Joslin Diabetes Center

I worked in the Laffel Lab at Joslin Diabetes Center as a Clinical Research Assistant. I worked closely with a team of medical professionals and investigators, study participants with Type 2 Diabetes, and medical device manufacturers (like Insulet and Dexcom) in conducting several clinical trials. This ranged from coordinating recruitment, study visits, following protocols, device inventory management, and sponsor visits for pivotal trials seeking FDA approval for automated insulin delivery (AID) systems (like the Omnipod 5 and Dexcom G7) to acting as a psychosocial interventionist for an internal study evaluating the impact of pump therapy on adolescent mental health and wellness.

The main medical device trials I worked on included the Omnipod 5 pivotal trial and the Dexcom G7 continuous glucose monitor. I coordinated high-risk human-subjects research, directed recruitment and enrollment pipelines, and worked with industry sponsors and principal investigators to collect mixed-methods data while holding data integrity, regulatory compliance, and device performance validation.

Without a doubt, clinical trials in academia are pressure-cooker workplaces. During the training session for one major trial, I brought up to our team a discussion about the need to regularly schedule providers to conduct EKGs on prospective participants (which was needed to meet an eligibility requirement related to general heart health). After some deliberation on how everyone's hands were tied for time (the NPs and physicians would also work in clinic half the time, in addition to research), I suggested a solution: to perform EKGs on participants myself. I had done hundreds of EKGs during my experience working in the CVICU and Cardiac Surgical units at BIDMC. The PI, Lori, approved the decision and this lifted a huge burden from our team and the sponsor in meeting the deadlines for study phases in a complete and precise way to clear the FDA evals under a swift timeline.

I also served as an interventionist on HAPPY-T1D, an NIH-funded study of psychosocial outcomes in adolescents using pump therapy, and contributed to peer-reviewed publications on device performance in pediatric Type 2 populations, and in one case (the Dexcom G7), for pregnant populations.

This is the work that redirected me. I came in on a medical path and spent two years watching people live with a device that was making decisions on their behalf, sometimes trusting it further than it had earned and sometimes not far enough. That gap is what I went to graduate school to study.