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Cited by 6Diabetes Management and ResearchIntravenous Infusion Technology and SafetyPatient Safety and Medication Errors

Performance of a Continuous Subcutaneous Insulin Infusion (CSII) Pump With Acoustic Volume and Flow Sensing in Simulated High-Consequence Situations

Open access
Butterfield, Robert D., Sims, Nathaniel M.·2024·IEEE Open Journal of Engineering in Medicine and Biology
DOI 10.1109/ojemb.2024.3408092PMC PMC11329218
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Abstract

Goal: An insulin pump's failure to deliver insulin in the right amount at the right time is a preventable cause of hospitalization. We evaluated key performance metrics of a novel insulin pump that prevents “silent insulin non-delivery” caused by blockage, delivery of air and site leakage. This is accomplished via an acoustic sensor that measures the volume of insulin delivered with each pulse in real-time. Methods: We tested long and short-term flow accuracy, occlusion-detection time and pressure, and air management of the new device (ND) versus 3 U.S. commercial insulin pumps (CIPs) using standardized methods. Results: The ND outperformed CIPs on long-term basal flow rate error. Occlusion detection was 5 to 30 times faster depending on the basal rate and resulted in significantly lower (2 to 5x) pressures at time of occlusion. With air included in the drug reservoir, the tested CIPs can infuse air without detection, while the ND prevented air delivery without interruption. Conclusions: Bench tests of the ND versus 3 commercially available pumps showed improved occlusion detection and air management without flow performance tradeoffs. Additionally, the lower delivery pressure measured at time of occlusion suggests a substantially lower potential for site leakage at both basal and bolus rates. These enhancements combine to decrease the likelihood of silent insulin non-delivery.

AI snapshot

Written from the paper’s full text.

TL;DR

Bench testing compared a novel acoustic volume/flow-sensing insulin pump (ND) against three U.S. commercial insulin pumps (CIPs) in simulated high-consequence situations. The ND showed better long-term basal flow accuracy, faster occlusion detection at lower pressures, and prevented delivery of air introduced into the reservoir.

Key findings

  • Long-term basal flow rate error was lower for ND than CIPs; ND was the only pump with all errors less than ±5%. The greatest over-infusion was 21.4% at 0.1 U/h by OP, and the greatest under-infusion was 10% by MM at 0.1 U/h.
  • Occlusion detection by ND was 5 to 22.5 times faster than CIPs depending on basal rate, and pressure at occlusion was 2 to 5 times lower. At 12 U/h, mean occlusion pressures were ND 6.51 psi (6.39–6.59), OP 23.62 psi (18.07–32.98), MM 14.25 psi (14.02–14.55), and TD 20.77 psi (18.76–23.71).
  • With 0.2 mL air in the reservoir, OP, MM, and TD delivered air without alarm, while ND did not deliver air and did not alarm. In exploratory testing with 1.5 mL air in six NDs, none delivered air; each delivered the full fluid contents and then alarmed that the reservoir was empty.
  • Short-term PKCV variability at 0.1 U/h was similar for MM, TD, and ND at approximately 7%, while OP reached 15%; AAMI TIR101 considers 7% low/acceptable and 15% unfavorable for medications requiring titration.

Methods

  • Bench study comparing ND against Medtronic 600/700 series (MM; 3 devices), Tandem t:slim X2 (TD; 3 devices), and Insulet Omnipod (OP; 10 devices). Long- and short-term flow accuracy used U100 insulin at 0.1, 0.3, and 1.0 U/h, gravimetric measurement, and AAMI TIR101 methods including PKCV analysis; Table I reports 557 h for OP, 883 h for MM, 1649 h for TD, and 970 h for ND, with approximately 4145 hours analyzed.
  • Occlusion detection time was measured at 0.3–1.0 U/h using distilled water, a hemostat to create occlusion, and a stopwatch. Occlusion pressure was measured at 12 U/h with an inline calibrated pressure sensor. Air management was tested by replacing 0.2 mL of reservoir fluid with air, priming, orienting pumps to promote air migration to the outlet, and running at 15 U/h; an exploratory test used 1.5 mL air in six NDs.
  • Long-term flow rate error was computed by linear least-squares fit; short-term variability used a one-compartment pharmacokinetic model with a 60-minute half-life for rapid-acting insulin analog.

