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Cited by 28Diabetes Management and ResearchIntravenous Infusion Technology and SafetyDiabetes Management and Education

The DOI matches its Crossref record; 22 of the 22 references it cites were found in a registry or an index; 24 of the 53 sources its claims cite were checked for support.

Evaluation of Extended Infusion Set Performance in Adults with Type 1 Diabetes: Infusion Set Survival Rate and Glycemic Outcomes from a Pivotal Trial

Open access
Brazg, Ron, Garg, Satish K., Bhargava, Anuj, Thrasher, James R., Latif, Kashif, Bode, Bruce W., Bailey, Timothy S., Horowitz, Barry S., Cavale, Arvind, Kudva, Yogish C., Kaiserman, Kevin B., Grunberger, George, Reed, John Chip, Chattaraj, Sarnath, Zhang, Gina, Shin, John, Chen, Vivian, Lee, Scott W., Cordero, Toni L., Rhinehart, Andrew S., Vigersky, Robert A., Buckingham, Bruce A.·2022·Diabetes Technology & Therapeutics
DOI 10.1089/dia.2021.0540PMC PMC9353978
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Abstract

Background: Standard insulin infusion sets (IISs) are to be replaced every 2 to 3 days to avoid complications and diabetic ketosis due to set failure. This pivotal trial evaluated the safety and performance of a new extended-wear infusion set (EIS) when used for 7 days by adults with type 1 diabetes (T1D). Methods: This single-arm, nonrandomized trial enrolled adults (18–80 years of age) with T1D, who used their own MiniMed™ 670G system with insulin lispro or insulin aspart and the EIS for up to 7 days, across 12 consecutive wears. Safety endpoints included incidence of serious adverse events (SAEs), serious adverse device effects (SADEs), unanticipated adverse device effects (UADEs), severe hypoglycemia (SevHypo), severe hyperglycemia (SevHyper), diabetic ketoacidosis (DKA), and skin infection. The EIS failure rate due to unexplained hyperglycemia (i.e., suspected occlusion), the overall EIS survival rate, glycemic control outcomes (i.e., A1C, mean sensor glucose and time spent in established glucose ranges), total daily insulin delivered, and satisfaction with the EIS were determined. Results: The intention to treat population ( n = 259, 48% men, 45.0 ± 14.1 years) wore a total of 3041 EIS devices. No SADE, UADE, or DKA events was reported. Overall rates of SAEs, SevHypo, SevHyper, and skin infection were 3.8, 2.5, 104.1, and 20.1 events per 100 participant-years. The rate of EIS failure due to unexplained hyperglycemia at the end of day 7 was 0.1% (95% confidence interval [CI]: 0.03–0.51) and 0.4% (95% CI: 0.16–1.00) for insulin lispro and aspart use, respectively. Overall EIS survival rate at the end of day 7 was 77.8% (95% CI: 76.2–79.3), glycemic control did not change, and participants reported greater satisfaction with the EIS compared with standard IISs worn before the study ( P < 0.001). Conclusions: This investigation demonstrates that the EIS, when worn for up to 7 days, was safe and rated with high satisfaction, without adversely affecting glycemic control in adults with T1D. Clinical Trial Registration number: NCT04113694 ( https://clinicaltrials.gov/ct2/show/NCT04113694 ).

Overview

AI snapshot

Written from the paper’s full text.

TL;DR

In a single-arm pivotal trial, a new Medtronic extended-wear insulin infusion set (EIS) was worn up to 7 days by adults with type 1 diabetes using MiniMed 670G systems, with no serious adverse device effects, unanticipated adverse device effects, or DKA. The EIS had a 77.8% overall survival rate at day 7, low failure due to unexplained hyperglycemia, stable glycemic control, and higher user satisfaction than standard infusion sets.

Key findings

  • Among 259 intention-to-treat adults (45.0 ± 14.1 years; 48% men) wearing 3041 EIS devices, there were no SADE, UADE, or DKA events; overall rates of SAEs, severe hypoglycemia, severe hyperglycemia, and skin infection were 3.8, 2.5, 104.1, and 20.1 events per 100 participant-years, respectively.
  • EIS failure due to unexplained hyperglycemia at end of day 7 was 0.1% (95% CI 0.03–0.51) with insulin lispro and 0.4% (95% CI 0.16–1.00) with insulin aspart; overall EIS survival at end of day 7 was 77.8% (95% CI 76.2–79.3).
  • Glycemic control did not change: A1C went from 7.2% ± 0.6% to 7.1% ± 0.6% (Δ −0.1 ± 0.4), and mean sensor glucose, coefficient of variation, time in glucose ranges, and total daily insulin delivered remained stable across 7 days of wear.
  • Participants reported significantly greater satisfaction with the EIS than with standard IISs worn before the study across ease of insertion, comfort, duration, time to change, and convenience (all P < 0.001).

Methods

  • Prospective, single-arm, nonrandomized trial at 15 U.S. investigational centers enrolling adults 18–80 years with type 1 diabetes who used their own MiniMed 670G system with insulin lispro or insulin aspart and wore the EIS for up to 7 days across 12 consecutive wears.
  • The intention-to-treat population was n = 259; 3041 EIS devices were worn (1561 with insulin lispro, 1480 with insulin aspart), and 248 participants completed the study.
  • Endpoints included safety events, EIS failure due to unexplained hyperglycemia, overall EIS survival excluding not-for-cause removals, glycemic outcomes (A1C, sensor glucose, time in ranges, total daily insulin), and satisfaction; satisfaction scores were compared with a Wilcoxon signed-rank test.

