Bench-Side Dose Accuracy of an Open-Source Ultra-Low-Cost Insulin-Pump, With Testing Conducted to IEC 60601-2-24
Open accessAbstract
With the prevalence of diabetes higher than ever, governments and people with diabetes are facing significant treatment and indirect costs associated with managing their condition. An ultra-low-cost insulin pump is a possible solution to improving health disparities. This article presents test results for an insulin-pump built from low-cost components (bill of materials < $US100). All testing was completed in accordance with IEC60601-2-24, and results were benchmarked against a commercial pump. Results showed the ultra-low-cost pump has comparable accuracy to the commercially available insulin pump with testing displaying an overall accuracy of 0.089% and −0.392%, respectively. These results show that an ultra-low-cost pump can accurately deliver insulin in limited bench testing. Testing in other environments and scenarios is required to fully meet IEC60601-2-24 standards.
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Written from the paper’s full text.
TL;DR
An open-source ultra-low-cost insulin pump (bill of materials < US$100) was bench-tested to IEC 60601-2-24 and showed comparable dose accuracy to a commercial Medtronic 640G, with overall basal accuracy of 0.089% vs −0.392%, respectively. The authors conclude the accuracy is promising but limited by single-device bench testing and the need for further testing.
Key findings
- Basal testing: the ultra-low-cost pump had an overall accuracy of 0.089% and variability of 24%; the commercial pump had an overall accuracy of −0.392% and maximum variability of 44%.
- Bolus testing per IEC 60601-2-24: for 0.025 U, the ultra-low-cost pump delivered a mean of 0.029 U (+16.00% deviation) vs commercial 0.021 U (−16.00%); for 1 U, 1.018 U (+1.82%) vs 0.9818 U (−1.824%); for 5 U, 5.12 U (+2.4%) vs 4.98 U (+0.4%).
- The ultra-low-cost pump showed <1% error over the 930-minute testing schedule and tended to over-deliver at all bolus sizes; the commercial pump results were similar to previous literature, supporting the test methodology.
Methods
- The ultra-low-cost, open-source pump used a stepper motor and plunger to compress an insulin cartridge, standard consumables, a 3D printed case, and a total bill of materials < US$100; it was benchmarked against an in-warranty Medtronic 640G.
- Bench testing followed IEC 60601-2-24 Sections 50.104 (basal) and 50.106 (bolus), using a Mettler Toledo XP105 microscale with 5 decimal places, degassed class III water, a <3 mm paraffin oil layer, and a full standard infusion set and cannula without site hub.
- Basal rate was 1 U/h; a 180 U cartridge and 5 U maximum bolus were used, with 5-minute settling and scale reset between boluses; results were presented as trumpet curves and box-and-whisker plots, with bolus data processed per IEC 60601-2-24.
Limitations
- Stated: only a single ultra-low-cost pump and a single commercial pump were tested; production-line variability, interval sampling for quality control, and accuracy changes over a typical 4-year in-warranty lifespan were not addressed.
- Stated: full comparison to manufacturer accuracy was not possible because the commercial pump’s trumpet curve was not presented as required by the standard and no test methodology was given; the microscale had a maximum possible error of ±5.6% for a 0.025 U dose, the ultra-low-cost pump was calibrated using the same scale used for testing, and feedback control and other safety systems were not yet implemented.
- Evident: testing was bench-only and did not assess in-vivo or clinical performance; the abstract notes that testing in other environments and scenarios is required to fully meet IEC 60601-2-24 standards.
Model-written summary. Check it against the paper before relying on it.
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Cites
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Claims the paper makes
0 of 28 cited sources checked · 0 supported · 0 flagged
- Findingown data§ Discussion
The ultra-low-cost insulin pump delivered insulin with an error of less than 1% over the 930-minute testing schedule.
“The ultra-low-cost insulin pump demonstrated a high level of accuracy in insulin delivery, with an error of <1% over the 930-minute testing schedule.”
- Also stated in: § Conclusions · boosted
“The ultra-low-cost insulin-pump design demonstrated positive accuracy results.”
Quote in the paperSubstantial claim - Also stated in: § Conclusions · boosted
- Findingown data§ Discussion
Delivery of the very small 0.025 U boluses had the most variability, in both the test and the commercial insulin pump.
“It was observed that the delivery of the very small 0.025 U boluses had the most variability, in both the test and commercial insulin pump.”
