CoChat
Sign Up
Cited by 32Diabetes Management and ResearchIntravenous Infusion Technology and SafetyCentral Venous Catheters and Hemodialysis

Reduced Silent Occlusions with a Novel Catheter Infusion Set (BD FlowSmart): Results from Two Open-Label Comparative Studies

Open access
Gibney, Michael, Xue, Zhenyi, Swinney, Monica, Bialonczyk, Damian, Hirsch, Laurence·2016·Diabetes Technology & Therapeutics
DOI 10.1089/dia.2015.0342PMC PMC4790215
Open this paper in CoChat — free accountOpen PDF

Abstract

Background: Insulin pump users experience periods of unexplained hyperglycemia. In some cases these may be due to insulin flow interruptions termed “silent occlusions,” which occur without activating the pump alarm and may require set replacement. Materials and Methods: In-line pressure profiles of a novel infusion set with a 6-mm, 28-gauge polymer, dual-ported catheter (BD FlowSmart™; Becton Dickinson and Co., Franklin Lakes, NJ) were compared with those of an existing infusion set (Quick-set ® ; Medtronic MiniMed, Northridge, CA) in two separate studies involving insulin diluent infusions over 2.5–4.5-h periods in healthy adults without diabetes. Study 1, a pilot study ( n = 25), compared the occurrence of flow interruption events (silent occlusions and/or occlusion alarms) between the two infusion sets and between manual or device-assisted insertion methods. Study 2 ( n = 60) was designed to show ≥50% reduction in flow interruption events with the BD set after manual insertions. (Silent occlusions were defined by a continuous pressure rise for ≥30 min.) Results: In Study 1, significantly fewer silent occlusions were seen with BD FlowSmart versus Quick-set infusion sets for both manual (three of 22 [13.6%] vs. 12 of 24 [50%]; P = 0.012) and mechanical (two of 24 [8.3%] vs. nine of 25 [36%]; P = 0.037) insertions, yielding risk reductions of 73% (95% confidence interval [CI], 25–91%) and 77% (95% CI, 17–94%), respectively. In Study 2, flow interruption events occurred in three of 117 (2.6%) and 12 of 118 (10.2%) BD FlowSmart and Quick-set infusion sets, respectively, yielding a 75% risk reduction (95% CI, 20–92%; P = 0.030). Percentage of time with flow interruption was significantly lower with BD sets in both studies ( P < 0.02). Leakage (>0.5 IU or 5 μL) occurred infrequently and did not differ between sets. Conclusions: A novel side-ported insulin infusion set demonstrated significant reductions in flow interruptions, including silent occlusions, versus a leading marketed set, which may improve insulin delivery.

AI snapshot

Written from the paper’s full text.

TL;DR

In two open-label randomized studies in healthy adults without diabetes, a novel dual-ported BD FlowSmart infusion set delivered insulin diluent with significantly fewer silent occlusions and flow interruptions than the Quick-set infusion set. The authors conclude this may improve insulin delivery consistency, but real-world relevance in CSII patients remains to be confirmed.

Key findings

  • In Study 1 (n = 25), silent occlusions were significantly less frequent with BD FlowSmart than Quick-set for manual insertion: 3/22 (13.6%) vs. 12/24 (50%), P = 0.012, risk reduction 73% (95% CI 25–91%); and for mechanical insertion: 2/24 (8.3%) vs. 9/25 (36%), P = 0.037, risk reduction 77% (95% CI 17–94%).
  • In Study 2 (n = 60), flow interruption events occurred in 3/117 (2.6%) BD FlowSmart vs. 12/118 (10.2%) Quick-set sets, a 75% risk reduction (95% CI 20–92%; P = 0.030). Silent occlusions were 1/117 (0.9%) vs. 12/118 (10.2%), P = 0.003, a 92% reduction (95% CI 51–99%).
  • Percentage of time with flow interruption was significantly lower with BD sets in both studies (P < 0.02).
  • Leakage (>0.5 IU or 5 μL) occurred infrequently and did not differ significantly between sets; combined leakage was 6 episodes out of 340 sets (1.8%).