Limitations

  • The paper states the study was open-label and nonrandomized without a comparator, which limits causal interpretation.
  • The paper states participants were required to use Auto Mode on the MiniMed 670G, which may limit generalizability of glycemic findings to open-loop pump users.
  • The paper states the population was majority white and had relatively well-controlled glycemia at baseline; the text also makes evident that the single-arm design and lack of a concurrent control group constrain comparisons with standard infusion sets.

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

Integrity signals

Registry

Crossref · 10.1089/dia.2021.0540

Cites

22 of 22 references verified0 citation errors · 0 not checkable

Statistics

Nothing to recompute.

Verification

Claims the paper makes

24 of 53 cited sources checked · 15 supported · 1 flagged · accuracy not yet measured

  • Findingown data

    The overall EIS survival rate by the end of day 7 was greater than previously reported survival rates for standard IIS devices worn for similar durations (69%, 63%, 43%, 33%, and 32%).

    “The overall EIS survival rate of 77.8% (95% CI: 76.2–79.3) by the end of day 7 was greater than previously reported survival rates of 69% (n = 40 total participants and 80 total steel cannula sets),9 63% (n = 40 total participants, 80 total soft cannula sets),9 43% (n = 20 total participants, 40 total sets in non-lipohypertrophied tissue),18 33% (n = 20 total participants and 40 total sets in lipo”
    Quote in the paperSubstantial claim1 of 3 sources checked
    • cites [9] Waldenmaier D, Zschornack E, Buhr A, et al.: A prospective study of insulin infusion set use for up to 7 days: early replacement reasons and impact on glycemic control. Diabetes Technol Ther 2020; 22: 734– 741. 32167382 source
    • cites [18] Karlin AW, Ly TT, Pyle L, et al.: Duration of infusion set survival in lipohypertrophy versus nonlipohypertrophied tissue in patients with type 1 diabetes. Diabetes Technol Ther 2016; 18: 429– 435. 27227290 PMC4931738 source
    • cites [8] 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 citation is attached to the claimed 69% steel and 63% soft-cannula survival rates. The paper’s Results instead report that, at the end of day 7, 32% of steel sets and 33% of Teflon sets were functioning (page unavailable). (LLM, conf=0.88)

      Checked by a reasoning model — may be wrong.

      Experimental — accuracy not yet measured
  • Premisecitation

    Prior rates of IIS failure due to unexplained hyperglycemia ranged from 19% to 30%.

    “rates of IIS failure due to “unexplained hyperglycemia” (i.e., hyperglycemia >250 mg/dL and a failed correction bolus due to suspected IIS occlusion) ranged from a relatively high 19%9 to 30%.8”
    Quote in the paperSubstantial claim1 of 2 sources checked
    • cites [9] Waldenmaier D, Zschornack E, Buhr A, et al.: A prospective study of insulin infusion set use for up to 7 days: early replacement reasons and impact on glycemic control. Diabetes Technol Ther 2020; 22: 734– 741. 32167382 source
    • cites [8] 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
  • Premisecitation

    Early feasibility and pilot IIS studies showed significant device-related adverse events that included increased hyperglycemia and functional or mechanistic issues with IIS use during longer durations of wear.

    “While early feasibility and pilot IIS studies showed significant device-related adverse events that included increased hyperglycemia and functional or mechanistic issues with IIS use during longer durations of wear,1–3”
    Quote in the paperSubstantial claim3 of 3 sources checked
    • cites [1] Pfutzner A, Sachsenheimer D, Grenningloh M, et al.: Using insulin infusion sets in CSII for longer than the recommended usage time leads to a high risk for adverse events: results from a prospective randomized crossover study. J Diabetes Sci Technol 2015; 9: 1292– 1298. 26341262 PMC4667306 source
    • cites [2] Schmid V, Hohberg C, Borchert M, et al.: Pilot study for assessment of optimal frequency for changing catheters in insulin pump therapy-trouble starts on day 3. J Diabetes Sci Technol 2010; 4: 976– 982. 20663464 PMC2909532 source
    • cites [3] 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 Results report significantly increased glucose levels and time spent above 180 mg/dL as pump infusion lines were worn from day 2 to day 5. The paper does not report significant mechanical problems with the infusion sets during its own trial; its Conclusions mention only a nonsignificant trend toward fewer catheter occlusions in another study. Thus it supports the prolonged-wear hyperglycemia finding, but not the full description of significant device-related events. (LLM, conf=0.85)

      Experimental — accuracy not yet measured
  • Premisecitation

    Few randomized studies have reported failure and survival rates when IIS devices are worn out to 7 days.

    “few randomized studies have reported failure and survival rates when IIS devices are worn out to 7 days.8,9”
    Quote in the paperSubstantial claim1 of 2 sources checked
    • cites [8] 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
    • cites [9] Waldenmaier D, Zschornack E, Buhr A, et al.: A prospective study of insulin infusion set use for up to 7 days: early replacement reasons and impact on glycemic control. Diabetes Technol Ther 2020; 22: 734– 741. 32167382 source
  • Premisecitation

    Schmid et al.'s pilot study reported average BG levels that increased from 135.0 ± 68.4 mg/dL to 208.8 ± 39.6 mg/dL from day 1 to 7 of IIS wear.