Limitations

  • The authors state that these preliminary results do not constitute a full suite of tests on multiple ND and CIP devices with sufficient duplicates for full statistical analysis, and that certain tests such as dynamic backpressure or head-height changes were not completed.
  • Evident from the text: testing was bench-only and did not measure clinical outcomes; occlusion and air tests used distilled water rather than insulin; flow accuracy testing was limited to constant basal delivery, though the authors argue results are extensible to bolus delivery.

Model-written summary. Check it against the paper before relying on it.

Integrity signals

Registry

Crossref · 10.1109/ojemb.2024.3408092

Cites

19 of 19 references verified0 citation errors · 0 not checkable

Statistics

Nothing to recompute.

Claims the paper makes

12 of 26 cited sources checked · 2 supported · 0 flagged · accuracy not yet measured

  • Premisecitation

    A recent analysis of MAUDE database narratives confirms that the most frequent pump alarms associated with adverse events are for occlusion or insulin flow blocked.

    “A recent analysis of MAUDE database narratives confirms that the most frequent pump alarms associated with adverse events are for “occlusion” or “insulin flow blocked” [11].”
    Quote in the paperSubstantial claim1 of 1 sources checked
  • Premisecitation

    Many of these AEs are classifiable as hazards by the 2010 FDA Office of Science and Engineering Laboratories (OSEL) hazard analysis framework.

    “Many of these AEs are classifiable as hazards by the 2010 FDA Office of Science and Engineering Laboratories (OSEL) hazard analysis framework [8].”
    Quote in the paperNot a substantial claim1 of 1 sources checked
    • cites [8] source

      The Preliminary Hazard Analysis (page unavailable) says the FDA/OSEL authors used FDA adverse-event reports to develop a generic insulin-pump hazard analysis and categorized hazardous situations. It does not establish that many of the particular AEs in the citing sentence are classifiable as hazards; it also distinguishes hazards from hazardous situations and causal events. (LLM, conf=0.81)

      Experimental — accuracy not yet measured
  • Premisecitation

    Device labeling warns that at clinically relevant insulin infusion rates, especially at the low basal flow rates for pediatric users, the detection of occlusion may not occur until after the onset of DKA.

    “Manufacturers are aware of the risks of SIND, and device labeling is replete with warnings that at clinically relevant insulin infusion rates, especially at the low basal flow rates for pediatric users, the detection of occlusion may not occur until after the onset of DKA [13].”
    Quote in the paperSubstantial claim1 of 1 sources checked
    • cites [13] source

      The Introduction (page not provided) says pumps can have accuracy problems at lower volumes and that occlusion can cause serious adverse events. The Discussion (page not provided) links occlusion to DKA and notes that alarms do not always warn of leakage or dislodgment. Neither passage says device labeling warns that occlusion detection at low pediatric basal rates may occur only after DKA begins. (LLM, conf=0.83)

      Experimental — accuracy not yet measured
  • Premisecitation

    Adverse events related to silent insulin non-delivery (SIND) are frequent for insulin pump users, with 40-50% of users experiencing one or more such adverse events per year.

    “Adverse events related to silent insulin non-delivery (SIND) are frequent occurrences for insulin pump users, with 40–50% of users experiencing one or more such adverse events per year [22].”
    Quote in the paperNot a substantial claim1 of 1 sources checked
    • cites [22] source

      The Results report that IIS failures were frequent, but 41.4% of respondents reported at least one failure per month, not per year; 96.6% reported at least one per year. The study measures broadly defined IIS failures rather than a separately counted category of SIND-related adverse events. (LLM, conf=0.88)

      Experimental — accuracy not yet measured
  • Premisecitation

    The most frequent pump alarms associated with adverse events in the FDA MAUDE database are for "occlusion" and "insulin flow blocked".