Quote in the paperNot a substantial claim - Findingown data§ Abstract
The ultra-low-cost insulin pump is built from low-cost components with a total bill of materials of less than $US100.
“This article presents test results for an insulin-pump built from low-cost components (bill of materials < $US100).”
- Also stated in: § Methods · plain
“The total bill of materials is less than $US100 at this writing.”
Quote in the paperSubstantial claim - Also stated in: § Methods · plain
- Findingreasoning§ Discussion
The maximum possible error of the measurement is ±5.6% for a 0.025 U dose.
“The maximum possible error when is therefore ±5.6% for a 0.025 U dose. 27”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [27] 27. Chemeurope. Weighing in the US Pharmacopeia: minimum weight and routine testing according general chapters 41 and 1251. https://q-more.chemeurope.com/q-more-articles/296/weighing-in-the-us-pharmacopeia.html. Published 2019. Accessed July 15, 2022. Articles from Journal of Diabetes Science and Technology are provided here courtesy of Diabetes Technology Society
Queued — the background check reaches it, usually within a day.
- Findingown data§ Discussion
The low-cost insulin pump has shown a tendency to over-deliver at all bolus sizes.
“The low-cost insulin pump has shown a tendency to over deliver at all bolus sizes (Figures 5-7).”
Quote in the paperSubstantial claim
- Interpretationcitation§ Discussion
The measured dose inaccuracy may not be significant in much of the population.
“suggesting this dose inaccuracy may not be significant in much of the population”
Quote in the paperNot a substantial claim - Interpretationcitation§ Discussion
For smaller children there may be added risk from the measured dose inaccuracy.
“but for smaller children there may be added risk.”
Quote in the paperNot a substantial claim - Premisecitation§ Discussion
An in-silico study found that an increased dose of 0.1 U affected blood glucose by 12.6 mg/dl in only 5% of the population.
“an in-silico study examining the insulin required to change blood glucose in children found an increased dose of 0.1 U affected blood glucose by 12.6 mg/dl in only 5% of the population, 26”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [26] 26. Campos-Náñez E, Layne JE, Zisser HC. In silico modeling of minimal effective insulin doses using the UVA/PADOVA type 1 diabetes simulator. J Diabetes Sci Technol. 2018;12(2):376-380. doi: 10.1177/1932296817735341. [DOI] [PMC free article] [PubMed] [Google Scholar] source
Checked before — its earlier verdict is held back until a new check runs.
- Study design and conductnone given§ Discussion
The main limitation of this investigation is that only a single ultra-low-cost pump and a single commercial pump were tested.
“The main limitation of this investigation is only a single ultra-low-cost pump and commercial pump were tested.”
Quote in the paperNot a substantial claim - Interpretationown data§ Abstract
An ultra-low-cost pump can accurately deliver insulin in limited bench testing.
“These results show that an ultra-low-cost pump can accurately deliver insulin in limited bench testing.”
Quote in the paperSubstantial claim
- May combine two claims. 18
- Classified as probably not a substantial claim. 20
May combine two claims.
Findingown data§ DiscussionThe ultra-low-cost pump's accuracy results were similar to those of the commercial pump, except that the test pump showed less variability.
“Results were similar to those observed with a commercial pump, except the test pump showed less variability.”
- Also stated in: § Abstract · plain
“Results showed the ultra-low-cost pump has comparable accuracy to the commercially available insulin pump with testing displaying an overall accuracy of 0.089% and −0.392%, respectively.”
Quote in the paperSubstantial claim- Also stated in: § Abstract · plain
May combine two claims.
Findingown data§ ResultsThe commercial pump displayed an overall accuracy of −0.392% and a maximum variability of 44% in basal testing.
“The commercial pump displays an overall accuracy of −0.392%, and a maximum variability of 44%.”
Quote in the paperSubstantial claimMay combine two claims.
Findingown data§ ResultsThe ultra-low-cost insulin pump showed an overall accuracy of 0.089% and a variability of 24% in basal testing.
“The ultra-low-cost insulin pump shows an overall accuracy of 0.089% and a variability of 24%.”
Quote in the paperSubstantial claimMay combine two claims.
Findingreasoning§ DiscussionThe accuracy of the microscale would be unlikely to affect results significantly for 1 U and 5 U boluses, with a maximum error of 0.14% and 0.028%, respectively.