    “The Schmid et al.'s pilot study of 12 adults (40.3 ± 12.6 years of age) using the MiniMed Comfort infusion set or MiniMed Silhouette infusion set (ConvaTec Unomedical A/S, Lejre, Denmark) reported average BG levels that increased from 135.0 ± 68.4 mg/dL to 208.8 ± 39.6 mg/dL from day 1 to 7 of IIS wear.2”
    Quote in the paperSubstantial claim1 of 1 sources checked
    • cites [2] Schmid V, Hohberg C, Borchert M, et al.: Pilot study for assessment of optimal frequency for changing catheters in insulin pump therapy-trouble starts on day 3. J Diabetes Sci Technol 2010; 4: 976– 982. 20663464 PMC2909532 source
  • Probably not a substantial claim. 19
  • It may state two separate claims as one. 29
  • The quote only partly states this claim. 2

  • Probably not a substantial claim.

    Premisecitation

    Standard insulin infusion sets should be changed every 2 to 3 days to prevent or reduce adverse events.

    “Standard IISs should be changed every 2 to 3 days,1–3 regardless of rapid-acting insulin used,4 to prevent or reduce adverse events (e.g., site failure resulting in hyperglycemia, skin inflammation, infection or pain at the IIS site, adhesive patch failure, etc.).”
    Quote in the paperSubstantial claim4 of 4 sources checked
    • cites [1] Pfutzner A, Sachsenheimer D, Grenningloh M, et al.: Using insulin infusion sets in CSII for longer than the recommended usage time leads to a high risk for adverse events: results from a prospective randomized crossover study. J Diabetes Sci Technol 2015; 9: 1292– 1298. 26341262 PMC4667306 source
    • cites [2] Schmid V, Hohberg C, Borchert M, et al.: Pilot study for assessment of optimal frequency for changing catheters in insulin pump therapy-trouble starts on day 3. J Diabetes Sci Technol 2010; 4: 976– 982. 20663464 PMC2909532 source
    • cites [3] 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
    • cites [4] Kerr D, Morton J, Whately-Smith C, et al.: Laboratory-based non-clinical comparison of occlusion rates using three rapid-acting insulin analogs in continuous subcutaneous insulin infusion catheters using low flow rates. J Diabetes Sci Technol 2008; 2: 450– 455. 19885209 PMC2769745 source

  • Probably not a substantial claim.

    Premisecitation

    Prior overall findings determined that 7-day wear, irrespective of steel or Teflon cannula, did not adversely influence glycemic control.

    “Overall findings from the latter determined that 7-day wear (irrespective of steel or Teflon cannula) did not adversely influence glycemic control”
    Quote in the paperSubstantial claim1 of 2 sources checked
    • cites [8] 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 Abstract reports no increase in hyperglycemia or daily insulin requirements when a set was successfully used for seven days. The Discussion makes clear that this analysis excluded sets that failed; the unqualified claim overlooks those failures, including failures associated with hyperglycemia. The finding therefore does not apply to seven-day wear overall. (LLM, conf=0.90)

      Experimental — accuracy not yet measured
    • cites [9] Waldenmaier D, Zschornack E, Buhr A, et al.: A prospective study of insulin infusion set use for up to 7 days: early replacement reasons and impact on glycemic control. Diabetes Technol Ther 2020; 22: 734– 741. 32167382 source

  • It may state two separate claims as one.

    Premisecitation

    While early standard IIS device studies confirmed manufacturer indications for 2- to 3-day use due to increased risk of IIS site reactions or compromised glycemic control, more recent studies with greater numbers of study participants have reported minimal or no issues with glycemia over time or fewer adverse events associated with extended IIS wear.

    “Thus, while early standard IIS device studies confirmed manufacturer indications for 2- to 3-day use due to increased risk of IIS site reactions or compromised glycemic control, more recent studies with greater numbers of study participants have reported minimal or no issues with glycemia over time or fewer adverse events associated with extended IIS wear.8,9,18,19”
    Quote in the paperNot a substantial claim1 of 4 sources checked
    • cites [8] 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

      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
    • cites [9] Waldenmaier D, Zschornack E, Buhr A, et al.: A prospective study of insulin infusion set use for up to 7 days: early replacement reasons and impact on glycemic control. Diabetes Technol Ther 2020; 22: 734– 741. 32167382 source
    • cites [18] Karlin AW, Ly TT, Pyle L, et al.: Duration of infusion set survival in lipohypertrophy versus nonlipohypertrophied tissue in patients with type 1 diabetes. Diabetes Technol Ther 2016; 18: 429– 435. 27227290 PMC4931738 source
    • cites [19] Freckmann G, Arndt S, Fiesselmann A, et al.: Randomized cross-over study comparing two infusion sets for CSII in daily life. J Diabetes Sci Technol 2017; 11: 253– 259. 27605591 PMC5478026 source

  • Probably not a substantial claim. The paper’s conclusions may not depend on it.

