Evidence map›Paper›PMID 26798083›Full record

Trial reportJournal of diabetes science and technology2016

Injection Technique and Pen Needle Design Affect Leakage From Skin After Subcutaneous Injections.

Kezia Ann Præstmark, Bente Stallknecht, Morten Lind Jensen, Thomas Sparre, Nils Berg Madsen, Jonas Kildegaard

Open access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of diabetes science and technology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
2.2field-weighted citation impact, top 13% 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

14 citing papers in PubMed, 1 synthesis or guideline pooled it, 39 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Impact of Injection Speed, Volume, and Site on Pain Sensation.Journal of diabetes science and technology · 2018
    Trial
  4. Article
  5. Article
  6. Article
  7. Design Development of the SMARTCLICAdvances in therapy · 2023
    Article
  8. Review
  9. Review
  10. Article
  11. Insulin Injection Practices in a Population of Canadians with Diabetes: An Observational Study.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2020
    Article
  12. The Injection Technique Factor: What You Don't Know or Teach Can Make a Difference.Clinical diabetes : a publication of the American Diabetes Association · 2019
    Article
  13. Subcutaneous Administration of Biotherapeutics: An Overview of Current Challenges and Opportunities.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2018
    Review
  14. 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

6 authors at 2 institutions in 1 country.

Kezia Ann PræstmarkDepartment of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark Novo Nordisk A/S, Device R&D, Hillerød, Denmark kezj@novonordisk.com.
Bente StallknechtDepartment of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.
Morten Lind JensenNovo Nordisk A/S, Medical & Science Devices, Søborg, Denmark.
Thomas SparreNovo Nordisk A/S, Medical & Science Devices, Søborg, Denmark.
Nils Berg MadsenNovo Nordisk A/S, Device R&D, Hillerød, Denmark.
Jonas KildegaardNovo Nordisk A/S, Insulin Pharmacology, Måløv, Denmark.
Novo Nordisk (Denmark) · DKUniversity of Copenhagen · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAfter a subcutaneous injection fluid might leak out of the skin, commonly referred to as leakage or backflow. The objective was to examine the influence of needle design and injection technique on leakage after injections in the subcutaneous tissue of humans and pigs.

methodLeakage data were obtained from a post hoc analysis of clinical trial data and from a pig study. Data from the clinical study were used to determine leakage as a function of injection volume, speed and region. Data from the pig study were used to determine leakage as a function of needle wall thickness, needle taper, injection angle, and wait time from end of injection to withdrawal of needle from skin.

resultsLeakage volume was positively related to injection volume. Injections in the abdomen caused less leakage than thigh injections. A 32G needle caused less leakage than a 31G and a 32G tip (tapered) needle, and a "straight in" 90° needle insertion angle caused less leakage than an angled (~45°) insertion. Wait times of minimum 3 seconds caused less leakage than immediate withdrawal of the needle after injection. Needle wall thickness and injection speed did not influence leakage.

conclusionsLeakage will be minimized using a thin needle, using 90° needle insertion in the abdomen, injecting maximum 800 µL at a time, and waiting at least 3 seconds after the injection until the needle is withdrawn from the skin.

Indexed as

NeedlesAdultAgedAnimalsDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2Double-Blind MethodFemaleHumansHypoglycemic AgentsInjections, SubcutaneousInsulinMaleMiddle AgedSkinSwineHypoglycemic AgentsInsulinbackflowinjection techniqueinsulin injectionsleakagepen needle

Identifiers

PMID26798083
PMCPMC4928216
OpenAlexW2268577918

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.