    “Adverse event analysis from the FDA MAUDE database confirms that the most frequent pump alarms associated with adverse events are for “occlusion” and “insulin flow blocked” [11].”
    Quote in the paperSubstantial claim1 of 1 sources checked
  • Classified as probably not a substantial claim. 18
  • May combine two claims. 22

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    Insulin pumps, particularly automated insulin delivery (AID) pumps which communicate with or incorporate continuous glucose monitoring systems (CGMs), are associated with a lower incidence of hospitalization for diabetic ketoacidosis (DKA) compared to those that rely on multiple daily injections.

    “Insulin pumps, particularly automated insulin delivery (AID) pumps which communicate with or incorporate continuous glucose monitoring systems (CGMs), are associated with numerous benefits, including a lower incidence of hospitalization for diabetic ketoacidosis (DKA) compared to those that rely on multiple daily injections [3].”
    Quote in the paperNot a substantial claim1 of 1 sources checked
    • cites [3] source

      The Diabetic Ketoacidosis section reports lower DKA event rates with pump therapy than with injection therapy in children, adolescents, and young adults with type 1 diabetes. It reports DKA events rather than hospitalization rates, and the Discussion says continuous glucose monitoring was not analyzed; the study therefore does not establish the claimed benefit particularly for AID pumps. (LLM, conf=0.90)

      Experimental — accuracy not yet measured

  • Classified as probably not a substantial claim. May combine two claims.

    Premisecitation

    Delayed detection and notification of occlusion without the user's awareness was highlighted as an operational source of hazardous situations, together with underdose due to presence of air replacing insulin in the reservoir or delivery path.

    “Delayed detection and notification of “occlusion without the user's awareness” was highlighted as an operational source of hazardous situations, together with underdose due to presence of air replacing insulin in the reservoir or delivery path—either of which can lead to hospitalization.”
    Quote in the paperSubstantial claim1 of 1 sources checked
    • cites [8] source

      Split into 2 atoms — 0 confirmed, 2 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.

      Experimental — accuracy not yet measured

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Premisecitation

    Device labeling warns that extreme care must be taken by the user to avoid introduction of air when filling the reservoir, and to be aware that outgassing of air can occur as insulin warms or when ambient pressure falls.

    “The labeling also warns that extreme care must be taken by the user to avoid introduction of air when filling the reservoir, and to be aware that outgassing of air can occur as insulin warms (e.g., after refrigerated storage) or when ambient pressure falls (e.g., air travel).”
    Quote in the paperNot a substantial claim1 of 1 sources checked
    • cites [13] source

      The Introduction discusses pump reservoirs and priming problems, and the Discussion reports instances of incorrect priming, but neither gives the claimed device-labeling warning. Searches for air entering the reservoir, outgassing as insulin warms, and falling ambient pressure found no passage addressing those points. (LLM, conf=0.73)

      Experimental — accuracy not yet measured

  • May combine two claims.

    Premisecitation

    The principal hazards are insulin overdose leading to hypoglycemia, and insulin underdose leading to DKA.

    “The principal hazards are insulin overdose leading to hypoglycemia, and insulin underdose leading to DKA.”
    Quote in the paperSubstantial claim1 of 1 sources checked
    • cites [8] source

      The Preliminary Hazard Analysis identifies overdose and underdose as the most likely hazardous situations in insulin pump use. It links overdose to hypoglycemia, but links underdose to hyperglycemia, not specifically to DKA; searches for “DKA” and “ketoacidosis” found no passage making that link. (LLM, conf=0.88)

      Experimental — accuracy not yet measured

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Premisecitation

    SIND and other operational issues with CIPs are a persistent socio-technical burden on persons with diabetes and on caregivers, prompting "burnout" and "consideration of pump discontinuation".