    Interpretationcitation

    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”
    Quote in the paperNot a substantial claim1 of 1 sources checked
    • cites [20] Gibney M, Xue Z, Swinney M, et al.: Reduced silent occlusions with a novel catheter infusion set (BD FlowSmart): results from two open-label comparative studies. Diabetes Technol Ther 2016; 18: 136– 143. 26701357 PMC4790215 source

      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

  • Probably not a substantial claim. The paper’s conclusions may not depend on it.

    Premisecitation

    There were multiple definitions of a failed correction dose, with 1 h or 60-90 min as the elapsed time by when a single correction dose was required to decrease BG by 50 mg/dL.

    “There were also multiple definitions of a failed correction dose where 1 h8,18 or 60–90 min9 was the elapsed time by when a single correction dose was required to decrease BG by 50 mg/dL.”
    Quote in the paperNot a substantial claim1 of 3 sources checked
    • cites [8] 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
    • cites [18] Karlin AW, Ly TT, Pyle L, et al.: Duration of infusion set survival in lipohypertrophy versus nonlipohypertrophied tissue in patients with type 1 diabetes. Diabetes Technol Ther 2016; 18: 429– 435. 27227290 PMC4931738 source
    • cites [9] Waldenmaier D, Zschornack E, Buhr A, et al.: A prospective study of insulin infusion set use for up to 7 days: early replacement reasons and impact on glycemic control. Diabetes Technol Ther 2020; 22: 734– 741. 32167382 source

  • It may state two separate claims as one.

    Premisecitation

    The follow-up 3-month randomized crossover study reported a trending increase in IIS-related issues including hyperglycemia, increased frequency of IIS changes (from 73 to 143 changes), increased number of infusion set-related adverse events (from 305 to 517 events), and site reactions (from 1.7 ± 2.2 to 7.5 ± 14.0 events/participant), all of which were significant.

    “The follow-up 3-month randomized crossover study1 with 22 adults (39.0 ± 11.0 years of age) using the MiniMed Mio infusion set or Inset II™ infusion set (ConvaTec Unomedical A/S) also reported a trending increase in IIS-related issues that included hyperglycemia, increased frequency of IIS changes (from 73 to 143 changes), increased number of infusion set-related adverse events (from 305 to 517”
    Quote in the paperNot a substantial claim1 of 1 sources checked
    • cites [1] Pfutzner A, Sachsenheimer D, Grenningloh M, et al.: Using insulin infusion sets in CSII for longer than the recommended usage time leads to a high risk for adverse events: results from a prospective randomized crossover study. J Diabetes Sci Technol 2015; 9: 1292– 1298. 26341262 PMC4667306 source

  • It may state two separate claims as one.

    Premisecitation

    In Schmid et al.'s study, events resulting in IIS change occurred more frequently after day 3 and impaired insulin absorption resulting in hyperglycemia was significant by day 7.

    “While only a few study participants reached 7-day IIS wear, events resulting in IIS change occurred more frequently after day 3 and impaired insulin absorption resulting in hyperglycemia was significant by day 7.”
    Quote in the paperSubstantial claim1 of 1 sources checked
    • cites [2] Schmid V, Hohberg C, Borchert M, et al.: Pilot study for assessment of optimal frequency for changing catheters in insulin pump therapy-trouble starts on day 3. J Diabetes Sci Technol 2010; 4: 976– 982. 20663464 PMC2909532 source

      The Patient Characteristics section reports that events requiring infusion-set changes began on day 3 and became more frequent during and after that day. The Figure 4 discussion reports that the rise in mean blood glucose reached statistical significance on day 7, but the Discussion says changes in insulin absorption only “appeared” to occur; it does not establish impaired absorption as the cause or report a statistically significant absorption measurement. (LLM, conf=0.87)

      Experimental — accuracy not yet measured

  • It may state two separate claims as one.

    Premisecitation

    A recent pilot study of 22 adults using varied insulin delivery systems demonstrated a survival rate of 82% at 6.8 days of wear during use of a novel IIS with multiple perforations within the cannula shaft, without significant change in glucose or daily insulin delivered at this time point.

    “In addition to these findings, a recent pilot study of 22 adults (40.1 ± 14.3 years of age) using varied insulin delivery systems demonstrated a survival rate of 82% at 6.8 days of wear, during use of a novel IIS with multiple perforations within the cannula shaft (i.e., Lantern technology [ConvaTec, Inc., Deeside, United Kingdom]) without significant change in glucose or daily insulin delivered”
    Quote in the paperNot a substantial claim1 of 1 sources checked
    • cites [22] Lal RA, Hsu L, Zhang J, et al.: Longevity of the novel ConvaTec infusion set with Lantern technology. Diabetes Obes Metab 2021; 23: 1973– 1977. 33822472 PMC8720264 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. The paper’s conclusions may not depend on it. It may state two separate claims as one.

    Premisecitation

    Patel et al. indicated that kinking at initial insertion of Teflon-cannula IISs contributed to 15% of the total IIS failure rate, although investigational staff inserted all IIS devices during the study.