“The accuracy of the microscale would be unlikely to affect results significantly for 1 U and 5 U boluses, with a maximum error of 0.14% and 0.028%, respectively.”
Quote in the paperNot a substantial claimMay combine two claims.
Study design and conductcitation§ DiscussionThe commercial pump results are validated by using the same methodology and providing similar overall results to previous literature, reinforcing that the testing methodology used was robust.
“Results obtained for the commercial pump are validated by using the same methodology and providing similar overall results to those in previous literature, 20 reinforcing the testing methodology used was robust.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [20] 20. Freckmann G, Kamecke U, Waldenmaier D, Haug C, Ziegler R. Accuracy of bolus and basal rate delivery of different insulin pump systems. Diabetes Technol Ther. 2019;21:201-208. doi: 10.1089/dia.2018.0376. [DOI] [PMC free article] [PubMed] [Google Scholar] source
Checked before — its earlier verdict is held back until a new check runs.
Probably not a substantial claim: may not pass S2 (checkable), S4 (based).
Premisenone given§ IntroductionFor an ultra-low-cost insulin pump to be viable, it must offer acceptable accuracy for clinical use.
“For an ultra-low-cost insulin pump to be viable, it must offer acceptable accuracy for clinical use.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Premisecitation§ IntroductionPacific and Māori peoples are reported to have the lowest median weekly income.
“With Pacific and Māori peoples reported to have the lowest median weekly income”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [10] 10. Stats New Zealand. Labour market statistics (income): June2018 quarter. https://www.stats.govt.nz/information-releases/labour-market-statistics-income-june-2018-quarter. Published 2018. Accessed July 8, 2022.
Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Study design and conductnone given§ MethodsThe class III water was degassed before use, ensuring consistency between tests.
“The class III water was degassed before use, ensuring consistency between tests.”
Quote in the paperNot a substantial claimClassified as probably not a substantial claim.
Premisecitation§ IntroductionDiabetes disproportionately affects those least able to afford care.
“diabetes disproportionally affects those least able to afford care.8,10 -12”
Quote in the paperSubstantial claim0 of 3 sources checked- cites [8] 8. Holder-Pearson L, Chase JG. Socio-economic inequity: diabetes in New Zealand. Front Med (Lausanne). 2022;9:756223. [DOI] [PMC free article] [PubMed] [Google Scholar] source
Checked before — its earlier verdict is held back until a new check runs.
- cites [10] 10. Stats New Zealand. Labour market statistics (income): June2018 quarter. https://www.stats.govt.nz/information-releases/labour-market-statistics-income-june-2018-quarter. Published 2018. Accessed July 8, 2022.
Not checked in the free run.
- cites [11] 11. McKergow E, Parkin L, Barson D, Sharples K, Wheeler B. Demographic and regional disparities in insulin pump utilization in a setting of universal funding: a New Zealand nationwide study. Acta Diabetol. 2017;54:63-71. doi: 10.1007/s00592-016-0912-7. [DOI] [PubMed] [Google Scholar] source
Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Premisecitation§ IntroductionContinuous subcutaneous insulin infusion is associated with improved clinical outcomes in both type 1 diabetes and insulin-dependent type 2 diabetes.
“Continuous subcutaneous insulin infusion is associated with improved clinical outcomes in both type 1 diabetes (T1D)2 -4 and insulin-dependent type 2 diabetes (T2D).5,6”
Quote in the paperNot a substantial claim0 of 3 sources checked- cites [2] 2. Steineck I, Cederholm J, Eliasson B, et al. Insulin pump therapy, multiple daily injections, and cardiovascular mortality in 18 168 people with type 1 diabetes: observational study. BMJ. 2015;350:h3234. doi: 10.1136/bmj.h3234. [DOI] [PMC free article] [PubMed] [Google Scholar] source
Queued — the background check reaches it, usually within a day.
- cites [3] 3. Karges B, Schwandt A, Heidtmann B, et al. Association of insulin pump therapy vs insulin injection therapy with severe hypoglycemia, ketoacidosis, and glycemic control among children, adolescents, and young adults with type 1 diabetes. JAMA. 2017;318:1358-1366. doi: 10.1001/jama.2017.13994. [DOI] [PMC free article] [PubMed] [Google Scholar] source
Queued — the background check reaches it, usually within a day.
