Evidence map›Paper›PMID 22027314›Full record

ArticleJournal of diabetes science and technology2011

Dose accuracy of the ClikSTAR, NovoPen 4, and Luxura insulin pens: results of laboratory and field studies.

Arnd Friedrichs, Nils Basso, Steffen Adler

Abstract read
In one paragraph

Article in Journal of diabetes science and technology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Review
  2. 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
  3. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

3 authors.

Arnd FriedrichsLWS Risk Management Consult, Brannenburg, Germany. arnd.friedrichs@lwsgroup.com
Nils Basso
Steffen Adler

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA high dosing accuracy is needed to maintain normal glycemia in patients with diabetes. This study investigated the dose accuracy of the commonly used reusable insulin pens ClikSTAR®, NovoPen® 4, and Luxura®.

methodsPens were tested in a laboratory setting by one trained technician who delivered four doses of 30 U from each of 15 pens per pen model (a total of 60 doses from each pen model). Pens were also tested in a simulated clinical setting by 48 people with diabetes. Each participant delivered 27 doses: three doses of 30 U from each of three pens per pen model. Overall, the technician delivered 180 doses and the participants 1296 doses.

resultsAll pens met the tolerance limits defined by the German edition of the International Standardization Organization (ISO) 11608-1:2000 standard [30 ± 1.5 U (28.5-31.5 U)]. All doses were delivered within the limits proposed by the ISO, except for two doses with Luxura in the clinical setting. In laboratory testing, the mean dose delivered by ClikSTAR (29.69 U) or Luxura (29.89 U) was less than the expected 30 U and significantly less than the mean dose delivered by NovoPen 4 (30.04 U; p < .001 for both comparisons). Similar results were observed in the simulated clinical setting. NovoPen 4 had the greatest variance in laboratory testing but the least in the simulated clinical setting.

conclusionsThis study demonstrates comparable dose accuracy and variability of the ClikSTAR, Luxura, and NovoPen 4 insulin pens. The slight differences in mean doses between pens are unlikely to be clinically significant.

Indexed as

AdultDiabetes Mellitus, Type 1Drug Delivery SystemsFemaleHumansHypoglycemic AgentsInjections, SubcutaneousInsulinMaleHypoglycemic AgentsInsulin

Identifiers

PMID22027314
PMCPMC3208877

What OpenQuestion holds

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Registered trials

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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.