    “For instance, Patel et al., indicated that kinking at initial insertion of Teflon-cannula IISs (MiniMed Quick-Set infusion set [Medtronic]) contributed to 15% of the total IIS failure rate, although investigational staff inserted all IIS devices during the study.8”
    Quote in the paperNot a substantial claim1 of 1 sources checked
    • cites [8] 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 that 15% of Teflon catheters failed on initial insertion because of kinking, and the Methods state that study staff inserted all infusion sets. The 15% figure is a failure rate for Teflon sets, not the proportion of the total IIS failure rate attributable to kinking as the citing sentence suggests. (LLM, conf=0.88)

      Experimental — accuracy not yet measured

  • Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.

    Premisecitation

    Some of the aforementioned studies reported that standard IIS survival appeared to depend heavily on the individual user, as ∼42% of Patel et al.'s study participants were able to wear an IIS for 6-7 days and 75% of those in Waldenmaier et al.'s study wore at least one standard IIS for 7 days.

    “Interestingly, some of the aforementioned studies reported that standard IIS survival appeared to depend heavily on the individual user, as ∼42% of the Patel et al.'s study participants were able to wear an IIS for 6–7 days and 75% of those in Waldenmaier et al.'s study wore at least one standard IIS for 7 days.”
    Quote in the paperNot a substantial claim1 of 2 sources checked
    • cites [8] 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
    • cites [9] Waldenmaier D, Zschornack E, Buhr A, et al.: A prospective study of insulin infusion set use for up to 7 days: early replacement reasons and impact on glycemic control. Diabetes Technol Ther 2020; 22: 734– 741. 32167382 source

  • It may state two separate claims as one.

    Premisecitation

    Early studies of extended standard IIS wear demonstrated deterioration in glycemic control and significant IIS- or IIS site-related adverse events.

    “Early studies of extended standard IIS wear demonstrated deterioration in glycemic control and significant IIS- or IIS site-related adverse events.1–3”
    Quote in the paperSubstantial claim3 of 3 sources checked
    • cites [1] Pfutzner A, Sachsenheimer D, Grenningloh M, et al.: Using insulin infusion sets in CSII for longer than the recommended usage time leads to a high risk for adverse events: results from a prospective randomized crossover study. J Diabetes Sci Technol 2015; 9: 1292– 1298. 26341262 PMC4667306 source
    • cites [2] Schmid V, Hohberg C, Borchert M, et al.: Pilot study for assessment of optimal frequency for changing catheters in insulin pump therapy-trouble starts on day 3. J Diabetes Sci Technol 2010; 4: 976– 982. 20663464 PMC2909532 source
    • cites [3] 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 (page unavailable) report that glycemic control deteriorated after 48 hours of pump infusion line use. The Introduction (page unavailable) describes a serious infusion-site infection after prolonged wear, but attributes it to an earlier case report; this study does not demonstrate significant IIS- or site-related adverse events of its own. (LLM, conf=0.85)

      Experimental — accuracy not yet measured

  • Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.

    Findingown data

    The intention to treat population comprised 259 adults with type 1 diabetes, mean age 45.0 ± 14.1 years, who wore a total of 3041 EIS devices, including 1561 with insulin lispro and 1480 with insulin aspart.

    “The demographics of the intention to treat population (n = 259, 45.0 ± 14.1 years of age, min–max 18.7–77.4 years) who wore a total of 3041 EIS devices (1561 used with insulin lispro and 1480 used with insulin aspart) are listed in Table 1.”
    Quote in the paperNot a substantial claim

  • The quote only partly states this claim.

    Findingown data

    The rate of EIS failure due to unexplained hyperglycemia at the end of day 7 was 0.4% (95% CI: 0.16-1.00) for insulin aspart use.

    “Insulin aspart | 127 | 1480 | 6 | 0.4”
    Quote in the paperSubstantial claim

  • It may state two separate claims as one.

    Findingown data

    There were no serious adverse device effects, unanticipated adverse device effects, or diabetic ketoacidosis events.

    “There were no SADE, UADE, or DKA events.”
    Quote in the paperSubstantial claim

  • It may state two separate claims as one.

    Findingown data

    The overall rates of serious adverse events, severe hypoglycemia, severe hyperglycemia, and skin infection were 3.8, 2.5, 104.1, and 20.1 events per 100 participant-years, respectively.

    “The overall rates of SAEs, SevHypo, SevHyper, and skin infection were 3.8, 2.5, 104.1, and 20.1 events per 100 participant-years.”
    Quote in the paperSubstantial claim

  • It may state two separate claims as one.

    Findingown data

    There was no serious adverse device event, UADE, or episode of DKA.

    “There was no serious adverse device event, UADE, or episode of DKA.”
    Quote in the paperSubstantial claim

  • It may state two separate claims as one.

    Findingown data

    Glucose variability was 35.6% ± 5.7% on day 1 and 30.5% ± 4.7% on day 7.

    “Glucose variability was 35.6% ± 5.7% on day 1 and 30.5% ± 4.7% on day 7 and TDD was relatively unchanged (54.3 ± 28.6 U, 53.5 ± 28.5 U, and 53.6 ± 28.0 U on days 1, 4, and 7, respectively).”
    Quote in the paperSubstantial claim

  • It may state two separate claims as one.

    Findingown data

    In this study, excluding the initial training visit, participants inserted the EIS on their own, the rate of kinking at insertion was 0.5%, and 99.6% of participants were able to wear at least one EIS for 7 days.

