Trial reportDiabetes, obesity & metabolism2018
Injecting without pressing a button: An exploratory study of a shield-triggered injection mechanism.
Trial report in Diabetes, obesity & metabolism, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02627287 (A Comparative Trial Focusing on Injections With the Medical Device DV3316 Pen-injector Versus FlexPen), which is not on this map. Cited by 3 papers.
What it found
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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.
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.
A Comparative Trial Focusing on Injections With the Medical Device DV3316 Pen-injector Versus FlexPen
Who cites it
3 citing papers in PubMed.
- Injecting without pressing a button: An exploratory study of a shield-triggered injection mechanism.Diabetes, obesity & metabolism · 2018Trial
- Novel Robust Needle Tip Design Enables Needle Reuse and Reduced Skin Trauma in Combination With Autoinjector Needle Shields.Journal of diabetes science and technology · 2025Article
- Analysis of "Laboratory and Benchtop Performance of a Mealtime Insulin Delivery System".Journal of diabetes science and technology · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsTo evaluate the injection success and user perception of a shield-triggered pen-injector mechanism.
methodsThe trial (ClinicalTrials.gov NCT02627287) was an exploratory, two-centre, one-visit, open-label, randomized controlled trial conducted in Germany in 150 injection-experienced individuals with type 1 or type 2 diabetes. Participants self-administered subcutaneous injections of a placebo solution using a prototype shield-triggered pen-injector, DV3316 (Novo Nordisk, Bagsvaerd, Denmark), and FlexPen (Novo Nordisk, Bagsvaerd, Denmark). Injection success was evaluated on a yes/no basis by the investigator. Participant confidence, leakage of fluid and pain were evaluated after each injection. Pain and device experience were assessed after completion of all injections with each pen-injector. Overall preference was assessed after completion of all injections with both pen-injectors.
resultsInjection success was high with both pen-injectors (97.0%, DV3316 vs 99.7%, FlexPen). Participant confidence in dose delivery was similar for the two devices (88% of injections with DV3316 vs 81% with FlexPen were scored as "extremely confident"). The median injection pain score on a visual analogue scale (0-100) was 3 with DV3316 vs 4 with FlexPen after each injection, and 4 with DV3316 vs 5 with FlexPen after all injections with each device. After all injections were completed, 55% of participants reported an overall preference for DV3316 vs 21% for FlexPen.
conclusionThis study demonstrates that injection-experienced individuals can achieve a high injection success rate with a shield-triggered pen-injector, with similar patient confidence and injection pain compared with FlexPen.
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Registered trials
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.