Methods

  • Two open-label, randomized studies in healthy adults without diabetes at TKL Research, Inc. (Fairlawn, NJ), in July and August 2014: Study 1 pilot (n = 25) compared BD FlowSmart vs. Quick-set and manual vs. mechanical insertion; Study 2 (n = 60) tested ≥50% reduction in flow interruptions with BD FlowSmart after manual insertion.
  • Four infusion sets (two BD FlowSmart, two Quick-set) were inserted into randomly prespecified abdominal quadrants by trained nurses. Insulin diluent was infused at basal 0.01 mL/h for 2–3 h, then a 0.1 mL bolus, with tubing clamped as a positive control.
  • In-line pressure was measured with disposable pressure transducers and a data logger. A silent occlusion was defined as a continuous pressure rise for ≥30 min without an occlusion alarm. Flow interruptions were compared using Fisher’s exact test; proportion of time with interruption was compared using Wilcoxon rank sum test.

Limitations

  • The paper states a major limitation was use of insulin diluent in healthy subjects rather than insulin in CSII patients; other stated limitations include trained nurses performing insertions rather than subjects, relatively short infusion durations, and limited ambulatory activity, which may not reflect true real-world prevalence.
  • The authors state a controlled, multicenter study of longer duration in patients with type 1 diabetes using CSII is needed to determine real-world relevance.
  • Evident from the text: the studies were open-label, used a surrogate diluent rather than insulin, enrolled healthy adults without diabetes, and were short-term with controlled insertion, so findings may not generalize to routine pump users or longer wear times.

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

Integrity signals

Registry

Crossref · 10.1089/dia.2015.0342

Cites

18 of 18 references verified0 citation errors · 0 not checkable

Statistics

Nothing to recompute.

Claims the paper makes

3 of 19 cited sources checked · 0 supported · 0 flagged · accuracy not yet measured

  • Interpretationcitation

    Silent occlusions contribute to the occurrence of unexplained hyperglycemia and glycemic variability in patients using CSII.

    “Based on our findings as well as previous reports,15,16,18 we believe that silent occlusions contribute to the occurrence of unexplained hyperglycemia and glycemic variability in patients using CSII.”
    Quote in the paperSubstantial claim2 of 3 sources checked
    • cites [15] Patel PJ, Benasi K, Ferrari G, et al.: Randomized trial of infusion set function: steel versus Teflon. Diabetes Technol Ther 2014; 16: 15– 19 24090124 PMC3887416 source

      The Discussion (page not available) describes unexplained hyperglycemia in CSII users that resolves after changing the infusion set, and reports unexpected hyperglycemia and/or infusion-set occlusion. It does not identify those occlusions as silent or establish that they contribute to glycemic variability. (LLM, conf=0.84)

      Experimental — accuracy not yet measured
    • cites [16] Renard E, Guerci B, Leguerrier AM, et al.: Lower rate of initial failures and reduced occurrence of adverse events with a new catheter model for continuous subcutaneous insulin infusion: prospective, two-period, observational, multicenter study. Diabetes Technol Ther 2010; 12: 769– 773 20809682 source
    • cites [18] Thethi TK, Rao A, Kawji H, et al.: Consequences of delayed pump infusion line change in patients with type 1 diabetes mellitus treated with continuous subcutaneous insulin infusion. J Diabetes Complications 2010; 24: 73– 78 19395280 PMC2854665 source

      The Conclusions report that glycemic control deteriorated after 48 hours of pump infusion line use, with increases in several glucose measures, and discuss a possible effect on glucose variability. They do not identify silent occlusions as the cause or characterize the hyperglycemia as unexplained; the mention of catheter occlusions concerns a separate study. (LLM, conf=0.84)

      Experimental — accuracy not yet measured
  • Findingown data

    Silent occlusions can occur shortly after insertion of the infusion set (<4 h postinsertion).