    “Survey data confirms that SIND and other operational issues with CIPs are a persistent socio-technical burden on persons with diabetes and on caregivers, prompting “burnout” and “consideration of pump discontinuation” [22].”
    Quote in the paperNot a substantial claim1 of 1 sources checked
    • cites [22] source

      The Conclusions (page unavailable) report that monthly insulin infusion site (IIS) failures were associated with stronger feelings of burnout and more frequent consideration of pump discontinuation. The Results include caregivers among survey respondents, but the paper does not establish that these outcomes occurred specifically among caregivers or that IIS failures caused them. Its survey concerns IIS failures, not other pump operational issues generally. (LLM, conf=0.85)

      Experimental — accuracy not yet measured

  • May combine two claims.

    Premisecitation

    SIND may occur as frequently as once per month and is detected more frequently by chemical measurement of (or by symptoms of) hyperglycemia or DKA than by pump alerts or alarms.

    “Survey data and pump downloads reveal that SIND may occur as frequently as once per month and is detected more frequently by chemical measurement of (or by symptoms of) hyperglycemia or DKA than by pump alerts or alarms [22], [23].”
    Quote in the paperSubstantial claim2 of 2 sources checked
    • cites [22] source

      The Results report that 41.4% of respondents experienced at least one infusion-site failure per month. Among those with a history of failure, first detection by glucometer or CGM (56.2%) or hyperglycemia symptoms (9.9%) was more common than detection by pump alarm (25.0%). The Conclusions state that DKA incidence was not collected, so this source does not support the DKA part of the claim. (LLM, conf=0.86)

      Experimental — accuracy not yet measured
    • cites [23] source

      The Discussion (page unavailable) says infusion-site leakage often goes unnoticed until hyperglycaemia is detected because current pumps lack leakage-detection alarms. It does not establish that SIND occurs once per month, report survey or pump-download findings, or compare detection by DKA symptoms with pump alerts across SIND events. (LLM, conf=0.83)

      Experimental — accuracy not yet measured

  • May combine two claims.

    Findingown data

    The lowest basal rate (0.1 U/h) had the largest long-term flow rate errors, with the exception that the ND had a slightly larger error at 0.3 U/h than at 0.1 U/h.

    “The lowest basal rate (0.1 U/h) had the largest errors, with one exception, in that ND had a slightly larger error at 0.3 U/h than at 0.1 U/h).”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    In all cases in the 1.5 mL air challenge, the ND did not deliver the air from the reservoir, and instead delivered the full fluid contents of the drug reservoir.

    “In all cases, the ND did not deliver the air from the reservoir, and instead delivered the full fluid contents of the drug reservoir.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    Pumps MM, TD, and ND produced similar short-term PKCV values that were larger (approximately 7%) at the lowest tested basal flow rate of 0.1 U/h.

    “pumps MM, TD, and ND produced similar CV values that were larger (approximately 7%) at the lowest tested basal flow rate of 0.1 U/h.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    All CIP pumps could be observed to infuse air without detection, while the ND prevented air in the reservoir from being delivered.

    “All CIP pumps could be observed to infuse air without detection while ND prevented air in the reservoir from being delivered.”
    • Also stated in: § Results · plain
      “The data shows OP, MM, and TD pumps were able to deliver the reservoir air, without interruption or alarm, until the reservoir was completely empty, whereas ND continued to deliver fluid uninterrupted, neither alarming nor delivering the air placed in the reservoir.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Premisecitation

    The ND provides rapid detection of insulin non-delivery due to delivery pathway occlusion, along with other advanced functionality.

    “The device provides rapid detection of insulin non-delivery due to delivery pathway occlusion, along with other advanced functionality as might be expected from the ability to automate adjustment of the volume and timing of insulin delivery pulses as required to manage blood glucose levels [18], [19].”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [18], [19]

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

  • May combine two claims.

    Interpretationown data

    Bench tests of the ND versus 3 commercially available pumps showed improved occlusion detection and air management without flow performance tradeoffs.

    “Bench tests of the ND versus 3 commercially available pumps showed improved occlusion detection and air management without flow performance tradeoffs.”
    Quote in the paperSubstantial claim
    • Rests on an assumption: The ND employs an acoustic sensor system to measure in real time the volume of insulin delivered with each delivery mechanism pulse.
    • Rests on an assumption: In other relevant aspects, the ND does not differ technically from currently available CIPs.

