Evidence map›Paper›PMID 24124963›Full record

ArticleJournal of diabetes science and technology2013

Dose accuracy and injection force of different insulin glargine pens.

Arnd Friedrichs, Janine Bohnet, Volker Korger, Steffen Adler, Manfred Schubert-Zsilavecz, Mona Abdel-Tawab

Open access · bronzeAbstract read
In one paragraph

Article in Journal of diabetes science and technology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
2.4field-weighted citation impact, top 11% 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

8 citing papers in PubMed, 19 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
  4. Boluses in Insulin Therapy.Journal of diabetes science and technology · 2017
    Review
  5. Article
  6. Clinical Use and Evaluation of Insulin Pens.Journal of diabetes science and technology · 2015
    Article
  7. Functional Evaluation of the Reusable JuniorSTAR® Half-Unit Insulin Pen.Journal of diabetes science and technology · 2015
    Article
  8. Dialing torque preferences of people with diabetes when using insulin pens: a pilot study.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2015
    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.

Arnd FriedrichsLWS Risk Management Consult, Bahnhofstr. 9, D-83098 Brannenburg, Germany. arnd.friedrichs@lwsgroup.com.
Janine Bohnet
Volker Korger
Steffen Adler
Manfred Schubert-Zsilavecz
Mona Abdel-Tawab
Federal Union of German Associations of Pharmacists · DESanofi (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDose accuracy and injection force, representing key parameters of insulin pens, were determined for three pens delivering insulin glargine-based copies, Pen Royale (WR) and DispoPen (WD) for Glaritus® (Wockhardt) and GanLee Pen (GL) for Basalin® (Gan & Lee), compared with pens of the originator, ClikSTAR® (CS) and SoloSTAR® (SS) for Lantus® (Sanofi).

methodsUsing the weighing procedure recommended by DIN EN ISO 11608-1:2000, dose accuracy was evaluated based on nonrandomized delivery of low (5 U), mid (30 U), and high (60 U) dosage levels. Injection force was measured by dispensing the maximum dose of insulin (60 U for the GL, WR, and WD; 80 U for the SS and CS) at dose speeds of 6 and 10 U/s.

resultsAll tested pens delivered comparable average doses within the DIN EN ISO 11608-1:2000 limits at all dosage levels. The GL revealed a higher coefficient of variation (CV) at 5 U, and the WR and WD had higher CVs at all dosage levels compared with the CS and SS. Injection force was higher for the WR, WD, and GL compared with the CS and SS at both dose speeds. In contrast to the CS and SS with an end-of-content feature, doses exceeding the remaining insulin could be dialed with the WR, GL, and WD and, apparently, dispensed with the WD.

conclusionsAll pens fulfilled the dose accuracy requirements defined by DIN EN ISO 11608-1:2000 standards at all three dosage levels, with the WR, WD, and GL showing higher dosage variability and injection force compared with the SS and CS. Thus, the devices that deliver insulin glargine copies show different performance characteristics compared with the originator.

Indexed as

Disposable EquipmentDrug Delivery SystemsHumansHypoglycemic AgentsInjections, SubcutaneousInsulin GlargineInsulin, Long-ActingHypoglycemic AgentsInsulin GlargineInsulin, Long-Acting

Identifiers

PMID24124963
PMCPMC3876380
OpenAlexW2108250342

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.