    “These findings also confirm that silent occlusions can occur shortly after the insertion of the infusion set (<4 h postinsertion)”
    Quote in the paperNot a substantial claim
  • Findingown data

    In Study 1, silent occlusions occurred in 2 of 24 (8.3%) mechanically inserted BD FlowSmart sets versus 9 of 25 (36%) mechanically inserted Quick-set sets.

    “mechanical (two of 24 [8.3%] vs. nine of 25 [36%]; P = 0.037) insertions”
    Quote in the paperSubstantial claim
  • Findingown data

    In Study 2, BD FlowSmart reduced the risk of flow interruptions by 75% (95% CI 20-92%; P = 0.030) compared with Quick-set.

    “yielding a 75% risk reduction (95% CI, 20–92%; P = 0.030).”
    Quote in the paperSubstantial claim
  • Findingown data

    In Study 1, silent occlusions occurred in 3 of 22 (13.6%) manually inserted BD FlowSmart sets versus 12 of 24 (50%) manually inserted Quick-set sets.

    “for both manual (three of 22 [13.6%] vs. 12 of 24 [50%]; P = 0.012)”
    Quote in the paperSubstantial claim
  • May combine two claims. 14
  • The quote only partly states this claim. 6
  • Classified as probably not a substantial claim. 4

  • May combine two claims.

    Premisecitation

    A 15% failure rate of polymer catheters over the 8-h period following insertion was observed by Patel et al., and nearly 9% of soft cannula insertions failed within a 6-h period by Renard et al.

    “Furthermore, a 15% failure rate of polymer catheters (blood glucose value of >250 mg/dL and not decreasing at least 50 mg in 1 h post–correction bolus) over the 8-h period following insertion was observed by Patel et al.15 and in nearly 9% of soft cannula insertions within a 6-h period by Renard et al,16 suggesting that existing polymer catheters have a tendency to fail upon insertion.”
    Quote in the paperSubstantial claim1 of 2 sources checked
    • cites [15] Patel PJ, Benasi K, Ferrari G, et al.: Randomized trial of infusion set function: steel versus Teflon. Diabetes Technol Ther 2014; 16: 15– 19 24090124 PMC3887416 source

      The Results report a 15% failure rate on initial insertion of Teflon catheters due to kinking, detected hours later. They do not specify that all 15% failed within 8 hours; the Results describe those failures as occurring on the first day. The Introduction also gives a different primary failure threshold (>300 mg/dL), though the analysis included eight events above 250 mg/dL with an unsuccessful correction bolus. The Renard finding has a separate citation and is not judged here. (LLM, conf=0.88)

      Experimental — accuracy not yet measured
    • cites [16] Renard E, Guerci B, Leguerrier AM, et al.: Lower rate of initial failures and reduced occurrence of adverse events with a new catheter model for continuous subcutaneous insulin infusion: prospective, two-period, observational, multicenter study. Diabetes Technol Ther 2010; 12: 769– 773 20809682 source

  • May combine two claims.

    Findingown data

    Leakage events occurred infrequently and did not differ significantly between BD FlowSmart and Quick-set sets.

    “Leakage (>0.5 IU or 5 μL) occurred infrequently and did not differ between sets.”
    • Also stated in: § Leakage events · plain
      “There were no statistically significant differences in the occurrence of leakage between the study sets or with insertion methods.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    In Study 1, there were seven occlusion alarms with Quick-set and none with BD FlowSmart; no significant difference was observed.

    “In Study 1, there were in total seven occlusion alarms or no delivery alerts with the Medtronic set (five manual insertions and two with inserter) and none with the BD set (Table 2). There were no significant differences in occlusion alarms with either method of set insertion.”
    Quote in the paperNot a substantial claim

  • The quote only partly states this claim.

    Findingown data

    In Study 2, silent occlusions were significantly decreased by 92% with BD FlowSmart compared with Quick-set (95% CI 51-99%; P = 0.003).

