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

Area of Science:

• Medical Devices
• Diabetes Management
• Injection Technology

Background:

• Pen-injectors are crucial for subcutaneous drug delivery in diabetes management.
• User experience and injection success are key factors in device adoption.
• Evaluating novel injection mechanisms is essential for improving patient self-care.

Purpose of the Study:

• To assess the injection success rate of a novel shield-triggered pen-injector (DV3316).
• To evaluate user perception, including confidence, pain, and device experience, of the DV3316 compared to FlexPen.
• To determine overall participant preference between the two pen-injector devices.

Main Methods:

• An exploratory, randomized controlled trial involving 150 injection-experienced individuals with diabetes.
• Participants self-administered placebo injections using the DV3316 and FlexPen devices.
• Injection success, participant confidence, pain, and device experience were systematically evaluated.

Main Results:

• High injection success rates were observed for both DV3316 (97.0%) and FlexPen (99.7%).
• Participant confidence and median injection pain scores were comparable between the two devices.
• A significant majority (55%) preferred the DV3316 over the FlexPen (21%).

Conclusions:

• The shield-triggered DV3316 pen-injector achieves high injection success in experienced individuals.
• Patient confidence and injection pain associated with DV3316 are similar to the established FlexPen.
• The DV3316 shows potential for improved user preference in diabetes self-injection.