Joslin Diabetes Center

I was a Clinical Research Assistant in the Laffel Lab at Joslin Diabetes Center, running clinical trials for FDA-regulated diabetes devices. I worked day to day with physicians, nurse practitioners, principal investigators, study participants with Type 2 Diabetes, and device sponsors like Insulet and Dexcom. My job covered the day-to-day operations of pivotal trials for automated insulin delivery systems: recruitment, study visits, protocol adherence, device inventory, and sponsor visits.

The main trials were the Omnipod 5 pivotal trial and the Dexcom G7 continuous glucose monitor. This was high-risk human-subjects research. I directed recruitment and enrollment pipelines and collected mixed-methods data with sponsors and PIs, holding the line on data integrity, regulatory compliance, and device performance validation.

One bottleneck from that time stays with me. Eligibility for a major trial required an EKG on every prospective participant, and during training it became clear nobody had time to run them; the NPs and physicians split their weeks between clinic and research. I had done hundreds of EKGs in the CVICU and cardiac surgical units at BIDMC, so I offered to run them myself. Lori, the PI, approved it. That one change lifted a real burden from the team and the sponsor and kept the study phases complete, precise, and on schedule for a swift FDA 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, for the Dexcom G7, in 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. If you’re working on a device people have to trust with their health, I’d like to hear what you’re building.