    “In Study 2, silent occlusions were significantly decreased by 92% with the new infusion set (95% CI, 51–99%; P = 0.003).”
    Quote in the paperSubstantial claim

  • The quote only partly states this claim.

    Findingown data

    In Study 1, BD FlowSmart reduced the risk of silent occlusions by 73% (95% CI 25-91%) for manual insertions compared with Quick-set.

    “corresponding to significant risk reductions of 73% (95% CI, 25–91%; P = 0.012) and 77% (95% CI, 17–94%; P = 0.037), respectively.”
    Quote in the paperSubstantial claim

  • May combine two claims. The quote only partly states this claim.

    Findingown data

    In Study 1, flow interruption events occurred in 3 of 22 (13.6%) manually inserted BD FlowSmart sets versus 14 of 24 (58.3%) manually inserted Quick-set sets.

    “Manual (n = 24) | 12 (50.0%, 31.4–68.6%) | 34.9% (28.7–45.6%) | 5 (20.8%, 9.2–40.5%) | 14 (58.3%, 38.8–75.5%)”
    • Also stated in: § Silent occlusions · plain
      “Manual (n = 22) | 3 (13.6%, 4.8–33.3%)h | 21.1% (19.8–39.5%) | 0 (0%, 0–14.9%)i | 3 (13.6%, 4.8–33.3%)j”
    Quote in the paperSubstantial claim

  • The quote only partly states this claim.

    Findingown data

    In Study 2, silent occlusions occurred in 1 of 117 (0.9%) BD FlowSmart sets versus 12 of 118 (10.2%) Quick-set sets.

    “One BD infusion set experienced a silent occlusion (with 16.4% time of flow interruption) versus 12 Quick-set infusion sets that had silent occlusions (median time with flow interruption, 14.9%; P = 0.002)”
    Quote in the paperSubstantial claim

  • The quote only partly states this claim.

    Findingown data

    In Study 1, flow interruption events occurred in 2 of 24 (8.3%) mechanically inserted BD FlowSmart sets versus 10 of 25 (40%) mechanically inserted Quick-set sets.

    “Inserter (n = 25) | 9 (36.0%, 20.3–55.5%) | 26.7% (24.8–40.7%) | 2 (8%, 2.2–25.0%) | 10 (40%, 23.4–59.3%)”
    • Also stated in: § Silent occlusions · plain
      “Inserter (n = 24) | 2 (8.3%, 2.3–25.9%)f | 23.4% (22.3–24.5%) | 0 (0%, 0–13.8%) | 2 (8.3%, 2.3–25.9%)g”
    Quote in the paperSubstantial claim

  • The quote only partly states this claim.

    Findingown data

    In Study 1, BD FlowSmart reduced the risk of silent occlusions by 77% (95% CI 17-94%) for mechanical insertions compared with Quick-set.

    “corresponding to significant risk reductions of 73% (95% CI, 25–91%; P = 0.012) and 77% (95% CI, 17–94%; P = 0.037), respectively.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    In Study 2, occlusion alarms were infrequent (total n = 3) and no difference was observed between sets.

    “Occlusion alarms were infrequent (total n = 3) in Study 2, and no difference in such alarms was observed between the two sets in Study 2 (Table 3).”
    Quote in the paperNot a substantial claim

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

    Study design and conductreasoning

    Study 2 was designed to have 80% statistical power to detect a ≥50% reduction in flow interruptions with BD FlowSmart, requiring 100 tests per set type and 60 subjects.

    “Given the occurrence rate of such events observed with the Quick-set in Study 1 (approximately 35% of sets), each infusion set type required 100 tests, giving a total of 200 insertions to maintain 80% statistical power in Study 2 (two-sided test with α = 0.05).”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Interpretationreasoning

    Reduced flow interruptions with BD FlowSmart may result in more consistent and reliable infusion of insulin and may help reduce hyperglycemic events and glycemic variability in CSII users.

