumatic Tube System
Ward, L. G., Heckman, M. G., Warren, A. I., et al. (2012) · Hospital Pharmacy · doi:10.1310/hpj4801-33 · Cited by 12 · see citing works
Evaluation of the Accuracy of Current Tubeless Pumps for Continuous Subcutaneous Insulin Infusion
Ziegler, R., Oliver, N., Waldenmaier, D., Mende, J., Haug, C., & Freckmann, G. (2021) · Diabetes Technology & Therapeutics · doi:10.1089/dia.2020.0525 · Cited by 11 · see citing works
Self-citationDescription of a Novel Patch Pump for Insulin Delivery and Comparative Accuracy Evaluation
Baumstark, A., Mende, J., Uchiyama, J., Haug, C., & Freckmann, G. (2022) · Journal of Diabetes Science and Technology · doi:10.1177/19322968211000441 · Cited by 5 · see citing works
Self-citationKochar, I. S., Sethi, A., & Ramachandran, S. (2020) · Dubai Diabetes and Endocrinology Journal · doi:10.1159/000507391 · Cited by 2 · see citing works
Flagged first, then by citations
Cited by
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Islam, M. T., Hasan, M. W., Hassan, M. F., & Çeşmeci, Ş. (2024) · Pharmaceutics · doi:10.3390/pharmaceutics16070944 · Cited by 39 · see citing works
- Authors
- Mende, J., Baumstark, A., Waldenmaier, D., Amirouche, A., Barraud, A., Fridez, P., Haug, C., & Freckmann, G.
- Affiliations
- Universität Ulm (DE)
- AMF Medical SA, Ecublens, Switzerland
- Corresponding author
- Mende, Jochen
- Venue
- Journal of Diabetes Science and Technology
- Publisher
- SAGE Publications
- Published
- 2022-05-20
- Volume
- 17
- Issue
- 6
- Pages
- 1644-1648
- ISSN
- 1932-2968 (ISSN-L)
- PMC
- PMC10658680
- OpenAlex
- W4281257499
- Cited by
- 1
- References
- 7
- Citations by year
- 2024: 1
- FWCI
- 0.15
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Journal of Diabetes Science and Technology (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (submittedVersion)
- Funders
- AMF Medical SA
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Physical Sciences › Engineering › Biomedical Engineering › Intravenous Infusion Technology and Safety
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmaceutical Science › Advancements in Transdermal Drug Delivery
- Keywords
- occlusion detection, insulin delivery, pump prototype
- MeSH terms
- Humans, Hypoglycemic Agents, Insulin, Insulin Infusion Systems, Transdermal Patch, Insulin, Regular, Human
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.
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Classified by jev-1.13-20260917 (gold-guideline-v0.2) on 2026-10-13.
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Statistics and arithmetic are recomputed, not judged.
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