Aim: We sought to design an insulin delivery method that would overcome barriers to insulin therapy and meet the needs of the users, adults with diabetes, and their health care providers (HCPs).
Methods: We conducted focus groups and human factors studies with users to learn about their needs and requirements. We then designed an insulin delivery device, PAQ, with features that met the user's requirements. Iterative design and human factors testing (HFT) was performed with adults with diabetes on ⩾2 injections/day and HCPs. In parallel, studies were conducted to identify an adhesive that stayed adhered for 3 days and caused minimal, if any, dermal irritation. Pilot clinical studies were then initiated.
Results: Users want a way to administer insulin that is simple, discreet, safe, and effective. A summative HFT found the device was easy to learn and use. All participants (30/30, 100%) successfully completed the key performance measures tested. An adhesive validation study in 30 adults with diabetes found 90% of the devices remained adhered to the participant's application site at the end of 3 days with minimal skin irritation. Data from 3 clinical studies revealed 74-75% transitioned from injectable insulin to the device with the first fixed basal rate selected, improved glycemic control, and participants' satisfaction with the device.
Conclusion: The collective data from the HFT, adhesive, and clinical studies demonstrated that the device provides a method of insulin delivery that overcomes barriers to injectable insulin, meets the needs of the user, and achieves glycemic control.
Keywords: adherence; continuous subcutaneous insulin infusion; insulin delivery; insulin pumps; type 2 diabetes.