    “Reduced flow interruptions may result in more consistent and reliable infusion of insulin and may help reduce the occurrence of hyperglycemic events and of glycemic variability in CSII users.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Study design and conductcitation

    Other limitations include the use of trained nurses to manage insertions, relatively short duration of infusions, and limited ambulatory activities, which might not reflect the true prevalence of pressure-related or leakage events.

    “Other limitations, including the use of trained nurses to manage insertions rather than the subject, relatively short duration of infusions, and limited ambulatory activities by subjects, might not reflect the true prevalence of pressure-related or leakage events and unexplained hyperglycemia as reported by others9,16 but are inherent to the nature of the investigations performed.”
    Quote in the paperNot a substantial claim0 of 2 sources checked
    • cites [9] van Bon AC, Bode BW, Sert-Langeron C, et al.: Insulin glulisine compared to insulin aspart and to insulin lispro administered by continuous subcutaneous insulin infusion in patients with type 1 diabetes: a randomized controlled trial. Diabetes Technol Ther 2011; 13: 607– 614 21457066 source
    • cites [16] Renard E, Guerci B, Leguerrier AM, et al.: Lower rate of initial failures and reduced occurrence of adverse events with a new catheter model for continuous subcutaneous insulin infusion: prospective, two-period, observational, multicenter study. Diabetes Technol Ther 2010; 12: 769– 773 20809682 source

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

    Study design and conductown data

    Both studies were open-label, randomized studies involving healthy subjects without diabetes.

    “Study 1 (n = 25) and Study 2 (n = 60) were both open-label, randomized studies involving healthy subjects without diabetes.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Premisecitation

    The IIS is often considered the "Achilles heel" of CSII, and issues with sets are a major reason for patient frustrations with CSII, including discontinuing pump therapy.

    “The IIS is often considered to be the “Achilles heel” of CSII, and issues with the sets are one of the major reasons for patient frustrations with CSII, including discontinuing insulin pump therapy.6”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [6] Heinemann L, Krinelke L: Insulin infusion set: the Achilles heel of continuous subcutaneous insulin infusion. J Diabetes Sci Technol 2012; 6: 954– 964 22920824 PMC3440169 source

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

    Premisecitation

    The American Diabetes Association and the European Association for the Study of Diabetes issued a joint statement contrasting the paucity of publications related to IISs and insulin flow blockage with the large number of IIS-related adverse events on the FDA MAUDE database.

    “Recently, the American Diabetes Association and the European Association for the Study of Diabetes issued a joint statement on insulin pump benefits and risks, in which the paucity of publications related to IISs and insulin flow blockage was contrasted with the large number of IIS-related adverse events on the Food and Drug Administration MAUDE database.8”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [8] Heinemann L, Flemming GA, Petrie JR, et al.: Insulin pump risks and benefits: a clinical appraisal of pump safety standards, adverse event reporting, and research needs. A Joint Statement of the European Association for the Study of Diabetes and the American Diabetes Association Technology Working Group. Diabetes Care 2015; 38: 716– 722 25776138 source

  • May combine two claims.

    Premisenone given

    Insulin pump users experience periods of unexplained hyperglycemia, which in some cases may be due to silent occlusions.

    “Insulin pump users experience periods of unexplained hyperglycemia. In some cases these may be due to insulin flow interruptions termed “silent occlusions,” which occur without activating the pump alarm and may require set replacement.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Premisecitation

    Pressure thresholds vary among pumps, such that rises in blood glucose concentration may last up to 5 h before the occlusion alarm sounds.

    “These pressure thresholds vary among pumps, such that rises in blood glucose concentration may last up to 5 h before the occlusion alarm sounds—depending on the pump, the alarm pressure setting, the type and length of infusion set tubing, etc.11”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [11] van Bon AC, Dragt D, deVries JH: Significant time until catheter occlusion alerts in currently marketed insulin pumps at two basal rates. Diabetes Technol Ther 2012; 14: 447– 448 22548715 source

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

    Premisecitation

    Blood glucose values rise 1 mg/dL for each minute an IIS is disconnected from the pump (for at least 30 min) under basal infusion conditions, and the elevation persists 3-3.5 h after reconnecting.