    “In this study, and excluding the initial training visit, participants inserted the EIS on their own and the rate of kinking at insertion was a low 0.5% with 99.6% participants being able to wear at least one EIS for 7 days.”
    Quote in the paperSubstantial claim

  • It may state two separate claims as one. The quote only partly states this claim.

    Findingown data

    The EIS failure rate due to unexplained hyperglycemia and both unexplained hyperglycemia and device-related SevHyper was 1.1% for insulin lispro and 1.2% for insulin aspart.

    “| Insulin lispro | 132 | 1561 | 17 | 1.1 |”
    • Also stated in: § Effectiveness endpoint evaluation · plain
      “| Insulin aspart | 127 | 1480 | 18 | 1.2 |”
    Quote in the paperSubstantial claim

  • It may state two separate claims as one.

    Premisecitation

    The MiniMed 670G system pivotal trial used a definition of SevHyper of BG >300 mg/dL and blood ketones >0.6 mM and involved use of a 3-day IIS.

    “The MiniMed 670G system pivotal trial15 used a definition of SevHyper of BG >300 mg/dL and blood ketones >0.6 mM and involved use of a 3-day IIS.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [15] Bergenstal RM, Garg S, Weinzimer SA, et al.: Safety of a hybrid closed-loop insulin delivery system in patients with type 1 diabetes. JAMA 2016; 316: 1407– 1408. 27629148 source

  • It may state two separate claims as one.

    Premisecitation

    For users of both CSII and CGM technologies, the combined application and intervals of device change can be burdensome because of numerous adhesive patch removals and increased risk of skin irritation, skin reactions, or adhesive tape allergies, with minimal days for recovery.

    “Thus, for users of both CSII and CGM technologies, the combined application and intervals of device change can be burdensome because of numerous adhesive patch removals and increased risk of skin irritation,5,6 skin reactions,5,6 or adhesive tape allergies,7 with minimal days for recovery.”
    Quote in the paperSubstantial claim0 of 3 sources checked
    • cites [5] Berg AK, Norgaard K, Thyssen JP, et al.: Skin problems associated with insulin pumps and sensors in adults with type 1 diabetes: a cross-sectional study. Diabetes Technol Ther 2018; 20: 475– 482. 29893593 source
    • cites [6] Christensen MO, Berg AK, Rytter K, et al.: Skin problems due to treatment with technology are associated with increased disease burden among adults with type 1 diabetes. Diabetes Technol Ther 2019; 21: 215– 221. 30943072 source
    • cites [7] Heinemann L, Kamann S: Adhesives used for diabetes medical devices: a neglected risk with serious consequences? J Diabetes Sci Technol 2016; 10: 1211– 1215. 27566734 PMC5094339 source

  • It may state two separate claims as one.

    Study design and conductown data

    The survival rate analysis was based on 2788 of 3041 infusion sets after excluding not-for-cause removals unrelated to the investigational device, including 234 early removals, 14 removals due to insulin depletion, and 5 due to pump replacement.

    “The survival rate analysis was based on 2788 of 3041 infusion sets, excluding not-for-cause removals unrelated to the investigational device, where 234 sets were inadvertently removed by the participants early (<174 h) due to time calculation error and 19 sets were removed due to insulin depletion (n = 14) and pump replacement (n = 5).”
    Quote in the paperSubstantial claim

  • It may state two separate claims as one.

    Premisecitation

    The new EIS includes a new H-cap connector and tubing with new fluid path design that improve insulin preservative retention and stability.

    “Iterative advancements relative to earlier IIS devices designed for 2 to 3 days of wear included a new H-cap connector and tubing with new fluid path design that improve insulin preservative retention and stability,12”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [12] Ilany J, Cohen O, Konvalina N, et al.: Clinical study of a new extended wear infusion set design. Diabetes Technol Ther 2020; 22: A- 27. source

  • Probably not a substantial claim. The paper’s conclusions may not depend on it.

    Study design and conductcitation

    Sample size estimation was based on previously published single-center data.

    “Sample size estimation was based on previously published single-center data.14”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [14] Buckingham BA, Marcal T, Hoffman L, et al.: Testing a novel infusion set for extended wear duration. Diabetes 2020; 69: 997- P. source

  • Probably not a substantial claim. It may state two separate claims as one.

    Study design and conductreasoning

    Approximately 300 enrolled participants were estimated to ensure that 240 met eligibility criteria, with approximately half using insulin lispro and half using insulin aspart.

    “Approximately 300 enrolled participants were estimated to ensure that 240 met eligibility criteria, with approximately half using insulin lispro and half using insulin aspart.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim. The paper’s conclusions may not depend on it.

    Study design and conductown data

    A total of 248 participants completed the study.

    “A total of 248 participants completed the study.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.

    Study design and conductown data

    There were 291 adults enrolled in the trial, 29 screen failures, 4 early withdrawals, and 10 withdrawals after at least one EIS insertion.

    “There were 291 adults who enrolled in the trial, 29 screen failures, 4 early withdrawals and 10 withdrawals after, at least, one insertion of an EIS (Fig. 2).”
    Quote in the paperNot a substantial claim

  • It may state two separate claims as one.