  • Classified as probably not a substantial claim. May combine two claims.

    Study design and conductcitation

    Long-term flow rate accuracy was computed using linear-least squares fit, and short-term variability was evaluated using the AAMI TIR101 PKCV method.

    “Long-term flow rate accuracy was computed using linear-least squares fit, and short-term variability was evaluated using the AAMI TIR101 “PKCV” method [20].”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [20] AAMI TIR101:2021 fluid delivery performance testing for infusion pumps

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

  • Classified as probably not a substantial claim.

    Study design and conductcitation

    Insulin flow at 0.1, 0.3, and 1.0 U/h from all 4 types of pumps was measured gravimetrically in alignment with AAMI test method TIR101 in an environmentally controlled test laboratory.

    “Insulin (U100) flow at 0.1, 0.3, and 1.0 U/h from all 4 types of pumps was measured gravimetrically in alignment with AAMI test method TIR101 in an environmentally controlled test laboratory located on a thick concrete ground floor at nominal office temperatures of 21+/−2 °C and ambient pressure of 99--102 kPa.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites AAMI TIR101

      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

    Continuous subcutaneous insulin infusion (CSII) pump therapy is an established standard of care for children and adults with Type 1 Diabetes.

    “Continuous subcutaneous insulin infusion (CSII) pump therapy, which maintains a “basal rate” of short-acting insulin in pulses delivered periodically through a tiny cannula inserted just under the skin, is an established standard of care for children and adults with Type 1 Diabetes [1], [2].”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [1], [2]

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

  • Classified as probably not a substantial claim.

    Premisecitation

    Literature cites silent insulin non-delivery as a longstanding, significant clinical and socio-technical concern for the diabetes community.

    “Literature cites this as a longstanding, significant clinical and socio-technical concern for the diabetes community [9], [10].”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [9], [10]

      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

    Since 2013, more than 2.6 million adverse events (AEs) have been reported for insulin pumps to the US FDA's Manufacturer and User Facility Device Experience (MAUDE) database.

    “Notwithstanding these benefits, since 2013, >2.6 million adverse events (AEs) have been reported for insulin pumps (FDA product codes LZG, OYC, OZO, OZP, QFG) to the US FDA's Manufacturer and User Facility Device Experience (MAUDE) database [5], [6], [7].”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [5], [6], [7]

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

  • Classified as probably not a substantial claim.

    Study design and conductnone given

    Calibrated analytic balances were used to acquire mass data once every ten seconds.

    “Calibrated analytic balances (Sartorius MCE2255-2S00-I, 0.00001 g resolution) were used to acquire mass data once every ten seconds.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    Current diabetes clinical management emphasizes user education, hypervigilance, and frequent manual and invasive blood glucose/ketone testing.

    “Current diabetes clinical management emphasizes user education, hypervigilance, and frequent manual and invasive blood glucose/ketone testing [14], [15], [16], [17].”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [14], [15], [16], [17]

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

  • Classified as probably not a substantial claim. May combine two claims.

    Study design and conductcitation

    Long and short-term flow accuracy, occlusion detection time/pressure, and air management capability were assessed for the ND, MM, TD, and OP following, where appropriate, AAMI standards, including PK-CV analysis.

    “Long and short-term flow accuracy, occlusion detection time/pressure, and air management capability were assessed for the ND, MM, TD, and OP following, where appropriate, Association for the Advancement of Medical Instrumentation (AAMI) standards [AAMI TIR101:2021 (TIR)], including PK-CV analysis, which includes a pharmacokinetic model with drug half-life (decay time) as a parameter.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites AAMI TIR101:2021

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

  • May combine two claims.

    Interpretationcitation

    Per the AAMI TIR101 guideline, the 7% short-term variation is considered low or acceptable, and the 15% level is unfavorable for medications requiring titration.

    “Comparing these results to the AAMI TIR101 guideline, the 7% variation is considered low or acceptable, and the 15% level unfavorable for medications requiring titration”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites AAMI TIR101

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

  • Probably not a substantial claim: may not pass S2 (checkable). May combine two claims.