    “It has been previously reported that blood glucose values rise 1 mg/dL for each minute an IIS is disconnected from the pump (for at least 30 min), under basal infusion conditions. The elevation of blood glucose concentration persisted for 3–3.5 h after reconnecting the infusion set.19”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [19] Zisser H: Quantifying the impact of a short-interval interruption of insulin-pump infusion sets on glycemic excursions. Diabetes Care 2008; 31: 238– 239 18056889 source

      Not checked in the free run.

  • May combine two claims.

    Premisecitation

    Approximately 60% of patients with type 1 diabetes using CSII experienced at least one episode of unexplained hyperglycemia during a 13-week study period, and 30% experienced an occlusion alarm.

    “van Bon et al.9 reported that approximately 60% of patients with type 1 diabetes using CSII experienced at least one episode of unexplained hyperglycemia during a 13-week study period, and 30% of subjects experienced an occlusion alarm.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites van Bon et al. [9] van Bon AC, Bode BW, Sert-Langeron C, et al.: Insulin glulisine compared to insulin aspart and to insulin lispro administered by continuous subcutaneous insulin infusion in patients with type 1 diabetes: a randomized controlled trial. Diabetes Technol Ther 2011; 13: 607– 614 21457066 source
20 of 20

  • The paper relies on this without support.

    The internally developed algorithm used to calculate silent occlusions and flow interruptions correctly identifies these events.

    “Silent occlusions and flow interruptions were calculated using an algorithm developed internally.”

  • The paper relies on this without support.

    The authors' employment at BD did not influence or bias the measurements and findings.

    “All authors are BD employees, but the measurements and findings were not influenced or biased by this factor.”
2 of 2

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 difference in occlusion rates represented a 75% risk reduction (95% CI, 20-92%; P = .030) with the novel technology.

    “The difference in occlusion rates represented a 75% risk reduction (95% CI, 20-92%; P = .030) with the novel technology.”

    From Insulin Pump Occlusions: For Patients Who Have Been Around the (Infusion) Block (2017) · cites this paper as [1]

    The Abstract reports a 75% risk reduction with BD FlowSmart in Study 2, with the stated confidence interval and P value. But it identifies the outcome as flow interruptions, not occlusion rates alone. The Results distinguish flow interruptions, which combine silent occlusions and occlusion alarms, from silent occlusions, for which Study 2 reports a 92% reduction. (LLM, conf=0.88)

    Experimental — accuracy not yet measured

  • In the second study, flow interruption events occurred in 3 of 117 (2.6%) and 12 of 118 (10.2%) novel and traditional IIS, respectively.

    “In the second study, flow interruption events occurred in 3 of 117 (2.6%) and 12 of 118 (10.2%) novel and traditional IIS, respectively.”

    From Insulin Pump Occlusions: For Patients Who Have Been Around the (Infusion) Block (2017) · cites this paper as [1]

    The Results > Flow interruptions section (page unavailable) reports a 75% reduction in Study 2 flow interruptions with the BD set versus the Medtronic set, supporting the comparison. The available non-abstract passages do not give the claimed event counts or denominators of 3/117 and 12/118, so those exact figures cannot be verified from them. (LLM, conf=0.82)

    Experimental — accuracy not yet measured

  • The variability in reporting may, in part, be due to the variability in clinical infusion set failures, where some are partial and/or transient and can be seen frequently when monitoring infusion pressures that do not result in alarm (i.e., silent occlusions).