    Interpretationown data

    The EIS, when worn for up to 7 days, was safe and rated with high satisfaction, without adversely affecting glycemic control in adults with type 1 diabetes.

    “This investigation demonstrates that the EIS, when worn for up to 7 days, was safe and rated with high satisfaction, without adversely affecting glycemic control in adults with T1D.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim. The paper may give no reason why it holds. It may state two separate claims as one.

    Interpretationreasoning

    Extending the wear duration of IIS devices to closely align with CGM sensor change intervals would reduce diabetes management burden, IIS waste, and insulin loss associated with more frequent IIS changes.

    “Extending the wear duration of IIS devices to closely align with that of CGM sensor change intervals would not only reduce diabetes management burden but also reduce IIS waste and insulin loss associated with more frequent IIS changes.”
    Quote in the paperNot a substantial claim
    • Rests on an assumption: Continuous glucose monitoring systems often used in conjunction with CSII pump therapy can function for at least 7 days before a sensor change.

  • Probably not a substantial claim.

    Study design and conductcitation

    A sample size of at least 100 for each insulin type would yield power >80% to demonstrate a failure rate due to unexplained hyperglycemia, on wear-day 6 or 7, of ≤20% with a two-sided 0.05 significance level.

    “A sample size of at least 100 for each insulin type would yield power >80% to demonstrate a failure rate due to unexplained hyperglycemia, on wear-day 6 or 7, of ≤20% (with two-sided 0.05 significance level).”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim. The paper’s conclusions may not depend on it.

    Premisecitation

    In Freckmann et al.'s study, 18.7% had kinked cannulas.

    “In Freckmann et al.'s study, where the study participants (N = 80 total) inserted their IIS devices (Accu-Chek™ FlexLink infusion set and Accu-Chek FlexLink Plus infusion set [Roche Diabetes Care, Mannheim, Germany]), 18.7% had kinked cannulas.19”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [19] Freckmann G, Arndt S, Fiesselmann A, et al.: Randomized cross-over study comparing two infusion sets for CSII in daily life. J Diabetes Sci Technol 2017; 11: 253– 259. 27605591 PMC5478026 source

  • Probably not a substantial claim. It may be too vague to check against evidence. The paper’s conclusions may not depend on it. It may state two separate claims as one.

    Interpretationreasoning

    These different results likely reflect iterative modifications in IIS device performance, IIS insertion devices, and user experience, or a combination of these factors.

    “These different results likely reflect iterative modifications in IIS device performance, IIS insertion devices, and user experience, or a combination of these factors.”
    Quote in the paperNot a substantial claim

  • It may state two separate claims as one.

    Premisecitation

    A recent medical economics Markov Chain Monte Carlo model analysis of standard IIS clinical data versus this study EIS trial data showed a greater average lifetime of 151.6 versus 66.0 h, resulting in 75 fewer set changes per year, for the EIS.

    “A recent medical economics Markov Chain Monte Carlo model analysis of standard IIS clinical data8,18 versus this study EIS trial data showed a greater average lifetime of 151.6 versus 66.0 h, resulting in 75 fewer set changes per year, for the EIS.23”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [23] Kwa T, Zhang G, Shepard K, et al.: The improved survival rate and cost-effectiveness of a 7-day continuous subcutaneous insulin infusion set. J Med Econ 2021; 24: 837– 845. 34154504 source

  • Probably not a substantial claim. The paper’s conclusions may not depend on it.

    Interpretationnone given

    The differences in failure rates observed across these studies were likely due to multiple factors, including study participant selection and definitions of infusion set failure.

    “The differences in failure rates observed across these studies were likely due to multiple factors, including study participant selection and definitions of infusion set failure.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.

    Premisecitation

    In Waldenmaier et al.'s study, participants could use an accompanying insertion device, and no issues with kinking at IIS insertion were reported.

    “While a different Teflon-cannula IIS device (YpsoPump™ Orbit™ soft infusion set [Ypsomed AG, Burgdorf, Switzerland]) was used in Waldenmaier et al.'s study, participants could use an accompanying insertion device, and no issues with kinking at IIS insertion were reported.9”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [9] Waldenmaier D, Zschornack E, Buhr A, et al.: A prospective study of insulin infusion set use for up to 7 days: early replacement reasons and impact on glycemic control. Diabetes Technol Ther 2020; 22: 734– 741. 32167382 source

  • Probably not a substantial claim. The paper’s conclusions may not depend on it.

    Study design and conductreasoning

    The Auto Mode function, which included multiple periods of time when insulin delivery was suspended to prevent hypoglycemia, served as a more rigorous test of infusion set function than an open-loop system where there is continuous insulin delivery.

    “However, the Auto Mode function, which included multiple periods of time (some lasting hours) when insulin delivery was suspended to prevent hypoglycemia, served as a more rigorous test of infusion set function than an open-loop system where there is continuous insulin delivery.”
    Quote in the paperNot a substantial claim

  • It may state two separate claims as one.

    Interpretationown data

    Glycemic control and participant-reported satisfaction during EIS use were favorable.

    “Glycemic control and participant-reported satisfaction during EIS use were favorable.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.

    Study design and conductown data

    The study population included a majority of white participants with relatively well-controlled glycemia at study start.