    Interpretationreasoning

    These improvements advance the state of the art in drug delivery and may likely enable a future reduction in adverse events caused by SINDs.

    “These improvements advance the state of the art in drug delivery and may likely enable a future reduction in adverse events caused by SINDs.”
    Quote in the paperNot a substantial claim
    • Rests on an assumption: Bench-test performance differences between the ND and the CIPs translate into reduced clinical adverse events (SIND) in real-world use.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    Certain tests of performance, for example dynamic backpressure or head height changes, were not completed.

    “Certain tests of performance with, for example, dynamic backpressure, or head height changes, were not completed.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Interpretationown data

    The ND's acoustic volume measurement ability allows it to detect occlusions in the delivery path sooner and at much lower pressures than conventional CIP technology.

    “ND's unique acoustic volume measurement ability allows it to detect occlusions in the delivery path sooner and at much lower pressures than conventional CIP technology.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Interpretationown data

    The ND incorporates a substantial capacity for sequestering air that may be present in the drug reservoir, and provides reliable and appropriate detection of, and alarm notification for, air entering the delivery mechanism.

    “These additional exploratory results suggest the ND incorporates a substantial capacity for sequestering air that may be present in the drug reservoir, as well as provides reliable and appropriate detection of, and alarm notification for, air entering the delivery mechanism.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S4 (based). May combine two claims.

    Interpretationreasoning

    Although testing was limited to constant flow (basal delivery), the results are extensible to bolus delivery, in that a bolus may be considered a short-duration high basal rate.

    “Although testing was limited to characterization of constant flow (basal delivery), the results are extensible to bolus delivery, in that a bolus may be considered a short-duration high basal rate.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S4 (based). May combine two claims.

    Premisereasoning

    Because the risk of fluid loss due to site leakage increases with increased hydraulic pressure, the maximum pumping pressure experienced during a blockage can serve as a key indicator of the risk of fluid loss during a site blockage.

    “Since the risk of fluid loss due to site leakage logically increases with increased hydraulic pressure, the maximum pumping pressure experienced during a blockage can serve as a key indicator of the risk of fluid loss during a site blockage.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim. May combine two claims.

    Study design and conductown data

    Approximately 4145 hours of micro-gravimetric flow accuracy data were analyzed with respect to long-term flow rate error, and short-term-flow variability was computed using methods defined in AAMI TIR101.

    “Approximately 4145 hours of micro-gravimetric flow accuracy data were analyzed with respect to long-term flow rate error, and short-term-flow variability was computed using methods defined in AAMI TIR101.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites AAMI TIR101

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

  • May combine two claims.

    Interpretationown data

    The ND outperformed 3 legacy designs on long-term flow rate error, speed of occlusion detection, pressure at occlusion, and air management.

    “The ND outperformed 3 legacy designs on long-term flow rate error, speed of occlusion detection, pressure at occlusion, and air management.”
    Quote in the paperSubstantial claim

  • Classified as probably not a substantial claim. May combine two claims.

    Study design and conductnone given

    These preliminary results do not constitute a full suite of tests on multiple ND and CIP devices, with sufficient duplicates suitable for full statistical analysis.

    “These preliminary results do not constitute a full suite of tests on multiple ND and CIP devices, with sufficient duplicates suitable for full statistical analysis.”
    Quote in the paperSubstantial claim
30 of 30

  • The paper relies on this without support.

    The ND employs an acoustic sensor system to measure in real time the volume of insulin delivered with each delivery mechanism pulse.

    “The device under test, the FDA-cleared ND, employs an acoustic sensor system to measure in real time the volume of insulin delivered with each delivery mechanism pulse.”

  • The paper relies on this without support.

    In other relevant aspects, the ND does not differ technically from currently available CIPs.

    “In other relevant aspects, the ND does not differ technically from currently available CIPs.”

  • The paper relies on this without support.

    The underlying mechanical technology by which CIP manufacturers deliver insulin has not changed substantially in approximately 30 years.

