Evidence map›Paper›PMID 26319228›Full record

Trial reportJournal of diabetes science and technology2015

Evaluation of Intradermal and Subcutaneous Infusion Set Performance Under 24-Hour Basal and Bolus Conditions.

Elaine McVey, Steven Keith, Joshua K Herr, Diane Sutter, Ronald J Pettis

Abstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of diabetes science and technology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
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

5 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. Article
  5. Subcutaneous Insulin Administration: Sufficient Progress or Ongoing Need?Journal of diabetes science and technology · 2019
    Article
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

5 authors.

Elaine McVeyBD Technologies, Research Triangle Park, NC, USA MaxPoint Interactive, Morrisville, NC, USA.
Steven KeithBD Technologies, Research Triangle Park, NC, USA Parker Hannifin Corporation, Madison, WI, USA.
Joshua K HerrBD Technologies, Research Triangle Park, NC, USA.
Diane SutterBD Technologies, Research Triangle Park, NC, USA.
Ronald J PettisBD Technologies, Research Triangle Park, NC, USA Ron_J_Pettis@bd.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis study sought to assess the function and delivery reliability of intradermal (ID) infusion sets used with commercial insulin pumps.

methodHealthy subjects (n = 43) were randomized to either ID or subcutaneous (SC) arms, and received basal/bolus placebo delivery for 24 hours. Subjects received 4 of 8 infusion set combinations (ID: microneedle design A or B, with 2 pump brands [Animas or MiniMed]; SC: Teflon Quickset or steel Rapid-D, Animas pump only, with or without overtaping) and were evaluated for pump occlusion alarms, fluid leakage, pain, and tissue tolerability. A novel algorithm was developed to determine flow consistency based on fluid pressure, and the duration and occurrence rate for periods of unalarmed but interrupted flow ("silent occlusions'") were compared.

resultsID delivery was successfully maintained over the 24-hour infusion period. The number of silent occlusions was lower for ID microneedle cannula design B than A (P < .01) and lower for Rapid-D SC device compared to Quick-set (P = .03). There was no significant difference in the number of occlusion alarms between the ID and SC devices with the Animas pump. However, the pumps tested with ID devices had significantly different alarm rates (MiniMed 29.5%, Animas 0%, P < .001). Leakage and tissue tolerability were comparable across devices.

conclusionThe ID infusion set reliably delivered diluent for an extended 24-hour period in healthy subjects and was well tolerated. Silent occlusion flow interruptions could be detected in both ID and SC infusion sets using a proprietary algorithm. This algorithm is a promising method for quantitatively evaluating infusion set flow performance.

Indexed as

Insulin Infusion SystemsAdolescentAdultAlgorithmsClinical AlarmsEquipment DesignEquipment FailureFeasibility StudiesFemaleHealthy VolunteersHumansHypoglycemic AgentsInfusions, SubcutaneousInsulinMaleMaterials TestingHypoglycemic AgentsInsulincontinuous subcutaneous insulin deliveryinsulin infusion catheter setsinsulin pump occlusionintradermal insulin deliverysilent occlusion

Identifiers

PMID26319228
PMCPMC4667298

What OpenQuestion holds

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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.