- cites [4] 4. Auzanneau M, Karges B, Neu A, et al. Use of insulin pump therapy is associated with reduced hospital-days in the long-term: a real-world study of 48,756 pediatric patients with type 1 diabetes. Eur J Pediatr. 2021;180(2):597-606. doi: 10.1007/s00431-020-03883-2. [DOI] [PMC free article] [PubMed] [Google Scholar] source
Queued — the background check reaches it, usually within a day.
May combine two claims.
Premisecitation§ IntroductionFor the commercial pump used in this study, the manufacturer states an accuracy of ±20% for boluses less than 0.1 U and ±5% for all other boluses and basal rates.
“For the commercial pump used in this study, the manufacturer states an accuracy of ±20% for boluses less than 0.1 U and ±5% for all other boluses and basal rates, 18”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [18] 18. Medtronic. Minimed 640G system user guide. Date unknown. https://hcp.medtronic-diabetes.com.au/sites/default/files/minimed-640g-system-user-guide-mmol.pdf. Accessed July 18, 2022.
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
May combine two claims.
Premisecitation§ DiscussionZiegler et al. showed an over-delivery of 9.1% on average, with only 70.7% of doses delivered within ±15%, with the same commercial pump at 0.1 U increments.
“Ziegler et al 24 showed an over-delivery of 9.1% on average, with only 70.7% of doses delivered within ±15% with the same commercial pump at 0.1 U increments.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [24] 24. Ziegler R, Waldenmaier D, Kamecke U, Mende J, Haug C, Freckmann G. Accuracy assessment of bolus and basal rate delivery of different insulin pump systems used in insulin pump therapy of children and adolescents. Pediatr Diabetes. 2020;21(4):649-656. doi: 10.1111/pedi.12993. [DOI] [PubMed] [Google Scholar] source
Classified as probably not a substantial claim. May combine two claims.
Study design and conductcitation§ Methods1 U/h was chosen as a suitable basal rate to evaluate accuracy, having been used in other studies.
“Therefore, 1 U/h was chosen as a suitable basal rate to evaluate accuracy. In addition, it has been used in other studies.20,24”
Quote in the paperSubstantial claim0 of 2 sources checked- cites [20] 20. Freckmann G, Kamecke U, Waldenmaier D, Haug C, Ziegler R. Accuracy of bolus and basal rate delivery of different insulin pump systems. Diabetes Technol Ther. 2019;21:201-208. doi: 10.1089/dia.2018.0376. [DOI] [PMC free article] [PubMed] [Google Scholar] source
Checked before — its earlier verdict is held back until a new check runs.
- cites [24] 24. Ziegler R, Waldenmaier D, Kamecke U, Mende J, Haug C, Freckmann G. Accuracy assessment of bolus and basal rate delivery of different insulin pump systems used in insulin pump therapy of children and adolescents. Pediatr Diabetes. 2020;21(4):649-656. doi: 10.1111/pedi.12993. [DOI] [PubMed] [Google Scholar] source
May combine two claims.
Premisecitation§ IntroductionThe IEC testing standard does not specify minimum accuracy, specifying only how data should be collected.
“The International Electrotechnical Commission (IEC) testing standard does not specify minimum accuracy, specifying only how data should be collected. 17”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [17] 17. Standards New Zealand. IEC 60601-2-24:2012. https://www.standards.govt.nz/shop/iec-60601-2-242012/. Published October 2012. Accessed November 19, 2022.
Not checked in the free run.
Classified as probably not a substantial claim.
Study design and conductcitation§ MethodsThe pump was tested using the methodology given in IEC60601-2-24, Sections 50.104 (basal testing) and 50.106 (bolus testing).
“The pump was tested using methodology given in IEC60601-2-24 (IEC60601-2-24), Sections 50.104 (basal testing), and 50.106 (bolus testing). 17”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [17] 17. Standards New Zealand. IEC 60601-2-24:2012. https://www.standards.govt.nz/shop/iec-60601-2-242012/. Published October 2012. Accessed November 19, 2022.
Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing).
Premisecitation§ IntroductionIn New Zealand, the greatest diabetes prevalence is seen in Māori, Pacific, and Indo-Asian ethnic groups.