    “Despite wide understanding of the burden of these hazards and adverse events, the underlying mechanical technology by which CIP manufacturers deliver insulin has not changed substantially in ∼30 years.”

  • The paper relies on this without support.

    Because CIPs cannot directly detect flow of insulin, indirect surrogate measures such as pressure or motor load are common technical strategies employed by CIP manufacturers to detect occlusion, but these secondary measures may fail to detect occlusion in a clinically relevant timeframe.

    “Because they cannot directly detect flow of insulin, indirect, surrogate measures (i.e., sensors for pressure or motor load) are common technical strategies employed by CIP manufacturers to detect occlusion, but these secondary measures may fail to detect occlusion in a clinically relevant timeframe.”

  • The paper relies on this without support.

    Bench-test performance differences between the ND and the CIPs translate into reduced clinical adverse events (SIND) in real-world use.

    “These improvements advance the state of the art in drug delivery and may likely enable a future reduction in adverse events caused by SINDs.”

  • The paper relies on this without support.

    A hard occlusion created by a hemostat at or near the infusion set cannula represents the occlusions that occur in clinical use.

    “Once flow was visually verified at the infusion set cannula, a hemostat was applied, and a stopwatch (Control Company 4-channel timer) was started.”
6 of 6

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?

  • The twiist AID System detects interruptions of insulin delivery due to occlusion substantially faster than other available pumps and supports dose-delivery accuracy.

    “A recent bench testing study showed that the system detects interruptions of insulin delivery due to occlusion substantially faster than other available pumps and supports dose-delivery accuracy,11”

    From Clinical utility of the twiist Automated Insulin Delivery System: first study with twiist (2026) · cites this paper as [11]

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.

  • Discussion reverses which pump had lower occlusion pressure

    Minor

    The discussion says pressures were lower for the CIPs, while Table II shows ND had the lowest mean pressure.

  • Competitor occlusion pressures exceed the stated triple limit

    Minor

    Table II reports an OP mean pressure of 23.62 psi versus 6.51 psi for ND, a ratio of 3.63 rather than at most three. TD's mean is also more than three times ND's.

    Reported 3 · recomputed 3.628264

  • Equation for mean compartment volume takes a square root

    Minor

    Equation (8) takes the square root of the summed volumes divided by a count; that is not the mean compartment volume it is stated to calculate.

3 of 3

Cites

Flagged first, then by citations

Research works printed but not linked: 1

  1. Bronzino, 1999, Biomedical Engineering Handbook

Cited by

Sorted by citations

Related

Authors
Butterfield, R. D., & Sims, N. M.
Affiliations
  • Association for the Advancement of Medical Instrumentation (US)
  • Massachusetts General Hospital (US)
ORCID
Venue
IEEE Open Journal of Engineering in Medicine and Biology
Publisher
Institute of Electrical and Electronics Engineers (IEEE)
Published
2024
Volume
5
Pages
593-599
ISSN
2644-1276 (ISSN-L)
DOI
10.1109/ojemb.2024.3408092
PMC
PMC11329218
OpenAlex
W4399337710
Cited by
6
References
19
Citations by year
2026: 2 · 2025: 2 · 2024: 2
FWCI
1.65
Type
journal article
Language
en
Open access
Licence
Locations
  • IEEE Open Journal of Engineering in Medicine and Biology (publishedVersion, cc-by-nc-nd)
  • PubMed (publishedVersion)
  • PubMed Central (submittedVersion, cc-by-nc-nd)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Funders
DEKA Research and Development Corporation
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
  • Physical Sciences › Engineering › Biomedical Engineering › Intravenous Infusion Technology and Safety
  • Health Sciences › Health Professions › Emergency Medical Services › Patient Safety and Medication Errors
Keywords
insulin pump therapy, insulin pump, acoustic sensing, occlusion detection, air management, bolus infusion

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 2026-10-13.

Classified by jev-1.13-20260917 (gold-guideline-v0.2) on 2026-10-13.

Cited sources are checked by gpt-6-sol.

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 ›

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