Evidence map›Paper›PMID 25633967›Full record

ArticleJournal of diabetes science and technology2015

Functional Evaluation of the Reusable JuniorSTAR® Half-Unit Insulin Pen.

David Klonoff, Irina Nayberg, Ivana Rabbone, Catherine Domenger, Udo Stauder, Hamid Oualali, Thomas Danne

Abstract readEvaluation Study
In one paragraph

Article 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. Trial
  2. Observational
  3. Insulin-delivery methods for children and adolescents with type 1 diabetes.Therapeutic advances in endocrinology and metabolism · 2020
    Review
  4. Review
  5. Boluses in Insulin Therapy.Journal of diabetes science and technology · 2017
    Review
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

7 authors.

David KlonoffDiabetes Research Institute, Mills-Peninsula Health Services, San Mateo, CA, USA dklonoff@diabetestechnology.org.
Irina NaybergDiabetes Research Institute, Mills-Peninsula Health Services, San Mateo, CA, USA.
Ivana RabboneS.S.V.U. Endocrinologia e Diabetologia, Ospedale Infantile Regina Margherita, Turin, Italy.
Catherine DomengerSanofi, Paris, France.
Udo StauderSanofi, Frankfurt, Germany.
Hamid OualaliSanofi, Frankfurt, Germany.
Thomas DanneKinder und Jugendkrankenhaus "Auf der Bult," Diabetes Centre for Children and Adolescents, Hannover, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe functional performance of the JuniorSTAR(®) (Sanofi, Paris, France) half-unit insulin pen was evaluated through a series of specific objective tests to assess the dose accuracy, pen weight, injection force, and dialing torque.

methodPens (n = 60) were tested under standard atmospheric conditions with 3 different types of insulins manufactured by Sanofi (insulin glargine, insulin glulisine, and biphasic insulin isophane). The dose accuracy was tested according to the ISO 11608-1:2012 standards. Injection doses of 0.010, 0.155, and 0.300 ml were evaluated. For mean weight evaluation, the pens without the cartridge were weighed on precision balances. The injection force was measured using a texture analyzer and the dialing torque was measured using a torque meter.

resultsJuniorSTAR met the ISO 11608-1:2012 criteria for dose accuracy as all the delivered doses were within the predefined limits for all types of insulin tested. The mean weight of the JuniorSTAR pen was 33.4 g (SD = 0.075). The mean injection force was 6.0 N (SD = 0.8), 4.3 N (SD = 0.4), and 5.1 N (SD = 0.6) for insulin glargine, insulin glulisine, and biphasic insulin isophane, respectively. The mean dialing torque was 5.09 Ncm (SD = 0.29) and 5.88 Ncm (SD = 0.53) for setting and correcting a dose, respectively.

conclusionsTogether with results from a previously reported usability survey, these results show that the JuniorSTAR reusable, half-unit pen is a lightweight and accurate device for insulin delivery with a dialing torque and injection force suitable for young people with type 1 diabetes.

Indexed as

Diabetes Mellitus, Type 1Equipment ReuseHumansHypoglycemic AgentsInsulinReproducibility of ResultsSyringesTorqueHypoglycemic AgentsInsulindose accuracyhalf-unitinjection forceinsulin penJuniorSTAR®weight

Identifiers

PMID25633967
PMCPMC4604544

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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.