“In New Zealand, the greatest diabetes prevalence is seen in Māori, Pacific, and Indo-Asian ethnic groups. 9”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [9] 9. Health Quality & Safety Commission New Zealand. Diabetes. Date unknown. https://www.hqsc.govt.nz/our-programmes/health-quality-evaluation/projects/atlas-of-healthcare-variation/diabetes/. Accessed July 20, 2021.
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
Probably not a substantial claim: may not pass S3 (load-bearing).
Premisecitation§ IntroductionInsulin-pump therapy (continuous subcutaneous insulin infusion) is considered the best available treatment method for insulin-dependent diabetes.
“Insulin-pump therapy, or continuous subcutaneous insulin infusion is considered the best available treatment method for insulin-dependent diabetes. 1”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [1] 1. Seidinova A, Ishigov I, Peyami C, Seidinov S. [EFFECTIVENESS OF PUMP INSULIN THERAPY IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS (REVIEW)]. Georgian Med News. 2018(284):51-55. [PubMed] [Google Scholar]
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Study design and conductcitation§ MethodsA 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”
Quote in the paperNot a substantial claim0 of 3 sources checked- cites [20] 20. Freckmann G, Kamecke U, Waldenmaier D, Haug C, Ziegler R. Accuracy of bolus and basal rate delivery of different insulin pump systems. Diabetes Technol Ther. 2019;21:201-208. doi: 10.1089/dia.2018.0376. [DOI] [PMC free article] [PubMed] [Google Scholar] source
Checked before — its earlier verdict is held back until a new check runs.
- cites [22] 22. 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. doi: 10.1177/1932296818788349. [DOI] [PMC free article] [PubMed] [Google Scholar] source
Not checked in the free run.
- cites [23] 23. 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. J Diabetes Sci Technol. 2014;8(6):1133-1141. doi: 10.1177/1932296814543946. [DOI] [PMC free article] [PubMed] [Google Scholar] source
May combine two claims.
Premisecitation§ IntroductionHigh initial purchase costs and ongoing costs for consumables mean insulin pump technology is underutilized.
“High initial purchase costs and ongoing costs for consumables ($NZ8800-$NZ10,000, $NZ2340, respectively) 7 mean this technology is underutilized.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [7] 7. Pharmac New Zealand Government. Insulin pump. Date unknown. https://schedule.pharmac.govt.nz/ScheduleOnline.php?osq=Insulinpump&code=C0115123968. Accessed August 3, 2022.
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
Classified as probably not a substantial claim.
Interpretationreasoning§ IntroductionAcceptable accuracy is judged by comparison to commercially available models and accuracy parameters provided by manufacturers and FDA regulatory documents.
“Therefore, acceptable accuracy is by comparison to commercially available models and accuracy parameters provided by manufacturers and the U.S. Food and Drugs Administration (FDA) regulatory documents.”
Quote in the paperSubstantial claimClassified as probably not a substantial claim. May combine two claims.
Premisecitation§ IntroductionThe Summary of Safety and Effectiveness Datasheet for the commercial pump states all hourly intervals should be within ±5%, with a cumulative error no greater than ±10%.
“while the Summary of Safety and Effectiveness Datasheet states all hourly intervals should be within ±5%, with a cumulative error no greater than ±10%. 19”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [19] 19. Food and Drug Administration. Summary of safety and effectiveness datasheet (SSED). www.accessdata.fda.gov/cdrh_docs/pdf15/P150001b.pdf. Published 2016. Accessed November 4, 2022.
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).
Study design and conductnone given§ MethodsUsing a full standard infusion-set and cannula without the site hub removed ensures results are comparable to use in-vivo.
“The use of a full standard infusion-set and cannula without site hub removed ensures results are comparable to use in-vivo.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Premisecitation§ DiscussionPercentage errors are known to increase with smaller dose sizes.
“Percentage errors are known to increase with smaller dose sizes23 -25”
Quote in the paperNot a substantial claim0 of 3 sources checked- cites [23] 23. 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. J Diabetes Sci Technol. 2014;8(6):1133-1141. doi: 10.1177/1932296814543946. [DOI] [PMC free article] [PubMed] [Google Scholar] source
- cites [24] 24. Ziegler R, Waldenmaier D, Kamecke U, Mende J, Haug C, Freckmann G. Accuracy assessment of bolus and basal rate delivery of different insulin pump systems used in insulin pump therapy of children and adolescents. Pediatr Diabetes. 2020;21(4):649-656. doi: 10.1111/pedi.12993. [DOI] [PubMed] [Google Scholar] source
- cites [25] 25. Laubner K, Singler E, Straetener J, Siegmund T, Päth G, Seufert J. Comparative dose accuracy of durable and patch insulin pumps under laboratory conditions. Diabetes Technol Ther. 2019;21(7):371-378. doi: 10.1089/dia.2019.0089. [DOI] [PubMed] [Google Scholar] source
Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Study design and conductcitation§ DiscussionFull comparison to manufacturer-provided accuracy results is not possible because the given trumpet curve is not presented as required by the unit standard and no description of test methodology is given.
