Case Study: First Site Globally to Enroll a Patient in Type 1 Diabetes Clinical Trial

How Profound’s embedded endocrinology model, proactive patient identification, and patient-centric scheduling helped accelerate enrollment

Clinical trials can place significant demands on participants, particularly when protocols require frequent dosing visits, intensive assessments, and extended time at the research site. For people managing Type 1 diabetes alongside work and daily life, that additional commitment can become a meaningful barrier to participation.

For one endocrinology study operating under an aggressive startup and recruitment timeline, these challenges were compounded by narrow inclusion criteria that further limited the pool of eligible participants.

By embedding research directly within the Principal Investigator’s practice, Profound Research combined proactive EMR-driven patient identification with close physician collaboration and patient-centric scheduling to help address both sides of the enrollment challenge: finding appropriate patients and making study participation more manageable.

The result: First Patient Screened Globally and First Patient Enrolled Globally.

The Challenge: Complex Study Requirements Meet Real-World Patient Demands

Identifying appropriate participants for the study required navigating narrow inclusion criteria and intensive endocrinology assessments. Once identified, participants also faced frequent dosing visits and prolonged visit durations requiring a significant investment of time.

These requirements created an enrollment challenge that extended beyond patient eligibility. Potential participants needed to determine whether the demands of the study could realistically fit alongside their work and daily lives.

Within an aggressive startup and recruitment timeline, the research team needed an approach that could efficiently identify qualified candidates while reducing unnecessary barriers to participation.

The Solution: Embedded Research with a Patient-Centric Approach

With the research site embedded directly within the Principal Investigator’s practice, the Profound team was able to leverage direct EMR access to proactively identify and pre-screen potentially eligible patients.

Close collaboration with the Principal Investigator helped maintain alignment around protocol-specific eligibility requirements and patient identification strategies. The team could focus its recruitment efforts on patients whose clinical histories indicated they may be appropriate candidates for the study.

That collaboration extended to the participant experience. Patient-centric scheduling helped the team coordinate the study’s demanding visit requirements while working to minimize the burden on participants and accommodate the realities of their daily lives.

Together, proactive patient identification, physician engagement, and thoughtful scheduling helped the site move efficiently from startup to screening and enrollment.

The Outcome: First Patient Enrolled Globally

Profound’s integrated model and patient-first operational approach translated into strong early study performance.

Key Study Achievements:

• First Site to Screen a Patient Globally
• First Site to Enroll a Patient Globally

The combination of proactive EMR-driven recruitment, close collaboration with the Principal Investigator, and patient-centric study coordination positioned the site as a top performer across the study.

What This Means for Sponsors

Enrollment performance depends on more than identifying patients who meet protocol criteria. Particularly in studies with demanding visit schedules, successful recruitment also requires understanding the practical realities that can influence a patient’s ability and willingness to participate.

Embedding research within the Principal Investigator’s practice helps bring these considerations together. Direct EMR access supports targeted patient identification, close physician collaboration strengthens pre-screening and recruitment, and patient-centric scheduling can help reduce the practical burden associated with participation.

For sponsors, this integrated approach can support both efficient enrollment and a study experience designed around the needs of the patients whose participation makes clinical research possible.

Looking Ahead

Global-first enrollment milestones are built on preparation, collaboration, and an understanding of both protocol requirements and patient needs.

In this Type 1 diabetes study, Profound’s embedded endocrinology model helped the research team identify appropriate candidates, collaborate closely with the Principal Investigator, and approach scheduling with the participant experience in mind.

The result—First Patient Screened Globally and First Patient Enrolled Globally—demonstrates how integrating research into established clinical practices can help accelerate study progress while keeping patients at the center of clinical research.