Patient tutorials that supported Dexcom’s commercial success
Medical Minds developed the patient self-training tutorials that facilitated classification of Dexcom continuous glucose monitoring (CGM) systems as Class II rather than Class III medical devices, including self-training in the product labeling as a key differentiator. This significantly improved the ease and cost-effectiveness of training, contributing to the company’s commercial success. The tutorials were the first-ever online interactive guides designed to help individuals with diabetes set up and use their CGM systems.
When we first met our Dexcom clients, the company had just introduced Dexcom Seven, the first CGM system approved for up to 7 days of continuous use. At the time, this innovative device represented the “wave of the future in diabetes.” Dexcom employed highly skilled certified diabetes educators (CDEs), who met with patients one-on-one throughout the US instructing them on sensor insertion and how to track glucose levels using a handheld receiver.
Critical steps implemented by our Medical Minds team that have supported Dexcom’s commercial success in global markets include working with CDEs in the field to understand training needs; designing tutorials based on current principles of learning development related to digital devices; as well as understanding the requirements for Human Factors testing and FDA submission; and working with a language translation company to produce materials in multiple languages. We also developed presentations of the pivotal Diamond study data that supported the first approval of CGM for use in treatment decisions without fingersticks.
CGM is now the standard of care and Dexcom is the market leader.