“Full comparison to manufacturer provided accuracy results is not possible because the given trumpet curve is not presented as required by the unit standard and no description of test methodology is given. 18”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [18] 18. Medtronic. Minimed 640G system user guide. Date unknown. https://hcp.medtronic-diabetes.com.au/sites/default/files/minimed-640g-system-user-guide-mmol.pdf. Accessed July 18, 2022.
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based). May combine two claims.
Study design and conductreasoning§ DiscussionThe commercial pump used in this study was not brand new but was within warranty and would be expected to perform within the manufacturer's stated accuracy parameters.
“Whilst the commercial pump used in this study was not brand new, the device was within warranty and would be expected to perform within the manufacturer’s stated accuracy parameters.”
Quote in the paperNot a substantial claim- Rests on an assumption: The in-warranty commercial pump used as the benchmark performs within the manufacturer's stated accuracy parameters.
Probably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing), S4 (based).
Interpretationnone given§ DiscussionThere is likely to be variability between pumps from any production line.
“There is likely to be variability between pumps from any production line”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Interpretationreasoning§ DiscussionThe effect of a low-cost insulin pump on pump cost and equity of access to care varies depending on where it is used.
“In terms of pump cost, and equity of access to care, the effect of a low-cost insulin pump varies depending on where it is used.”
Quote in the paperNot a substantial claimMay combine two claims.
Study design and conductnone given§ DiscussionThe microscale used for testing had a readability of 0.01 mg and a repeatability of 0.007 mg, meeting the IEC standard requirements.
“The microscale used for testing had a readability of 0.01 mg, and a repeatability of 0.007 mg, meeting the IEC standard requirements.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Premisecitation§ DiscussionIn countries such as New Zealand, insulin costs are low, with a vial costing between NZ$25 and NZ$45.
“In countries such as New Zealand, insulin costs are low, with a vial costing between NZ$25 and NZ$45. 7”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [7] 7. Pharmac New Zealand Government. Insulin pump. Date unknown. https://schedule.pharmac.govt.nz/ScheduleOnline.php?osq=Insulinpump&code=C0115123968. Accessed August 3, 2022.
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based). May combine two claims.
Interpretationreasoning§ DiscussionThe accuracy of the ultra-low-cost pump was calibrated using the same scale used for testing, which could explain why the overall accuracy of this pump is closer to the set value.
“Finally, the accuracy of the ultra-low-cost pump was calibrated using the same scale used for testing, which could explain why the overall accuracy of this pump is closer to the set value.”
Quote in the paperNot a substantial claim
The paper relies on this without support.
The in-warranty commercial pump used as the benchmark performs within the manufacturer's stated accuracy parameters.
“Whilst the commercial pump used in this study was not brand new, the device was within warranty and would be expected to perform within the manufacturer’s stated accuracy parameters.”
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Vigersky, R. A., Huang, S., Cordero, T. L., Shin, J., Lee, S. W., Chhabra, H., Kaufman, F. R., & Cohen, O. (2018) · Endocrine Practice · doi:10.4158/ep-2017-0234 · Cited by 43 · see citing works
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(2019) · doi:10.1089/dia.2018.0376 · Cited by 35 · see citing works
Socio-Economic Inequity: Diabetes in New Zealand
Holder-Pearson, L., & Chase, J. G. (2022) · Frontiers in Medicine · doi:10.3389/fmed.2022.756223 · Cited by 32 · see citing works
Self-citationChlup, R., Runzis, S., Castañeda, J., Lee, S. W., Nguyen, X., & Cohen, O. (2017) · Diabetes Technology & Therapeutics · doi:10.1089/dia.2017.0283 · Cited by 30 · see citing works
Kamecke, 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
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Design of an open source ultra low cost insulin pump
Payne, M., Pooke, F., Fulton, H., Shaw, H., Coulson, T., Knopp, D. J., Holder-Pearson, L. R., Campbell, J. D., & Chase, J. G. (2022) · HardwareX · doi:10.1016/j.ohx.2022.e00375 · Cited by 11 · see citing works
Self-citation(2021) · doi:10.1007/s00431-020-03883-2 · Cited by 10 · see citing works
[EFFECTIVENESS OF PUMP INSULIN THERAPY IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS (REVIEW)].