    “The variability in reporting may, in part, be due to the variability in clinical infusion set failures, where some are partial and/or transient and can be seen frequently when monitoring infusion pressures that do not result in alarm (i.e., silent occlusions).20”

    From Evaluation of Extended Infusion Set Performance in Adults with Type 1 Diabetes: Infusion Set Survival Rate and Glycemic Outcomes from a Pivotal Trial (2022) · cites this paper as [20]

    Split into 2 atoms — 1 confirmed, 1 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.

    Experimental — accuracy not yet measured

  • Occlusions of insulin infusion sets occur frequently.

    “Occlusions do occur frequently”

    From Insulin Pump Occlusions: For Patients Who Have Been Around the (Infusion) Block (2017) · cites this paper as [1]

  • In the first study (n=25), significantly fewer silent occlusions occurred with the novel IIS than with the traditional IIS for both manual (3 of 22 [13.6%] vs 12 of 24 [50%]; P = .012) and mechanical (2 of 24 [8.3%] vs 9 of 25 [36%]; P = .037) insertions.

    “In the first study, significantly fewer silent occlusions occurred with the novel IIS than with the traditional IIS for both manual (3 of 22 [13.6%] vs 12 of 24 [50%]; P = .012) and mechanical (2 of 24 [8.3%] vs 9 of 25 [36%]; P = .037) insertions.”

    From Insulin Pump Occlusions: For Patients Who Have Been Around the (Infusion) Block (2017) · cites this paper as [1]

Cites

Flagged first, then by citations

Research works printed but not linked: 3

  1. Keith S, , McVey E, , Pettis RJ: High sensitivity occlusion detection using fluid pressure monitoring during basal insulin infusion. Diabetes, 2013; 62(suppl 1):A249–A250.
  2. Bolick N, , Morel D, , Gerth S, et al.: Reduction of silent occlusion occurrence during continuous subcutaneous insulin infusion [abstract]. Diabetes Technol Ther, 2015; 17(Suppl 1):A35.
  3. Bolick N, , Morel D, , Alarcon J, et al.: In vivo flow evaluation and correlation to insulin pharmacokinetics of continuous subcutaneous insulin infusion sets [abstract]. Diabetes, 2015; 64(Suppl 1):A274–A275.

Cited by

Sorted by citations

Related

Authors
Gibney, M., Xue, Z., Swinney, M., Bialonczyk, D., & Hirsch, L.
Affiliations
Becton Dickinson (United States) (US)
Corresponding author
Hirsch, Laurence
ORCID
Venue
Diabetes Technology & Therapeutics
Publisher
SAGE Publications
Published
2016-03
Volume
18
Issue
3
Pages
136-143
ISSN
  • 1520-9156 (ISSN-L)
  • 1557-8593
DOI
10.1089/dia.2015.0342
PMC
PMC4790215
OpenAlex
W2198907533
Cited by
32
References
18
Citations by year
2026: 1 · 2024: 4 · 2023: 3 · 2022: 1 · 2020: 1 · 2019: 4 · 2018: 8 · 2017: 5 · 2016: 5
FWCI
5.21
Type
journal article
Language
en
Open access
Licence
Locations
  • Diabetes Technology & Therapeutics (publishedVersion, cc-by-nc)
  • PubMed Central (publishedVersion, cc-by-nc)
  • PubMed (publishedVersion)
Funders
Leona M. and Harry B. Helmsley Charitable Trust
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 › Central Venous Catheters and Hemodialysis
Keywords
insulin pump therapy, leakage, continuous glucose monitoring, diabetes management, hypoglycemia risk
MeSH terms
Adolescent, Adult, Aged, Catheterization, Catheters, Indwelling, Equipment Design, Equipment Failure, Female, Humans, Insulin Infusion Systems, Male, Materials Testing, Middle Aged, New Jersey, Pilot Projects, Specialties, Nursing, Young Adult, Quality Improvement, Catheter Obstruction

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 2026-11-05.

Classified by jev-1.13-20260917 (gold-guideline-v0.2) on 2026-11-05.

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 ›

Are you an author, or do you see a problem with this page? Request a review