Evidence map›Paper›PMID 35533132›Full record

ArticleJournal of diabetes science and technology2023

In Vivo Study of the Inflammatory Tissue Response Surrounding a Novel Extended-Wear Kink-Resistant Insulin Infusion Set Prototype Compared With a Commercial Control Over Two Weeks of Wear Time.

Jasmin R Kastner, Gabriella Eisler, Marc C Torjman, Abdurizzagh Khalf, David Diaz, Alek R Dinesen, Channy Loeum, Paul J Strasma, Jeffrey I Joseph

Open access · bronzeAbstract read
In one paragraph

Article in Journal of diabetes science and technology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.3field-weighted citation impact, top 19% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 9 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 1 institution in 1 country.

Jasmin R KastnerDepartment of Anesthesiology, The Jefferson Artificial Pancreas Center, Thomas Jefferson University, Philadelphia, PA, USA.ORCID 0000-0002-0821-3778
Gabriella EislerDepartment of Anesthesiology, The Jefferson Artificial Pancreas Center, Thomas Jefferson University, Philadelphia, PA, USA.
Marc C TorjmanDepartment of Anesthesiology, The Jefferson Artificial Pancreas Center, Thomas Jefferson University, Philadelphia, PA, USA.
Abdurizzagh KhalfDepartment of Anesthesiology, The Jefferson Artificial Pancreas Center, Thomas Jefferson University, Philadelphia, PA, USA.
David DiazDepartment of Anesthesiology, The Jefferson Artificial Pancreas Center, Thomas Jefferson University, Philadelphia, PA, USA.
Alek R DinesenDepartment of Anesthesiology, The Jefferson Artificial Pancreas Center, Thomas Jefferson University, Philadelphia, PA, USA.
Channy LoeumDepartment of Anesthesiology, The Jefferson Artificial Pancreas Center, Thomas Jefferson University, Philadelphia, PA, USA.
Paul J StrasmaCapillary Biomedical Inc, Irvine, CA, USA.
Jeffrey I JosephDepartment of Anesthesiology, The Jefferson Artificial Pancreas Center, Thomas Jefferson University, Philadelphia, PA, USA.ORCID 0000-0002-4945-2070
Thomas Jefferson University · US

Funding

Multi-Orifice Continuous Subcutaneous Insulin Infusion Catheter with Reduced Pharmacokinetic Variability and Rapid On-Off Pharmacodynamic ActionsR43DK110969 · NIDDK · CAPILLARY BIOMEDICAL, INC. · PI STRASMA, PAUL J · 2016 to 2017
$269k
NIDDK NIH HHS R43 DK110969
6 · The paper itself

Abstract

backgroundInfusion set function remains the limiting factor of insulin pump therapy due to nonmetabolic complications. Here, we tested an investigational extended-wear infusion set prototype with a soft, angled, wire-reinforced cannula with three additional side holes, and compared failure mechanisms and tissue response with a commercial Teflon control.

methodsA total of 48 Teflon and 48 prototype infusion sets were inserted subcutaneously every other day for 14 days in 12 swine and infused with dilute insulin. After two weeks, tissue around cannulas was excised, and occlusions, leaks, and kinks were determined. Tissue was processed and stained to assess the total area of inflammation (TAI) and the inflammatory layer thickness (ILT) around the cannulas. Data were analyzed using Fisher's exact, analysis of variance-general linear model, Kruskal-Wallis, and post hoc tests.

resultsOn average, the TAI surrounding the investigational cannula was 52.6% smaller than around the commercial control. The ILT was 66.3% smaller around investigational cannulas. Kinks occurred in 2.1% (investigational) vs 32.4% (commercial) cannulas (

conclusionsThe data suggest that the infusion set prototype elicits less inflammation over an extended wear time and is resistant to kinking, compared with a commercial Teflon device. This is consistent with previously published data on the impact of cannula material/angle on the inflammatory tissue response. We highlight the following important aspects of infusion set design: (1) secure skin adhesion, (2) reliable cannula insertion, (3) automatic removal of the stylet, (4) cannula material/design that resists kinking, and (5) minimization of local tissue inflammation.

Indexed as

Hypoglycemic AgentsInsulin Infusion SystemsAnimalsCatheterizationDiabetes Mellitus, Type 1InflammationInsulinPolytetrafluoroethyleneSwineHypoglycemic AgentsInsulinPolytetrafluoroethyleneCSII therapyextended-wear infusion setinflammatory tissue responseinsulin infusion setinsulin pump therapyswine model

Identifiers

PMID35533132
PMCPMC10658669
OpenAlexW4229452233

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.