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Ultra-Low-Cost Insulin Pump V2
(2022) · Mendeley · doi:10.17632/xb4tykn5gd.1
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Sorted by citations
Daniell, H., SINGH, R. K., Mangu, V., Nair, S. K., Wakade, G., & Balashova, N. V. (2023) · Biomaterials · doi:10.1016/j.biomaterials.2023.122142 · Cited by 38 · see citing works
A DIY ‘bionic pancreas’ is changing diabetes care — what's next?
Drew, L. (2023) · Nature · doi:10.1038/d41586-023-02648-9 · Cited by 6 · see citing works
Single-arm, first-in-human feasibility study results for an ultra-low-cost insulin pump
Payne, M., Pooke, F., Wilkinson, T. M., Holder-Pearson, L. R., Chamberlain, B., de Bock, M. I., & Chase, J. G. (2024) · BMC Endocrine Disorders · doi:10.1186/s12902-024-01652-y · Cited by 3 · see citing works
Self-citationLow-cost, low-power, clockwork syringe pump
Pooke, F., Payne, M., Holder-Pearson, L. R., Heaton, D., Campbell, J. D., & Chase, J. G. (2023) · HardwareX · doi:10.1016/j.ohx.2023.e00469 · Cited by 1 · see citing works
Self-citationMora, J. E. G., & Rivadeneira, P. S. (2025) · SN Computer Science · doi:10.1007/s42979-025-03846-0 · Cited by 1 · see citing works
Mora, J. E. G., Arbeláez-Córdoba, N., Balcázar, N., & Rivadeneira, P. S. (2025) · Journal of Diabetes Investigation · doi:10.1111/jdi.70072 · Cited by 1 · see citing works
Improving Energy Management in Artificial Pancreas Using an Event-Trigger MPC Strategy
Mora, J. E. G., & Rivadeneira, P. S. (2024) · Communications in computer and information science · doi:10.1007/978-3-031-74595-9_12
Mora, J. E. G., & Rivadeneira, P. S. (2025) · e-Prime - Advances in Electrical Engineering Electronics and Energy · doi:10.1016/j.prime.2025.100988
Transformations in Diabetes Care: Lessons From Commons‐Based, Peer‐Produced Citizen Science
O’Donnell, S., & Quigley, M. (2026) · Sociology of Health & Illness · doi:10.1111/1467-9566.70140
- Authors
- Payne, M., Pooke, F., Holder-Pearson, L., Chase, J. G., de Bock, M., Campbell, J., & Knopp, J.
- Affiliations
- University of Canterbury (NZ)
- Department of Paediatrics, University of Otago, Christchurch, New Zealand
- Corresponding author
- Payne, Matthew
- ORCID
- Venue
- Journal of Diabetes Science and Technology
- Publisher
- SAGE Publications
- Published
- 2022-12-08
- Volume
- 18
- Issue
- 3
- Pages
- 709-713
- ISSN
- 1932-2968 (ISSN-L)
- PMC
- PMC11089868
- OpenAlex
- W4310957490
- Cited by
- 9
- References
- 20
- Citations by year
- 2026: 1 · 2025: 3 · 2024: 2 · 2023: 3
- FWCI
- 1.48
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Journal of Diabetes Science and Technology (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- NZ National Science Challenge 7, Science for Technology and Innovation (2019-S3-CRS)
- University of Canterbury (Doctoral Scholarship)
- 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 › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
- Keywords
- insulin pump, open-source medical devices, dose accuracy, diabetes management, health disparities
- MeSH terms
- Equipment Design, Humans, Hypoglycemic Agents, Insulin, Insulin Infusion Systems
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.
Claims read by deepseek-v4.1-flash under definition version 3 (extract-v3) on 2026-11-06.
Classified by jev-1.13-20260917 (gold-guideline-v0.2) on 2026-11-06.
Statistics and arithmetic are recomputed, not judged.
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