Comparison of Patient Preference for Two Insulin Injection Pen Devices in Relation to Patient Dexterity Skills

Pfützner, Andreas; Schipper, Christina; Niemeyer, Marcus; Qvist, Marianne; Löffler, Andrea; Forst, Thomas; Musholt, Petra B.

doi:10.1177/193229681200600423

Cited by 33 publications

(24 citation statements)

References 18 publications

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“…Some formal summative testing of a given device across the intended user groups in the selected indication has also been reported 20,21. With regard to formative testing with the intent of identifying potential hazards and providing design input, only limited work on pen injectors can be found in the literature 14,15. To our knowledge, no studies involving users selected to be applicable across different indications have been published.…”

Section: Introductionmentioning

confidence: 99%

Usability of devices for self-injection: results of a formative study on a new disposable pen injector

Lange¹,

Richard²,

Bradley³

2014

MDER

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This article presents a late-stage formative usability study of a pen-injector platform device. Such devices are used for the subcutaneous delivery of biopharmaceuticals, primarily for self-administration by the patient. The study was conducted with a broad user population, defined to represent user characteristics across a range of indications. The goals of the study were to confirm that the pen could be used without recurring patterns of use errors leading to hazardous situations, to evaluate the comprehension of the instructions for use (IFU), and to determine if training is necessary. In the study, a total of 36 participants in six groups (health care providers, caregivers, adolescents, diabetics with retinopathy, diabetics with neuropathy, and patients with arthritis) each read the IFU, prepared the device, and performed two simulated injections into an injection pad. Any use errors, near misses, or deviations from the IFU procedure were recorded. The overall success rate (injection completed by the participant without need for assistance) was 94% for the first and 100% for the second injection. Ninety-two percent of the participants reported that they felt confident using the device, 100% found the IFU helpful, and 75% found the device positively comfortable to use. Overall, a total average of 3.35 deviations and errors per user and injection were recorded (there were no near misses). Subtracting the errors without any potential for negative consequences for the injection or the user (trivial deviations), as well as those related to attaching and removing the pen needle (independent of the design of the pen itself), led to an average of 1.31 potentially relevant deviations per user and injection. It was concluded that the pen injector together with the IFU could be safely and efficiently used by all user groups without any training, and thus that the device and IFU in their current form are well suited for use in a range of specific applications.

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Section: Introductionmentioning

confidence: 99%

Usability of devices for self-injection: results of a formative study on a new disposable pen injector

Lange¹,

Richard²,

Bradley³

2014

MDER

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“…This highlights that participants had a positive perception of the shield‐triggered mechanism. Previous design modifications aimed at improving the ease of pen‐injector handling and use have had a positive impact on patient confidence and preference, especially among those with impaired manual dexterity . In addition, the shield of the DV3316 hides the needle during injection, which in a similar manner to contact‐activated figure puncture lancets, may help alleviate anxiety in some people and enhance user acceptabilty .…”

Section: Discussionmentioning

confidence: 99%

“…the needle into the skin, users must fully depress the dose button and wait for several seconds after the end-of-dose click or until the dose counter has returned to zero before withdrawing the needle from the skin. Issues associated with most pen-injectors include difficulty depressing the extended-dose button, especially among young patients or patients with impaired manual dexterity, strength or nerve function, 9,10 and premature needle withdrawal, leading to underdelivery of dose. 11,12 DV3316 is a prototype multiple-use pen-injector with a shieldtriggered injection mechanism developed by Novo Nordisk A/S.…”

mentioning

confidence: 99%

Injecting without pressing a button: An exploratory study of a shield‐triggered injection mechanism

Zijlstra

Coester

Heise

et al. 2018

Diabetes Obesity Metabolism

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AimsTo evaluate the injection success and user perception of a shield‐triggered pen‐injector mechanism.MethodsThe trial (http://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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“…In summary, the study completed by Pfützner and colleagues 26 is one of the first to investigate preference and usability of pen devices in patients with visual and dexterity limitations. Future studies of diabetes technology should follow suit, as they provide health care professionals with a better understanding of how to best care for patients with these special needs.…”

Section: The First Insulin Pen Was Introduced In the Unitedmentioning

confidence: 99%

“…26 The investigators' primary objective was to determine if patient preference is influenced by dexterity skills, with and without visual limitations. The secondary objectives included the impact of dexterity and cognitive function on ability to use the devices correctly.…”

Section: The First Insulin Pen Was Introduced In the Unitedmentioning

confidence: 99%

Analysis of Comparison of Patient Preference for Two Insulin Injection Pen Devices in Relation to Patient Dexterity Skills

Antinori-Lent

2012

J Diabetes Sci Technol

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Insulin therapy is the cornerstone of medical treatment for many patients with diabetes. Self-administration of this life-saving medication is no longer limited to the traditional vial and syringe. Instead, more and more patients worldwide are using prefilled insulin pen devices. Ease of use, convenience, confidence in dosing accuracy, and improved quality of life are just a few of their advantages. As with any medical technology, safe and proper use is vital. Many studies have examined pen device preference and usability. Until now, no study has included patients with both visual and dexterity impairments. To ensure safe and simple self-administration of insulin for all patients, it is time for the special needs of patients with diabetes to be considered not only during product development, but during postmarketing studies as well.

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Comparison of Patient Preference for Two Insulin Injection Pen Devices in Relation to Patient Dexterity Skills

Cited by 33 publications

References 18 publications

Usability of devices for self-injection: results of a formative study on a new disposable pen injector

Usability of devices for self-injection: results of a formative study on a new disposable pen injector

Injecting without pressing a button: An exploratory study of a shield‐triggered injection mechanism

Analysis of Comparison of Patient Preference for Two Insulin Injection Pen Devices in Relation to Patient Dexterity Skills

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