    “In addition, the study population also included participants, a majority of whom were white, with relatively well-controlled glycemia at study start.”
    Quote in the paperNot a substantial claim

  • It may state two separate claims as one.

    Interpretationown data

    The Medtronic extended infusion set described in this study was safely worn for up to 7 days by adults without adversely affecting glycemic control and with favorable user satisfaction.

    “The Medtronic extended infusion set described in this study was safely worn for up to 7 days by adults without adversely affecting glycemic control and with favorable user satisfaction.”
    Quote in the paperSubstantial claim

  • It may state two separate claims as one.

    Premisecitation

    One randomized crossover study investigating intended real-world 3-day use of standard IIS devices reported comparable failure rates (or unplanned IIS changes) of 16%-20%, and ∼40% were due to unexpected high glucose, occlusion alarms, or backflow of insulin.

    “It is also important to note that one randomized crossover study investigating intended real-world 3-day use of standard IIS devices reported comparable failure rates (or unplanned IIS changes) of 16%–20% and that ∼40% were due to unexpected high glucose, occlusion alarms, or backflow of insulin.19”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [19] Freckmann G, Arndt S, Fiesselmann A, et al.: Randomized cross-over study comparing two infusion sets for CSII in daily life. J Diabetes Sci Technol 2017; 11: 253– 259. 27605591 PMC5478026 source
40 of 40

  • The paper relies on this without support.

    Continuous glucose monitoring systems often used in conjunction with CSII pump therapy can function for at least 7 days before a sensor change.

    “However, continuous glucose monitoring (CGM) systems often used in conjunction with CSII pump therapy can function for ≥7 days before a sensor change.”
1 of 1

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.

  • Severe hypoglycemia while not wearing an EIS counted as occurring during wear

    Minor

    The paper says one of the two severe hypoglycemia events occurred when the participant was not wearing an EIS, but Table 2 counts both events under safety outcomes during EIS wear.

1 of 1

Citations

Cites

Flagged first, then by citations

Research works printed but not linked: 1

  1. Chattaraj S, , Zhang G, , Anselmo E, et al.: The Medtronic extended wear infusion set: determining mechanisms of action. Diabetes Technol Ther, 2021; 23:A149.

Cited by

Sorted by citations

Related

Metadata

Authors
Brazg, R., Garg, S. K., Bhargava, A., Thrasher, J. R., Latif, K., Bode, B. W., Bailey, T. S., Horowitz, B. S., Cavale, A., Kudva, Y. C., Kaiserman, K. B., Grunberger, G., Reed, J. C., Chattaraj, S., Zhang, G., Shin, J., Chen, V., Lee, S. W., Cordero, T. L., Rhinehart, A. S., Vigersky, R. A., & Buckingham, B. A.
Affiliations
  • Rainier Clinical Research Center, Renton, Washington, USA.
  • Barbara Davis Center for Diabetes, Aurora, Colorado, USA.
  • Iowa Diabetes and Endocrinology Research Center (US)
  • Medical Investigations, Inc., Little Rock, Arkansas, USA.
  • AM Diabetes and Endocrinology Center, Bartlett, Tennessee, USA.
  • Atlanta Diabetes Associates (US)
  • AMCR Institute (US)
  • Metabolic Research Institute, Inc., West Palm Beach, Florida, USA.
  • Diabetes and Endocrinology Consultants of Pennsylvania, Feasterville Trevose, Pennsylvania, USA.
  • Mayo Clinic (US)
  • SoCal Diabetes, Torrance, California, USA.
  • Grunberger Diabetes Institute (US)
  • Endocrine Research Solutions, Roswell, Georgia, USA.
  • Medtronic (United States) (US)
  • Stanford Medicine (US)
Corresponding author
Buckingham, Bruce A.
ORCID
Venue
Diabetes Technology & Therapeutics
Publisher
SAGE Publications
Published
2022-07-28
Volume
24
Issue
8
Pages
535-543
ISSN
  • 1520-9156 (ISSN-L)
  • 1557-8593
DOI
10.1089/dia.2021.0540
PMC
PMC9353978
OpenAlex
W4221083646
Semantic Scholar
6336acfa4f845ee5d308430be7b61c6759fd590b
Cited by
28
References
21
Citations by year
2026: 4 · 2025: 5 · 2024: 5 · 2023: 7 · 2022: 7
FWCI
4.44
Type
journal article
Language
en
Open access
Licence
Locations
  • Diabetes Technology & Therapeutics (publishedVersion, cc-by-nc)
  • PubMed Central (publishedVersion, cc-by-nc)
  • PubMed (publishedVersion)
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
type 1 diabetes, continuous glucose monitoring, insulin pump therapy, MiniMed 670G, insulin lispro, insulin aspart, diabetic ketoacidosis, severe hypoglycemia, severe hyperglycemia, glycemic control, HbA1c, time in range, device safety, patient satisfaction
MeSH terms
Adult, Blood Glucose, Diabetes Mellitus, Type 1, Female, Humans, Hyperglycemia, Hypoglycemia, Hypoglycemic Agents, Insulin, Insulin Infusion Systems, Male, Survival Rate, Diabetic Ketoacidosis, Insulin Lispro

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.

A language model drew the claims from the paper on 2026-11-06, under version 3 of the claim definition (model deepseek-v4.1-flash, prompt extract-v3).

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